PP&R Guide - France

Pharmaceutical Pricing &
Reimbursement Concise Guide
FRANCE
Published December 2017

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France, Pharmaceutical Pricing & Reimbursement Concise Guide

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PREFACE
IQVIA’s Concise Guide to Pharmaceutical Pricing & Reimbursement is a series of syndicated reports
detailing the pricing and reimbursement systems in 31 countries worldwide:
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Finland, France,
Germany, Greece, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Poland,
Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Turkey, UK, and USA.
The Concise Guide series is researched and written by a team of multilingual analysts with combined
experience in the field of pricing & reimbursement of more than 70 years. Information is gathered and
collated from a variety of quantitative and qualitative sources, including primary and secondary data,
local experts in IQVIA’s international offices, and a worldwide network of personal contacts in
industry, government, payer organisations, consultancy and academia – all with unique insights and
understanding of the pricing and reimbursement environment.
Country reports are updated on an annual basis and available individually or in groups. Content is
structured consistently with common themes to help compare information across countries.
For more information contact:
IQVIA Service Centre
tel: +44 (0)203 075 5888
fax: +44 (0)203 075 5292
http://www.iqvia.com/contact

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Table of Contents
FRANCE ................................................................................................................................................. 1
HEALTHCARE SYSTEM .................................................................................................................. 1
Facts & Figures .......................................................................................................................... 1
Market Indicators ........................................................................................................................ 2
Provision & Funding ................................................................................................................... 4
Overview .............................................................................................................................. 4
Statutory Health Insurance System ..................................................................................... 5
Complementary Health Insurance ....................................................................................... 6
Funding ................................................................................................................................ 7
PRICING ........................................................................................................................................... 9
Prescription Drugs ...................................................................................................................... 9
Overview .............................................................................................................................. 9
CEPS ................................................................................................................................... 9
Standard Pricing Procedure ..............................................................................................10
Accelerated Pricing Procedure ..........................................................................................12
Paediatric Medicines .........................................................................................................14
Accompanying Technologies.............................................................................................14
Conditional Pricing .............................................................................................................14
Health Economic Evaluation..............................................................................................14
Pricing Agreements ...........................................................................................................15
Spending Caps ..................................................................................................................16
Generic Drugs ..........................................................................................................................17
Pricing Rules......................................................................................................................17
Pricing Procedure ..............................................................................................................17
Biosimilars .........................................................................................................................17
Hospital Drugs ..........................................................................................................................18
T2A System .......................................................................................................................18
T2A Exclusions and Liste de Rétrocession .......................................................................18
ATU/post-ATU ...................................................................................................................20
Actual Prices ......................................................................................................................20
OTC Drugs ...............................................................................................................................21
Reimbursed OTCs .............................................................................................................21
Non-reimbursed OTCs ......................................................................................................21
REIMBURSEMENT ........................................................................................................................21
Admission to Reimbursement ..................................................................................................21
Patient Participation ...........................................................................................................21
CT ......................................................................................................................................22
Application Process ...........................................................................................................22
Medical Benefit Rating Systems ........................................................................................24
Assessment and Decision .................................................................................................25
Final Decision ....................................................................................................................26
Restricted Reimbursement ................................................................................................26
Reimbursement Categories .....................................................................................................27
100% Reimbursement .......................................................................................................27
Standard Reimbursement ..................................................................................................27

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Reimbursement Prices .............................................................................................................28
Reference Price Reimbursement System .........................................................................28
Hospital Reimbursement ..........................................................................................................28
Hospital Supply Authorisation............................................................................................28
Formularies ........................................................................................................................30
Funding ..............................................................................................................................30
Changes in Reimbursement Status .........................................................................................33
Five-year Reviews .............................................................................................................33
Exceptional Reviews .........................................................................................................34
Post-marketing Studies .....................................................................................................34
Reimbursement Rate Changes .........................................................................................34
Changes to Reimbursed Indications .................................................................................35
Delistings ...........................................................................................................................35
Changes in Reimbursement Prices .........................................................................................35
European Price Guarantee ................................................................................................35
Other Price Guarantees .....................................................................................................36
Five-year Reviews .............................................................................................................37
Other Price Revisions ........................................................................................................37
Conditional Pricing .............................................................................................................38
Off-patent Originals and Generics .....................................................................................38
Price Consistency ..............................................................................................................39
Targeted Price Cuts ...........................................................................................................39
Price Increases ..................................................................................................................39
PHARMACOECONOMICS .............................................................................................................39
Pharmacoeconomic Requirements ..........................................................................................39
HE Evaluations ..................................................................................................................39
PRICE BUILD UP ...........................................................................................................................43
Wholesalers .............................................................................................................................43
Margins ..............................................................................................................................43
Discounts ...........................................................................................................................43
Social Security Contribution ..............................................................................................43
Background........................................................................................................................44
Drug Shortages .................................................................................................................44
Retail Pharmacies ....................................................................................................................45
Margins: Reimbursed Drugs ..............................................................................................45
Margins: Non-reimbursed Drugs .......................................................................................47
Discounts ...........................................................................................................................47
Background........................................................................................................................47
Dispensing Doctors ..................................................................................................................49
Sales Tax .................................................................................................................................49
COST CONTAINMENT ..................................................................................................................49
Industry Paybacks ....................................................................................................................49
Tax on Reimbursed Turnover ............................................................................................49
Clause de Sauvegarde ......................................................................................................49
Conventions System ..........................................................................................................51
Hepatitis C Medicines ........................................................................................................52
Temporary Use Drugs .......................................................................................................53

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Credits ...............................................................................................................................54
Promotional Costs ....................................................................................................................54
Promotion-based Tax ........................................................................................................54
Advertising .........................................................................................................................55
Promotional Information Charter .......................................................................................55
Sunshine Act......................................................................................................................56
Patient Co-payments................................................................................................................56
Pharmaceuticals ................................................................................................................56
Out-patient Care ................................................................................................................58
In-patient Care ...................................................................................................................59
Prescribing Controls .................................................................................................................60
Prescribing Targets ...........................................................................................................60
Guidelines ..........................................................................................................................62
Exception Drugs ................................................................................................................62
Feedback ...........................................................................................................................62
Campaigns.........................................................................................................................62
Prescribing Restrictions .....................................................................................................63
Generics ...................................................................................................................................63
Generic Substitution ..........................................................................................................63
INN Prescribing .................................................................................................................65
Prescribing Targets ...........................................................................................................65
Generic and Off-patent Price Cuts ....................................................................................65
Biosimilars .........................................................................................................................66
National Action Plan ..........................................................................................................66
Rx-to-OTC Switches ................................................................................................................67
Switches ............................................................................................................................67
Easier Patient Access to OTCs .........................................................................................67
OTC Sales .........................................................................................................................67
Parallel Trade ...........................................................................................................................68
Parallel Exports .................................................................................................................68
Parallel Imports ..................................................................................................................68
FUTURE DEVELOPMENTS ..........................................................................................................68
Outlook .....................................................................................................................................68
Social Security Finance Law .............................................................................................68
Supreme Audit Court: Pricing Reforms .............................................................................70
Accord Cadre .....................................................................................................................72
Generic Pricing ..................................................................................................................72
Pharmacy Remuneration ...................................................................................................72
National Health Strategy ....................................................................................................73
Future of Health Insurance ................................................................................................73
Proposed New Evaluation Systems ..................................................................................74

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FRANCE
HEALTHCARE SYSTEM
Facts & Figures
France: Key Facts & Figures
Demographics Economics
Population…… 67.1 million GDP…… US$2,599 billion
Median age41 years GDP per capitaUS$44,245
Life expectancy at birth82 years GDP growth rate1.8%
Source: US Census Bureau International Inflation rate1.1%

Database (figures for 2017)
Source: The Economist Intelligence Unit
(estimates for 2017)
Healthcare Pharmaceuticals
Total healthcare exp US$295.1 billion Market size (MSP)US$33,393 million
Total healthcare exp per capUS$4,464 Growth (US$)… 1.1%
Total healthcare exp as % GDP 11.1% Growth (US$, fixed rate)1.7%
Source: OECD Health Data 2017 (figures for Source: MIDAS

2014) (figures for 12 months to Q3 2017)

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Market Indicators
France: Fastest Growing Therapy Classes (ATC 3)
Country Sales, Growth, Growth,
Therapeutic 12 months to 12 months to 12 months to
Therapeutic Class
Code Q3 2017, Q3 2017/2016 Q3 2017/2016,
$(millions) $(%) Fixed Rate $(%)
TOTAL FRANCE 33393 1 2
MAB
L1G 1779 7 7
ANTINEOPLASTICS
PROTEIN KINASE
L1H 1247 16 17
INH A-NEO
ANTI-TNF
L4B 1238 -1 -1
PRODUCTS
J5C HIV ANTIVIRALS 1080 -3 -3
ANTIVIRALS EXCL
J5B 926 3 4
ANTI-HIV
NON-NARCOTIC
N2B 924 -4 -3
ANALGESICS
OTHER
L4X IMMUNOSUPP- 830 13 14
RESSANTS
OCULAR
S1P 614 9 9
ANTINEOVASC.
MULTIPLE
N7A 610 2 2
SCLEROSIS
BLOOD
B2D 599 1 1
COAGULATION
Total Others 23545 0 0
Source: MIDAS

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France: Leading Products
Growth, 12
Country Sales, Growth, 12
months to Q3
12 months to months to Q3
Product Name Active Ingredient(s) 2017/2016,
Q3 2017, 2017/2016
Fixed Rate
$(millions) $(%)
$(%)
HUMIRA ADALIMUMAB 481 1 2
OPDIVO NIVOLUMAB 361 68 69
LUCENTIS RANIBIZUMAB 346 10 10

ENOXAPARIN
LOVENOX 328 -1 -1
SODIUM
AVASTIN BEVACIZUMAB 304 -17 -16
DOLIPRANE PARACETAMOL 299 4 4
MABTHERA RITUXIMAB 298 3 3

LEDIPASVIR +
HARVONI 292 -9 -8
SOFOSBUVIR
REMICADE INFLIXIMAB 274 -20 -20
HERCEPTIN TRASTUZUMAB 270 2 2
Source: MIDAS

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France: Leading Corporate Groups
Country Sales, Growth, Growth,
Key Marketing 12 months to 12 months to 12 months to
Company(s) Q3 2017, Q3 2017/2016, Q3 2017/2016,
$(millions) $(%) Fixed Rate $(%)
NOVARTIS 2704 6 7
SANOFI 2429 -4 -3
MYLAN 1892 3 3
ROCHE 1548 -4 -4
MERCK & CO 1547 -2 -1
PFIZER 1377 -5 -4
SERVIER 1373 0 0
JOHNSON & JOHNSON 1250 10 11
BRISTOL-MYERS SQB. 1132 17 18
GILEAD SCIENCES 1083 1 1
Source: MIDAS
Provision & Funding

Overview
The Ministry for Solidarity and Health (Ministère des Solidarités et de la Santé; known as the
Ministère des Affaires Sociales et de la Santé prior to the new Macron government coming to power
in May 2017) determines healthcare policy at the national level and holds overall responsibility for the
(top-level) organisation of the healthcare system. The day-to-day organisation and coordination of
primary, secondary and medico-social (eg care for the elderly and the handicapped) care services
meanwhile falls to the 17 Regional Health Agencies (agences régionales de santé, ARS), semi-
independent authorities under the auspices of the Ministry for Solidarity and Health. The ARS also
hold responsibility for funding primary, secondary and medico-social care services (through finance
received from the State, health insurers, and other regional funds), as well as disease prevention and
health promotion.
The social security system provides (among other benefits) all individuals who work or reside in
France with health insurance cover (universal sickness protection – see below), which includes access
to comprehensive primary and secondary care services and pharmaceuticals. Almost all of the
population also take out supplementary private health insurance.

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Statutory Health Insurance System
- Universal Sickness Protection
Universal sickness protection (protection universelle maladie) was implemented from 1 January 2016
and entitles all people who work or reside in France “in a stable and regular manner” to healthcare
cover through the statutory health insurance system. The corresponding reforms require all persons
aged 18 and over to hold health insurance in their own name (rather than as a dependant, as
previously). Only minors under the age of 18 continue to be classified as “dependants” and are covered
under a parent’s health insurance.
Employees
All people in employment (together with any dependants under the age of 18) are automatically
entitled to health insurance cover. There is no minimum level of employment activity to qualify for
coverage: such criteria were lifted on 1 January 2016 when universal sickness protection was
implemented (see above). Benefits in relation to health insurance cover (as well as other benefits
provided by the social security system, for example, linked to pensions and unemployment) are
accessed via subscription to one of the régimes or schemes. There are currently three main schemes:
• Some 80% of the population subscribe to health insurance cover via the general scheme
(régime general). The scheme is administered by the Caisse nationale de l’assurance maladie
des travailleurs salariés (CNAMTS).
• A further 6% of the population – craftsmen, small retailers/manufacturers and the self-

employed – obtain benefits via the Régime social des indépendants (RSI). The RSI will
however be assumed into the general scheme over a two-year period commencing from 1
January 2018.
• Farmers and farm workers (around 4% of the population) benefit from health insurance cover
through the agricultural scheme (Régime agricole).
There are also a number of much smaller ‘special’ schemes through which specific population groups
(eg miners, electricity/gas industry employees, railway workers and members of parliament) receive
health insurance benefits.
Residents
Those persons who are not eligible for coverage on account of their employment (eg the unemployed),
qualify instead based on their residence in France, on the condition that they have been resident for
more than three (uninterrupted) months.
Certain persons/groups qualify for coverage on the grounds of residency but are exempted from the
three-month rule, namely: students enrolled in academic exchange programmes, persons in receipt of
certain social security benefits (eg relating to housing, family or old-age), refugees and asylum
seekers, persons returning to France after international voluntary work, and family members of a
person with cover via employment/residency who are coming to live in France.
Notably, universal sickness coverage (couverture maladie universelle, CMU) was rendered obsolete
by the 1 January 2016 implementation of universal sickness protection. Previously, the scheme had
provided healthcare benefits to those ineligible for coverage (via employment/as a dependent) under
any of the other schemes (see above), for example divorcees and the unemployed (both of whom now
typically qualify for coverage on the grounds of residency).

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Complementary Health Insurance
Complementary private health insurers play an important role in healthcare provision and funding.
Indeed, 95% of the population have complementary health coverage. Policies can be subscribed either
individually, or on a group basis (ie via employer-held policies [see below], or under a family
member’s policy). Not-for-profit insurers (known as mutuelles), of which there are more than 450 in
total, hold over half of the complementary insurance market. The remainder of the market is covered
by private for-profit insurers and provident institutions.
Private policies usually provide cover for patient co-payments incurred in the statutory system (see
‘Cost Containment: Patient Co-payments’) and may also provide for additional benefits, for example
osteopathy, ophthalmic care, dental care, OTCs, private hospital rooms etc. Premiums vary according
to level of cover, age, and place of residence. The average premium is €90.25 per month for health
cover with a mutelle for a family of two adults and two children (based on an August 2015 study).
The government funds or subsidises complementary health insurance cover for low-income
individuals (see below).
- Employment-based Compulsory Complementary Insurance
Employers are since 1 January 2016 legally obliged to provide all employees (except those who already
hold coverage) with complementary health insurance coverage. Employers may also opt to extend
coverage to employees’ dependents, but are not required to do so.
Employment-based plans are required to provide, at a minimum, coverage for:
• Co-payments incurred in the statutory health insurance system, eg on physician consultations
(see ‘Cost Containment: Patient Co-payments’).
• The daily in-patient charge (see ‘Cost Containment: Patient Co-payments’).
• Dental care fees.
• Ophthalmic care.
Half (50%) of the cost of employees’ (group) coverage premiums are financed by employers; the rest
of the premium cost is automatically deducted from employees’ wages.
Employees with short term contracts of less than three months, and part-time workers (contracted for
up to 15 hours a week) can opt to either receive complementary health insurance cover through their
employer, or receive a financial allowance (“health payment”) calculated based on their salary and the
(theoretical) monthly cost to the employer of a group premium covering the employee.
- State-funded/assisted Complementary Insurance
The government funds/subsidises complementary insurance for low-income groups:
• State-funded complementary insurance cover (couverture maladie universelle
complémentaire, CMU-C): Available to individuals (and their dependants) resident in
France (for a minimum of three months) and whose household income falls below a fixed
level (€8,723 per annum in 2017, for an individual in metropolitan France). CMU-C covers
the cost of patient co-payments incurred in the statutory health insurance system, including
the daily in-patient fee (see ‘Cost Containment: Patient Co-payments’) and removes the
requirement for patients to cover any co-payment up front. Beneficiaries can opt to access
complementary cover via one of the statutory health insurance schemes or a private insurer
(in the case of the latter, provided that they feature on a government list of participating
insurers). In 2016, a total of 4.91 million people benefited from CMU-C.

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• Financial assistance for the purchase of complementary insurance (aide à
l’acquisition d’une complémentaire santé, ACS): Low-income families/individuals
whose monthly income exceeds the CMU-C threshold by no more than 35% can apply for
financial help (ranging from €100-€550 in 2017) towards the cost of purchasing
complementary insurance. Beneficiaries of ACS are exempt from certain patient co-payments,
and are exempted from the payment of up-front physicians’ fees where they have selected
their complementary insurance provider from a pre-approved list established by the
government. Some 1.51 million people received ACS in 2016.
Funding
- Funding Sources
Healthcare is financed by the statutory health insurance system (77.0% in 2016), complementary
insurers (13.3%), households (ie co-payments, 8.3%), and the central government (including the
CMU-C [see above], 1.4%).
- Social Security Deficit
In recent years, concerted efforts have been made to address (and ultimately eliminate) the combined
deficit of the social security system, including that of the health insurance branch which alone stands
at €4,100 million in 2017 (€5,200 million for the combined social security deficit). Accordingly, the
2018 Social Security Finance Law (Loi de financement de la sécurité sociale, LFSS) includes measures
intended to reduce the health insurance deficit to €800 million (€2,200 for the combined social
security deficit) by the end of 2018 (see ‘Future Developments: Outlook’).
- Fund for Financing Pharmaceutical Innovation
A new Fund for Financing Pharmaceutical Innovation (Fonds de financement de l’innovation
pharmaceutique, FFIP) was established within the CNAMTS under the provisions of the 2017 Social
Security Finance Law (LFSS). Designed to allow for peaks and troughs in spending on innovative
high-cost treatments, the fund is financed via:
• An annual allowance from the statutory health insurance system geared to the national target
growth rate for reimbursed healthcare spending (objectif national des dépenses de
l’assurance maladie, ONDAM). The allowance will be increased by 5% annually over the
period 2017-2020. Notably, this is the total contribution towards the cost of innovative high-
cost drugs made by the statutory health insurance system.
And;
• Manufacturer rebates linked to:
° Price-revision clauses (as set out in conventions signed between manufacturers and the
Pricing Committee [CEPS]- see ‘Pricing: Prescription Drugs’)
° Spending on reimbursed drugs exceeding the taux Lh – see ‘Cost Containment: Industry
Paybacks’
° Drugs with temporary use authorisation (Autorisation Temporaire d’Utilisation, ATU)

(see ‘Reimbursement: Hospital Reimbursement’)
° Hepatitis C drugs (see ‘Cost Containment: Industry Paybacks’).

7
The balance of the fund is in turn used to cover the cost of:
• High-cost hospital drugs excluded from the diagnosis-related group (DRG)-type of hospital
funding (see ‘Reimbursement: Hospital Reimbursement’)
• Drugs with an ATU
• Drugs that are “post-ATU” ie in the period after marketing authorisation has been granted,
but before regular reimbursement commences (see ‘Reimbursement: Hospital
Reimbursement’)
• Drugs on the liste de rétrocession (see ‘Reimbursement: Hospital Reimbursement’) when

dispensed to hospital in-patients.
In theory, in years when spending on high-cost drugs grows only slowly the fund can build up a
surplus which can be used to absorb the cost of higher spending in other years, for example when new
high-cost innovative drugs arrive on the market.
The fund was endowed with an initial €876 million under the provisions of the 2017 LFSS. According
to a September 2017 report by the Supreme Audit Court (Cour des comptes) on the finances of the
social security system (see also ‘Supreme Audit Court: Pricing Reforms’ in ‘Future Developments:
Outlook’), the fund received funds totalling €7,012 million in 2017, but paid out €7,231 million leaving
it with a deficit of €219 million.
- Background
All patients are encouraged to elect a treatment practitioner (médecin traitant) charged with
maintaining their medical dossier and coordinating their care, for example, arranging referrals to
other healthcare professionals including specialists, where appropriate. There are no constraints over
a patient’s choice of treatment practitioner, who can be a general practitioner (GP) or any type of
specialist, practising in the out-of-hospital or hospital sector in any geographical location. Patients
(excluding those under 16 years of age) who do not elect a treatment practitioner, or who consult a
physician (GP or specialist) other than their treatment practitioner in the first instance, are
reimbursed at a lower rate. Exceptions apply to (direct) consultations with gynaecologists,
ophthalmologists, stomatologists or (for patients aged 16-25 only) a psychiatrist.
Physicians receive fee-for-service payments, the level of which depend on whether they are a GP or
specialist, and whether they practice in ‘Sector 1’ or ‘Sector 2’:
• ‘Sector 1’ physicians apply nationally-determined fixed fees. The patient co-payment (see ‘Cost
Containment: Patient Co-payments’) is calculated based on this amount.
• ‘Sector 2’ physicians are free to set their own (higher) rates. The patient co-payment (see ‘Cost
Containment: Patient Co-payments’) is calculated based on the Sector 1 level, meaning that
patients pay a higher contribution.
° ‘Sector 2’ physicians who adhere to the “Optam” model commit to guaranteeing that they
will set their fees only ‘moderately’ higher than the national level. The patient co-payment
(see ‘Cost Containment: Patient Co-payments’) is consequently lower than would be the
case for other Sector 2 physicians.
On top of these fees, most GPs and specialists are eligible for performance-related fees, including fees
relating to prescribing and chronic disease management (see ‘Cost Containment: Prescribing
Controls’).

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As at 31 January 2015, there were 3,089 hospitals in France:
• 1,389 were public establishments, including 178 regional hospital centres, 692 acute/local
hospitals, 96 psychiatric hospitals, and 153 establishments specialising in long-term care.
• 1,009 were profit-making private clinics
• 691 were not-for-profit institutions contracted to the public sector, including 21 specialist
cancer centres.
PRICING
Prescription Drugs
Overview
There are no controls over the prices of non-reimbursed drugs.
In the case of reimbursed drugs, prices are regulated by the Pricing Committee (Comité économique
des produits de santé, CEPS), an inter-ministerial committee under the joint authority of the Ministry
for Solidarity and Health (previously known as the Ministry for Social Affairs and Health), and the
Ministry for the Economy and Finance. There are two different pricing procedures, namely:
• The standard pricing procedure (see ‘Standard Pricing Procedure’, below)
• An accelerated pricing procedure for certain innovative drugs (see ‘Accelerated Pricing
Procedure’, below).
Full details of both of these procedures are described below. However, before a drug can apply for a
price, it must have undergone:
• Assessment by the Transparency Commission (Commission de la Transparence, CT) (see
‘Reimbursement: Admission to Reimbursement’). All drugs must go through this assessment.
• A health economic (HE) evaluation, for (certain) innovative drugs (see ‘Health Economic
Evaluation’, below and ‘Pharmacoeconomics: Pharmacoeconomic Requirements’)
CEPS
The Pricing Committee comprises a President, Vice-President, and nine representatives:
• five from the government, drawn from the Social Security Directorate (Direction de la
sécurité sociale), and Directorate General for Health (Direction générale de la santé), among
others.
• three from the main health insurance fund (CNAMTS)
• one from the representative association of private health insurers.
Notably, pricing policy, as applied by CEPS, is defined in three ways:

• By legislation
• Through ministerial instruction, commonly laid out in “Lettres d’orientation” to CEPS
• Via the government-industry Accord Cadre agreement (see below).

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- Accord Cadre
The Accord Cadre is signed between CEPS and the pharmaceutical industry association (Les
entreprises du médicament, Leem) and provides the framework for pharmaceutical policy, including
in relation to pricing and reimbursement.
The first such agreement was signed in 2003 and applied to the retail sector only. Most notably, it
introduced the accelerated pricing procedure for (certain) innovative drugs (see ‘Accelerated Pricing
Procedure’, below). That agreement was subsequently amalgamated into a joint retail-hospital sector
Accord Cadre, which was amended and extended in December 2012 and expired on 31 December
2015. The existing Accord Cadre dates from 31 December 2015. It amends and extends earlier
versions and covers the period 31 December 2015 – 31 December 2018. With respect to the latter, it is
noteworthy that the Supreme Audit Court (Cour des comptes) published in September 2017 its latest
annual report on the finances of the social security system in which it criticised the provisions of the
agreement – see ‘Future Developments: Outlook’.
Standard Pricing Procedure

- Application
Manufacturers are required to submit to CEPS a pricing dossier, consisting of:
• A copy of the drug’s official marketing authorisation (autorisation de mise sur le marché,
AMM).
• Economic evidence: requested manufacturer’s selling price (MSP) and five-year sales volume
forecasts (with full justification for each).
• A copy of the reimbursement dossier submitted to the CT, and requested medical benefit
ratings (see ‘Medical Benefit Rating Systems’ in ‘Reimbursement: Admission to
Reimbursement’).
- Criteria
The MSP of a new reimbursed drug is determined through negotiations between CEPS and the
manufacturer. According to legislation, this process must take into account:
• The drug’s improvement in medical benefit (amélioration du service médical rendu, ASMR)
rating versus therapeutic equivalents (see Table 1 in ‘Reimbursement: Admission to
Reimbursement’).
• The outcome of a health economic evaluation, where relevant (see below).
• Prices of drugs in the same therapeutic class (or clinical comparators).
• Sales volume forecasts.
• Conditions of use (eg length of treatment, number of doses per treatment) and planned use
(eg target population).

10
In addition to the above, consideration may be given to:
• price revision clauses, where applicable (see ‘Pricing Agreements’, below)
• investment in research and development (R &D) and/or production in the European Union
(EU) (see below)
• other factors including: public health needs, budgetary constraints and market conditions (ie
the financial impact of the price on health insurance spending and/or spending growth for the
corresponding drug class). However, since consideration of these elements is not formalised,
the weight they carry in the final pricing decision is unclear.
Investment in R&D
The current (December 2015) Accord Cadre agreement (see above) formalises the possibility for CEPS
to take into account during pricing negotiations a company’s level of investment in R&D and/or
production in the EU for the purpose of setting an initial price. This applies to all drugs (ie those
following both the standard and accelerated pricing procedures). It is understood that where these
factors are considered favourably by CEPS, the manufacturer may be awarded a price guarantee
period of between 18 and 24 months (for any medicine not covered by the European price guarantee
period granted to certain innovative drugs – see ‘Accelerated Pricing Procedure’, below).
- Agreement
Once established, the MSP is valid for a period of five years (see ‘Reimbursement: Changes in
Reimbursement Prices’).
The drug’s price and reimbursement rate (see ‘Reimbursement: Reimbursement Categories’) are
subsequently published in the Journal Officiel.
Pricing negotiations can be lengthy where CEPS and the manufacturer struggle to reach agreement
over a price.
Rarely, negotiations between CEPS and the manufacturer may be terminated without agreement. In
such instances, CEPS has the authority to impose a price (taking into account the factors set out
above). It is understood that this has only been the case on one occasion since 2011 (and related to
price cuts imposed on manufacturers following a price review, rather than at the time of setting initial
prices). Where CEPS imposes a price, the Minister for Solidarity and Health has 15 days in which to
oppose the price and set a price it deems to be appropriate. If the manufacturer is not prepared to
accept the imposed price, it can set its own price – but without reimbursement.
- Timelines
The current (31 December 2015) Accord Cadre (see ‘Accelerated Pricing Procedure’, below) commits
to speed up the reimbursement procedure for all drugs judged to offer therapeutic progress (ie with an
ASMR rating of I to IV – see ‘Reimbursement: Admission to Reimbursement’). The aim is to meet the
180-day limit for the combined pricing and reimbursement process stipulated by the EU
Transparency Directive.
The accord also reiterates CEPS’ commitment to proposing a pricing agreement (ie establishing a
proposed price) within 75 days of the CT issuing the final results of its assessment, for any drug
granted an ASMR rating of I to IV (see ‘Reimbursement: Admission to Reimbursement’).

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- Price Guarantee
European Price Guarantee
A five-year European-level price guarantee applies to all drugs granted an ASMR rating of I to III (and
IV under certain conditions) (see ‘Reimbursement: Changes in Reimbursement Prices’).
R&D Related Price Guarantee
An 18-24 month price guarantee period may meanwhile be granted by CEPS to products not eligible
for the European price guarantee (see above) where the manufacturer has invested in R&D and/or
production in the EU (see above).
Accelerated Pricing Procedure

(Certain) innovative drugs are eligible to use an accelerated pricing procedure, or price notification
(dépôt de prix) system, which has been in place since 2003 under the terms of the successive Accord
Cadre agreements (see above).
- Eligibility
The accelerated pricing procedure is restricted to use by drugs:
• granted an ASMR rating of I to III for their principal indication (see Table 1 in
‘Reimbursement: Admission to Reimbursement’); Or
• with an ASMR rating of IV, on the condition that:
° The daily cost of treatment does not exceed that of the current therapeutic equivalent.
Alternatively, the manufacturer must demonstrate that the drug will generate cost savings
for the health insurance system, despite its higher treatment cost.
° The drug is not intended to replace a genericised product, or one that will soon face
generic competition.
- Procedure
To use the accelerated pricing procedure, the company must submit a corresponding application to
CEPS. The application can be submitted once the company has received notification of the results of
the CT’s assessment (and that of the Commission for Economic Evaluation and Public Health,
Commission evaluation économique et de santé publique [CEESP], where relevant – see
‘Reimbursement: Admission to Reimbursement’ and ‘Pharmacoeconomics: Pharmacoeconomic
Requirements’), and for up to one month after. The manufacturer can request an audition with CEPS
prior to submitting the application.
As part of the application, manufacturers are required to make a number of commitments:
• Ensuring that the proposed MSP is “consistent with” the price of the same drug in Germany,
Italy, Spain and the UK. In practice, this means that the MSP should neither exceed the
highest price in these markets nor undercut the lowest.
• Refunding any additional costs incurred by the health insurance system if sales of the drug
exceed the forecast supplied with the original application.
• Communicating to CEPS, on an annual basis, details of sales volumes and reimbursement

status of the same drug in Germany, Italy, Spain and the UK. The manufacturer must also
commit to price modification at a later date if prices change in one or more of the four
reference countries, or if a revised reimbursement/health economic evaluation for the drug
becomes available.

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• Informing both CEPS and the CT of any new scientific evidence that could negatively impact
the drug’s risk-benefit profile.
• Conducting post-marketing studies, if stipulated by CEPS/the CT or CEESP.
• An agreement that any conditions attached to the drug’s use may be amended, if justified by
either sales volumes in France, or combined sales volumes in France and the reference
markets.
In addition to the above compulsory commitments, manufacturers can opt to propose price revision
clauses (see ‘Pricing Agreements’, below).
- Decision
The application is by default accepted, unless:
• CEPS issues a written rejection within two weeks of submission; or
• CEPS requests a second audition within eight days of submission in the case of companies
which had a preliminary audition prior to submitting the application. Where a second
audition is held, the manufacturer is able to amend the application afterwards. In such
instances, a maximum of three weeks is permitted (from submission of the revised
application) for the CEPS to reject it, or by default accept it (within two weeks, see bullet
above).
At the end of the two-week period and for successful applications, a pricing agreement (see ‘Pricing
Agreements’, below) is signed (within 48 hours of the end of the two-week period) between CEPS and
the manufacturer and then published in the Journal Officiel.
According to the terms of the Accord Cadre, CEPS can reject an application on any of the following
grounds:
• public health considerations
• a proposed price which is “excessive” in relation to prices in the reference markets, or in

relation to the outcome of the health economic evaluation conducted by CEESP (see
‘Pharmacoeconomics: Pharmacoeconomic Requirements’)
• perceived incompatibility between the manufacturer’s projected sales volumes and the target
population identified by the CT
• insufficient commitments from the manufacturer (see above)
• if the manufacturer has failed to honour a commitment made as part of a previous application
under the accelerated pricing procedure
• for drugs with an ASMR of IV, a failure to meet the conditions for eligibility for the fast-track
procedure, or where CEPS determines that the drug would incur more cost for the health
insurance system than the comparator treatment.
Manufacturers cannot appeal a negative decision; nor can they enter into negotiations with CEPS. In
the event that the application is refused, the company can instead submit a pricing application in
accordance with the standard procedure (see above).
- Uptake
There is no requirement for eligible drugs to use the dépôt de prix system; manufacturers can opt to
follow the regular pricing procedure (see ‘Standard Pricing Procedure’, above) instead. Indeed, no
products used the accelerated procedure in 2015, and just one in 2014 (two in both 2013 and 2012).

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- European Price Guarantee
A five-year European price level guarantee applies to all products with an ASMR rating of I-III (and IV
under certain conditions), irrespective of the pricing procedure they followed ie the standard or
accelerated procedure. For details, refer to ‘Reimbursement: Changes in Reimbursement Prices’.
Paediatric Medicines
For paediatric drugs in areas of clinical need (as established by the European Medicines Agency
[EMA]), the MSP is set at a level that ensures that the daily cost of treatment is equal to the daily cost
of treatment in adult patients.
Accompanying Technologies
The current (December 2015) Accord Cadre stipulates that CEPS can take into account for the
purpose of setting the price of a medicine, estimated cost savings for the health insurance system of
accompanying technologies (eg devices). In such cases, the manufacturer is required to provide
evidence of the estimated cost saving (eg via appropriate studies).
Conditional Pricing
In instances where CEPS and the manufacturer cannot reach agreement on a price, either CEPS or the
manufacturer can propose to establish a conditional price pending further post-marketing studies.
Notably, the current (December 2015) Accord Cadre states that so-called “performance contracts” can
be established for any drug (ie there are no eligibility criteria in terms of ASMR), and can enable CEPS
to set the price of the drug at a higher level than its ASMR would otherwise permit, on the condition
that its therapeutic effect/efficacy is demonstrated to be higher via real-life studies. Full details of the
type of post-marketing (real-life) studies required are defined as part of the corresponding pricing
agreement between CEPS and the manufacturer (see ‘Pricing Agreements’, below).
Depending on the outcome of post-marketing studies, the price of the drug may subsequently be
reduced (or remain unchanged), or the company may be required to pay back a proportion of sales
turnover (see ‘Reimbursement: Changes in Reimbursement Prices’).
According to a report published in September 2017 by the Supreme Audit Court (Cour des comptes), a
total of 13 “performance contracts” were established over the period 2008-2015. In all but one case,
the higher prices set for the drugs in question under the contracts were found not to be justified.
Orientations ministérielles issued by the government to CEPS in 2016 state that the Committee
should limit the use of “performance contracts” to drugs in areas of unmet clinical need.
Health Economic Evaluation

Health economic (HE) evaluations are since October 2013 taken into consideration by CEPS for the
purpose of price setting (and reviews – see below). CEESP is charged with conducting the HE
assessments, which are compulsory for drugs meeting both of the following criteria:
• The manufacturer of the drug is seeking an ASMR rating of I, II or III (see Table 1 in
‘Reimbursement: Admission to Reimbursement’); and
• The product is expected to have a “significant financial impact for health insurers” ie drugs
(based on all reimbursed indications) with forecast turnover of €20 million (including tax –
see ‘Price Build Up: Sales Tax’) or above during the second full year of commercialisation
(although manufacturers of drugs with forecast turnover below this level may still be obliged
to provide health economic data in cases where the impact of the drug on the healthcare
system is expected to be significant).

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Where both of these criteria are fulfilled by a given drug, the manufacturer is required to submit a HE
dossier to the High Authority for Health (Haute Autorité de Santé, HAS) for eventual assessment by
CEESP. The process runs in parallel with the drug’s evaluation by the CT for reimbursement purposes
(see ‘Reimbursement: Admission to Reimbursement’). CEESP’s final opinion, once available, is
communicated to CEPS and the manufacturer before being made publicly available. For details, see
‘Pharmacoeconomics: Pharmacoeconomic Requirements’.
Products fulfilling the above criteria are also required to undergo a HE evaluation at the time of
price/reimbursement reassessment (see ‘Reimbursement: Changes in Reimbursement Prices’); actual
turnover, including tax, is taken into account, rather than forecast turnover during the second year of
commercialisation.
According to HAS, a total of 18 HE assessments were carried out in 2016.
Pricing Agreements
The MSP of a given drug, once established (via either the standard or accelerated procedure), is set out
in a confidential pricing agreement (known as a “convention”) signed between the manufacturer and
CEPS. Only one such agreement is made between CEPS and each manufacturer; addenda to the
original agreement are made for each new drug subsequently admitted to reimbursement.
The agreement includes details of:
• the agreed MSP of the drug
• details of any post-marketing studies that may be required (see ‘Conditional Pricing’, above)
• any applicable price revision clauses (see below) or price-volume clauses (in the case of
orphan drugs – see below)
• potential paybacks (see ‘Cost Containment: Industry Paybacks’).
- Price Revision Clauses

Price revision clauses can be included in any pricing agreement between a manufacturer and CEPS,
but are most common in relation to innovative drugs with an ASMR rating of I to III which have been
granted a price “consistent” with European levels (see above) and for which the cost impact is difficult
to estimate.
Price volume clauses are the most common arrangement. In such cases, a volume limit it set for a new
drug (often for a five-year period), typically in instances where a drug has a high ASMR rating for
some but not all of its indications, or for only a limited population sub-group, or for public health
reasons (eg to restrict usage of antibiotics). In the event that the volume limit is exceeded, CEPS may
apply a price reduction or request rebates from the manufacturer. A degree of flexibility is usually
agreed so that minor breaches, which may self-correct, do not trigger penalties. In 2015, rebates
totaling €573 million were paid in relation to volume clauses (covering the year 2014).
Other types of clauses that may be negotiated include outcomes-based clauses (see ‘Conditional
Pricing’, above), and cost of treatment clauses. With respect to the latter, these tend to be negotiated
where it is difficult to apply a flat price at the time of the CEPS assessment (for example, where there
is considerable variation in European prices of the drug). In such cases, different prices may be
established for each dosage of the active ingredient based on hypothetical prescription proportions. A
price revision clause may then be linked to the cost of daily treatment (coût de traitement journalier,
CTJ) as a way to ensure that high-dose, high-priced drugs are not used excessively. If the actual cost of
daily treatment turns out to be higher than that set out in the agreement between the manufacturer
and CEPS, the price for each dosage may be cut to reduce the cost of daily treatment.

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Notably, price revision clauses may be renegotiated if, for example, a drug’s reimbursed indications
are extended.
- Orphan Drugs
Price-volume or outcomes-based agreements may be signed between manufacturers and CEPS. Such
agreements are intended to ensure access to orphan drugs at a cost which is sustainable for the health
insurance system.
Price-volume Agreements
CEPS can request that manufacturers of orphan medicines with an estimated cost per patient of more
than €50,000 conclude a price-volume agreement. In such cases:
• The price of the orphan drug can be set at the European level (ie “consistent with” prices in
Germany, Italy, Spain and the UK), subject to a limit set by CEPS on total reimbursed
turnover, based on the estimated number of patients.
• If sales exceed the pre-defined limit, the manufacturer is required to fund provision of the
drug to all eligible patients, without restrictions.
There is no obligation for manufacturers of drugs meeting this criterion to sign a price-volume
agreement, however.
Performance-based Agreements
Alternatively, manufacturers of orphan drugs indicated for the treatment of a number of patient
groups can sign a performance-based agreement with CEPS, either on their own initiative or that of
CEPS. Such agreements may be favoured where the drug’s therapeutic benefit varies according to sub-
populations, and where post-marketing studies are of limited value owing to the small numbers of
patients treated. All performance-based agreements include details of the indicators which will allow
for an evaluation of the drug’s performance, as well as the conditions for any eventual repayments
from manufacturers.
- Rebates
According to CEPS, rebates paid by manufacturers linked to price revision clauses (including those
linked to orphan drugs) totalled €1,015 million in 2015. Price-volume clauses (see above) accounted
for 56% of rebates, while 10% were outcomes-based (ie linked to the outcome of post-marketing
studies/collation of real-world data – see ‘Conditional Pricing’, above). A further 10% were linked to
orphan drug price-volume agreements.
Spending Caps
- Hepatitis C Drugs
Total annual spending on new direct-acting antiviral (DAA) hepatitis C drugs, including Sovaldi
(sofosbuvir), is capped due to their high cost. Rebates are due from manufacturers if the cap is
exceeded (see ‘Cost Containment: Industry Paybacks’).
It is understood that price cuts were applied to all hepatitis C drugs in April 2017 to reflect the
extension of reimbursed indications for such treatments (see ‘Reimbursement: Changes in
Reimbursement Status’).
- Drugs with ATU
A cap of €10,000 per patient per year is imposed on drugs with temporary use authorisation (ATU –
see ‘Reimbursement: Hospital Reimbursement’). Manufacturers are liable to pay a rebate where costs
exceed this level, and the drug records annual turnover of €30 million or over (see ‘Temporary Use
Drugs’ in ‘Cost Containment: Industry Paybacks’).

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Generic Drugs
Pricing Rules
Generics are required to offer a minimum 60% discount versus the pre-patent expiry price (at
manufacturer’s selling price, MSP) of the branded original. It is possible that this discount will be
revised upwards in the future, in line with an August 2016 recommendation from the Ministries of
Finance, Economy and Health (see ‘Generic Pricing’ in ‘Future Developments: Outlook’).
A reduced discount versus the original brand (ie a higher price) may be permitted in some instances,
for example:
• If the price of the off-patent original is very low
• where production costs for the generic are considered to be high
• if the market for the active ingredient is small.
Any manufacturer seeking a reduced discount versus the MSP of the original must submit full
supporting evidence to the Pricing Committee (CEPS).
Notably, the price of the off-patent original is reduced by 20% on commercialisation of the first
generic version (see ‘Reimbursement: Changes in Reimbursement Prices’). A further price cut for
both the generic (-7%) and the off-patent original (-12.5%) is enforced 18 months after patent expiry,
unless the active ingredient has been incorporated into the reference pricing system (see
‘Reimbursement: Changes in Reimbursement Prices’).
The public price of a generic is never permitted to exceed 90% of the public price of the off-patent
original (post-patent expiry).
Generics manufacturers are required to declare to CEPS all discounts granted to pharmacists on
generics (see ‘Price Build Up: Wholesalers’ and ‘Price Build Up: Retail Pharmacies’).
Pricing Procedure
Generics are not usually subject to pricing negotiations with CEPS. Negotiations may nevertheless
take place where the manufacturer is seeking a reduced discount versus the MSP of the off-patent
original (see above).
Similarly, full assessment by the Transparency Committee (CT) is not usually required for generics
(unlike for other prescription medicines – see ‘Reimbursement: Admission to Reimbursement’). That
said, exceptions apply. Full assessment is for example undertaken where the presentation differs in
some way from the original drug (different indications or pack sizes), or where the original product is
not already reimbursed.
Biosimilars
Biosimilars are required to offer a discount versus the MSP of the original biotechnology drug, the
level of which is understood to range from 11-20% according to the peculiarities of the market.
The price of the original biotechnology drug is reduced on commercialisation of the first biosimilar
version. According to CEPS, the reduction should not be less than 15%, and should eventually reach
20%.

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Hospital Drugs
The pricing regulations for drugs used in hospitals are set out below.
T2A System
There are no controls over the prices of all drugs included in the diagnosis-related group (DRG)-type
hospital funding system (Tarification à l‘activité, T2A) (see ‘Reimbursement: Hospital
Reimbursement’); manufacturers are free to set their own prices.
T2A Exclusions and Liste de Rétrocession

Under the terms of the successive Accord Cadres (see ‘Pricing: Prescription Drugs’), the Pricing
Committee (CEPS) regulates the prices of certain drugs used in hospitals, namely:
• High-cost drugs featured on the liste en sus (ie the list of high-cost drugs excluded from the
T2A tariffs - see ‘Reimbursement: Hospital Reimbursement’).
• Drugs included on the liste de rétrocession (hospital drugs suitable for dispensing to out-
patients and charged to the ambulatory sector, rather than the hospital – see
‘Reimbursement: Hospital Reimbursement’). Notably, hospital-only (réserve hospitalier, RH)
drugs do not feature on the list.
- T2A Exclusions
The pricing procedure for T2A-exclusions runs in parallel to the evaluation of the drug for inclusion
on the list so that both a positive decision with regards inclusion on the list and the drug’s price can be
published in the Journal Officiel simultaneously.
Manufacturers are required to submit a corresponding application to CEPS including the following
information:
• A copy of the drug’s marketing authorisation
• Pricing information
• The results of the drug’s assessments by the Transparency Commission (CT – see
‘Reimbursement: Admission to Reimbursement’) and, where applicable, the Commission for
Economic Evaluation and Public Health (CEESP – see ‘Pricing: Prescription Drugs’).
Prices are established by means of negotiations between the manufacturer and CEPS, although the
latter reserves the right to set the price where negotiations fail.
Prices can subsequently be revised – for example, if prices change in the major EU markets, or new
data become available which would affect the outcome of the drug’s assessment by the CT or CEESP
(see ‘Reimbursement: Changes in Reimbursement Prices’).

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- Liste de Rétrocession
Manufacturers must notify CEPS of the drug’s proposed price in the eight days following formal
inclusion on the liste de rétrocession (10 days following the formal granting of marketing
authorisation [AMM] for drugs included on the list prior to having received AMM). Together with the
proposed price (at MSP, for each pack size), the manufacturer must also provide CEPS with the
following:
• Prices and reimbursement status in the major European Union (EU) countries. Annual sales
volumes are also required if the product has been commercialised in any of the major EU
countries for more than 12 months.
• Details of the drug’s price history in France for the preceding three years, where applicable.
• The results of the drug’s assessments by the CT (see ‘Reimbursement: Admission to

Reimbursement’) and, where applicable, CEESP (see ‘Pricing: Prescription Drugs’).
• Three-year sales volume forecasts.
• A commitment to inform CEPS annually of the price and sales volume for the drug in the
major EU markets, as well as any changes in the product’s reimbursement status in these
countries.
Manufacturers may also include a commitment to conduct real-life studies, where these may be
beneficial to the application.
- Decision
In the absence of a formal rejection within two weeks of submission, the price notification is deemed
accepted and is published in the Journal Officiel.
If the application is rejected by CEPS (within two weeks), the manufacturer has another two weeks in
which to submit a revised proposed MSP, or to submit any missing elements (where these were the
grounds for rejection). CEPS then has 10 days in which to either reject the price definitively, or to
accept it (by doing nothing). In the event that the manufacturer does not submit a revised price within
two weeks (or does not submit the missing elements), the initial price rejection issued by CEPS
becomes definitive. Where the price is rejected definitively, CEPS can set a price it deems appropriate.
Prices determined under this system can subsequently be revised – for example, if prices change in
the major EU markets, or new data become available which would affect the outcome of the drug’s
assessment by the CT or CEESP (see ‘Reimbursement: Changes in Reimbursement Prices’).
- European Price Guarantee
A five-year European price guarantee applies to any hospital (or retail) drug granted an improvement
in medical benefit (ASMR) rating of I to III (IV under certain conditions) (see ‘Reimbursement:
Changes in Reimbursement Prices’).
- Maximum Prices
The MSPs established for T2A exclusions and liste de rétrocession drugs are maximums: actual prices
(ie the prices paid by hospitals) may be lower (see ‘Actual Prices’, below).

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ATU/post-ATU
Certain drugs can be granted temporary use authorisation (Autorisation Temporaire d’Utilisation,
ATU) (see ‘Reimbursement: Hospital Reimbursement’) so that they can be reimbursed in the hospital
system prior to marketing authorisation approval. These products are known as “post-ATU” drugs in
the period after marketing authorisation has been granted, but before regular reimbursement
commences (see ‘Reimbursement: Admission to Reimbursement’).
Manufacturers can freely set the prices of all drugs with an ATU which is valid for the period between
the granting of an ATU and the formal commencement of reimbursement (ie the period during which
the drug has ATU or post-ATU status). However, manufacturers are required to pay a rebate if the net
price of the drug upon reimbursement (as established by CEPS – see ‘T2A Exclusions and Liste de
Rétrocession’, above) is lower than the price initially set by the manufacturer (see ‘Temporary Use
Drugs’ in ‘Cost Containment: Industry Paybacks’).
An annual spending cap also applies to drugs with an ATU; manufacturers are liable for rebates where
the cap is exceeded (see ‘Temporary Use Drugs’ in ‘Cost Containment: Industry Paybacks’).
Actual Prices
The actual prices of hospital drugs are determined through either negotiations or tenders. In both
cases, and in order to lever their collective bargaining power, groups of hospitals (eg groups of
university hospitals, regional/sub-regional groups – see also below) act together as follows:
• For patented branded drugs, prices (together with any discounts and rebates) are negotiated
between manufacturers and groups of hospitals. In some instances, portfolio agreements are
signed. The ensuing contracts are usually valid for 12/24 months (but may be renewable
once).
° According to a report on hospital purchasing published in July 2017 by the Supreme Audit
Court (Cour des comptes), discounts/rebates on drugs included on the liste en sus/liste de
rétrocession (see above) are minimal (equivalent to around 2.5% of total combined
hospital purchasing on these drugs) owing to a reluctance on the part of manufacturers’ to
reduce their prices beneath the maximum level established by CEPS (see above).
• For multisource drugs (ie off-patent originals and generics), competitive tenders are issued by
groups of hospitals in a bid to secure the most advantageous prices (as well as discounts and
rebates). Contracts tend to be signed for a period of 12 months, and may be renewed once or
twice.
- Groupements Hospitaliers de Territoire
Notably, a wide-ranging December 2015 healthcare reform law provided for the establishment of 135
groupements hospitaliers de territoire (GHTs), which are intended to provide a platform for
cooperation between groups of hospitals in a given area (each region is divided into a number of
GHTs; all public hospitals are required to belong to a GHT, private hospitals can opt to join a GHT).
This includes in relation to care (eg coordinating across the GHT medical staffing as well as medical
imaging and biological services, better defined patient pathways across providers) and purchasing,
including for medicines. The transfer of responsibilities to GHTs must be completed by 1 January
2018. In time, it is hoped that the GHTs will generate savings on account of their size.

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OTC Drugs
Reimbursed OTCs
Where reimbursed, OTCs have their prices controlled in the same way as all other reimbursed
(prescription) drugs (see ‘Pricing: Prescription Drugs’). Around two thirds of OTCs can be reimbursed
when prescribed by a doctor.
Non-reimbursed OTCs
Manufacturers are free to set the prices of all non-reimbursed OTCs.
REIMBURSEMENT
Admission to Reimbursement
Although the health minister has the final authority to decide whether a drug should be admitted to
reimbursement, decisions in practice rest with the Transparency Commission (Commission de la
Transparence), which is part of the High Authority for Health (Haute Autorité de la Santé, HAS).
Manufacturers of new branded drugs seeking reimbursement are required to submit a corresponding
application to the CT.
Patient Participation
Patients/patient associations play a consultative role in the evaluation of drugs (and medical devices)
for the purpose of initial (reimbursement) assessments, as well as for re-evaluations of existing
reimbursed medicines (eg at the time of the five-year reviews – see ‘Reimbursement: Changes in
Reimbursement Status’). Patient participation was originally introduced with effect from 21
November 2016 for a six-month trial period (ie to run until 21 May 2017), but in September 2017 the
HAS announced that it was to be made permanent owing to its perceived success.
The HAS publishes each week on its website a list of products for which the opinion of
patients/patient associations is invited. This is obtained by means of a questionnaire compiled by the
HAS, using which the patient/patient associations have 45 days (30 days under the initial trial) in
which to submit their views on the treatment. This may include details relating to the impact on daily
life of the disease to be treated, as well as broader societal, ethical and social considerations. In the
case of medicines, these comments are then forwarded by the HAS to the CT and, where appropriate
the Commission for Economic Evaluation and Public Health (CEESP – see ‘Pricing: Prescription
Drugs’ and ‘Pharmacoeconomics: Pharmacoeconomic Requirements’), for consideration as part of
their evaluation of the drug.
According to the HAS, over the six months 21 November 2016 to 21 May 2017, 24 sets of feedback
were received from 18 different patient associations in relation to 22 medicines (including seven
medicines and one vaccine seeking admission to reimbursement for the first time).

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CT
The CT assesses all new patented branded drugs seeking reimbursement. The results of this
assessment are critical for subsequent pricing negotiations between the manufacturer and the Pricing
Committee (CEPS) (see ‘Pricing: Prescription Drugs’).
Generics are not usually assessed by the CT, although there are exceptions (see ‘Pricing: Generic
Drugs’).
- Membership
Members of the CT are selected by the HAS. The Committee comprises:
• 21 permanent members, including 20 experts in the domain of medicines evaluation
(including the president and vice-president) and one patient association representative. These
members all sit on the Commission in a deliberative capacity and have full voting rights. All
sit for a three-year term (twice renewable).
• Seven supplementary members, including six experts in medicines evaluation and one patient
association representative. These members have a purely consultative function.
• Seven additional members with a purely consultative function, including representatives from
the National Agency for Drug Safety (Agence nationale de sécurité du medicament et des
produits de santé, ANSM), the Director General for Social Security (Directeur générale de la
sécurité sociale), and the main health insurance funds.
Prior to July 2015, patient representatives did not sit on the Commission as either deliberative or
consultative members. Corresponding legislative changes increased by one the number of permanent
members, and supplementary members in order to allow patient representatives to play a role in the
CT. The same changes removed from the CT a representative from the pharmaceutical industry
association (Leem) (who previously sat as an additional member in a purely consultative capacity).
Application Process
- Early Assessment
Innovative drugs fulfilling certain criteria (see below) are eligible to undergo early assessment by the
CT ie as soon as the marketing authorisation (autorisation de mise sur le marché, AMM) application
has been submitted to either the ANSM or the Committee for Medicinal Products for Human Use
(CHMP) within the European Medicines Agency (EMA). Eligible for early assessment is any drug
which:
• is a new treatment option for the indicated condition (based on drug class, or method of
action); and
• represents significant therapeutic progress in terms of efficacy or tolerance; and
• addresses a previously unmet clinical need.
For any drug deemed to fulfil these requirements, the CT is permitted to commence its assessment of
the drug straight away. However, the CT can only issue its decision following formal submission of the
reimbursement dossier once marketing authorisation has been granted.

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- Pre-submission
Before an AMM has been granted, manufacturers of drugs “presumed to be innovative” can make a
pre-submission to the CT and CEPS. This can be made:
• Once the CHMP has signalled its approval, for drugs following the centralised (EMA)
marketing authorisation procedure
• Once the official summary of product characteristics (résumé des caractéristiques du produit,
RCP) become available, for drugs following the national (ANSM) approval process.
For eligible drugs, manufacturers are required to submit the standard reimbursement dossier (see
below) minus the AMM/RCP, along with a note to indicate that the dossier relates to a pre-
submission. The AMM/RCP must subsequently be submitted as soon as they become available.
- Standard Application
Once marketing authorisation has been issued, manufacturers can submit an application for
reimbursement. The application should be addressed to the minister in charge of social security, with
a copy addressed to the CT. The manufacturer must also submit simultaneously a pricing application
to CEPS (see ‘Pricing: Prescription Drugs’) and, where applicable, a health economic evaluation to
CEESP (see ‘Pharmacoeconomics: Pharmacoeconomic Requirements’).
For each of the drug’s approved indications, the dossier should include:
• Manufacturer’s details.
• Context and general information, including description of the disease to be treated, and
whether the drug is novel (eg new mechanism of action/therapeutic class/method of
administration).
• Product information, including active ingredient, anatomical therapeutic chemical (ATC)

code, indication/s to which the application applies, and details of the drug’s form, dosage,
pack size, method of administration, and any prescribing restrictions.
• Proof of marketing authorisation (where available – see above) in France, as well as details of
the product’s commercialisation (ie whether it has been marketed, and approved indications)
in other European Union (EU) countries and in North America (other countries can also be
cited, where deemed relevant).
• Proposed medical benefit (service médical rendu, SMR) rating and improvement in medical
benefit (amélioration du service médical rendu, ASMR) rating (for each indication) – see
‘Medical Benefit Rating Systems’, below.
• Details of any medical devices, tests and therapeutic/diagnostic acts associated with use of the
drug (including with respect to the latter, health economic [HE] data).
• Information on the product’s reimbursement status in Belgium, Germany, Italy, the

Netherlands, Spain and the UK (as well as other EU and non-EU countries where pertinent),
together with copies of the results of any health technology assessments (HTAs) issued by
other national HTA authorities (eg the Institute for Quality and Efficiency in Health Care,
IQWiG, in the case of Germany).
• Details of comparator treatments (eg reimbursement status, SMR and ASMR ratings),
including drugs, medical devices and/or other treatments.

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• Analysis of clinical data relating to use of the drug (prescription/sales volumes, average
treatment duration, average dosage, and details of any medicines/medical devices to be used
concurrently).
• Full analysis of the drug’s tolerance and efficacy relevant for the CT’s assessment of the drug’s
SMR and ASMR ratings (as demonstrated/validated by [pre-]clinical data, expert opinion,
publications etc).
• Assessment of the drug’s importance for public health (gravity of the disease to be treated,
incidence and prevalence of the disease in France, impact of the drug on mortality and
morbidity).
• Information on the current treatment strategy, and expected place of the drug in treatment
strategy.
• Details of any ongoing/planned studies requested by the ANSM or CEPS, along with any other
information the manufacturer deems to be pertinent to the application.
As a general rule, manufacturers must demonstrate that a new drug has a therapeutic value equal or
superior to existing reimbursed comparator drugs to be granted reimbursement.
Medical Benefit Rating Systems

The CT assesses, based on the information supplied by the manufacturer in the reimbursement
dossier (see above), the drug’s perceived medical benefit (SMR) rating and improvement in medical
benefit (ASMR) rating for each indication for which reimbursement is requested.
- SMR Rating
To determine a drug/indication’s SMR, the CT considers the following:
• The severity of the disease
• The product’s efficacy and safety (including side-effects)
• The importance of the drug in the treatment strategy and in comparison to other available
therapies
• Whether the drug is intended for curative, preventative or symptomatic treatment
• Its benefit in relation to public health (eg reduction in mortality/morbidity or disability).
Based on these factors, the CT can award an SMR rating of:
• Major/important
• Moderate
• Weak
• Insufficient (in which case the drug is not eligible for reimbursement).
The SMR rating dictates the reimbursement rate (see ‘Reimbursement: Reimbursement Categories’).

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- ASMR Rating
For the purpose of determining the ASMR rating, the CT compares efficacy and tolerance data for the
new drug with data for available comparators (existing reimbursed medicines, medical devices and
procedures). If there is no direct comparator, an indirect comparison is made by the CT, on the basis
of criteria established by the HAS.
The ASMR rating awarded to a drug reflects its relative value compared to alternative therapies (see
Table 1, below). A new method of administration can be considered as offering an improvement in
medical benefit, provided it can be demonstrated to have a significant clinical effect.
A drug can hold different ASMR ratings for different indications. Products which are not awarded an
ASMR of I-IV (ie have an ASMR rating of V, signifying no therapeutic progress – see Table 1, below)
are not eligible for reimbursement, unless they offer cost savings versus alternative treatments.
The ASMR rating awarded is critical for pricing purposes (see ‘Pricing: Prescription Drugs’) ie a high
ASMR rating usually equates to a high(er) ex-factory price.
Table 1: Improvement in medical benefit (ASMR) ratings
ASMR Rating Description
Major therapeutic progress eg has a major effect on mortality rates

I
linked to severe illness
II Important progress in terms of therapeutic efficacy and/or tolerance
III Moderate progress in terms of therapeutic efficacy and/or tolerance
IV Minor progress in terms of therapeutic efficacy and/or tolerance
V No therapeutic progress
Note: Ratings of VI and 00 are possible but rare. A rating of VI signifies an unfavourable rating with
regards to suitability for reimbursement, while a rating of 00 is effectively unclassified and signifies
‘progress difficult to specify’.
- Other Criteria
In addition to the SMR and ASMR criteria, the CT’s assessment also considers treatment duration,
posology and estimated patient population.
Assessment and Decision

As part of the assessment process, the CT can opt to consult with one or more external experts. This
may be the case where the CT is seeking clarification on, for example, the therapeutic need for the
drug, or its place in current treatment strategy, or the target patient population.
After discussion of the dossier (including feedback from any external experts) within the Commission,
a vote is held. All decisions are taken by majority vote.
Subsequently, the CT’s (draft) opinion is forwarded to the manufacturer who has ten days in which to
respond in writing with comments on the CT’s assessment, or to request a hearing. If neither are
received within ten days, the CT’s draft opinion becomes definitive.

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If the company requests a hearing, any supporting arguments/documentation must be submitted to
the CT eight days prior to the actual hearing. The company has fifteen minutes in which to present
their case at the time of the hearing, with support from experts if desired.
All comments/evidence/arguments from the company (which cannot be supported by new data, not
previously submitted), submitted either in writing or at the hearing, are then considered by the CT at a
second meeting. The CT’s definitive opinion (which may or may not differ from its original draft
opinion) is then subject to another (majority) vote, after which it is forwarded to the manufacturer.
The CT held 50 hearings in 2015, around half of which related to first reimbursement applications.
Across all 50 hearings (including those relating to indication extensions and reviews of a drug’s
reimbursement status), the CT’s initial decision was upheld in 78% of cases. In two cases, the SMR
rating for the drug/indication was revised in the manufacturer’s favour (ie upwards).
It should be noted that additional information can be requested from the manufacturer at any point
from submission of the reimbursement dossier and prior to the CT issuing its definitive decision.
- Post-marketing Studies
The CT can stipulate in its final opinion that the manufacturer collate additional data on the drug’s use
following admission to reimbursement. This may happen where there is uncertainty about the short-
or long-term impact of the drug’s reimbursement on public health, for example. In 2015, such studies
were requested by the CT in relation to 12 new drugs seeking reimbursement.
The results of post-marketing studies are considered by the CT for the purpose of reviewing the drug’s
reimbursement status (see ‘Reimbursement: Changes in Reimbursement Status’).
Full details of post-marketing studies are defined in the pricing agreement signed between the
manufacturer and CEPS (see ‘Pricing: Prescription Drugs’).
Final Decision
Once available, the CT’s final decision is forwarded to the manufacturer and:
• CEPS for pricing purposes (see ‘Pricing: Prescription Drugs’)
• The National Union of Health Insurers (UNCAM) which determines the reimbursement rate
(see ‘Reimbursement: Reimbursement Categories’); and
• The health minister, who has the final authority to decide whether a drug should be
reimbursed.
The Commission’s decision is also published on the HAS website within one month.
Restricted Reimbursement
The CT may determine to restrict reimbursement for certain (high-cost) medicines to limited
indications (and therefore a limited number of patients) where there are concerns over the potential
budget impact or the safety/appropriateness of use of the drug in the wider population, for example.
At the time of writing (December 2017), there were 61 drugs (251 presentations) subject to restricted
reimbursement (known as ‘exception drugs’ [médicaments d’exception]), including Aranesp
(darbepoetin alfa), Cimzia (certolizumab pegol), Humira (adalimumab), Kalydeco (ivacaftor), and
Xolair (omalizumab).

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For all ‘exception drugs’, the CT compiles, on the advice of the government’s chief medical committee
(Haut comité medical de la sécurité sociale), a therapeutic information sheet (fiche d’information
thérapeutique, FIT) at the time of admission to reimbursement. The FIT is published in the Journal
Officiel as an annexe to the drug’s price and reimbursement rate.
Physicians are required to prescribe all ‘exception drugs’ on a special script with four copies
(compared to the usual two). The prescriber must also confirm that the drug is issued in accordance
with the FIT. Where the conditions of the FIT are not met, the drug is not reimbursed.
Reimbursement Categories
Drugs are reimbursed at one of four reimbursement rates, in the range of 0-100%.
100% Reimbursement
Full (100%) reimbursement is granted to irreplaceable and/or very high cost medicines. This includes
expensive hospital medicines included on the liste de rétrocession (see ‘Reimbursement: Hospital
Reimbursement’); all other liste de rétrocession medicines are 65% reimbursed.
Standard Reimbursement
All other drugs are reimbursed at the standard rates of 15%, 30%, or 65% (see Table 2, below); the rate
to be applied is determined by the National Union of Health Insurers (UNCAM), based on the drug’s
medical benefit (SMR) rating, as assessed by the Transparency Commission (CT – see ‘Admission to
Reimbursement’). Drugs judged by the CT to have an insufficient SMR (or ‘SMRI’) are not
reimbursable. The majority of drugs are 65% reimbursed.
Reimbursement rates have not been revised since 2011.
Table 2: Standard Reimbursement Rates
Reimbursement Category Reimbursement Rate Examples
Essential medicines eg diabetes

SMR1 major/important 65%
treatments
Drugs for symptomatic treatment of
SMR1 moderate 30% non-serious illness, and magistral
preparations
SMR1 weak 15% Antivirals, tranquilisers etc
Notes:
1Medical benefit rating (see ‘Reimbursement: Admission to Reimbursement’)

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Reimbursement Prices
All drugs are reimbursed at their actual price, unless they are included in the active ingredient-based
reference price reimbursement system.
Reference Price Reimbursement System

Reference price (tarif forfaitaire de responsabilité, TFR) groups are established by the Pricing
Committee (CEPS). Each group comprises the off-patent branded original and corresponding
generics, based on the same dose and pack size. Notably, modified-release versions can be included in
the same group as the corresponding original. Some 2,600 medicines are covered by the TFR system
(around 19% of all medicines on the market).
As a general rule, new groups are created for products which record generic substitution levels below
certain thresholds following the establishment of generic competition:
• Below 60%, 12 months after genericisation
• Below 80%, 36 months after genericisation.
The reference price is set at the average of the prices of all generics in the group. In theory, patients
are liable for any excess over the reference price but in practice such charges are rare since most off-
patent brands reduce their prices to the reference level.
Hospital Reimbursement
Hospital Supply Authorisation
All medicines (including those also eligible for retail sale) intended for use in hospitals must seek
inclusion on the list of drugs approved for hospital use (liste des spécialités agréées aux collectivités
publiques et divers services publiques). Decisions on inclusion are taken by the health minister, on
the advice of the High Authority for Health (HAS- based on as assessment of the drug’s medical
benefit [SMR] rating – see ‘Reimbursement: Admission to Reimbursement’ and ‘Reimbursement:
Reimbursement Categories’). The health minister subsequently also determines inclusion on the list of
T2A exclusions/ liste de rétrocession (see below).
All drugs which feature on the list of drugs approved for hospital use are 100% reimbursed for
hospital in-patients.
There are nevertheless exceptions to the above requirement, for:
• Drugs granted temporary use authorisation (Autorisation Temporaire d’Utilisation, ATU) by
the National Agency for Drug Safety (ANSM) prior to official marketing authorisation (see
below); and
• Drugs granted a recommendation for off-label use (Recommendation Temporaire

d’Utilisation, RTU) by the ANSM (see below).

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- ATU
Certain drugs may be used before they have official marketing authorisation, on the condition that
they obtain temporary use authorisation (ATU). The ANSM can issue an ATU for any drug fulfilling all
of the following conditions:
• The drug is to treat, prevent or diagnose a serious or rare disease; and
• There is no existing treatment available; and
• The drug is presumed to be effective and safe, based on current scientific evidence.
There are two types of ATU:

• ATU nominative (ATUn): the drug is authorised for the treatment of an individual patient,
who must be unable to participate in a clinical trial. The request is submitted by the
prescribing doctor. There were 149 ATUn in place as at December 2017.
• ATU de cohorte (ATUc): applies for a sub-group of patients. The request is submitted by the
manufacturer, who commits to apply for official marketing authorisation within a set
timeframe. For such drugs, the ANSM compiles a protocole d’utilisation thérapeutique et de
recueil d’information (PUT) which details the permitted patient sub-group, and
requirements/mechanisms for collecting data on the drug’s effectiveness, side-effects etc, and
for monitoring patients. As at December 2017, there were 17 ATUc in place.
These products are known as “post-ATU” drugs in the period after marketing authorisation has been
granted, but before regular reimbursement commences (see ‘Reimbursement: Admission to
Reimbursement’).
- RTU
A recommendation for off-label use (RTU) can be established by the ANSM for a (hospital or retail
sector) drug which meets all of the following criteria:
• Already has marketing authorisation for a different indication
• Is already commercialised in France
• Addresses an unmet clinical need (ie there is no alternative existing drug authorised in France
in the target indication)
• Is perceived to have a favourable risk/benefit profile.
Provision for RTUs was included in the December 2011 regulatory system reform bill. They are
intended to make off-label usage safer by allowing such usage to fulfil a public health need, or ensure
access to a treatment by sub-groups (not studied or targeted under the original marketing
authorisation).
RTUs can be granted for a term of up to three years, and can be renewed. Manufacturers are required
to monitor all patients treated in the context of an RTU.
Where an RTU exists, the prescriber must show how the patient meets the requirements of the RTU
(rather than submitting a formal application as is the case with an ATU – see above). The prescriber is
also required to inform the patient of the off-label prescription, and to collect data as specified in the
RTU.
By December 2017, a total of 15 RTUs had been granted (11 were understood to be still in force).
Perhaps most notably, an RTU is in place for Avastin (bevacizumab) to treat wet age-related macular
degeneration (wet AMD), contrary to the wishes of its manufacturer Roche.

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Formularies
By law, all hospitals (either individual hospitals or groups of hospitals) must have a Committee for
Medicines and Medical Devices (Comité du medicament et des dispositifs médicaux stériles,
COMEDIMS) whose primary role is to draw up the drug formulary. The Committee comprises up to
27 members who each sit for a four-year term, including 20 doctors and pharmacists, and a
representative from the nursing staff. The hospital director may also sit on the COMEDIMS, though
purely in a consultative role. The Committee meets at least three times each year.
Formulary listing decisions are based on therapeutic and economic considerations. Conditions (eg
first/second-line treatment, treatment duration) may be attached to the listing by the COMEDIMS in
order to ensure cost-effective prescribing.
The COMEDIMS is also charged with compiling an annual activity report, drawing up prescribing
guidelines (either for therapeutic groups eg antibiotics, or pathologies), and combating iatrogenic
illness.
Funding
A diagnosis-related group (DRG)-type system of funding, known as Tarification à l’activité (T2A), is
in place in all (public and private) hospitals. For the purpose of the T2A system, all patients are
classified based on their principal diagnosis and co-morbidities into a DRG group (groupe homogène
de malades, GHS), to which one (or more) DRG tariff(s) (groupe homogène du séjour) apply. GHS
tariffs are adjusted according to the hospital’s profile (ie they are not fixed at the national level).
Moreover, different tariff scales (but the same GHS groups) apply in the public and private sector
(those in the private sector are lower since physicians’ fees are not integrated into the tariffs, unlike in
the public sector).
The T2A system applies to the majority of hospital services (all activities which fall into general
medicine, surgery, obstetrics and odontology), but excluding emergency care, transplant services and
psychiatric care. Emergency care is instead funded by nationally applicable per-case fees. Annual
payments are meanwhile allocated to cover the cost of transplant services, psychiatry and other
“general interest” services, including those linked to teaching, research and innovation (the so-called
MERRI allowance).
- T2A Exclusions
High-cost Drugs
High-cost drugs are excluded from the GHS tariffs and are instead invoiced on top of the regular
tariffs, provided that they feature on a corresponding list of eligible drugs (known as the liste en sus).
The list is (since 2014) indication-based, and includes cancer treatments, anticoagulation factors,
immunoglobulin etc.
Legislation published in March 2016 formalised the criteria for inclusion and exclusion of drugs on
the liste en sus. Accordingly, to be included on the list a drug must:
• Have an improvement in medical benefit (ASMR) rating of I, II or III (see Table 1 in
‘Reimbursement: Admission to Reimbursement’) for the indication to which the listing
relates. Drugs with an ASMR of IV can only be included where deemed to be in the interests of
public health, in the absence of a pertinent comparator treatment, or where comparator
treatments with an ASMR IV are already listed.
• Have a medical benefit (SMR) rating (see ‘Reimbursement: Reimbursement Categories’) of

major/important for the indication to which the listing relates.
• Fulfil other criteria relating to cost (ie have a price equivalent to more than 30% of the
corresponding GHS).

30
Generic versions of drugs already included on the list, biosimilar versions of original biotech drugs
featured on the list, as well as line extensions and new dosages of listed drugs are presumed to fulfil
the above criteria and are automatically listed.
Drugs can be removed from the list for either some/all of their indications where they cease to fulfil
the above requirements, for instance if their SMR/ASMR rating is revised (downwards) or where their
price falls to a level which would allow the drug to be funded via the regular GHS tariff, or where they
generate “unjustified” expense for the healthcare system.
Notably, 10 drugs were removed from the list in August/September 2016 for some or all of their
indications in the wake of the publication of the formal criteria for inclusion on the liste en sus (see
above). Affected products included (for all indications) Javlor (vinflunine) and Remodulin
(treprostinil), as well as (for certain indications only) Avastin (bevacizumab) and Alimta
(pemetrexed).
Products on the liste en sus are 100% reimbursed when used in line with the drug’s marketing
authorisation and for specified indications, or in the case of off-label usage, in accordance with the
drug’s RTU (see above).
Hospitals incur a financial penalty where chemotherapy treatment leads to a prescription for a drug
featured on the liste en sus – see ‘Rational Use of Medicines’, below.
ATU
For drugs with an ATU (see above), the manufacturer can set its own price or supply the medicine
free-of-charge to hospitals.
Manufacturers of drugs with an ATU are liable for repayment of the difference in sales revenue where
the net price established by CEPS at the end of the ATU period (ie when the drug is formally granted
reimbursement) is lower than the initial price set by the manufacturer (for the duration of the ATU,
where the price is set by the manufacturer, see above) (see also ‘Temporary Use Drugs’ in ‘Cost
Containment: Industry Paybacks’).
Additionally, since January 2017 a cap of €10,000 per patient per year on reimbursed spending
applies to any ATU drug registering total turnover of €30 million or more. Manufacturers are liable to
repay any spending above this level (see ‘Temporary Use Drugs’ in ‘Cost Containment: Industry
Paybacks’).
Devices and Outliers
High-cost medical devices are similarly excluded from the regular GHS tariffs and are billed
separately. Neonatal care, or stays of exceptionally long duration, for example, are meanwhile eligible
for supplementary daily rates.
- Rational Use of Medicines
Hospitals are encouraged to ensure the rational use of high-cost medicines via the initiatives set out
below.
CBU
All hospitals are required to sign a rational usage agreement for medicines and medical devices
(Contrat de bon usage des medicaments et des produits et prestations, CBU) with the Regional
Health Agency and a representative from the main health insurance fund (CNAMTS – see ‘Healthcare
System: Provision & Funding’). Such agreements typically cover a period of three to five years.
CBUs detail targets/commitments from the hospital, including in relation to the appropriate and
correct (ie in line with the drug’s marketing authorisation and permitted reimbursed usage) use of
T2A excluded drugs (and devices), as well as products subject to an ATU/RTU (see above).

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Each hospital must produce annually a report evaluating its performance in relation to the
commitments/targets set out in the CBU. In the event that the hospital does not submit this annual
report to the required timeline, or is found to have breached the terms of the agreement, it incurs a
reduction of up to 30% in the level of reimbursement it receives for T2A exclusions (drugs and
devices) in the following financial year.
Reduction in GHS Tariffs
Where chemotherapy treatment results in a prescription for a high-cost T2A excluded drug, the
hospital incurs a financial penalty (via a reduction in the GHS tariff relating to the chemotherapy).
This measures was introduced with effect from March 2015 and is intended to make physicians more
aware of their prescribing in relation to high-cost T2A exclusions where alternative treatment options
(ie less costly drugs which are included in the regular GHS tariffs) exist.
- Liste de Rétrocession
The liste de rétrocession includes hospital drugs that can be dispensed (by hospital pharmacies) to
hospital out-patients and billed to the patient’s health insurer as opposed to the hospital.
All such drugs have constraints on distribution, dispensing or administration, or require follow-up
after prescribing eg blood products, antiretrovirals, hepatitis B/C drugs, certain antibiotics and
antifungals, cancer drugs and orphan drugs. For inclusion on the list, drugs must either have
marketing authorisation or be approved for use prior to marketing authorisation via an ATUc (see
above).
Additionally, some drugs are subject to the same rules as liste de rétrocession drugs, but are not
formally included on the list, namely: hospital preparations and magistral preparations, drugs subject
to a special import licence (except where they are classified as hospital-only [see below]), and drugs
approved for use prior to marketing authorisation via either an ATUn, or an RTU (see above; except
where they are classified as hospital-only [see below]).
Other key features of the list are:
• Products classified as hospital-only (réserve hospitalière, RH) are not eligible for inclusion on
the list. Products falling into all other prescribing restriction categories can be included ie
hospital prescription (PH), initial hospital prescription (PIH), hospital specialists only (PRS).
• Select liste de rétrocession drugs can also be dispensed via the retail pharmacy network.
Antiretrovirals and hepatitis B medicines are the only dual circuit drugs.
• Expensive liste de rétrocession drugs are 100% reimbursed; others are 65% reimbursed.
• When used by hospital in-patients, liste de rétrocession drugs are:
° Included in the T2A tariffs; or included on the liste en sus (see above) and invoiced in
addition to the regular tariffs
° In the case of drugs with an ATU, reimbursed based on the cost charged by the
manufacturer (see above).
° Hospital preparations and magistral preparations are reimbursed based on their cost of
manufacture.
- Fund for Financing Pharmaceutical Innovation
The newly created Fund for Financing Pharmaceutical Innovation (FFIP – see ‘Healthcare System:
Provision & Funding’) is designed to cover the costs related to all high-cost drugs on the liste en sus
(see above) and liste de rétrocession, as well drugs with ATU/post-ATU status (see above).

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Changes in Reimbursement Status
Five-year Reviews
Every five years, a given drug is subject to a review of its reimbursement status (and price – see
‘Reimbursement: Changes in Reimbursement Prices’). Five-yearly reviews apply to all retail (but not
hospital) drugs.
Manufacturers are required to submit an application for renewal of reimbursement status a minimum
of 180 days prior to expiry of the drug’s reimbursement status (fixed on admission to reimbursement).
The dossier requirements are similar to those for a first application for reimbursement (see
‘Reimbursement: Admission to Reimbursement’). Reviews are conducted by the Transparency
Commission (CT), which looks primarily at the drug’s medical benefit (SMR) rating and considers
whether new data/studies/real-life usage etc (where relevant, as demonstrated by post-marketing
studies) support its current rating or justify its modification. A drug must still be judged by the CT to
have a ‘sufficient’ medical benefit (see ‘Reimbursement: Reimbursement Categories’) for its primary
indication to retain reimbursement.
The CT takes into account for the purpose of the re-evaluation the views of patients/patient
associations. Patients/patient associations can submit their views on a treatment, including details
relating to the impact on daily life of the illness to be treated, as well as broader societal and ethical
considerations (see ‘Reimbursement: Admission to Reimbursement’).
Notably, the CT may in some instances determine to review the drug’s improvement in medical
benefit (ASMR) (used for pricing purposes – see ‘Pricing: Prescription Drugs’) at the same time. This
may happen where tolerance levels to the drug have proven better than anticipated, for example.
In the majority of cases, reimbursement re-evaluations do not result in a change to the drug’s SMR
rating and therefore reimbursement rate. However, the SMR rating can be modified for any of the
following reasons:
• Where actual usage does not confirm the drug’s benefit as judged from clinical trials
• Where newly marketed drugs are perceived to perform better
• If new data indicate a low level of tolerance to the product
• Where the drug’s place in therapy has changed.
Where the CT determines to modify a drug’s SMR it can do so for some/all of its indications.
Alternatively, the CT may recommend that a drug be delisted (for some/all of its indications)
following the review on any of the following grounds:
• The drug’s SMR is judged to be insufficient
• The drug is judged not to offer therapeutic progress (ie ASMR V) or a reduction in treatment
costs
• Where the price is not judged to reflect its therapeutic value
• Where the drug’s form/dose or pack size are not justified by its therapeutic use
• If the manufacturer has neglected to inform the authorities of a change in data on which the
drug’s original reimbursement listing was based
• Marketing for the drug (to healthcare professionals) fails to meet the required standard (eg
via the promotion of off-label usage, or where promotional materials do not fulfil the legal
requirements).

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Where the CT determines to delist a drug, or modify its reimbursement rate, the manufacturer has
one month in which to respond in writing, or to request an audition with the CT. Notably, in both of
these scenarios, the CT also reviews the reimbursement status of all other medicines belonging to the
same therapeutic group.
Legislation stipulates that decisions pertaining to reimbursement reviews must be taken prior to the
date of expiry of a given drug’s reimbursement status. The decision is subsequently published in the
Journal Officiel by the date of expiry of reimbursement status at the latest. By this same date, the
manufacturer must be notified of the decision; if this deadline is not met, the drug’s reimbursement
status is renewed (unchanged) by default.
- HE Evaluation
Innovative drugs fulfilling the criteria for health economic evaluation at launch (see ‘Pricing:
Prescription Drugs’) are subject to another health economic evaluation every five years. To this end,
manufacturers of affected drugs are required to provide real-world evidence (RWE), including safety
and appropriate use data in order to ensure continued reimbursement.
Exceptional Reviews
Individual products, and therapeutic areas, may also be subject to exceptional reviews. These may be
initiated by the CT, the High Authority for Health (HAS) or the health minister, as well as (in the case
of individual products) by the manufacturer. Exceptional reviews may be held where new data on the
drug’s therapeutic value become available, following authorisation of indication extensions, or on the
basis of post-marketing studies (requested by the CT or CEPS), among others. Such reviews can be
conducted for both retail and hospital drugs and, in the case of retail drugs, are in addition to the five-
yearly reviews (see above).
Post-marketing Studies
In some instances, the CT may request at the time of admission to reimbursement the collation of
post-marketing studies for a given drug (see the section ‘Post-marketing Studies’ in ‘Reimbursement:
Admission to Reimbursement’). The results of such studies are considered by the CT for the purpose
of reviewing the drug’s reimbursement status, for example at the time of the five-year review (see
above). The exact timeframe for such studies (and the resulting reimbursement review) are agreed
with the manufacturer at the time of admission to reimbursement. The drug’s reimbursement status
may be revised as a result of the review to reflect the outcome of the post-marketing studies.
CEPS may also request post-marketing studies. These are typically linked to conditional pricing
arrangements (see the section ‘Conditional Pricing’ in ‘Pricing: Prescription Drugs’).
Reimbursement Rate Changes

Reimbursement rate changes have occurred previously. For instance, the reimbursement rate for
drugs with a moderate SMR rating (see ‘Reimbursement: Reimbursement Categories’) was reduced
from 35% to 30% in January 2011.
Under reforms effective from 6 February 2015, patients covered by the state medical aid (aide
médicale de l’État, AME) scheme, which enables (low-income) patients resident in France illegally
(for more than three months) to access healthcare, are no longer entitled to reimbursement for
prescription medicines that have a ‘weak’ medical benefit (SMR) rating. As a result, adults covered by
the scheme must pay the full cost of these medicines out-of-pocket (see ‘Cost Containment: Patient
Co-payments’). Previously, these medicines were 100% reimbursed (and still are for children covered
by the AME scheme).

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Changes to Reimbursed Indications
Changes to a drug’s reimbursed indications can be made outside of scheduled or exceptional reviews.
For example, reimbursed access to high-cost innovative hepatitis C drugs was extended in early 2017
to all patients, regardless of their level of liver disease. It is understood that pricing agreements (see
‘Pricing: Prescription Drugs’) between CEPS and manufacturers of such drugs were renegotiated in
order to reduce their prices and prevent a dramatic increase in reimbursed spending on the extension
of reimbursed access to additional patients. Indeed, in April 2017 it was reported that Gilead Sciences
had signed a new pricing agreement with CEPS for its innovative hepatitis C drugs Sovaldi
(sofosbuvir) and Harvoni (ledipasvir + sofosbuvir). The agreement reportedly reduced from 1 April
2017 the prices of both drugs; by 30% in the case of Sovaldi.
Delistings
A drug can be delisted per se, or for certain indications only.
Delistings can occur at the request of the manufacturer, or by decision of the CT/health minister, for
example where a drug’s SMR rating is judged to be insufficient following a (scheduled five-
yearly/exceptional) review by the CT (see ‘Five-year Reviews’, above).
For example, medicines containing aliskiren to treat hypertension – namely Rasilez (aliskiren) and
Rasilez HCT (aliskiren and hydrochlorothiazide) - were delisted from 7 October 2017. The delistings
followed a review by the CT which found that the medicines had an insufficient SMR. Domperidone
(original and generic versions) indicated for the relief of nausea and vomiting in children was
meanwhile delisted from 3 March 2017, also on the grounds of insufficient medical benefit.
Changes in Reimbursement Prices

European Price Guarantee
- Eligibility
The prices of certain innovative retail and hospital drugs are guaranteed to remain at European levels
for five years under the terms of the Accord Cadre (see ‘Pricing: Prescription Drugs’). Eligible for the
guarantee are:
• All drugs granted an ASMR (improvement in medical benefit) rating of I to III (see Table 1 in
‘Reimbursement: Admission to Reimbursement’), and which have undergone a health
economic evaluation (see ‘Pricing: Prescription Drugs’ and ‘Pharmacoeconomics:
Pharmacoeconomic Requirements’).
• Drugs awarded an ASMR IV rating based on a comparison with other medicines recently
granted an ASMR of I to III, and which (where appropriate) have undergone a health
economic evaluation (see ‘Pricing: Prescription Drugs’ and ‘Pharmacoeconomics:
Pharmacoeconomic Requirements’).
• Antibiotics with a new active ingredient and an ASMR rating of IV (since January 2016, under
the terms of the most recent Accord Cadre agreement).
The guarantee applies to all drugs fulfilling these criteria, regardless of the pricing procedure they
have followed (see ‘Pricing: Prescription Drugs’ and ‘Pricing: Hospital Drugs’).

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- Price Guarantee Period
For drugs eligible for the price guarantee, the Accord Cadre stipulates that the price (agreed by
manufacturers with the Pricing Committee [CEPS]) will be no lower than the lowest price applied in
the four largest European markets (excluding France ie Germany, Italy, Spain and the UK).
The price guarantee typically last for five years, but can be extended/shortened in the following
circumstances:
• For paediatric drugs, a one-year extension may be granted
• For drugs granted an indication extension with an ASMR of I to III, or IV based on a

comparison with other medicines recently granted an ASMR of I-III, an extension of up to one
year may also be granted, provided that the indication is aimed at a different target
population.
• The guarantee can be shortened by up to one year if the drug is granted an indication
extension with an ASMR rating of IV or V for a significantly larger target population than the
indication qualifying for the initial guarantee. This provision does not apply where the drug
was granted an indication extension with an ASMR of IV, based on a comparison with other
medicines recently granted an ASMR of I to III.
• In the case of hospital drugs granted temporary use authorisation (ATUc – see
‘Reimbursement: Hospital Reimbursement’), the price guarantee period commences from the
official issue of marketing authorisation ie before publication of the drug’s price in the
Journal Officiel, provided that the time between the two is no longer than seven months.
• The price guarantee period can be reduced if the manufacturer of a drug with an ATU does
not submit a reimbursement application/request for inclusion on the list of drugs authorised
for hospital usage within 30 days of the official issue of marketing authorisation. If the
application is delayed beyond the 30-day limit, the price guarantee is shortened by the
equivalent amount.
• The guarantee period can also be reduced where combined total volume sales in France,
Germany, Italy, Spain and the UK exceed forecasts.
- Exchange Rate Guarantee
The prices of innovative drugs eligible for the European price guarantee cannot be cut as a result of
any “heavy and rapid” depreciation of the pound sterling against the euro.
- Post-guarantee Price Reviews
At the end of the guarantee period, the price of a given drug is reviewed by CEPS. The review can
result in a price cut.
Other Price Guarantees

The current Accord Cadre formalises the possibility for CEPS to take into account during pricing
negotiations a company’s investment in R&D and/or production in the EU for the purpose of setting
an initial price. Where these factors are considered favourably, CEPS may determine to guarantee the
price of the drug for a period of between 18 and 24 months (for any medicine not already covered by
the European price guarantee – see above).

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Five-year Reviews
Every five years the reimbursement price (and reimbursement status – see ‘Reimbursement: Changes
in Reimbursement Status’) of a given drug is reviewed. For this purpose, manufacturers are required
to submit a reimbursement renewal dossier. Economic data (sales volumes and prices for the previous
three years, and forecast sales volumes for the next three years) must be submitted to CEPS
simultaneously.
Innovative drugs fulfilling the criteria for health economic evaluation at launch (see ‘Pricing:
Prescription Drugs’), are subject to a further health economic evaluation at the time of the five-year
review. To this end, manufacturers must submit real-world evidence, including safety and appropriate
use data (see ‘Reimbursement: Changes in Reimbursement Status’).
The price review can result in price reductions. The exact level of any price cut is subject to negotiation
between CEPS and the manufacturer, although CEPS retains the right to determine the level of the
price cut where negotiations fail.
- Criteria
The 2017 Social Security Finance Law (LFSS) formalised the criteria taken into account by CEPS for
the purpose of establishing (via negotiations with the manufacturer) a price at the time of a pricing
review (including at the time of the five-year reviews – see above). Accordingly, the following criteria
must be considered:
• the length of time the drug has been reimbursed
• net price (or net purchase price for hospital drugs) of the drug and comparator treatments
• reimbursed value sales (both recorded and forecast)
• net cost of treatment where the drug is used in conjunction with another drug
• the existence of lower prices (less any rebates or taxes) in Germany, Italy, Spain or the UK.
Other Price Revisions

In addition to the scheduled five-year review, a price review can be initiated at any time by either the
manufacturer or CEPS. This may be the case where:
• new data becomes available (eg health economic data)
• where there is a substantial change in “elements” which formed the basis for the current price
(eg a change to the drug’s ASMR rating – see ‘Reimbursement: Changes in Reimbursement
Status’)
• where prices (in the EU) change
• in the event that a new dosage/indication is authorised. With respect to the latter, it is
noteworthy that the CEPS may ultimately agree that a drug granted an indication extension
may maintain its price (unaltered), where the target population is expected to slowly increase
over time.
The criteria taken into account for the purpose of establishing (via negotiations between the
manufacturer and CEPS) a revised price are defined in law (see above).
Prices may also be revised (ie cut) in accordance with the terms of pricing agreements agreed between
CEPS and manufacturers (see ‘Pricing: Prescription Drugs’).

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Conditional Pricing
For products for which a conditional price has been established (see the section ‘Conditional Pricing’
in ‘Pricing: Prescription Drugs’), CEPS may determine to reduce the price (or leave it unchanged)
based on the outcome of post-marketing studies, or the manufacturer may be required to pay back a
proportion of sales revenue. Full details of such arrangements (ie type of studies, criteria for price
modification/paybacks) are set out in the pricing convention signed between the manufacturer and
CEPS.
Off-patent Originals and Generics

- Off-patent Originals
Price cuts are applied to off-patent originals following patent expiry:
• the manufacturer’s selling price (MSP) of the off-patent original is cut by 20% following the
marketing of the first generic version. Full/partial exemption from this requirement can be
granted in any of the following circumstances:
° the first generic is marketed more than five years after patent expiry
° the costs of manufacturing are prohibitive
° the 20% reduction would result in an insufficient price differential with generic versions
(a minimum 10% differential is required – see below).
• A further price cut of 12.5% (at MSP) is applied 18 months after patent expiry, unless the
active ingredient has already been included in the reference price reimbursement system (see
below and ‘Reimbursement: Reimbursement Prices’).
Off-patent originals subject to the reference price reimbursement system are also impacted by
changes in the reimbursement price for the active ingredient (see below).
- Generics
The following rules apply to the prices of generics:
• The public price of a generic is not permitted to exceed 90% of the public price of the
corresponding off-patent original (following patent expiry). Generics manufacturers can be
required to reduce their prices to maintain this differential.
• 18 months after the patent expiry of the (off-patent) original, the prices of generic versions are
reduced by 7% (at MSP). This price cut does not however apply if the active ingredient has
already been incorporated into the reference price reimbursement system (see below and
‘Reimbursement: Reimbursement Prices’).
Notably, the MSP of a generic drug cannot exceed 40% of the pre-patent expiry MSP of the branded
original (see ‘Pricing: Generic Drugs’).
Generics included in the reference price reimbursement system are also impacted by changes in the
reimbursement price of the active ingredient (see below).
- Reference Price Reimbursement
For active ingredients subject to the reference price reimbursement system (see ‘Reimbursement:
Reimbursement Prices’), reimbursement prices change as a result of inclusion of new presentations
into the system, or if CEPS determines to change the reimbursement price.

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- Exceptional Cuts
Exceptional price cuts may be applied to both off-patent originals and/or generics – see ‘Targeted
Price Cuts’, below.
Price Consistency
CEPS may determine to apply price cuts for “price consistency” reasons. This typically happens in
therapeutic classes with high levels of generic competition. Such price cuts (which may be based on
the cost of daily treatment) can only be applied where the following conditions are fulfilled:
• A minimum of one year has elapsed since the commercialisation of cheaper medicines, and
• The product to which the price cut is applied has been judged to offer little or no therapeutic
progress for the majority of its indications.
ACE inhibitors and sartans have both been impacted by price cuts on the grounds of price consistency
in recent years.
Targeted Price Cuts

Targeted price cuts are a feature of the French market and typically feature in the annual Social
Security Finance Law (LFSS).
The draft 2018 LFSS targets savings of €1,490 million from medicines and medical devices, including
€480 million from targeted price cuts on medicines (see ‘Future Developments: Outlook’). This is
comparable to the savings sought in previous years.
Price Increases
Price increases are rare, and are typically only considered for therapeutically important products for
which there are no cheaper options available. Manufacturers seeking a price increase must submit a
corresponding request to CEPS.
PHARMACOECONOMICS
Pharmacoeconomic Requirements
HE Evaluations
Health economic (HE) evaluations are utilised as a means to support pricing and reimbursement
decisions and are mandatory for any innovative drug which:
• Claims additional benefit over comparators ie for which the manufacturer is seeking an
improvement in medical benefit (ASMR) rating of I, II or III (see Table 1 in ‘Reimbursement:
Admission to Reimbursement’); and
• Is expected to have a significant financial impact (based on all reimbursed indications) on

healthcare spending, either on account of its price/expected volume sales, or in terms of its
impact on provision of care/professional practice. In practice, this means drugs expected to
record turnover of €20 million or over during the second full year of commercialisation.

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With effect from January 2016 and under the terms of the current (December 2015) industry-
government Accord Cadre (see ‘Pricing: Prescription Drugs’), a formal budget impact analysis is
conducted as part of the HE evaluation for drugs meeting a separate cost threshold (see ‘Dossier
Submission’, below).
Notably, HE evaluations are required for any innovative drug meeting the above criteria at the time of
initial reimbursement listing, as well as at the time of the re-evaluation of its price and reimbursement
status every five years (see ‘Reimbursement: Changes in Reimbursement Status’ and ‘Reimbursement:
Changes in Reimbursement Prices’).
The results of the HE assessment are used by the Pricing Committee (CEPS) at the time of
establishing (initial) prices (see ‘Pricing: Prescription Drugs’) in order to ensure that the prices of
innovative drugs are proportional to their effectiveness.
- Initial Assessment
Manufacturers of all innovative drugs fulfilling the ASMR criteria (ie seeking an ASMR of I, II or III –
see above) are required to submit to the High Authority for Health (HAS) a submission notice. Where
the drug is also expected to have a significant impact on healthcare spending, the notice must be
accompanied by a full HE dossier (see below). The notice sets out (briefly) product details, proposed
ASMR rating, forecast turnover in the second full year of commercialisation and (where appropriate)
predicted impact on the organisation of health care/medical practice/current care for patients. Based
on the notice, the HAS determines (primarily based on anticipated cost impact – see above) whether
the drug is required to undergo HE evaluation.
- Dossier Submission
For products subject to HE evaluation, manufacturers must submit a corresponding dossier to the
HAS for assessment by a dedicated commission, the Commission for Economic Evaluation and Public
Health (Commission d’évaluation économique et de santé publique, CEESP). A copy of the dossier
must also be submitted to CEPS and the Transparency Commission (CT). The HE evaluation is
conducted in parallel to the standard assessment for admission to reimbursement (see
‘Reimbursement: Admission to Reimbursement’).
Notably, manufacturers can request a pre-submission meeting with the HAS. These are intended to
provide manufacturers with guidance on how to conduct phase III trials in a way which will allow
them to obtain suitable data.
The HE dossier must include the following:
• Product information: name of the drug, indications, form/s, therapeutic class, previous use
(where appropriate, for example in the context of an ATU – see ‘Reimbursement: Hospital
Reimbursement’), date of marketing authorisation, as well as details of the medical benefit
ratings (SMR and ASMR – see ‘Reimbursement: Admission to Reimbursement’) sought and
any clinical trials underway.
• Copies of the pricing dossier submitted to CEPS, and the reimbursement dossier submitted to
the CT.
• A description of the disease to be treated (including morbidity, mortality etc), current

therapeutic strategy and place of the drug in treatment strategy, as well as full details of other
“therapeutic options” (including licensed and off-label treatments, and non-pharmaceutical
options) and new medicines expected to be marketed over the next 12 months for the same
disease.
• Full details of the target population.

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• Impact of the drug on the organisation of health care, medical practice, and current care for
patients.
• A synthesis of clinical data justifying the ASMR sought, including efficacy, tolerance and
compliance data.
• Details of the results of HE evaluations conducted for the drug by other international bodies
eg the National Institute for Health and Care Excellence (NICE) in England, and the Institute
for Quality and Efficiency in Health Care (IQWiG) in Germany.
• A cost-effectiveness evaluation, including: the type of economic evaluation and

method/modelling used (either cost-utility or cost-effectiveness) with justification, outcomes
(including cost per quality-adjusted life year [QALY]), a breakdown of costs, net benefit, and a
sensitivity analysis.
• A budget impact analysis, for drugs with turnover in excess of €50 million during the second
full year of commercialisation. This should include (over a period of three to five years):
° Target population for each year (ie its predicted growth over the timeframe of the budget
impact analysis)
° A complete breakdown of reimbursed costs
° Full analysis of the drug’s impact on the healthcare system, including changes in the use
of healthcare resources following its introduction (eg an eventual transfer of costs from
the hospital to the retail sector)
° Type of modelling used, and a sensitivity analysis.
It should be noted that the dossier must conform to (methodological) health economic guidelines
issued by the HAS in October 2011, and (where relevant) budget impact analysis guidelines published
by the College of Health Economists (Collège des économistes de la santé, CES) in 2008. Importantly,
where incomplete or inappropriate data are submitted, the dossier is not evaluated and the CEESP
issues straight away its definitive opinion on the drug which sets out only the reasons why it was
unable to assess the drug’s cost-effectiveness.
- Evaluation
Following submission, the dossier is first subject to a preliminary analysis in order to ensure it is
complete and that the methodology the manufacturer has used is appropriate. As part of this analysis,
CEESP can request clarification from the manufacturer on questions it may have (eg technical
questions relating to the methodology). Subsequently, CEESP compiles its draft opinion which is
submitted to the manufacturer once available. The latter has the opportunity to make comments, or
request a hearing with CEESP. These written/oral comments are considered by CEESP before it issues
its definitive opinion, which is communicated both to the manufacturer and CEPS, and then made
publicly available (after publication of the drug’s price in the Journal Officiel).
By law, CEESP’s opinion is based on a comparative analysis of the drug’s perceived cost-effectiveness.
Importantly, CEESP does not make a judgment on the drug in terms of proposed price, or
positive/negative reimbursement recommendation. However, CEESP’s opinion may set out the
impact that varying the drug’s price has on its cost-effectiveness.

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- Results
CEESP Opinions
The CEESP issued in 2016 a total of 18 opinions for drugs/devices, including the PD-1 inhibitors
Opdivo (nivolumab) and Keytruda (pembrolizumab) indicated for the treatment of advanced
melanoma.
In 2015, CEESP issued 21 opinions covering three medical devices and 18 drugs, including Daklinza
(daclatasvir) for hepatitis C and Halaven (eribulin) for breast cancer. Of these 21 opinions, CEESP had
“major” reservations about seven dossiers which led it to conclude in all seven instances that it could
not deduce the product’s cost-effectiveness.
Impact on Prices
According to the HAS, prices were agreed in 2015 between CEPS and manufacturers for eight drugs
which had been evaluated by CEESP. Four (of the eight) drugs were awarded a price between 1% and
10% lower than the price requested by the manufacturer. These four drugs had a cost per QALY of
between €11,000 and €51,000. Another drug was awarded a price 21% lower than the price requested
by the manufacturer.
Role of HE
It is noteworthy that the role that health economics plays in pricing and reimbursement decisions
continues to be the subject of ongoing debate in France.
Most recently, in September 2017 the Supreme Audit Court (Cour des comptes) recommended
reinforcing the role of HE evaluations in pricing and reimbursement decisions. In this respect, the
Court suggests that “the presentation [by manufacturers as part of the pricing and reimbursement
application] of a number of cost-result ratio results calculated based on different price hypotheses”
should “become the rule”. The Court also advocates publishing the results of HE evaluations before
the drug’s final price in order to increase transparency, and strengthen the negotiating position of
CEPS. The recommendations were set out in the Court’s annual report on the finances of the social
security system. For further details, see ‘Future Developments: Outlook’.
- CEESP
In addition to its role in conducting HE evaluations of individual drugs, CEESP’s remit extends to the
compilation of HE-based prescribing and care guidelines for physicians, and recommendations
relating to public health programmes (eg cervical screening). It may also reassess the reimbursement
status of therapeutic groups (drugs and devices) where there are ethical, economic or societal (rather
than clinical) factors to consider.

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PRICE BUILD UP
Wholesalers
Margins
- Reimbursed Drugs
For reimbursed drugs, margins are regulated at both the wholesale and pharmacy levels.
The wholesale mark-ups are (since 1 January 2012) as follows:
• For drugs priced €0-450.00 at manufacturer’s selling price (MSP), a mark-up of 6.68% of the
MSP applies. There is a minimum mark-up of €0.30 per pack, and a maximum mark-up of
€30.06 per pack.
• For drugs priced (at MSP) above €450.00, there is no percentage mark-up; a flat rate of
€30.06 is applied.
Wholesalers are permitted to pass on all/some of their margin to pharmacists (see ‘Price Build Up:
Retail Pharmacies’).
- Non-reimbursed Drugs
There are no fixed margins for non-reimbursed drugs.
Discounts
Wholesalers (or manufacturers) may grant pharmacists discounts. For reimbursed drugs, the level of
such discounts is capped (per product line, per year) at:
• A maximum of 2.5% of the MSP for all branded drugs, except off-patent originals included in
the reference pricing (TFR) system (see ‘Reimbursement: Reimbursement Prices’)
• A maximum of 40% of the MSP for generics (whether included in the TFR system or not) and
off-patent originals subject to the TFR system, or included on the list of generic groups and
priced at the same level as other products in the same group.
The level of all such discounts must be specified on the invoice. However, actual discounts on generics
are understood to be higher on account of hidden rebates/discounts, for example in the form of
commercial cooperation agreements. In a bid to better understand (and ultimately address) this
problem, generics manufacturers are since 2014 required to declare to the Pricing Committee (CEPS),
on a product-by-product basis, all discounts granted to pharmacists on medicines. As things stand, the
data received from manufacturers are purely used for information purposes. However, a provision
included in the 2017 Social Security Finance Law (LFSS) states that such data can be taken into
account by CEPS for the purpose of revising prices. At the time of writing (December 2017), it was
understood that the data had yet to be used for this purpose however.
There are no limits on the discounts that wholesalers/manufacturers can grant to pharmacists on non-
reimbursed drugs and para-pharmacy products.
Social Security Contribution

All distributors (wholesalers and manufacturers selling directly to pharmacies) are required to pay an
annual social security contribution (known as the contribution ACOSS), calculated based on sales of
reimbursed drugs, excluding sales of orphan drugs with an annual turnover of below €30 million.

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For calculation purposes the contribution is applied only to the part of the wholesale selling price
(WSP) less than (€150 + the maximum permitted wholesale margin [ie 6.68% of the MSP]). There are
three parts to the contribution:
a) 1.75% of gross turnover (at WSP) for the year, plus
b) 2.25% of the difference between turnover in the current year versus the previous year, plus
c) 20% of the part of the wholesale margin surrendered to the pharmacist for branded drugs (ie
any discount on branded drugs exceeding 2.5% offered to pharmacists).
Notably, a + b (see above) is fixed at a maximum of 2.55%, and a minimum of 1.25%, of gross turnover
for the year.
A proposal to reduce the social security contribution (by exempting generics for the purpose of
calculating the tax), reportedly to provide “economic relief” to distributors in financial difficulty, was
introduced (and adopted) as an amendment to the draft 2018 Social Security Finance Law (LFSS), but
did not feature in the final version of the law.
Background
According to data from the pharmaceutical industry association (Leem), 57.9% of all drugs pass
through wholesalers (57.3% go on to retail pharmacies and 0.6% to hospitals). Direct distribution
accounts for the remainder (14.3% of all medicines are sold directly by manufacturers to pharmacies
and 27.8% to hospitals).
All wholesalers require a license from the National Agency for Drug Safety (Agence nationale de
sécurité du médicament et des produits de santé, ANSM). There are 42 registered wholesalers in total,
but just seven players (all full-liners) cover 98% of the market:
• OCP (part of the Celesio group)
• The regional full-liners CERP Rouen, CERP Rhin Rhône Méditerranée, and CERP Bretagne
Atlantique
• Alliance Healthcare (part of Alliance Boots)
• Phoenix Pharma (part of the Phoenix group)
• The cooperative group Giphar.
All full-liners must carry at least 90% of medicines with marketing authorisation, hold two weeks’
worth of stock at all times, and be able to provide delivery within 24 hours of an order being placed.
Around 20 short-liners are also present in the market. They typically carry a restricted range of
medicines (usually the most profitable) and deliver to a restricted number of pharmacies. In 2015,
they accounted for around 6% of the market (by volume) (compared to 3.6% in 2009), according to
data published by the Supreme Audit Court (Cour des comptes).
Drug Shortages
Drug supply problems are a growing concern. According to the National Chamber of Pharmacists
(Ordre national des pharmaciens), more than 200 products were subject to supply problems (ie out-
of-stock or in short supply) in October 2017 (latest data).
For certain medicines, manufacturers are required to inform the ANSM of any potential shortages in
supply, including details of for how long the shortage is expected to last and potential solutions (eg
switching to alternative dosages/forms where possible, redistributing existing stock). This applies to

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all “medicines of major therapeutic importance” (médicaments d’intérêt thérapeutique majeur,
MITM) ie those without therapeutic equivalents on the French market. A list of MITMs is maintained
by the ANSM. It features 97 presentations as at December 2017.
The ANSM is responsible for managing supply problems for MITMs. It can, for example, determine to
restrict usage of such drugs, make available for retail dispensing drugs destined for hospital supply
and/or arrange for importation of medicines from abroad, including those without marketing
authorisation in France.
Wholesalers are since January 2016 prohibited from exporting for sale outside of France MITMs
subject to supply problems.
Retail Pharmacies
Margins: Reimbursed Drugs
Pharmacy margins for reimbursed drugs are regulated. For these drugs, pharmacists earn both a
mark-up and one or more additional fees (see below).
Reforms to the pharmacy remuneration system, which aim to make remuneration less dependent on
the price of a drug and volumes dispensed, are ongoing.
Following months of negotiation, an eleventh addendum to the (2012) pharmacy convention – which
sets out details of pharmacy remuneration (including pharmacy fees, remunerated services, generic
dispensing targets etc) – was signed in July 2017 between the main health insurance fund (CNAMTS)
and the USPO pharmacy union. Notably, the other main pharmacy unions (FSPF and UNPF) refused
to sign (but were signatories to the original convention and all subsequent addenda).
The new addendum, which covers the period 2018-2022, provides for significant reforms, including:
• Revisions to the pharmacy mark-up
• The introduction of new pharmacy fees
• The introduction of new remunerated pharmacy services.
Details are set out below.
Notably, the government has set aside €280 million over three years to finance the changes to
pharmacy remuneration. Significantly, it has also indicated that pharmacies will be financially
compensated (until 2021) for any losses incurred by the changes.
- Mark-up
Pharmacy mark-ups are fixed.
As part of reforms to pharmacy remuneration, revised mark-ups (and price bands) take effect from 1
January 2018 (see Table 5, below). These mark-ups will subsequently be revised (downwards) from 1
January 2019, and then again from 1 January 2020 (see ‘Future Developments: Outlook’). New
pharmacy fees will be introduced from 1 January 2019 to compensate for the (downward) revisions to
mark-ups (see below and ‘Future Developments: Outlook’).

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Table 5: Pharmacy Mark-ups on Reimbursed Drugs, 1 January 2018-31 December
2018
For the part of the MSP: Mark-up (% of MSP)
€0-€1.91 10.0%
€1.92-€22.90 21.4%
€22.91-€150.00 8.5%
€150.01-€1,515.00 6.0%
Above €1,515.00 0.0%
Notes:
To encourage generic dispensing, the higher pharmacy margin by value earned on original off-
patent branded drugs (with the exception of those included in the reference price system) can also
be applied to generic versions
Additionally, pharmacists earn a higher mark-up on three-month packs of prescription drugs. The
mark-up is calculated as follows:
3x the cash value of the mark-up for the one-month pack, less 10%
- Fees
In addition to their mark-up, pharmacists earn fees, both linked to dispensing and for providing
certain services.
Dispensing Fees
Pharmacists earn a number of fees linked to dispensing reimbursed drugs:
• A flat fee per (monthly) pack of €1.02 (including tax). For three-month packs, the fee is €2.76.
• A fee of €0.51 (including sales tax) for dispensing complex scripts (ie those with more than
five drugs on the script).
Notably, the level of these fees is unchanged (ie are applied in 2018 at the same level as in 2017).
The applicable patient co-payment (see ‘Cost Containment: Patient Co-payments’) is calculated taking
into account these pharmacy fees.
Remunerated Services
On top of the above dispensing fees, pharmacists can also earn other fees linked to the provision of
services. For example, pharmacists are eligible for a fee of €50 (as of 1 January 2018, €40 previously)
per patient per year to monitor either asthma patients using a corticosteroid inhaler, or patients
taking anticoagulants.
Reforms
To reflect the planned downward revision of pharmacy mark-ups from 1 January 2019, new
dispensing fees will be introduced for reimbursed drugs as of the same date. New remunerated
services are also planned (see ‘Future Developments: Outlook’).

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- Targets
Pharmacists can also earn up to €3,000 per year if they reach their individual targets, including
targets relating to generic substitution (see ‘Cost Containment: Generics’).
Margins: Non-reimbursed Drugs

Pharmacy margins for non-reimbursed drugs are free from control.
Discounts
Discounts granted by wholesalers to pharmacists on branded drugs and generics are regulated (see
‘Price Build Up: Wholesalers’) and must be specified on the invoice.
Generic manufacturers are prohibited from offering pharmacists extra rebates (marges arrières) on
top of the regular discounts and are required to declare to the Pricing Committee (CEPS) all discounts
granted to pharmacies (see ‘Price Build Up: Wholesalers’). Hidden rebates/discounts on generics are
understood to be common, however.
Wholesalers may pass on some/all of their margin (most common on generics). In such instances, the
pharmacist is not obliged to pass the saving on to the payer (ie integration of the wholesale margin
into the pharmacy margin is permitted). That said, the part of the wholesale margin surrendered to
the pharmacist for branded drugs is subject to taxation (see ‘Price Build Up: Wholesalers’).
Background
According to data from the pharmaceutical industry association (Leem), there were a total of 21,592
retail pharmacies in France in 2016. On account of an over-supply of pharmacies, consolidation has
been encouraged within the sector in recent years.
The director general of the local regional health agency (ARS) takes decisions pertaining to
applications to open a new pharmacy, or relocate an existing one. In both instances, minimum
population and distance requirements apply.
In addition, only qualified pharmacists can own a pharmacy. Ownership is restricted to one outlet,
although the pharmacist can be a minority share-holder in up to four other pharmacies.
Pharmacists are nevertheless permitted to join together to form groups/cooperatives. The national
representative association of pharmacy cooperatives (collectif national des groupements des
pharmaciens d’officine, CNGPO) counts 12,000 pharmacy members (covering 13 cooperatives).
Pharmacies are also allowed to form collective purchasing groups (structure de regroupement à
l’achat, SRA) for non-reimbursed drugs and para-pharmacy products. In this respect, it is notable that
the local press reported in June 2017 that six pharmacy groups had announced the joint establishment
of a “negotiating structure” (named C6) intended to optimise (non-reimbursed) drug purchasing. It is
understood that the structure is charged with negotiating with manufacturers on behalf of the
pharmacy groups in order to achieve the best possible deal for their respective SRAs.
- Pharmacist Prescribing
Pharmacists can renew a prescription for a drug treating a chronic disease, and adjust the dosage of
the prescribed medicine provided that the patient has agreed a treatment protocol for the chronic
disease with their practitioner (see the sub-section ‘ALDs’ in ‘Cost Containment: Patient Co-
payments’), and the patient has elected the pharmacist as their “regular pharmacist” as part of the
protocol.

47
The prescription renewal can be made at the request of the patient’s practitioner, or with their
consent. The treatment protocol must stipulate how many repeat prescriptions can be issued and at
what intervals. The total duration of the prescribed treatment, including renewals, cannot exceed 12
months. The protocol may also require the pharmacist to monitor the patient (ie assess compliance,
tolerance etc) at set intervals.
In addition, pharmacists are permitted to issue one pack (smallest available pack size) of a recently
expired repeat prescription for a drug to treat a chronic condition where any interruption to treatment
could be prejudicial to the patient’s health. In the case of oral contraceptives, pharmacists can issue up
to six months’ supply on presentation of a prescription which has expired within the previous 12
months. The pharmacist is required to inform the prescribing doctor in both scenarios.
- Vaccine Administration
A pilot scheme whereby pharmacists are paid to administer the influenza vaccine to adult patients
who have previously received the vaccine (with the exception of pregnant women, and the
immunosuppressed) commenced in autumn 2017 in two regions: Auvergne-Rhône Alpes and
Nouvelle Aquitaine. Provision for the pilot featured in the 2017 Social Security Finance Law (LFSS).
- Unit-dose Dispensing
A pilot unit-dose dispensing scheme commenced in December 2014 and is scheduled to run until
December 2017. A total of 100 (volunteer) pharmacies in four regions (île de France, Limousin,
Lorraine and Provence-Alpes-Côte d’Azur) are partaking in the pilot, which covers 14 antibiotics:
amoxicillin + clavulanic acid, cefixime, cefpodoxime, cefotiam, ciprofloxacin, levofloxacin, ofloxacin,
lomefloxacin, pefloxacin, moxifloxacin, norfloxacin, enoxacin, flumequine, and thiamphenicol.
- OTCs
Retail pharmacies have a monopoly on sales of non-prescription (OTC) medicines. The majority of
OTC drugs must be kept behind the pharmacy counter, but a restricted number of OTCs (known as
‘médicaments en accès direct’) are eligible for display in pharmacy aisles for self-selection by patients.
The ANSM maintains a list of eligible products which is revised regularly. As at May 2017 (latest
version), a total of 420 drug presentations featured on the list (along with 75 homeopathy and plant-
based preparations). Such medicines are judged by the ANSM to be safe to use without the need for
diagnosis, initiation or follow-up by a physician.
The prices of OTC medicines tend to vary between pharmacies. Calls to liberalise OTC sales (ie to
permit their sale in non-pharmacy outlets) as a means to reduce prices continue to surface from time
to time. Indeed most recently, this was one of the recommendations made by the Supreme Audit
Court (Cour des comptes) in a September 2017 report on the social security finances (see also ‘Future
Developments: Outlook’).
Pharmacists are since July 2015 required to display a notice informing patients that the prices of non-
reimbursed medicines are not regulated.
- E-pharmacy
E-pharmacy is permitted for all non-prescription medicines.
Internet pharmacy services can be provided by established ‘bricks and mortar’ pharmacies only, and
require approval from the relevant ARS before they can begin trading. By law, the pharmacist must
ensure that a new patient completes an online questionnaire (providing details such as age, weight,
current medications, allergies etc) before their order can be processed.
A list of authorised e-pharmacy providers is published on the websites of both the ministry for
solidarity and health and the national chamber of pharmacists. As at December 2017, the list included
464 e-pharmacies.

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Since January 2017, patients in Paris can use an iPhone/android application (“Pharma Express”) to
order non-prescription medicines. It is understood that patients using the application may select one
of a number of partner pharmacies which offer e-pharmacy services to order their non-prescription
medicines, which are subsequently delivered by Pharma Express. According to local press reports, the
service is set to be extended to other large cities including Bordeaux, Lyon and Marseille.
Dispensing Doctors
License to dispense (reimbursed and non-reimbursed) medicines can be granted to physicians by the
director general of the relevant regional health agency (ARS) in the interests of public health (ie where
there is no local pharmacy). If a pharmacy subsequently opens in the area, the physician’s license
must be surrendered. It is understood that doctor dispensing is limited.
Sales Tax
The standard rate of VAT is 20.0%. Reduced rates apply to pharmaceuticals:
• 2.1% for reimbursed medicines
• 10% for non-reimbursed medicines.
COST CONTAINMENT
Industry Paybacks
Tax on Reimbursed Turnover
Tax is levied at the rate of 1.6% on manufacturers’ gross turnover on reimbursed (retail and hospital)
drugs, less any rebates due (see below), and net of any sales outside of France. Exempt for the purpose
of calculating the tax are sales relating to:
• Orphan drugs with reimbursed annual turnover of €20 million or less
• Generics (excluding reference-priced generics)
• Blood products.
Clause de Sauvegarde
A payback clause, known as the clause de sauvegarde, is activated if the national target growth rate
for reimbursed drug spending is exceeded in a given year.
The 2017 Social Security Finance Law (LFSS) modified the legal provisions relating to the payback
clause. It introduced for the first time two sub-targets for reimbursed spending growth on retail drugs
(taux Lv) and hospital drugs (taux Lh), which in 2017 are set at 0% and 2%, respectively. Paybacks are
required from manufacturers if either/both sub-targets are breached. Prior to 2017, a single target
(taux L) applied, with paybacks activated if the single target was breached.
Taken into account for the purpose of the taux Lv are sales of reimbursed retail drugs.

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Taken into account for the purpose of the taux Lh are sales of:
• Liste de rétrocession drugs (see ‘Reimbursement: Hospital Reimbursement’)
• High-cost drugs on the liste en sus (ie funded on top of the regular DRG-type hospital tariffs –
see ‘Reimbursement: Hospital Reimbursement’)
• Drugs with temporary use authorisation (ATU – see ‘Reimbursement: Hospital

Reimbursement’)
• “post-ATU” drugs ie drugs reimbursed after the initial ATU period, in the time between the
official granting of marketing authorisation and the official publication of a reimbursement
decision.
For the purpose of calculations, exemptions are granted to:

• Sales of any drugs falling into these categories where the manufacturer has signed an
individual convention with the Pricing Committee (CEPS) with a provision to this effect (see
below)
• Sales of orphan drugs with annual turnover of €30 million or less
• Generics (excluding generics included in the TFR reference price reimbursement system [see
‘Reimbursement: Reimbursement Prices’] and generics with a corresponding reference
product priced at generic levels).
Where the payback clause is triggered, repayments due from manufacturers are calculated as a
percentage (50%, 60% or 70%) of their net sales revenue on eligible drugs (less any rebates due eg in
relation to hepatitis C drugs and temporary use drugs [see below]), depending on the extent to which
the taux Lv/Lh is exceeded.
Notably, manufacturers can (and all/almost all do) opt out of the payback scheme by signing a
convention with provision to this effect. Such conventions detail more tailored repayments for the
manufacturer in the event that the taux Lv/Lh is breached. These tailored repayments must be
equivalent to 80% or more of the total repayment which would have been due under the general
payback scheme.
The clause de sauvegarde was activated in 2016 and 2015. In relation to the latter, CEPS indicates
that repayments totalling €109 million were theoretically due from manufacturers. However, all 185
manufacturers had signed pricing agreements with CEPS providing exoneration from the general
payback scheme, with the result that more tailored (reduced) repayments of €87.2 million were made
by companies instead.
Eventual repayments due from manufacturers under the taux Lh are transferred to the new Fund for
Financing Pharmaceutical Innovation – see ‘Healthcare System: Provision & Funding’.

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Conventions System
Signed between manufacturers and CEPS, individual conventions comprise up to three sections:
• Details of all reimbursed drugs commercialised by the manufacturer, and their agreed prices,
as well as any drug-specific repayment clauses (see ‘Pricing: Prescription Drugs’).
• A commitment from the manufacturer to promote its products appropriately and to

encourage the rational use of its drugs.
• Details of the repayments due in the event that the clause de sauvegarde is triggered (see
above). Manufacturers who do not include this provision are liable for repayments under the
general scheme.
For companies who have opted out of the general repayment scheme by signing an exonerating clause
(see above), more tailored repayments are calculated in any year that the clause de sauvegarde is
triggered. There are two types of repayments, linked to pharmacotherapeutic group and turnover,
respectively. In the case of the former, eventual repayments are calculated based on net annual
turnover, following deduction from the sales figures of repayments linked to product-specific rebates
(eg those due under price-volume agreements).
For calculation purposes, full/partial exemption is granted as follows:
• On a permanent basis: orphan drugs (subject to a €30 million limit on annual reimbursed
turnover), generics, drugs priced at generic levels, and products included in the reference
price reimbursement system (TFR – see ‘Reimbursement: Reimbursement Prices’) (see Table
6, below).
• For a defined period and subject to a €300 million limit on reimbursed turnover, drugs
judged to offer an improvement in medical benefit (ASMR) over comparators. The period and
level of exemption is determined by the level of the product’s ASMR (ie its ASMR rating – see
‘Reimbursement: Admission to Reimbursement’) (see Table 6, below). Manufacturers can opt
for a longer period of exemption than that specified (up to a maximum of five years) but at a
reduced rate of exemption, provided that the overall repayments would amount to the same
total.
• Special rules apply to paediatric drugs and drugs with an ATU (see Table 6, below).
• CEPS may also choose to grant additional (temporary) exemptions. For example, CEPS can
determine to (temporarily) exempt either partially or fully certain pharmacotherapeutic
groups for economic or public health reasons. Indeed, the current (December 2015) Accord
Cadre provides for (temporary) exemption from repayments for some/all of manufacturers’
turnover for antibiotics, as well as any other medicines intended to treat resistance to
antibiotics.

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Table 6: Repayment Exemptions
Drug Type Level of Exemption Period of Exemption
ASMR I1 100% 36 months
ASMR II1 100% 24 months
ASMR III1 50% 24 months
ASMR IV1 25% 24 months
Generics2 100% Permanent
Orphan Drugs 100% Permanent
Paediatric Drugs Exempted at one ASMR level above their actual ASMR1
Drugs with an ATU3 Determined by CEPS on an individual basis4
Notes:
1Where the ASMR is only valid for some of the drug’s approved indications, or different ASMR
ratings apply to different indications, the exemptions are calculated pro rata, according to the
number of patients treated.
2Including drugs priced at generic levels, and products included in the reference pricing system
(TFR – see ‘Reimbursement: Reimbursement Prices’) that are priced at the reference level.
3Temporary use authorisation (see ‘Reimbursement: Hospital Reimbursement’)
4In such instances, the exemption which the drug subsequently qualifies for (ie based on its
eventual ASMR) following official marketing authorisation is reduced to reflect the exemption
granted during the ATU period.
Hepatitis C Medicines
Repayments are due from manufacturers of high-cost hepatitis C medicines where combined
reimbursed sales exceed an annual cap (“W”), and sales have grown 10% versus the previous year. In
2017, the level of the cap is set at €600 million, down from €700 million in 2016 (and 2015, up from
€450 million in 2014 [applied retrospectively]).
The level of the rebate due depends on the extent to which the budgetary cap (“W) set for hepatitis C
drugs (which feature on a corresponding list drawn up by the High Authority for Health, HAS) is
exceeded (see Table 7, below).
Manufacturers’ combined turnover is calculated following deduction of:
• sales of any hepatitis C drug with total reimbursed sales of less than €45 million
• rebates linked to temporary use authorisation (ATU) (see below), or linked to individual
conventions (see above).
Each manufacturer’s contribution is limited to a maximum of 15% of their total (pre-tax) turnover on
medicines in France.

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Manufacturers can opt out of this general arrangement for hepatitis C drugs by signing a convention
(see above) with CEPS detailing more tailored repayments for such drugs in the event that they are
required. In these instances, the tailored repayments must be equivalent to 90% or more of the
repayment which would have been due under the general hepatitis C drug repayment scheme.
Table 7: Rebates due on Hepatitis C Drugs

Combined Turnover (all manufacturers) on Hepatitis C Level of Contribution (%
Drugs (C) turnover)
W < C ≤ (W +10%) 50%
(W + 10%) < C ≤ (W + 20%) 60%
C > (W + 20%) 70%
Notes:
W = budget cap
In 2015, repayments totalling €11.4 million were theoretically due from manufacturers in respect to
hepatitis C drugs under this scheme. However, only one manufacturer (Gilead) made contributions via
the general scheme; the other two manufacturers had signed an exonerating convention (stipulating
more tailored [lower] repayments) (see above).
The hepatitis C repayment scheme was introduced by the 2015 Social Security Finance Law (LFSS).
Notably, in line with a provision included in the 2017 LFSS, any rebates due from manufacturers in
relation to hepatitis C drugs are transferred to the Fund for Financing Pharmaceutical Innovation (see
‘Healthcare System: Provision & Funding’).
Temporary Use Drugs

Manufacturers of drugs with temporary use authorisation (ATU – see ‘Reimbursement: Hospital
Reimbursement’) are liable for rebates, as set out below. Rebates due in relation to ATU drugs are
transferred to the Fund for Financing Pharmaceutical Innovation (see ‘Healthcare System: Provision
& Funding’).
- Cap on Treatment Costs
The 2017 LFSS introduced a budget cap of €10,000 per patient per year for drugs with an ATU. Where
costs exceed this level, the manufacturer is required to repay the difference between actual reimbursed
spending and (€10,000 x the number of patients treated). The rebate only applies where the drug (in
the context of the ATU) records annual turnover of €30 million or over.
- Net Price
Manufacturers are since 2015 liable to pay a rebate if the (net) price set by CEPS at the end of the ATU
period when the drug is formally granted reimbursement is less than the initial price set by the
manufacturer (drugs subject to an ATU are freely priced by manufacturers). The amount of the rebate
payable is equivalent to the difference in sales revenue.
In 2015, six products (five hepatitis C drugs, including Daklinza [daclatasvir] and Olysio [simeprevir],
as well as the multiple sclerosis treatment Tecfidera [dimethyl fumarate]) were impacted by such
rebates, which totalled €64.3 million.

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Credits
It is noteworthy that manufacturers may be awarded credits (for price cuts, for example) which can be
used against rebates due (in relation to specified products, but also in relation to the clause de
sauvegarde and hepatitis C drugs – see above). Credits can be carried forward for a maximum of five
years.
Promotional Costs
Promotion-based Tax
Manufacturers’ promotional expenditure on reimbursed (retail and hospital) drugs is subject to
taxation. For the purpose of the tax, the following costs are taken into account:
• Spending on drug sales representatives, including related transport, meal and
accommodation costs
• Publication and advertising costs
• Direct and indirect costs pertaining to scientific events (venue hire, advertising, meals and
accommodation etc).
The rate of taxation is calculated based on the ratio (R) between promotional expenditure (once
certain rebates are deducted) and total reimbursed turnover (excluding tax) (see Table 8, below). A
four tranche scale applies (ie different rates may be applied concurrently). The rebates that can be
deducted prior to the calculation are as follows:
• A set amount, currently €2.5 million.
• 3% of spending on drug sales representatives (but excluding corresponding transport, meal

and accommodation costs).
• 75% of spending on scientific events.
• 30% of turnover (excluding tax) on sales of orphan drugs with annual turnover of €30 million
or under.
• 30% of turnover (excluding tax) on sales of generics (excluding reference-priced generics, and
generics for which the [off-patent] brand has reduced its price to generic levels).
Companies recording total reimbursed annual turnover (excluding tax) of less than €15 million are
exempted from payment of the tax (with some exceptions).

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Table 8: Promotion-based Tax, Brackets and Rates
Tax Bracket Tax Rate
R < 6.5% 19%
6.5% ≤ R < 12% 29%
12% ≤ R < 14% 36%
R ≥ 14% 39%
Note:
R is the ratio between promotional expenditure (after deduction of the rebates set out in the bullets
above) and total reimbursed turnover (excluding tax)
Advertising
Direct-to-consumer (DTC) advertising is prohibited for prescription drugs as well as reimbursable
OTCs.
Non-prescription medicines without any reimbursable presentation available can be advertised direct
to consumers. DTC advertising is also permitted for reasons of public health for smoking cessation
treatments and for vaccines which feature on a corresponding list drawn up by the health minister. In
all three cases, manufacturers are required to obtain a priori approval in the form of a (chargeable)
publicity visa (visa GP) issued by the national agency for drug safety (ANSM).
Publicity visas (in this instance a visa PM) is also required for all advertising aimed at medical
professionals. As with visa GPs, a priori application and approval (from the ANSM) is required.
Free samples can only be issued during the first two years of a product’s commercialisation. Moreover,
they can only be distributed on request to hospital-based physicians/pharmacists. Such samples are
limited to a maximum of four per year per physician/pharmacist.
Promotional Information Charter

A “promotional information charter”, signed between the pharmaceutical industry association (Leem)
and the Pricing Committee (CEPS) in October 2014, is intended to ensure the distribution of high-
quality information to (prescribing) physicians and ensure correct usage.
The charter stipulates, for example, that sales representatives are forbidden from distributing free
samples or advocating off-label usage, but must promote correct usage in accordance with the drug’s
marketing authorisation and licensed indications, and any relevant prescribing
recommendations/guidelines. It also sets standards in terms of ongoing training and evaluation for
sales reps. Notably, the charter also states that companies must report to the authorities any instances
of (unapproved) off-label usage of medicines.
A certification procedure is linked to the charter (ie certifying that manufacturers apply the charter).
All manufacturers of reimbursed drugs who have signed a convention with the Pricing Committee
(CEPS – see ‘Pricing: Prescription Drugs’) are required to obtain this certification from the High
Authority for Health (HAS).

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Sunshine Act
The so-called “Sunshine Act” sets out in law initiatives aimed at preventing conflicts of interest and
ensuring the transparency of interactions between healthcare professionals and the pharmaceutical
industry.
The Act stipulates, for example, that drug manufacturers must declare all payments/items of value
costing €10 or more, made to physicians, pharmacists, medical students, hospitals/clinics,
associations of professionals/patients etc.
Patient Co-payments
Pharmaceuticals and healthcare services are subject to co-payments/fees. Full details are set out
below.
Pharmaceuticals
Patients contribute towards the cost of pharmaceuticals as follows:
• Drugs are reimbursed at 100%, 65%, 30% or 15% (see ‘Reimbursement: Reimbursement
Categories’): the non-reimbursed portion is billed to patients. However, most patients hold
complementary insurance which typically covers this cost. Moreover, exemption from co-
payments are granted to certain patient groups, namely:
° Expectant mothers (from the sixth month of pregnancy onwards and for 12 days
postpartum).
° Beneficiaries of state-funded complementary insurance (CMU-C, see ‘Healthcare System:

Provision & Funding’), or financial assistance for the purchase of complementary
insurance (ACS – see ‘Healthcare System: Provision & Funding’).
° Persons entitled to state medical assistance (AME – see below)
° Patients with an “exonerating” chronic disease (ALD – see below).
• A fixed fee of €0.50 charged on each medicine pack (including magistral preparations),
subject to an annual maximum. Exceptions apply (see the section ‘Franchise Médicale’,
below).
• For patients opting for a more expensive version of a medicine included in the reference price
reimbursement system (see ‘Reimbursement: Reimbursement Prices’), the excess over the
reference price. The excess is payable on top of the non-reimbursed portion of the reference
price, and is not typically covered by complementary insurance (see below).
• Patients refusing generic substitution are required to pay the full public price of the drug up
front, rather than just the co-payment (and must then apply for reimbursement a posteriori).
Exceptions apply, however (see ‘Cost Containment: Generics’).
• Oral contraceptives, as well as contraceptive implants and the intrauterine device, are 100%
reimbursed for girls aged under 15 years of age (65% reimbursed for all other groups).

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- ALDs
Patients with an “exonerating” long-term chronic illness (or affection de longue durée, ALD) qualify
for 100% reimbursement for medicines and treatments (consultations, tests etc) linked to the
condition. The list of “exonerating” ALDs, namely illnesses which on account of their
seriousness/chronic nature required prolonged and costly treatment, is defined in law and includes
(among others): Parkinson’s disease, diabetes types 1 and 2, HIV/AIDS, severe epilepsy, multiple
sclerosis, Crohn’s disease, and cancer.
To be eligible for 100% reimbursement, patients with an “exonerating” ALD are required to draw up a
treatment protocol with their treatment practitioner, in conjunction with other healthcare
professionals/physicians involved in their care. The protocol is subsequently validated by the
consulting physician of the patient’s health insurer. The protocol details the medicines and treatments
(consultations, tests etc) required to treat the condition and qualifying for 100% reimbursement.
Patients are still required to cover the €1 fee and the franchise médicale (see ‘Out-patient Care’,
below), however. Notably, the standard reimbursement rates apply to medicines/treatments not
linked to the ALD.
100% reimbursement for medicines and treatments is also granted on an individual basis to patients
with other serious chronic or disabling conditions which are not defined in law as “exonerating” ALDs,
but which require long-term (six months or more) and costly treatment.
Patients with a “non-exonerating” ALD (classed as an illness which requires the patient to stop work
or receive treatment for six months or more) are reimbursed at the usual rates for medicines and
treatments linked to their conditions (see above and below). Since 1 January 2017, patients with an
ALD are exempt from paying up-front co-payments due on services and treatments via the third party
payer system (tiers payant – see below).
- Complementary Cover
95% of the population hold complementary insurance cover (either privately or state-funded CMU-C
– see ‘Healthcare System: Provision & Funding’) which typically covers the non-reimbursed cost of the
drug’s price (see above). Complementary insurance does not usually cover any excess over the
reference price, or (with the exception of the state funded CMU-C) the €0.50 per pack fee.
Some complementary insurance policies also provide cover for non-reimbursed medicines. For all
other non-reimbursed medicines, patients are liable for the full cost.
- In-patients
Drugs dispensed to patients during the course of hospitalisation are fully reimbursed. Patients are
however liable for other charges for hospital in-patient care (see ‘In-patient Care’, below).
- AME Scheme
Patients covered by the state medical aid (aide médicale de l’État, AME) scheme, which enables (low-
income) patients resident in France illegally (for more than three months) to access healthcare are
exempted from co-payments for most out-patient medicines. However, adult patients are since
February 2015 required to pay the full cost of medicines with a weak medical benefit (SMR – see
‘Reimbursement: Reimbursement Categories’) rating. Children covered by the AME scheme still
qualify for 100% reimbursement for these drugs.

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Out-patient Care
Patients are liable for fees in relation to out-patient services, as set out below.
- Consultation Fees
For physician consultations, a 30% co-payment typically applies. The co-payment is higher if the
physician opts to set their consultation fee above the nationally-determined level (see ‘Healthcare
System: Provision & Funding’).
Patients are encouraged to register with a (gatekeeper) treatment practitioner, who can be either a
general practitioner (GP) or specialist. Patients aged 16 years and over who have not registered with a
(gatekeeper) treatment practitioner, or who consult a physician (GP or specialist) other than their
treatment practitioner in the first instance, incur a 70% co-payment. Exemptions apply to direct
consultations with gynaecologists, ophthalmologists, stomatologists, or (in the case of patients aged
between 16 and 25) psychiatrists, as well as (in all instances) to children under the age of 16.
Expectant mothers (from the sixth month of pregnancy onwards and for 12 days postpartum),
beneficiaries of CMU-C and patients with an exonerating ALD (see above) are all exempted from all
co-payments on physician consultations at the 30%/70% level.
Laboratory tests are subject to a 30%/40% co-payment.
- Tiers Payant
The third-party payer (tiers payant) system exempts patients from paying up-front co-payments due
on treatments/services. Under this system, the care provider bills directly the patient’s statutory
insurer (and/or complementary insurer) for their portion of the fee.
The December 2015 healthcare reform provided for the compulsory extension to all patient groups of
the third-party payment system in relation to treatments/services provided by healthcare
professionals (physicians, midwives, physiotherapists etc) working in the out-of-hospital sector and
reimbursed by the statutory health insurance system. A corresponding provision was included in the
2018 draft Social Security Finance Law (which would extend the system from 1 January 2018, rather
than from 1 December 2017 as initially intended under the 2015 reform), but was overturned and did
not feature in the final version of the law approved by the lower house.
Application of the system was nevertheless made compulsory with effect from 1 January 2017 for
expectant mothers and ALD patients (optional for other patient groups).
Patients with certain types of complementary health insurance policies (so-called “contrats
responsables”) are since 1 January 2017 also eligible to use the third-party payer system in relation to
the complementary insurer’s portion of the bill. However, it is understood that the proportion of
physicians who bill complementary insurers directly for their portion of the bill is currently small, but
is higher for other healthcare professionals, for example midwives.
- Franchise Médicale
Patients are required to pay three charges, collectively known as the franchise médicale, up to a
combined annual ceiling of €50:
• €0.50 per reimbursable service provided by a healthcare professional (nurse, physiotherapist
etc but excluding general practitioners [GPs] and specialists), up to a maximum of €2.00 per
day and per professional.
• €2.00 per reimbursable medical transportation, excluding emergency transport, up to a

maximum of €4.00 per day.
• €0.50 per reimbursed medicine pack (see ‘Pharmaceuticals’, above).

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Certain patient groups are exempted from these charges, namely: children under the age of 18 years,
beneficiaries of the CMU-C, ACS or AME, expectant mothers (from the sixth month of pregnancy and
for 12 days postpartum), holders of a military disability pension (but only for services provided in the
course of treating the qualifying disability/injury), and victims of terror attacks (during the course of
treatment relating to the attack).
- €1 Fee
A €1 fee is levied (up to an annual maximum of €50) on all (GP and specialist) consultations,
diagnostic tests and laboratory tests carried out either in the out-of-hospital sector or hospital out-
patient departments. The exemptions are the same as for the franchise médicale (see above).
- €18 Fee
A €18 fee is also charged on services and treatments provided in the out-of-hospital and hospital
sectors and costing €120 or more. The following rules apply:
• If several treatments are provided during the course of a single consultation, the costs are
aggregated and the charge is levied if the combined amount is €120 or more.
• If multiple treatments costing €120 or more are provided as part of a single consultation, the
fee is only charged once.
• In the event of hospitalisation, the fee only applies once and is levied on the total costs, rather
than for every high-cost treatment.
• The fee does not apply to radiology services, emergency transport, or to services provided
after the 31st consecutive day of in-patient hospital treatment.
Exemption from the €18 fee is granted to: beneficiaries of the CMU-C, ACS or AME, holders of an
invalidity pension, people with disabilities, holders of a military pension (on account of illness or
disability incurred during service), low-income pensioners, expectant mothers (from the sixth month
of pregnancy and for 12 days postpartum), newborn babies, patients hospitalised due to an accident or
injury at work, patients receiving infertility treatment, all patients from the 31st consecutive day of
hospitalisation and all patients hospitalised with an “exonerating” ALD.
- Private Insurance
Complementary (private) insurance providers may cover some/all of the patient co-payments relating
to consultations and the €18 fee, but are not allowed to cover the franchise médicale or the €1 fee.
In-patient Care
Hospital in-patient treatment is subject to charges, as set out below.
- Daily Tariff
A fixed tariff of €18 per day is levied for stays in a general hospital (€13.50 per day in a psychiatric
hospital). The charge applies to all stays over 24 hours, including the day of discharge.
Exempt from the tariff are: beneficiaries of the CMU-C, the AME and ACS, expectant mothers (from
the sixth month of pregnancy and for 12 days postpartum), newborn babies, patients hospitalised due
to an accident or injury at work or work-related illness, holders of military pensions, children under
20 years of age with a disability, and victims of a terror attack (during the course of treatment relating
to the attack).

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- Total Cost Contribution
Patients are also required to pay 20% of the total costs of hospitalisation (excluding the fixed daily
tariff). Exemptions are permitted for: children, beneficiaries of the CMU-C or AME, expectant
mothers (from the sixth month of pregnancy and for 12 days postpartum), newborn babies, patients
hospitalised due to an accident at work or work-related illness, holders of military and invalidity
pensions, all patients from the 31st consecutive day of hospitalisation, all patients hospitalised on
account of an “exonerating” ALD, and victims of a terror attack (during the course of treatment
relating to the attack).
- Supplementary Fees
Supplementary fees can also be billed to the patient, including in relation to consultation fees where
the physician applies fees above the nationally-determined level, and/or for private rooms,
television/telephone etc.
- €18 fee
An €18 fee is levied on all services and treatments provided in the hospital (and out-of-hospital)
sectors and costing €120 or more (see above).
- Private Insurance
Some/all of the fees relating to hospitalisation, including the €18 fee, may be covered by
complementary (private) insurers depending on the policy.
Prescribing Controls
There are no prescribing budgets. Rational prescribing is nevertheless encouraged: details are given
below.
Prescribing Targets
- Performance-related Fees
All physicians earn fee-for-service payments (see ‘Healthcare System: Provision & Funding’). On top
of these, physicians can (since 1 January 2012) earn bonus payments linked to participation in a
performance-based remuneration system (rémunération sur objectifs de santé publique, ROSP).
Details of the ROSP system are set out in a convention signed between the main health insurance fund
(CNAMTS) and physicians’ unions. The most recent convention was signed in August 2016 and covers
the five years 2017-2021. Under this convention, the ROSP is linked to the quality of care (and
prescribing) only (under the previous convention, the ROSP was linked both to the quality of
care/prescribing and the organisation of care).
General practitioners (GPs), cardiologists, gastroenterologists and (from 2017) endocrinologists are
eligible to participate in the ROSP; other types of specialist are expected to become eligible during the
course of the current convention.

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The ROSP system sets objectives linked to a number of indicators (29 under the current convention,
including 17 new indicators which did not feature under the ROSP in place under the previous
convention) in three main areas:
• Prevention targets: for example, GPs are required to achieve 80% participation in breast
cancer screening programmes for women aged 50-74, 75% uptake of the influenza vaccine
among patient aged 65 and over, and 70% participation in colorectal screening programmes
for patients aged 50-74.
• Prescribing targets: increasing the proportion of generic prescriptions for statins (97%, versus
70% under the previous convention – see above), and antihypertensives (92%; 65%
previously), asthma treatments (86%), and urinary incontinence treatments (94%); as well as
treating 93% of diabetes patients with metformin. In addition, physicians are required to
ensure that 20% or more of their prescriptions for insulin glargine are for biosimilar versions,
and to reduce prescriptions for antibiotics.
Notably, a number of other indicators relating to prescribing which had featured previously
were removed with effect from 2017 under the new convention, including, for example targets
relating to generic prescriptions for antibiotics and antidepressants, and prioritising the
prescription of ACE inhibitors over sartans.
• Follow-up care: for patients with chronic diseases eg diabetes and renal insufficiency.
Notably, the targets are based on the guidelines/best practice recommendations issued by the High
Authority for Health (HAS) (see ‘Guidelines’, below).
The objectives are linked to a points system, which in turn forms the basis for determination of an
annual basis payment. Prescribing targets (see above) account for 35% of all possible points.
In 2017, the average bonus paid to participating physicians (relating to the year 2016) was €4,593,
according to the CNAMTS. The average bonus earned by GPs was €6,983. Further analysis by the
CNAMTS published in April 2017 indicated that physicians partaking in the ROSP system (in 2016 it
is assumed) attained or exceeded their objectives linked to prescribing for five out of the seven targets.
It is noteworthy that the Court of Audit suggested in July 2014 that the ROSP be made compulsory for
all physicians, and that failure to meet the targets should be penalised financially (at present, failure to
meet the objectives results in full/partial non-payment of the associated performance-related fee).
These suggestions have not been acted upon to date, however.
- Hospital Sector
A specific target for generic prescriptions (by volume) written by (public/private) hospital-based
physicians for patients on discharge from hospital was introduced for the first time by the 2015 Social
Security Finance Law (LFSS). The target was set at 39% for the year 2015, and 44% in 2016. However,
it is unclear whether a revised target has been established for 2017.
Individual hospitals may opt to sign a contract with the national union of health insurers (UNCAM)
defining prescribing objectives.

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Guidelines
The HAS’ remit extends to compiling (non-binding) guidelines for physicians which are intended to
support their professional activity. Its publications include:
• Prescribing guidelines for GPs covering the treatment of long-term chronic diseases (ALDs –
see ‘Cost Containment: Patient Co-payments’). These describe the optimal treatment pathway
and include a list of fully-reimbursed medical treatments, products and services linked to the
illness.
• Recommendations de bonne pratique (RBP), or best practice recommendations, are designed

to help physicians identify the most appropriate care (including medicines, where
appropriate), based on the latest scientific opinion and expert opinion. For example, in
November 2017 the HAS published a new RBP covering the treatment of depression in adults.
Notably, the RBP advises that anti-depressant medicines should not be routinely prescribed to
patients with mild depression, but should be prescribed only to patients with moderate/severe
depression. It also specifies which drug/s can be used as first-/second-/third-line therapy and
as a last resort.
• Fiches bon usage du médicament (BUM) set out key information for prescribers on a drug’s
medical benefit/improvement in medical benefit versus comparators (ie the results of a drug’s
assessment by the Transparency Commission [CT]) and place in therapeutic strategy. The
most recently published BUM (in November 2017) relates to Xolair (omalizumab) in the
treatment of severe asthma.
• The HAS’ Commission for Economic Evaluation and Public Health (CEESP) can draw up
health economics (HE)-based prescribing guidelines. The CEESP also conducts HE
evaluations of individual drugs for the purpose of setting initial prices (see
‘Pharmacoeconomics: Pharmacoeconomic Requirements’).
Exception Drugs
Prescribing restrictions apply to all ‘exception drugs’ (see ‘Reimbursement: Admission to
Reimbursement’). Physicians must prescribe all ‘exception drugs’ on specific scripts, and must declare
that the prescription is in line with the approved reimbursement indications and usage detailed on the
drug’s therapeutic information sheet (FIT).
Feedback
Physicians are visited by representatives from the health insurance funds who can provide feedback
on prescribing (eg against their targets – see ‘Prescribing Targets’, above), and prescribing advice.
Representatives may also encourage prescribing in line with national guidance (see above), and offer
advice on specific public health campaigns.
Hospitals may receive similar visits to discuss prescribing and drug usage.
Campaigns
The CNAMTS runs (occasional) campaigns aimed at physicians and patients and promoting rational
usage.
In September 2016, a generics information campaign was launched which is intended to build
confidence in the safety, efficacy and quality of generic medicines. The campaign was run by the
(then) ministry for social affairs and health (now the ministry for solidarity and health) in conjunction
with the CNAMTS and the national agency for drug safety (ANSM).

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Prescribing Restrictions
There are five categories of prescribing restrictions:
• Hospital usage only (médicament réservé à l’usage hospitalier, RH).
• Prescription by hospital specialist only (médicament à prescription hospitalière, PH).
• First prescription by a hospital specialist (medicament à prescription initiale hospitalière,

PIH). Subsequent prescriptions can be issued by any physician.
• Prescription by a certain type of specialist (medicament à prescription réservée à certains

médecins spécialistes, PRS) eg by cardiologists only.
• Prescription requiring follow-up, for example to ensure compliance with the drug regimen or
check for adverse reactions (médicament nécessitant une surveillance particulière pendant le
traitement, SP).
Notably, a drug can feature in more than one of the above categories.
All prescribing restrictions are determined by the ANSM as part of a drug’s marketing authorisation
(AMM) or temporary use authorisation (ATU). Prescribing restrictions can also be imposed in
response to new data relating to an existing drug. For example, the ANSM determined that with effect
from 16 March 2017 initial prescriptions for Vastarel (trimetazidine) and its generic versions can only
be written by cardiologists. Furthermore, the cardiologist is required to review the prescription
annually. According to the ANSM, the change reflects the recognised neurological side effects of the
drug, as well as high levels of off-label usage (90% of prescriptions for trimetazidine are for off-label
use in ophthalmology and/or otorhinolaryngology, according to the ANSM). Prescription renewals for
the drug can still be issued by any physician, including general practitioners (GPs).
Generics
Generics held 22.1% of the total (retail and hospital) market by value and 53.1% by volume, in the 12
months ending September 2017, based on IQVIA data.
Generic Substitution
Pharmacists are able to substitute a generic for a branded original medicine, subject to the following
conditions:
• The prescriber has not prohibited substitution (by writing “non-substitutable” on the script)
(see below). In 2016, 8.3% of scripts were marked as non-substitutable by physicians,
according to the main health insurance fund (CNAMTS).
° In August 2017, it was reported that the general practitioner (GP) union MG France had
called on the regulatory authorities to withdraw the possibility for physicians to prohibit
generic substitution. The union has reportedly advised its members not to use the option,
but rather to advise their patients to speak to their pharmacist who can advise them on
the most appropriate medicine. The development followed a statement by the health
minister that patients (ie as opposed to physicians) should be able to choose “the
medicine that best suits them”.
• The drug features on the list of generic groups drawn up by the National Agency for Drug
Safety (ANSM) (see below); and
• The substitution does not lead to additional costs for the health insurance system.

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Pharmacists are legally required to write on the script the brand name of the drug which has been
substituted.
- List of Generic Groups
The ANSM compiles and updates the list of drugs authorised for generic substitution (répertoire des
médicaments génériques). New additions to the list must be “officially” published on the ANSM’s
website before substitution can commence. Key features of the list are as follows:
• Groups are determined based on the same active ingredient, dose, form and method of
administration.
• Generics can be granted marketing authorisation and included on the list prior to the patent
expiry of the original brand in order to speed up substitution on patent expiry of the original.
• Manufacturers of original brands can grant one or more generic companies permission to
begin producing a generic version in France prior to patent expiry. The generic can only be
dispensed once the patent has expired on the branded original.
• Controversially, aspirin and paracetamol are excluded from the list (although paracetamol in
combination with other molecules does feature on the list).
- Tiers Payant Contre Génériques
Any patient who refuses generic substitution is required to pay the full cost of the drug up-front
(rather than just the applicable co-payment), except where:
• The product is included in the reference price system (TFR), in which case the patient pays
the applicable co-payment plus, where relevant, any difference between the price of the drug
dispensed and the reference price
• The branded product has a price lower than, or equal to, generic versions
• The pharmacist determines that the substitute may put the patient at risk, for example in the
case of patients with allergies, or in the case of elderly patients (see below)
• The prescribing doctor has prohibited substitution
• Drugs with a narrow therapeutic margin (namely the anti-epileptics lamotrigine,

levetiracetam, topiramate, sodium valproate, pregabalin and zonisamide, as well as
levothyroxine), as well as other drugs specifically excluded by the ANSM (buprenorphine and
mycophenolate mofetil).
- Substitution Targets
First introduced in 2006, generic substitution targets are established for pharmacists in a bid to boost
generic uptake.
Each year a national substitution target is fixed by agreement between the pharmacists’ associations
and the national union of health insurers (UNCAM). For 2017, the target is set at 86%, the same level
as in 2016 (which was not reached – see below).
To facilitate attainment of the overall national target, individual targets are established for each
pharmacy, and specific targets established for certain molecules – 28 in total in 2017 including
rosuvastatin, duloxetine, valsartan, clopidogrel and olanzapine. Attainment of these targets is linked
to additional remuneration for pharmacists (see ‘Price Build Up: Retail Pharmacies’).

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In addition, a separate target is established for issuing to patients aged 75 and over the same version
of specified molecules indicated for the treatment of chronic diseases. For 2017, the target is 90% of
patients in this age group to be issued with the same version of any of 19 molecules, including
atorvastatin, quetiapine, metformin, and ramipril. As with the generic substitution targets, attainment
of this target is linked to additional remuneration for pharmacists.
The national substitution rate reached 83.6% nationally in 2016.
- TFR
New reference price groups are created for products with generic substitution rates below fixed levels
at set intervals following the establishment of generic competition (see ‘Reimbursement:
Reimbursement Prices’). CEPS may also opt to create new groups where substitution levels stagnate.
In this respect, it is noteworthy that CEPS has repeatedly warned that it will include clopidogrel in the
TFR if substitution levels do not increase above 80%; for 2017, an individual substitution target has
been fixed for clopidogrel (see above).
- Incentives
Pharmacists are incentivised financially to substitute. Specifically, they are able to apply the higher
margin (by value) earned on off-patent original drugs (excluding those in the TFR) to generic drugs
(see ‘Price Build Up: Retail Pharmacies’).
Pharmacists are eligible for additional remuneration for achieving objectives linked to generic
substitution (see above and ‘Price Build Up: Retail Pharmacies’).
INN Prescribing
International non-proprietary name (INN) prescribing is compulsory since 1 January 2015.
Accordingly, all physicians (as well as dentists, midwives etc) working in both the hospital and out-of-
hospital sectors are required to specify the generic name of a drug on the script when writing a
prescription. They may also include the brand name where deemed necessary.
However, the Inspector General for Social Affairs (IGAS) reported in March 2016 that around 31% of
sector 2 GPs (ie those who set their own fees – see ‘Healthcare System: Provision & Funding’) and
52% of sector 2 specialists still prescribe by brand name only.
Prescribing Targets
Physicians are eligible for performance-related fees linked to generic prescribing targets (see ‘Cost
Containment: Prescribing Controls’).
A specific target for generic prescriptions by hospital-based physicians applied in 2015 and 2016.
However, it was unclear whether a revised target had been established for 2017 (see ‘Cost
Containment: Prescribing Controls’).
Generic and Off-patent Price Cuts

Scheduled price-cuts apply to generic and off-patent products (see ‘Reimbursement: Changes in
Reimbursement Prices’).

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Biosimilars
- Physician Switching
When prescribing a biological drug to a treatment naïve patient, the prescriber is required to write on
the script “commencing treatment”.
The ANSM states that physician-level substitution of a biological drug, either with another biological
drug or a biosimilar version, during the course of treatment is permissible where certain conditions
are met:
• The patient is informed of the possibility of substitution, and agrees to the switch.
• The patient receives appropriate follow-up care.
• The traceability of the drugs in question is guaranteed.
The physician performance-related remuneration system includes since 2017 a target related to
biosimilar prescribing (see ‘Cost Containment: Prescribing Controls’).
- Pharmacy-level Substitution
A provision included in the 2017 Social Security Finance Law (LFSS) states that pharmacists can
substitute a biological drug with a biosimilar version for patients who have not yet begun treatment,
and can substitute one biosimilar version with another to ensure continuity of treatment, on the
condition that:
• The physician has not prohibited substitution; and
• The drug features on the list of substitutable biological drugs. In September 2017, the ANSM
published the first such list which features 11 active ingredients.
However, it is understood that at the time of writing (December 2017) publication of a corresponding
“application decree” was still pending meaning that pharmacy-level substitution is not yet possible in
practice.
National Action Plan

Launched in April 2015, a national action plan for generics aims to increase the volume of prescribing
within the list of generic groups (see ‘Generic Substitution’, below) by 5% by (the end of) 2017. To
achieve this, the plan sets out the following objectives:
• Strengthen the prescription and use of generics in hospitals, care homes and the primary care
sector
• Increase confidence in generics among both prescribers and patients.
° To this end, a generics information campaign designed to build confidence in the efficacy,
safety and quality of generic medicines was launched in September 2016.
° Following the campaign the main health insurance fund (CNAMTS) reported that 75% of
physicians indicated that they would prescribe a generic versus 68% prior to the
campaign. Moreover, 58% of chronic patients indicated that they would accept a generic
medicine after the campaign compared to 52% beforehand.
• Extending the list of generic groups (see above)
• Implementing therapeutic tendering in hospitals.

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Separately, the government’s draft national health strategy for 2018-2022 includes a target of
ensuring that by 2020 one in every two prescriptions is for a medicine included on the list of generic
groups authorised for generic substitution (see above). The final strategy was expected to be
confirmed imminently at the time of writing (December 2017) (see ‘Future Developments: Outlook’).
Rx-to-OTC Switches
Switches
The National Agency for Drug Safety (ANSM) assesses applications to switch a product from
prescription only (prescription médicale obligatoire, PMO) to non-prescription (prescription
médicale facultative, PMF) status. Product switches are only considered for products with a proven
safety profile, and with a reimbursed therapeutic equivalent available.
Switches are uncommon. However, in July 2017 the Minister for Solidarity and Health Agnès Buzyn
announced a reverse switch (ie from PMF to PMO status) for all medicines containing codeine,
dextromethorphan, ethylmorphine or noscapine. The switch reflected concerns over the misuse of
such medicines when purchased on an OTC basis.
The association for non-prescription medicines (AFIPA) has in recent years led calls to switch to OTC
status medicines to treat minor ailments which are widely available OTC in other countries in order to
develop the non-prescription market in France. Furthermore, in April 2017 a group of pharmacists,
the family planning association and other health professionals sent an open letter to manufacturers of
the progesterone-only oral contraceptive pill inviting them to submit to either the ANSM or the
European Medicines Agency (EMA) a request for a prescription-only to OTC status change in France.
Easier Patient Access to OTCs

The ANSM also takes decisions pertaining to inclusion on the list of non-prescription medicines that
are eligible for self-selection by patients in pharmacy aisles (médicaments en accès direct) (ie as
opposed to kept behind the pharmacy counter).
Manufacturers seeking inclusion of their product on the list (where neither the active ingredient nor
indication already features) are required to submit to the ANSM: a clinical overview of the product
justifying the application, as well as proposed patient information leaflet, packaging and label with
changes versus the existing versions highlighted.
A total of 420 drug presentations feature on the most recent version of the list (which dates from May
2017).
OTC Sales
OTC sales accounted for 11.2% of the total (retail and hospital) market by value and 34.9% by volume
in the 12 months ending September 2017, based on IQVIA data.
Where prescribed by a doctor, some 80% of non-prescription medicines are reimbursable under the
statutory health insurance system. Certain complementary insurers will also reimburse non-
prescription medicines on the condition that they are purchased on the advice of a pharmacist; an
annual ceiling on the total reimbursement costs applies in most instances.

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Parallel Trade
Parallel Exports
Some manufacturers use supply quotas as a means to curtail parallel export activity.
Wholesalers are since January 2016 prohibited from exporting for sale outside of France “medicines
of major therapeutic importance” (MITMs – see ‘Price Build Up: Wholesalers’) which are subject to
supply problems.
Parallel Imports
Parallel import licences are granted by the national agency for drug safety (ANSM). A separate
application is required per product and per country of provenance. Licences are valid for a period of
five years (renewable). A total of 44 parallel import licences were granted between January and
December 2017 relating to products sourced from countries including Belgium, Greece, Italy and the
UK.
For the purpose of pricing, parallel imports must offer a 5% discount on the manufacturer’s selling
price of the corresponding original drug, irrespective of whether the latter is patented or off-patent.
FUTURE DEVELOPMENTS
Outlook
Social Security Finance Law
Following lengthy parliamentary debate, the 2018 Social Security Finance Law (Loi de Financement
de la Sécurité Sociale, LFSS) was definitively adopted by the lower chamber (Assemblée Nationale) on
4 December 2017 at its third and final reading. The LFSS is debated on an annual basis with its
provisions providing the framework for government policy in relation to the social security system (of
which health is one branch) for the year ahead.
According to Health Minister Agnès Buzyn, the legislation for 2018 includes measures intended to
reduce the combined social security deficit from €5,200 million to €2,200 million by the end of 2018
(€4,100 million to €800 million for the health insurance branch alone). The government’s ultimate
aim is to eliminate the combined social security deficit by 2020.
The key measures set out in the draft legislation (known as the PLFSS) and impacting on the
healthcare and pharmaceutical sectors are understood to feature in the final version of the 2018 LFSS:
details are set out below.
- ONDAM
The LFSS sets at 2.3% (up from 2.1% in 2017) the annual target growth rate for healthcare spending
(objectif national de dépenses d’assurance maladie, ONDAM) for the three years 2018, 2019 and
2020. The proposed sub-target is 2.4% for the ambulatory care sector and 2.0% for the hospital care
sector (2.2% taking into account proceeds from a proposed increase from €18 to €20 in the daily in-
patient tariff charged to patients, also featured in the LFSS).

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Savings Measures
In order to achieve the 2.3% target, Buzyn indicates that cost savings of €4,165 million are required, to
be realised as follows:
• Medicines and medical devices: €1,490 million in savings are envisaged via:
° Price cuts for medicines: €480 million
° Increasing generic uptake: €340 million
° Promoting biosimilars: €40 million
° Measures designed to reduce volume prescribing of drugs and medical devices: €320
million
° Price cuts for medical devices: €100 million
° Rebates from manufacturers: €210 million.
• Hospital sector: €1,465 million in savings are targeted, including €390 million via changes to
the liste en sus (ie high-cost drugs excluded from the diagnosis-related group [DRG]-type
hospital funding system – see ‘Reimbursement: Hospital Reimbursement’) and measures
impacting drugs with temporary use authorisation (ATU – see ‘Reimbursement: Hospital
Reimbursement’), as well as a further €575 million through optimising hospital purchasing.
• Measures to ensure the “pertinence” and quality of care, as well as cutting fees for some
laboratory tests (€335 million in total).
• Measures to ensure the “pertinence” of medical transport (€330 million) and sick notes (€240
million), as well as efforts to reduce fraud (€90 million).
- Healthcare Initiatives
The LFSS also makes provision for a number of initiatives impacting healthcare, including:
• With effect from 1 January 2018, compulsory vaccination for children against 11 diseases
(compared to three currently): diphtheria, tetanus, polio, whooping cough, hepatitis B,
pneumococcal infection, meningitis C, and haemophilus influenzae type B (Hib), as well as
measles, mumps and rubella (MMR).
• For a five-year period, projects will be piloted introducing new healthcare models designed to
improve the patient pathway. The LFSS indicates that the models to be tested could include
accountable-care organisations or “bundle payments” for a package of care.
• Moves to accelerate the admission to reimbursement of healthcare procedures.
• Developing the use of “telemedicine”, including tele-consultations.
It is noteworthy that a provision included in the initial version of the draft legislation which would
have provided for the compulsory extension to all patient groups of the third-party payer system in
relation to treatments/services provided by healthcare professionals (see ‘Cost Containment: Patient
Co-payments’) did not feature in the final version of the text.

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- Amendments
Notably, an amendment was introduced into the draft bill during parliamentary debate which
provided for a reduction in the annual social security contribution paid by distributors (wholesalers
and manufacturers selling directly to pharmacies) on sales of reimbursed retail drugs (see ‘Price Build
Up: Wholesalers’). However, the provision – which was reportedly designed to provide “economic
relief” to distributors in financial difficulty – did not feature in the final version of the text.
Supreme Audit Court: Pricing Reforms

In other recent developments, the Supreme Audit Court (Cour des comptes) in September 2017
published its latest annual report on the finances of the social security system. In its report, the Court
maintains that the social security budget faces significant risks in the years ahead. Indeed, it argues
that the government’s aim of eliminating the social security deficit by 2020 will be difficult to achieve
and will require an “acceleration and amplification” of cost-cutting initiatives. In this respect, the
Court goes on to advocate structural reforms which will better regulate social security spending,
ensure efficiency, and guarantee the sustainability of the system moving forward.
- Reimbursed Drug Spending
In relation to spending on reimbursed drugs, the Court notes that the ongoing arrival on the market of
new high-cost innovative drugs means that steps need to be taken to “rebalance” the negotiating
power of the regulatory authorities and “globalised” manufacturers.
Specifically, it advocates:
CEPS
• “Reinforcing the insufficient resources” of the Pricing Committee (CEPS – see ‘Pricing:
Prescription Drugs’)
• Granting CEPS the authority to set the prices of hospital drugs which are currently free from
price control (ie hospital drugs included in the DRG-type system of hospital funding: see
‘Reimbursement: Hospital Reimbursement’).
P&R Decisions
• Reinforcing the role of health economic (HE) evaluations in P&R decisions. In this respect,
the Court suggests that “the presentation [by manufacturers as part of the pricing and
reimbursement application] of a number of cost-result ratio results calculated based on
different price hypotheses” should “become the rule”. The Court also advocates publishing the
results of HE evaluations before the drug’s final price in order to increase transparency, and
strengthening the negotiating position of CEPS (at present, HE evaluations are made public
after publication of the drug’s price in the Official Journal).
• Introducing stricter criteria for the negotiation of rebates in relation to a reimbursed drug. In
this respect, the Court argues that there is currently too much reliance on rebates as a way to
reduce the cost of reimbursed drugs to the social security system. The negotiation of rebates
should be reserved for innovative drugs only; price cuts should be favoured for other
products, according to the Court.
• For drugs on the liste en sus (see ‘Reimbursement: Hospital Reimbursement’), piloting a new
approach to pricing which would allow multiple prices to be established for the same drug
(ie setting a different price for each indication).
• Conducting more systematic reviews of the prices of established medicines, for example when
indication extensions are granted.

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Accord Cadre
With respect to the Accord Cadre (see ‘Pricing: Prescription Drugs’, and below) between the
pharmaceutical industry and government (which provides the framework for pharmaceutical policy,
including price notification arrangements for innovative drugs and the terms of industry payback
arrangements), the Court maintains that the re-negotiation in 2018 of the agreement should be an
opportunity to “redefine” the relationship between the regulatory authorities and industry. More
specifically, it advocates revising certain provisions which it argues are “too favourable to
manufacturers,” for example the five-year European price guarantee granted to (certain) innovative
drugs. In this respect, it recommends:
• tightening the eligibility criteria for the price guarantee – only drugs with an improvement in
medical benefit (ASMR – see ‘Reimbursement: Admission to Reimbursement’) rating of I-III
(indicating major, significant or moderate therapeutic progress) should be eligible, according
to the Court.
• enlarging the number of reference countries (currently Germany, Italy, Spain and the United
Kingdom) used for the purpose of calculating the price of such drugs to include other
countries deemed to be “pertinent”, either on account of demographics (eg Poland) or
standard of living (eg Belgium, Luxembourg), or “eventually, all countries within the
European Union [EU]”.
• shortening the price guarantee period (see ‘Reimbursement: Changes in Reimbursement

Prices’).
International Cooperation
The Court recommends that France should lead the way in developing close cooperation with other
European countries with respect to purchasing (high-cost) drugs. It also advocates that France joins
existing multi-nation collaboration initiatives, for example the BeNeLuxA initiative through which
Belgium, the Netherlands, Luxembourg and Austria have committed to harmonise reimbursement
negotiations and health technology assessment (HTA).
- Pharmaceutical Distribution
With respect to pharmaceutical distribution, the Court is highly critical of what it perceives as
excessively high costs. Accordingly, it recommends reducing these costs via:
• Revising upwards from 60% (see ‘Pricing: Generic Drugs’) to 75% the discount that generic
drugs are required to offer compared with the price of the original brand in order to reflect the
significant rebates granted by generic manufacturers to pharmacists.
• Abolishing the current rule that stipulates that pharmacists can apply the higher pharmacy
margin earned on original (off-patent) brands to generic versions (see ‘Price Build Up: Retail
Pharmacies’).
• Basing wholesale remuneration on the number of packs delivered to pharmacies.
• Revising upwards part of the contribution paid by wholesalers on reimbursed retail drug
sales, specifically an element consisting of 20% of the part of the wholesale margin
surrendered to pharmacists for branded drugs (see ‘Price Build Up: Wholesalers’).
• Ensuring pharmacy remuneration is linked to the act of dispensing, and is not dependent on
the number of packs sold.
• Encouraging “rationalisation” (ie mergers and closures) within the retail pharmacy network in
order to address a perceived oversupply of pharmacies.

71
• Relaxing existing rules relating to pharmacy ownership. Specifically, the Court advocates
allowing non-pharmacists to own pharmacies (although dispensing would remain restricted
to qualified pharmacists). It also recommends that ownership of more than one outlet should
be allowed (it is assumed by non-pharmacists, as well as pharmacists).
• Simplify legislation regulating internet sales of medicines in order to promote e-sales.
• Liberalise the sale of non-prescription medicines (ie to permit their sale in non-pharmacy
outlets).
Accord Cadre
The current Accord Cadre agreement, which provides the framework for pharmaceutical policy over
the term of the agreement, is scheduled to expire at the end of 2018 (see ‘Pricing: Prescription Drugs’).
Accordingly, negotiations are likely to commence in early 2018 between CEPS and the pharmaceutical
industry association (Leem) for a new updated agreement.
Notably, the Supreme Audit Court in September 2017 advocated using the forthcoming negotiations
as an opportunity to “redefine” the relationship between the regulatory authorities and industry (see
above).
Generic Pricing
The price discount that generics are required to offer versus the original brand could be revised
upwards (from 60% - see ‘Pricing: Generic Drugs’). This was advocated by the Ministries of Finance,
and of Health in a letter to CEPS in August 2016, and more recently by the Supreme Audit Court in
September 2017 (see above).
Pharmacy Remuneration
Reforms to the pharmacy remuneration arrangements are underway. Downwards revisions to
pharmacy mark-ups (see ‘Price Build Up: Retail Pharmacies’) will take effect from 1 January 2019 and
again from 1 January 2020. The exact arrangements were not clear at the time of writing (December
2017).
To reflect the (downward) revisions to mark-ups, new pharmacy fees (see ‘Price Build Up: Retail
Pharmacies’) will be introduced for reimbursed drugs from 1 January 2019:
• €0.51 on all scripts
• €1.02 for dispensing complex scripts
• A fee of €2.04 (rising to €3.57 from 1 January 2020) for dispensing certain drugs eg
antivirals, immunosuppressants
• €0.51 (rising to €1.58 from 1 January 2020) for dispensing scripts for elderly patients (aged
70 years and over) or young children (under the age of three).
It is understood that additional remunerated pharmacy services will also be introduced from 2020, for
example, for conducting a medicines review for patients aged 65 years and over and with a long-term
chronic illness (ALD – see ‘Cost Containment: Patient Co-payments’), and patients aged 75 years and
over taking multiple medicines.

72
Provision for the overhaul of pharmacy remuneration arrangements is included in the eleventh
addendum to the (2012) pharmacy convention signed between the main health insurance fund
(CNAMTS) and USPO pharmacy union in July 2017. The reforms are ultimately intended to increase
the proportion of pharmacists’ total remuneration derived from fees (ie as opposed to the pharmacy
mark-up).
National Health Strategy

Health Minister Agnès Buzyn on 7 November 2017 launched a public consultation on the
government’s proposed national health strategy for the years 2018-2022. The strategy focuses on four
priority areas, namely: health promotion and disease prevention, social and geographical inequalities
in access to care, quality of care, and innovation.
Notably, with respect to medicines the draft strategy sets a target of ensuring that by 2020 one in
every two prescriptions is for a medicine included on the list of generic groups authorised for generic
substitution (see ‘Cost Containment: Generics’), and that biosimilars achieve 80% market penetration
by 2022.
The national health strategy is expected to be confirmed before the end of 2017.
Future of Health Insurance

In a separate report on the future of health insurance published on 1 December 2017, the Supreme
Audit Court suggests that to ensure quality and equal access to care moving forward the health system
should be reorganised. In this respect, its key recommendations include:
• Improving the financial management of the health insurance system, including via
eliminating the health insurance deficit.
• Redefining the parameters of mandatory health insurance coverage and complementary

health insurance coverage (see ‘Healthcare System: Provision & Funding’).
• Ensuring equal access to care by, for example, better controlling fees above the nationally
determined level applied by certain physicians (see ‘Healthcare System: Provision & Funding’)
and eliminating inequities in physician coverage nationwide.
• Improving the organisation of and optimal use of healthcare resources eg better coordination
between hospitals and community-based care, and measures to ease the pressure on
emergency departments.
• Ensuring high quality care, including by increasing the proportion of physicians’ fees which is
linked to performance (see ‘Cost Containment: Prescribing Controls’), and ensuring that
hospital funding encourages performance.
• Strengthening the steering of the healthcare system.

73
Proposed New Evaluation Systems
It is noteworthy that in recent years a number of proposals have been put forward to overhaul or
replace the existing medical benefit (SMR) and improvement in medical benefit (ASMR) systems (see
‘Reimbursement: Admission to Reimbursement’).
Most recently, in December 2015 a working group set up by the then-Minister for Social Affairs,
Health and Women’s Rights, to examine the problems of the current pricing and reimbursement
systems, set out three different scenarios for an overhaul of the SMR/ASMR system:
• Scenario 1: The medical benefit SMR system would be “clarified and simplified”. For the
purpose of determining a drug’s SMR rating, the emphasis would be on tolerance and efficacy
versus comparators, taking into account clinical need and the seriousness of the disease to be
treated. Meanwhile, the ASMR rating system, which plays a key role in determining a drug’s
price, would be replaced with a new “relative therapeutic value” (valeur thérapeutique
relative, VTR) rating system. A drug would be awarded a VTR rating of major, important,
minor, or none, based on its effect versus comparators, clinical pertinence, non-clinical
advantages, and the extent to which it meets demand.
• Scenario 2: A complete overhaul of the system which would see the existing dual (SMR and
ASMR) ratings system abolished in favour of a single (VTR – see above) rating system.
Moreover, the current reimbursement rates (100%, 65%, 30%, 15% – see ‘Reimbursement:
Reimbursement Categories’) would be replaced with a single reimbursement rate, most likely
of around 60%.
• Scenario 3: As with scenario 2, a single (VTR) rating system would be introduced, but a scale
of reimbursement rates would be retained. New drugs would be reimbursed at the same level
as marketed comparators, while the reimbursement rate of drugs without available
comparators would be determined according to the seriousness of the disease to be treated.
Another proposed system, the relative therapeutic index (index thérapeutique relatif, ITR) system,
was put forward by the High Authority for Health (HAS) in 2012. Under this system, every drug would
be given a single rating – based on its relative effectiveness – which would determine both its price
and reimbursement level, thereby eliminating the current SMR/ASMR systems. A drug’s ITR rating
would be determined by the CT (see ‘Reimbursement: Admission to Reimbursement’). It would
resemble the existing ASMR in that it would be granted according to the perceived level of therapeutic
improvement of a given drug, based on analyses of the product’s efficacy and effectiveness (with
emphasis on tolerance) versus comparators.
However, it remains unclear whether any such reform will ultimately be undertaken.

74
NAMES & ADDRESSES
Ministry for Solidarity and Health
Ministère des Solidarités et de la Santé
14 avenue Duquesne
75350 Paris 07 SP
France
Tel: (+33) 1 40 56 60 00
http://solidarites-sante.gouv.fr/
National Agency for Drug Safety

Agence nationale de sécurité du médicament et des produits de santé (ANSM)
143/147 boulevard Anatole France
93285 Saint-Denis Cedex
France
Tel: (+33) 1 55 87 30 00
communiation@ansm.sante.fr
http://ansm.sante.fr
Transparency Commission
Commission de la Transparence (CT)
5 avenue du Stade de France
93218 Saint-Denis La Plaine Cedex
France
https://www.has-sante.fr/portail/jcms/c_412210/fr/commission-de-la-transparence
Commission for Economic Evaluation and Public health

Commission d’évaluation économique et de santé publique (CEESP)
France
https://www.has-sante.fr/portail/jcms/c_1627022/fr/depot-d-un-dossier-en-vue-d-un-avis-d-
efficience

75
Pricing Committee
Comité économique des produits de santé (CEPS)
14 avenue Duquesne
75350 Paris 07 SP
France
http://solidarites-sante.gouv.fr/ministere/acteurs/instances-rattachees/article/ceps-comite-
economique-des-produits-de-sante
High Authority for Health

Haute Autorité de Santé (HAS)
France
Tel: (+33) 1 55 93 70 00
Fax: (+33) 1 55 93 74 00
Contact.presse@has-sante.fr
www.has-sante.fr
National health insurance fund for salaried workers

Caisse nationale de l’assurance maladie des travailleurs salariés (CNAMTS)
50 avenue du Professeur André Lemierre
75986 Paris Cedex 20
France
Tel: (+33) 1 72 60 10 00
www.ameli.fr
Pharmaceutical industry association

Les entreprises du médicament (Leem)
58 Boulevard Gouvion
Saint Cyr 75017
France
Tel: (+33) 1 45 03 88 88
Fax: (+33) 1 45 04 47 41
www.leem.org

76
Generic manufacturers association
Génériques Même Médicament (GEMME)
6 avenue Franklin D Roosevelt
75008 Paris
France
www.medicamentsgeneriques.info
Industry association for non-prescription medicines

Association française de l’industrie pharmaceutique pour une automédication responsable (Afipa)
8 rue Saint-Saëns
75015 Paris
France
Tel: (+33) 1 56 77 16 16
afipa@afipa.org
www.afipa.org

77

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Pharmaceutical Pricing &

Reimbursement Concise Guide

Published December 2017

Copyright © 2017 IQVIA. All rights reserved.

France, Pharmaceutical Pricing & Reimbursement Concise Guide

France, Pharmaceutical Pricing & Reimbursement Concise Guide

France, Pharmaceutical Pricing & Reimbursement Concise Guide

France, Pharmaceutical Pricing & Reimbursement Concise Guide

France, Pharmaceutical Pricing & Reimbursement Concise Guide

Population…… 67.1 million GDP…… US$2,599 billion

Median age41 years GDP per capitaUS$44,245

Life expectancy at birth82 years GDP growth rate1.8%

Source: US Census Bureau International Inflation rate1.1%

Total healthcare exp US$295.1 billion Market size (MSP)US$33,393 million

Total healthcare exp per capUS$4,464 Growth (US$)… 1.1%

Total healthcare exp as % GDP 11.1% Growth (US$, fixed rate)1.7%

Source: OECD Health Data 2017 (figures for Source: MIDAS

France, Pharmaceutical Pricing & Reimbursement Concise Guide

France, Pharmaceutical Pricing & Reimbursement Concise Guide

HUMIRA ADALIMUMAB 481 1 2

OPDIVO NIVOLUMAB 361 68 69

LUCENTIS RANIBIZUMAB 346 10 10

DOLIPRANE PARACETAMOL 299 4 4

MABTHERA RITUXIMAB 298 3 3

HERCEPTIN TRASTUZUMAB 270 2 2

Total Others 30140 1 2

France, Pharmaceutical Pricing & Reimbursement Concise Guide

MERCK & CO 1547 -2 -1

JOHNSON & JOHNSON 1250 10 11

BRISTOL-MYERS SQB. 1132 17 18

GILEAD SCIENCES 1083 1 1

Total Others 17059 1 1

Provision & Funding

France, Pharmaceutical Pricing & Reimbursement Concise Guide

• A further 6% of the population – craftsmen, small retailers/manufacturers and the self-

France, Pharmaceutical Pricing & Reimbursement Concise Guide

• The daily in-patient charge (see ‘Cost Containment: Patient Co-payments’).

• Dental care fees.

France, Pharmaceutical Pricing & Reimbursement Concise Guide

• Manufacturer rebates linked to:

° Drugs with temporary use authorisation (Autorisation Temporaire d’Utilisation, ATU)

° Hepatitis C drugs (see ‘Cost Containment: Industry Paybacks’).

France, Pharmaceutical Pricing & Reimbursement Concise Guide

• Drugs with an ATU

• Drugs on the liste de rétrocession (see ‘Reimbursement: Hospital Reimbursement’) when

France, Pharmaceutical Pricing & Reimbursement Concise Guide

• 1,009 were profit-making private clinics

• three from the main health insurance fund (CNAMTS)

• one from the representative association of private health insurers.

Notably, pricing policy, as applied by CEPS, is defined in three ways:

• Through ministerial instruction, commonly laid out in “Lettres d’orientation” to CEPS

• Via the government-industry Accord Cadre agreement (see below).

France, Pharmaceutical Pricing & Reimbursement Concise Guide

Standard Pricing Procedure

• The outcome of a health economic evaluation, where relevant (see below).

• Prices of drugs in the same therapeutic class (or clinical comparators).

• Sales volume forecasts.

France, Pharmaceutical Pricing & Reimbursement Concise Guide

France, Pharmaceutical Pricing & Reimbursement Concise Guide

PP&R Guide - France

PP&R Guide - France

PP&R Guide - France