Peningkatan Kapasitas Tenaga Kesehatan di Bidang Farmakoekonomi

Direktorat Jenderal Kefarmasian dan Alat Kesehatan

21 – 22 September 2022

Penetapan Prioritas Masalah

untuk Kajian Farmakoekonomi
Dwi Endarti, MSc, PhD, Apt
Fakultas Farmasi Universitas Gadjah Mada

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Universal Health
Coverage
Memastikan masyarakat
mendapatkan pelayanan kesehatan
berkualitas sesuai kebutuhan,
tanpa berisiko mengalami masalah
keuangan. (WHO)

→Health Technology Assessment

(HTA) berperan dalam
mengoptimalkan “service
coverage”

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Masalah ekonomi dalam pelayanan kesehatan → biaya dan permintaan makin meningkat →
sumber daya terbatas → diperlukan penetapan prioritas

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 Burden of
(chronic)
disease

The need User’s Policy

for priority expectation
& promise of and Finite
budgets
setting UHC practice

Growth in
technologies

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HTA in support of UHC
• WHO (25th World Health Assembly, Geneva, 2014):
→“It is vital that priority setting is an evidence-informed,
procedurally fair process that defines what will be
covered through universal health coverage.”

• Peraturan Presiden No 12 Tahun 2013 tentang Jaminan

Kesehatan: Menteri Kesehatan bertanggungjawab untuk
menjamin kendali mutu dan biaya.
→ Pasal 26: Pengembangan penggunaan teknologi dalam
manfaat JKN harus disesuaikan dengan kebutuhan medis
sesuai hasil penilaian teknologi kesehatan (Health
Technology Assessment).
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 HTA is a multidisciplinary process that uses explicit methods to
determine the value of a health technology at different points
in its lifecycle.
The purpose is to inform decision-making in order to promote

What is an equitable, efficient, and high-quality health system.

Health The dimensions of value for a health technology :

clinical effectiveness, safety, costs and economic implications,

Technology ethical, social, cultural and legal issues, organisational and

environmental aspects.

Assessment
A health technology is an intervention developed to prevent,
(HTA)? diagnose or treat medical conditions; promote health; provide
rehabilitation; or organize healthcare delivery.
The intervention can be a test, device, medicine, vaccine,
procedure, program or system.

Source: INAHTA/glossary http://www.inahta.net/ 6

 HTA can be applied at different points in the lifecycle of a health technology

Technology development Technology adoption

safety efficacy effectiveness Cost

affordability feasibility
effectiveness

Clinical studies/trials Observational

studies/pragmatic Pharmacoeconomic
studies : CBA, CEA, BIA Organizational
trial implication, social
CUA values, ethics, equity

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 The comparative analysis of two or more health care interventions in terms
of both their costs and consequences (outcome)
Drummond, et al 2015

COST OUTCOME
Direct cost (medical and Clinical outcome
non-medical)
Economic outcome
Indirect cost
Humanistic outcome
Studi Farmakoekonomi

Haute Autorité de Santé, 2015

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 Tools used in pharmacoeconomics
Cost analysis / Cost of Illness (COI)
Describing the costs of the treatment of
individual diseases.
Cost-Minimization Analysis (CMA)
Compares the costs for two equally
effective therapies.
Cost–Beneft Analysis (CBA)
Compares inputs and outputs expressed
in monetary units.
Drummond et al., 2015; Sullivan et al., 2014
Cost-Efectiveness Analysis (CEA)
Compares the cost of the different types of
therapy and monitors the clinical
effectiveness.
Cost-Utility Analysis (CUA)
Compares various therapies, inputs are
expressed in monetary units and outputs
are usually expressed in terms of quality-
adjusted life-years (QALY).
Budget Impact Analysis (BIA)
A tool of governmental institutions for deciding
whether or not to accept new interventions on
the basis of effectiveness and the cost which
becomes apparent in the next few years after its
introduction into the healthcare system.
Method Study P I C O Result Conclusion
COI Javanbakh Type 2 DM in - - Cost of T2DM Total National cost of a diagnosed T2DM consumed 8.69 % of
et al., 2011 Iran T2DM in 2009: USD 3.78 Billion total health expenditure

CMA Attanasio Vascular disease Atorvastati Simvastatin % reach LDL-C goal # sig difference Simvastatin required lower
et al., 2001 n cost

CBA Cote et al., Hypertension Pharmacy without Cost saving due to Ratio benefit to cost : 10 x Pharmacy health promotion
2003 health prevention of had + benefit
promotion complication

CEA Schaefer et Arthritis COX-2 NSAIDs GI event ICER: $7,476/ Additional cost of $7,476
al., 2005 inhibitor GI event avoided per 1
GI event avoided

CUA Hoyle et Chronic Myeloid Nilotinib High dose QALY ICER: £ 104,700/QALY Nilotinib not cost effective
al., 2011 Leukemia (CML) imatinib (UK threshold: £
20,000/QALY)
BIA Cortex et Pulmonary Treprostinil Standard Additional budget for Additional average consumption Treprostinil does not
al., 2017 Arterial therapy providing Treprostinil is £ 1,183,990.00 (0.0187% of the represent a significant
Hypertension (diuretics, compared to standard total financial impact of
(PAH) NYHA IV digitalis therapy budget allocated to medicine) mexican’s budget.
and
vasodilator
s)
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Interpretation of CUA
∆𝐶
= <𝑘
∆𝐸
• k is the maximum acceptable cost-effectiveness (CE-
threshold or ceiling ratio or WTP).
𝑘
• If the ICER is below k, then the intervention will be
implemented (cost-effective).
• CE threshold used to value whether a strategy is
affordable to be performed in particular setting.
• Example of national CE-threshold:
Country CE threshold (per QALY)

United Kingdom £20,000 – £30,000

Canada CA$20,000 – CA$100,000
USA US$50,000 – US$ 100,000
Netherlands €20,000 - €80,000
Thailand THB120,000 - 160,000

• Countries with no national threshold:

• < 1 GDP per capita: very cost effective
• 1 – 3 GDP per capita: cost effective
• > 3 GDP per capita: not cost-effective

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 Drug Management
Cycle
• Tahapan utama pengelolaan obat yang
efektif untuk menjamin ketersediaan obat
• Seleksi yang rasional, biaya yang
terjangkau, dan sistem suplai yang dapat
diandalkan → meningkatkan akses
terhadap obat.
• Seleksi → memilih obat sejumlah obat dari
yang tersedia di pasar → untuk digunakan
dalam sistem pelayanan kesehatan

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WHO Medicine Strategy, 2004
 Rationale of drug selection
✓ Drugs represent a
large part of the
public health budget
✓ Limited resources
✓ Large number of
drugs are available
on the market
The John Hopkins University, 2006
➢Improved drug availability
➢Regular drug supply
➢Simplified procurement, storage, and distribution
➢Lower procurement costs by buying larger
quantities of fewer drugs
➢Prescribers can become familiar with a smaller
number of drugs
➢Facilitates drug information and education
efforts
➢Improved drug therapy can lower health care
costs
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 Output of drug selection
➢A list of (essential) medicine for used in different level of health care system
➢A formulary system:
▪ Formulary list: (essential) medicine list
▪ Formulary manual: summary information on each medication on
formulary list
➢Formulary manual VS treatment guideline → presenting treatment
alternatives and recommending treatment of first choice
✓Formulary manual: medicine centered
✓Treatment guidelines: disease centered
➢WHO Model List of Essential Medicines, National List of Essential
Medicines/National Formulary, Hospital Formulary, etc.

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Management Sciences for Health, 2012
Drug selection target

Management Sciences for Health, 2012

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Application of HTA in national formulary decision making (Thailand)

The development of Thai NLEM

Teerawattananon et al. ZEFQ 2014 17

Permenkes 71 Tahun
2014 tentang Pelayanan
Kesehatan pada JKN

✓ Tim HTA bertugas

melakukan penilaian
terhadap pelayanan
kesehatan yang
dikategorikan dalam
teknologi baru,
metode baru, obat
baru, keahlian khusus,
dan pelayanan
kesehatan lain dengan
biaya tinggi.
✓ Tim HTA memberikan
rekomendasi kepada
Menteri mengenai
kelayakan pelayanan
kesehatan untuk
dimasukkan sebagai
pelayanan kesehatan
yang dijamin.

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Kriteria teknologi kesehatan dalam PTK-JKN
PMK No 51 Tahun tentang Pedoman Penilaian Teknologi Kesehatan dalam Program JKN

high volume : tingkat high variability :

high risk : penggunaannya high cost : penggunaannya
penggunaannya sangat penggunaannya memiliki
berisiko tinggi berbiaya tinggi
tinggi variasi yang besar

memiliki tingkat
memiliki dampak untuk
memiliki tingkat memiliki tingkat potensi penerimaan dari aspek
memperbaiki akses,
urgensi/kepentingan dalam penghematan biaya atau sosial, budaya, etika, politik,
kualitas, dan kesehatan bagi
kebijakan keterjangkauan biaya dan agama terhadap
penduduk
penerapan teknologi

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 • When no national HTA agency → some big hospitals would
like to take evidence-based decisions in regard with
equipment, technologies

• Even if existence of a national HTA agency → not all

Why technologies are evaluated at the national level (ex: medical

devices)

Hospital • Even if evaluated at national level → conclusions and

recommendations quite global and far from the local and
precise questions of a hospital.
Based-HTA? • Hospitals have a direct interest (medical, economic,
organisational) to push and speed-up the process of
assessment and reimbursement at the national level (ex:
medical procedures)

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 • Ambassador Model :
Clinicians recognized as ‘opinion leaders’ play
HB-HTA Models the role of ambassadors of the HTA
“message” inside the HCOs.
• Mini HTA :
Single professionals participate in the
assessment process collecting data at
organizational level to inform decision
makers at an higher level.
• Internal Committee :
Evidence is produced by multidisciplinary
groups (called internal committees)
representing different perspectives and
taking the responsibility of reviewing
evidences to issue recommendations useful
hospital-wide.
• HTA Unit :
Formal organizational structure based on
specialized HTA personnel working on a full
time basis inside the Unit. This model
represents the highest degree of structure for
hospital HTA.
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 Thinking of HTA questions

investment disinvestment
Introducing new Stop funding ongoing
technology/intervention technology/intervention

Narrowing down
Scaling up a pilot project
(targeting) the program

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 P = population

I = intervention

Scope
C = comparator(s)

O = outcome(s) to be measured

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Penetapan masalah kajian farmakoekonomi
• Identifikasi permasalahan kesehatan dan tujuan kajian → apa dan
mengapa penting?
• Pilih opsi untuk penyelesaian masalah kesehatan dan pembandingnya
• Tetapkan audiense/pengguna hasil kajian → informasi apa yang
dibutuhkan dan digunakan untuk apa hasil kajian?
• Tetapkan perspektif kajian → sesuai dengan audiense
• Tetapkan kerangka waktu dan analisis kajian
• Pilih metode kajian yang sesuai

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 TERIMA KASIH
“The choice to make good choices is the best choice you can choose.
Fail to make that choice and on most choices you will lose.”

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