1

Medicines Policy

Surviving the crisis

1

Miguel Vigeant GomesVice-President of the Executive BoardINFARMED, I.P. – National Authority for Medicines and Health Products

Vienna, 30th of September 2011

PORTUGAL

10 Millions inhabitants

National Health ServiceUniversal

comprehensive free of charge

covers 7 Millions inhabitants

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

All the inhabitants have the right to health to be delivered through NHS

2

Economic Context

Public deficit 2010

Source: Eurostat

Economic Context

GDP Growth 2011

Source: Eurostat

3

Total Health Expenditure as % of GDP - 2006 Despesa em Saúde em % do PIB (2006)

8 5U it d Ki d

Economic Context

10 59,5

8,17,1

9,07,3

9,76,2

7,38,4

9,18,5

9,9

GGreece

HungaryIreland

ItalyLuxembourgNetherlands

PolandPortugal

Slovak RepublicSpain

Sw edenUnited Kingdom

6

10,210,0

7,09,6

8,311,0

10,5

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

AustriaBelgium

Czech RepublicDenmark

FinlandFrance

Germany

Fonte: OECD HEALTH DATA 2009, Nov. 09

4

Total Medicines Expenditure as % of Total Health Expenditure - 2006 Despesa Total de Medicamentos em % de despesa com Saúde (2006)

Economic Context

21 8

21,7

19,9

16,3

15,9

14,8

14,3

14,2

13,7

13,3

Portugal

Spain

Luxembourg

France

Belgium

Germany

Finland

Ireland

Sw eden

Austria

7

8,5

31,8

29,7

27,2

22,8

22,7

21,8

0 5 10 15 20 25 30 35

Denmark

Hungary

Slovak Republic

Poland

Czech Republic

Greece

Portugal

Fonte: OECD HEALTH DATA 2009, Nov. 09

Total Medicines Expenditure as % of GDP - 2006

Despesa Total de Medicamentos em % do PIB (2006)

Economic Context

1,8

1,8

1,7

1,6

1,6

1,4

1,2

1,2

0,8

1,6

Italy

Spain

Poland

Czech Republic

Germany

Austria

Finland

Sw eden

Denmark

Belgium

8

2,6

2,2

2,2

2,2

1,8

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

Hungary

Greece

Portugal

Slovak Republic

France

Fonte: OECD HEALTH DATA 2009, Nov. 09

5

Total Medicines Expenditure per capita - 2006

Consumo de Medicamentos per capita nos países da OCDE - 2006

Economic Context

504517

530

536

542551

568

587

599644

710

Spain

Greece

Austria

Sweden

Norway

Germany

Italy

Switzerland

Belgium

France

Iceland

9

151221

226

288397

412

471

0 100 200 300 400 500 600 700 800

Poland

Czech Republic

Slovak Republic

Hungary

Portugal

Denmark

Finland

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

3.000

5%

10%

Overview of the medicines market

(ambulatory and hospitals)

500

1.000

1.500

2.000

2.500

-20%

-15%

-10%

-5%

0%

5%

* Prevision

** Agreement with EC, ECB, IMF

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

02007 2008 2009 2010 2011* 2012** 2013**

-25%

NHS expenditure (ambulatory) Hospital Consumpt ionTotal NHS expenditure (ambulatory + hospital) Growth rate of NHS expenditureGrowth rate of hospital consumption Growth rate of total NHS expenditure

6

IMF/ECB/EU Measures – Memorandum of Understanding

Reduction of the public health spending in medicines from 1,55% of GDP in 2010:

to 1,25% of the GDP until the end of 2012, around 525 Million€ reduction Vs 2010

and to 1% of GDP in 2013, around 942 Million reduction Vs 2010

11

Note: With the measures already in place, Infarmed estimates a 20,3% decrease in the public health spending withmedicines sold in pharmacies (aprox. 300M€).

IMF/ECB/EU Measures – Memorandum of Understanding

Generics maximum price is 60% of the branded medicine

Change payment system to distribution and pharmacies

Remove legal/administrative barriers to the Generics entrance in the market

12

Establish guidelines for the prescription of medicines

7

Reference Prescription Electronic Generic’s Reference Price System

Prescription by INN

Sustainability &

Access to Innovation

prescription

Price Competition

Evaluation for Evaluation for Financing Financing decisiondecision

active promotion

Industry Incentives (R&D)

Dessimination of information among Health Professional

Quality Assurance System of Medicines

Types of implemented measures:

Protocols with industry – Sustained growth

Price reductions

Reduction of Reimbursement Rate Levels

Positive Reimbursement Lists

Promotion of Generics

Reference PricingReference Pricing

Educational Campaigns for the Rational Use of Medicines

Dissemination of up-to-date Information to Healthcare Professionals

Development of Prescription Tools Supporting Prescribing Decisions

8

NHS Sustainability & Access to Innovation

•• Strong Therapeutic and Pharmacoeconomic evaluationStrong Therapeutic and Pharmacoeconomic evaluation

•• Review therapeutic groups for reimbursementReview therapeutic groups for reimbursement

•• Price competitionPrice competition

•• Quality Assurance System prescription of MedicinesQuality Assurance System prescription of Medicines

• HospitalsS f

Evaluation for Financing decision

NHS or third payer is responsible for all the expenses with in-patientconsumed medicines

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

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

9

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

Strong Therapeutic and Pharmacoeconomic evaluation

Clinical Assessment

EconomicAssessement

Relative effectiveness added therapeutic

Cost-effectiveness “value for money”added therapeutic

valuevalue for money

Evidence based report to suport the decision

Clinical Assessment

Strong Therapeutic and Pharmacoeconomic evaluation

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)

10

Economic Assessment

Strong Therapeutic and Pharmacoeconomic evaluation

Identify the value for money

- Comparative price analysis for generics and medicines withoutadded therapeutic value using equivalent daily posologies

- Economic evaluation study for medicines that fulfil anunmet need or with added therapeutic value (innovativeu et eed o t added t e apeut c a ue ( o at emedicines) in order to identify the cost-effectiveness ratio

Identify the implications for NHS budget

Reimbursement level

Review therapeutic groups for reimbursment

Reimbursement rates are 90%, 69%, 37% or 15%

Reimbursement rate is increased by 5% (90%) or 15% (all other rates)for people earning retiring pensions below national minimum wage,which also have

95% reimbursement rate on the 5 less expensive generics of the samehomogeneous group

11

Review therapeutic groups for reimbursment

Mesures Taken Q4 2010

Decreased Anti – ulcer therapy from 69 to 37%

Decreased Anti inflammatory from 69 to 37%

Decreased Anti depressives from 95 to 37%

Other changes in analysisOther changes in analysis

Price Competition

General Rules

Generic will be 50% (35% currently) cheaper than the referencemedicine

From the 5th Generic onwards applying for reimbursementdecision, the price must be 5% cheaper than the latest genericsubmitted for reimbursement, regardless its decision

There is an annual price revision based on the 4 referencecountries (Spain, France, Greece and Italy)

12

Reference price is set for the homogeneous group, which includesdi i ith th ti b t d h ti l f

Price Competition

Reference Price

medicines with the same active substance, dosage, pharmaceutical formand administration routeReimbursement value is established by the average on the 5 cheapest

generics ( from 2010 ) multiplied by the reimbursement rateDifference between to the medicines price (if higher) is to patient to payLow income pensioners get 95% reimbursement for all classes if gives 5

cheapest genericPatient Co-payement

A B C D E

Patient Co payement

R f P iR f P i31,1 €35

Sinvastatine / 20 mg / 60 units

Reference Price System

Reference Price: 4,30€

Reimbursement Rate: 37%

R i b d l

Reference Price: 4,30€

Reimbursement Rate: 37%

R i b d l3,5 € 1,9 € 1,6 € 0 0 €

31,1 €

27,7 €

1,6 €

27,0 €

5

10

15

20

25

30

35

Reimbursed value: 1,6€Reimbursed value: 1,6€

,6 € 0,0 €0

5

Sinvastatina Basi Simvasim 20

Price Patient co-payment

Health system co-payment Minimal Salary patient co-payment

Date: 15th September

13

Reference Price Evolution

Medicinal products price evolutionJan. 2008 – May 2011

20

Evolution of average prices per pack of generics

5

10

15

Euro

s

0

5

14

Generics market share evolution

There 182 Active Substances that cover 56% of the total market

Quality Assurance System prescription of Medicines

Dissemination of information among Health Professionals

Generics advertising campaign

IT support to prescribers

Therapeutic guidelines

IT tools to monitor prescription

15

Dissemination of information to Healthcare Professionals

Dissemination of information among Health Professionals

Advertising Campaign Advertising Campaign TargetTarget MaterialsMaterials Year Year

TV and POS

Generic Advertising Campaigns

Generic Medicines, find the differences PatientsTV and POS material 2001

Generic Medicines, people deserve it Patients POS2002 -2003

Generics, equal quality different price Patients

TV, Radio, Press and POS material 2004

Quality Safety and Efficacy Generics You can TV, Radio, Outdoors and 2007 -Quality, Safety and Efficacy. Generics. You can

trust. PatientsOutdoors and POS material

2007 -2008

Don't you think that beeing ill already costs enought

Patients / Health Professionals

Internet and POS 2009

You save, we all save Patients TV and Radio 2010

16

Generic Advertising Campaigns

Highest Market Share ever during the campaign

Infarmed_P\Genericos\2010\Campanha\Materiais\infarmed_G_30s_mpeg4.mp4

Development of prescription tools to support prescribing decisions

Electronic Medical Prescription

IT support to prescribers

p p p pp p g

On-line prescription system:

- Up-to-date information

- Doctors get alerts pop-ups on the cheapest medicinal products

- Information given to the patient also included in the medical

i ti b t th t th t ld b d if th d t ldprecription about the amount that could be saved if the doctor would

have chosen the cheapest medicine

17

Electronic Prescription - price information

Dissemination of information among Health Professionals

Dissemination of information to Healthcare Professionals

Additional measures being evaluated

Changes in the distribution and pharmacies margins (MoU)

Decrease in price of originals to generic level when first generic comes tothe market

Homogeneous groups to be created by therapeutic equivalence

Lower price level for marginal innovation