IMI

Working in partnership for better outcomes

Richard BergströmEFPIA Director General

ABPI Annual Conference, London, April 2016

Do we have the same goal?

ImpactOrganization

Outcomes focus has proven to deliver better outcomes at same or lower cost

Outcome

Cost

HC Value =

Examples with outcomes focus and increased HC value

1. Postoperative endophthalmitis 2. Swedish saving estimated based on US cost data

Patient. sat.

+20%

PE-rates1

-80%

Complic.

-21%

Mortality

-53%

Survival

+3%

NATIONELLA KATARAKTREGISTRET

Costs -25%

Costs2 -1%

Costs -28-36%

Costs-€515/pat.

Costs -6%

Where are we heading?

Pipelines are full (“no more me-toos”)

HTA: not a question of if, but of what patients and where are they?

Need to plan ahead

Value-based pricing meets budgets

Need capacity for deal-making, and tracking performance

Taking the life cycle perspective…

> €5 bn

Partnership2008 - 2024 €2.5 bn€2.5 bn

IMI – Europe’s partnership for health

Over 7,000 researchers

59 public-private consortia

An international, cross-sector community

764 academicteams

146 SMEs

433 EFPIA teams

25 patient orgs

17 regulators

Integrated evidence

generation

Access Regulatory

7

Parallel Scientific & HTA advice

Early and continuous dialogue

PAES & PASS

Conditional marketing

authorisation

Full marketing authorisation (evt.

Subject to conditions)

PRIME

REA/HTA

Early patient access: combination of existing and new tools within the current legal framework

MEAs

Pricing/Reimburseme

nt

ADAPT SMART

Patient preference

elicitation for B/R

Adaptive Pricing – managing

uncertainties

RWE and Health

Outcomes

GetReal

Accelerated assessment (and decision making)

Compassionate Use/Early access

schemes

8

BD4BO

Dealing with disruption – national level dialogue needs to seek new solutions for the introduction of major high-value innovations

Medium

Med

ium

Rel

ativ

e Va

lue

Hig

hLo

w

HighLow

Budget Impact

New solutions needed!

Clear the way

Likely focus on managed entry agreements/ adaptive

approaches

“The trouble with some new innovations is that even though they may be cost effective, the budget impact is so high that the system can’t cope” NICE (at a recent EU meeting on

pricing and reimbursement)

Planning budgeting and horizon scanning processes are variable around Europe

Often budget impact of major innovations is uncertain before launch (and in the early post launch period)

Lack of solution can lead to ‘payer panic’ and an focus on prices that have a strong VFM case

How to smooth market entry?

Unlikely to get used!

9

EFPIA Brussels Office

Leopold Plaza BuildingRue du Trône 108B-1050 Brussels - Belgium Tel: +32 (0)2 626 25 55

www.efpia.eu