LESSONS FROM EUROPE* October 6, 2015

EFPIA Japan Days

Richard Bergström
Director General, European Federation of Pharmaceutical Industries & Associations (EFPIA)
www.efpia.eu

The Innovative Medicines Initiative:
the largest public-private partnership for
health research worldwide

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2tackles grand health &societal challenges
Ebola

Resistant
infections

Dementias

Diabetes

Pain

SafetyPrevention

Healthoutcomes

Big Data

Early
Patient
AccessEnvironment

3Rs
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Since 2008 the pharmaceuticalindustry has already committed€ 1.2 billion in kind to 70projects

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4a typical IMI consortium
EFPIA
Pharma 4
Pharma 1
Pharma 5
Pharma 2
Pharma 6
Pharma 3

SMALL AND MEDIUMSIZED ENTERPRISESACADEMIA

PATIENTS’ORGANISATIONSHOSPITALSREGULATORS

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5over 7000 researchers
59 public-private consortia

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Towards integrated healthcare solutions
Focused: stratified medicines andhealthcare priorities
Healthcare solutions: prevention andtreatment
End-to-end: R&D, regulatory,
access/healthcare practiceCollaborations across stakeholders groups:
regulators, payers, users,
Multi-sector: within and beyond life
sciences to develop and test new ideas inreal life conditions*Priority medicines for Europe and the Worldwww.efpia.eu

7Overview
A neutral platform to engage with public partners (R&D,patients, regulators, health authorities...) to resolve their andindustry problems at the same time
A source of funding for pharmaceutical research – all activities
carried by public partners in the public-private consortium arefinanced by the EU
An industry driven agenda: the industry defines the agenda andthe topics, but the consortium is an “arranged marriage” – and itworks!
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8Experience with HTA in Europe

EFPIA Japan Days

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HTA vs International Reference Pricing

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10HTA evolution

Comparison: recent German vs. French evaluations
Comparison of Product Evaluations and Reimbursement Price Achieved(launches from 2011-2013)
Negotiatedreimbursed price

HAS ASMR
RatingG-BA Rating1• Scores suggest G-BA ratings
are more positive than
ASMRs

-53

Zelboraf

Considerable

Moderate

Gilenya

Minor

Minor-31

EsbrietNot Quantifiable

Minor-27

Victrelis

Not Quantifiable

Moderate-21

BriliqueConsiderable

Minor-11

Halaven

Minor

Minor-8• Factors include benefit in
sub-populations &comparator choice• Recent German assessments
resulted in lower prices thanlower ASMRs in France, evenwhen German rating washigher than French ASMR
• Only in extreme cases,
where the French evaluation
finds no additional benefit
and GBA is positive, German
reimbursed prices exceeded
those in France

IncivoNot Quantifiable

Moderate-8

YervoyConsiderable

Minor

-7

ZytigaConsiderable

Moderate-4

Edurant

Minor

No add. benefit

25

Eviplera

Minor

No add. benefit

27

1 Rating is the final G-BA rating given after initial IQWiG assessment
Source: IMS Consulting Group analysis, GBA, ASNM

Lower price in DE than FR
Lower price in FR than DE

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11GDP/head(PPS)of NUTS3 regions

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12Despite current heterogeneity:agreement to work together• No agreement on standards for economic evaluation (UK, Sweden, Germany,France all different); and differences in ability to pay• Free movement of people allows for cross-border health care, and can justify
collaboration on HTA• Recent experience shows that negotiations (“business to business”) more
important; health economics can at most inform a multi-criteria decision model• For medicines: consensus that countries should collaborate on a report onrelative efficacy at the time of launch, excluding economic considerations• European Commission plans Joint Action with countries (building on EUnetHTA,
to prepare for “joint work from 2020”• Increased focus on managed entry agreements (to handle scientifiv andeconomic uncertainty); a life-cycle approach; and real-world evidence (closelylinked to evolution of regulatory science).
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13Shaping European Relative Efficacy Assessment toimprove access to medicines in Europe
Europeanaccessproblem

 Large access differentials across Europe New medicines reach some countries with long delays
 In some countries, certain products are not available at all

driven byfragmented clinicalassessments

 Different assessment approaches lead to inconsistent access decisions
 Inconsistent evidence requirements create duplication and market access delays

Europeanassessment canimprove access Harmonisation of data requirements and assessment approach can accelerateassessments and end duplication
 EU-wide view on clinical performance can reduce access differentials

if performed inparallel to market
authorisation and inlieu of nationalassessment

 European clinical assessment must be separate from marketing authorization
process, but done concurrently to save time It must be integrated in national market access processes to avoid duplication

covering clinicalaspects only

 Economic assessments must be local to account for diversity in health systems
 Industry remains opposed to economic value assessment at EU level
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Thank You!
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