1 assessment of pharmaceuticals to inform reimbursement decisions in portugal vasco a. j. maria...

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Assessment of Pharmaceuticals to Inform Reimbursement Decisions

in Portugal

Vasco A. J. Maria

INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde

Portugal

VIII Curso de evaluación e selección de medicamentos

Palma de Mallorca, 7 de Mayo de 2010

PORTUGAL

10 Million inhabitants

National Health ServiceUniversal

comprehensive free of charge

covers all the population

Other Health Systems (Civil Servants, and other) responsible for 3 millions

All the population has the right to health to be delivered through NHS

Assessment of pharmaceuticals to inform

reimbursement decisions in Portugal



Total Health Expenditure as % of GDP - 2006

Despesa em Saúde em % do PIB (2006)

10,2

10,0

7,0

9,6

8,3

11,0

10,5

9,5

8,1

7,1

9,0

7,3

9,7

6,2

7,3

8,4

9,1

8,5

9,9

0,0 2,0 4,0 6,0 8,0 10,0 12,0

Austria

Belgium

Czech Republic

Denmark

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Luxembourg

Netherlands

Poland

Portugal

Slovak Republic

Spain

Sw eden

United Kingdom

Fonte: OECD HEALTH DATA 2009, Nov. 09



Total Medicines Expenditure as % of GDP - 2006

Despesa Total de Medicamentos em % do PIB (2006)

2,6

2,2

2,2

2,2

1,8

1,8

1,8

1,7

1,6

1,6

1,4

1,2

1,2

0,8

1,6

0 0,5 1 1,5 2 2,5 3

Hungary

Greece

Portugal

Slovak Republic

France

Italy

Spain

Poland

Czech Republic

Germany

Austria

Finland

Sw eden

Denmark

Belgium




Total Medicines Expenditure as % of Total Health Expenditure - 2006

Despesa Total de Medicamentos em % de despesa com Saúde (2006)

8,5

31,8

29,7

27,2

22,8

22,7

21,8

21,7

19,9

16,3

15,9

14,8

14,3

14,2

13,7

13,3

0 5 10 15 20 25 30 35

Denmark

Hungary

Slovak Republic

Poland

Czech Republic

Greece

Portugal

Spain

Luxembourg

France

Belgium

Germany

Finland

Ireland

Sw eden

Austria




Total Medicines Expenditure per capita - 2006

Consumo de Medicamentos per capita nos países da OCDE - 2006

151

221

226

288

397

412

471

504

517

530

536

542

551

568

587

599

644

710

0 100 200 300 400 500 600 700 800

Poland

Czech Republic

Slovak Republic

Hungary

Portugal

Denmark

Finland

Spain

Greece

Austria

Sweden

Norway

Germany

Italy

Switzerland

Belgium

France

Iceland

US$Fonte: OECD HEALTH DATA 2009, Nov. 09

• HospitalsNHS or third payer is responsible for all the expenses with in-patient consumed medicines

• PharmaciesNHS or third payer is responsible for all or part of the expenses with consumed medicines

on the purchasing act the consumer does not pay or pay only a part of medicine’s price





Source: INFARMED, I.P.; IMS Health; ACSS

Medicines Expenditure Growth2000-2008

-5%

0%

5%

10%

15%

20%

25%

30%

20002001

20022003

20042005

20062007

2008

Gro

wth

rat

e

Total Market (outpatient) NHS Market (outpatient)NHS expenditure (outpatient) Hospital Market



0

200

400

600

800

1000

1200

1400

1600

Mill

ion E

uro

s

Source: INFARMED 2009

Expenditure by NHS 1996-2008

Causes of growing drug expenditure:

Increase in population of elderly residents

Increase incidence and duration of chronic diseases

Continuing development of health technologies

Increase in health expectations by patients and

society

Higher prices (R&D costs, attrition rates)



Health Technology Assessment

What do we measure in HTA?

Relative effectivenessAdditional benefit in clinical practice of the new medicine in comparison with

alternative therapies (EBM)

Cost-effectivenessComparison of two relevant alternative

therapies (innovatorversus standard treatment)

Need to:

Promote the development of new tools to provide support on

decision making process - Economic Evaluation Studies of

Medicines (1998)

Create guidelines to implement good practices on the

execution and evaluation of Economic Evaluation Studies of

Medicines - Guidelines (1999)

Create levels of quality to graduate the clinical evidence used

for assessment of pharmaceuticals to inform reimbursement

decisions (2000)



Clinical

Assessment

Economic

Assessment

Relative effectiveness

added therapeutic value

Cost-effectiveness

“value for money”

Relative effectiveness and cost-effectiveness evaluation for reimbursement decision – ambulatory and hospital



Evidence based report to

support the decision

• Applicants

Marketing Authorization Holders (MAH)

(submit all necessary evidence)

• INFARMED

Administrative assistants

Pharmacists

Doctors

Health Economists

Executive Board of INFARMED

• Minister of Health

Assessment

Decision



10 external experts coming from universities and hospitals (doctors and health economists) *

Internal staff

– 6 economists

– 4 pharmacists

– 2 administrative assistants

Team:

* Names and CV are available at INFARMED webpage



Identify if the medicine is for an unmet need

Identify the relative effectiveness/added therapeutic value

Extent to which an intervention does more good than harm compared to one or more intervention alternatives for achieving the desired results when provided under the usual circumstances of health care practice.

(Pharmaceutical Forum)

Clinical Assessment



Identify the value for money

- Comparative price analysis for generics and medicines without added therapeutic value using equivalent daily treatment

- Economic evaluation study for medicines that fulfil an unmet need or with added therapeutic value (innovative medicines) in order to identify the cost-effectiveness ratio

Identify the implications for NHS budget

Economic Assessment



Application by MAH

Assessment Procedure

Application form (/CFT form)/Scientific information/Additional data

Clinical assessment

Preliminary Report (structured format)(critical appraisal and n. of patients)

Final Report

TherapeuticEquivalence

Added Therapeutic

Value

Inferior Therapeutic

Value

Additional data

PVH ≥ comp.

Price comparative analysis

Economic advantage

PositiveDecision

MEES [185d]

NegativeDecision

Therapeuticequivalence

Added therapeutic

value

Inferior therapeutic

value

PVH < comp.


Decision(positive/negative)

MEES/clinical report

Preliminary Report

Final Report

Additional data

Economic Assessment


Decision (positive/negative)

Reports (clinicians/economists/pharmacists)– Peer discussion and adoption by consensus

Consolidated Final Report

Summary report (to be publish in the webpage) (revised by assessors)

Proposal for CFT monitoring procedures)

Final proposal for Decision by MB


Final proposal for Decision by MB

Negative Decision

Information to MAH

10d for counter argumentation

Reanalysis

Final negative decision

Positive Decision

Contract (2 copies) to be signed by MAH

Signed contract(MAH + MB)

Information to MAH/HospitalsPublication in webpage


Agreement for 2 years (to be renewed)

Additional demonstration of ATVCeiling for NHS expenditure with the medicine in

all public hospitals Estimation of the number of patients to be treatedMonitoring mechanisms Consequences if ceiling is surpassedMaximum price considered to be adequate

Agreement and Signed Contract

Field of Application

NCE reimbursed since 2001

22 23

41

24

12

23

1520 17

327 6

14

2001 2002 2003 2004 2005 2006 2007 2008 2009 Jan-Mar2010

(*)

Ambulatory Hospitalar

(*) 3 under agreement negotiation

Medicines for Hospital usePositive Decision Negative decision

Abatacept Lenalidomida Ácido lipoico

Agalsidase Alfa Leuprorrelina Bevacizumab

Anidulafungina Levofolinato dissódico

Carbetocina

Ambrisentam Maraviroc Oxibato de sódio

Capecitabina Mecassermina Ziconotida

Cefeminox Panitumumab

Cladribina Raltegravir

Darunavir Ranibizumab

Dasatinib Sitaxentano

Efavirenz + emtricitabina + tenofovir

Sorafenib

Etravirina Tacrolímus

Fibrinogénio humano + Trombina humana

Temsirolímus

Gadoversetamida Tenofovir

Medicines for Hospital use

Year of Signature Number

2007 2

2008 7

2009 14

2010 (Jan-Mar) 3

Total 26

Number of agreements (contracts)

Critical Issues/Constraints

•Selection of comparators

•Uncertainty (lack of information)

•Orphan drugs (rare diseases)

•Target-population (subgroups)

•Budget impact

•Time pressure

•Pressure from pharmaceutical industry

Basic Principles:

Scientific independence Conflicts of interest

Robustness of assessment procedure Best experts in the field

Evidence based

Peer discussion and decision by consensus

Transparency Clear definition of criteria

Publication

Segregation between assessment and decision



Gracias por su atención

[email protected]

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