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An Introduction To European Market Access: Prepared For
An Introduction To European Market Access: Prepared For
Prepared for:
Seminar Public Health and Primary Care, Imperial College
Prepared by:
Professor Deborah Saltman
Page 1
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Pharmaceutical Products
Company
Heath Economics
Research Medical and Outcomes Marketing Manufacturing Sales
Research
Regulatory Reimbursem
approval ent approval
HTA Page 2
Pricing Reimbursement and Market Access
Page 3
What is required by these agencies?
Page 4
Market access framework for the UK
Source: PRMA Insights: Pricing and Reimbursement Success in NSCLC 2nd edition, 2012 Page 5
Market access framework for France
Taking effect in 2016, a new regulatory body, the National Agency for
the Safety of Medicines and Healthcare Products is likely to require
data from active comparator trials.
Source: PRMA Insights: Pricing and Reimbursement Success in NSCLC 2nd edition, 2012 Page 6
P&R landscape: France
Products will be awarded an ASMR and an SMR rating; ASMR 4 (parity) or ASMR 5
(EU reference pricing for product) would mean no price premium vs existing
products.
• SMR rating is based on 1. Innovative product of • ASMR ratings are getting lower
severity of the disease: significant therapeutic benefit • SMR ratings are increasingly
• major 2. Product of therapeutic benefit being used to deny or restrict
• important in terms of efficacy and/or reimbursement
• moderate reduction in side-effect profile • Importance of incremental
• minor 3. Existing product where clinical benefit (better efficacy
equivalent pharmaceuticals or better safety profile, as
• insufficient to justify
exist; moderate improvement evidenced in relevant clinical
reimbursement
in terms of efficacy and/or trials) will increase
• ASMR (incremental benefit
reduction in side-effect profile • Innovative technologies will
vs SOC) is rated between 1
4. Minor improvement in terms of require pharmacoeconomic
and 5:
efficacy and/or utility studies showing that they
• major (1)
5. No improvement but still provide cost-savings and
• important (2) improve disease management
granted recommendations to
• moderate (3) be listed • Patient stratification is
• minor (4) becoming increasingly
• none (5) important to limit budget
impact
Page 7
Premium pricing
HAS has recently advocated replacing the ASMR and SMR ratings with
a single index of “therapeutic benefit”.
Page 8
Note: HAS does not report the number of ASMR 5 ratings that are given.
Market access framework for Germany
Page 9
Market access framework for Spain
Page 10
Market access framework for Italy
Page 11
EU M5 payors and HTA authorities
Page 12
EU M5 payors/HTA authorities
Page 13
Stakeholder influence by country
High influence
Some influence
Low influence
National level
Regional level
Local level
Page 14
Across Europe, market access terms are becoming more restrictive
Key market access themes Comment
• Formal cost-effectiveness
• Growing importance of cost-effectiveness
requirements at launch
Head-to-head
• Establishing the SOC or comparator important
data vs SOC
Real-world
observational • Real-world data may help achieve market access
data
Page 16
Note: EoL refers to standard of care considerations around the end of life.
Same data, different access
Avastin
Avastin + IFL offers a 4.7 month Not recommended by NICE or SMC
median improvement in OS vs IFL
(mCRC)
+ placebo (20.3 vs 15.6 months)
Reimbursed (ASMR 2)
Page 17
Increasing use of risk-sharing agreements
Particularly in oncology.
Page 18
Focus of HTA critiques
Across HTAs the areas of consistent criticism were the survival data,
utility data, and choice of active comparators.
SMC
NICE
TC
IQWiG
Prepared for:
Seminar Public Health and Primary Care, Imperial College
Prepared by:
Professor Deborah Saltman
Page 20
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