EuroMEEting - Genetic Alliance UK

22
THEME 4
This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
Theme 4 | Clinical Study Endpoints and HTA/Cost
Effectiveness
Olivier Chassany, Medical Head, Clinical Research & Development Department,
Assistance Publique - Hôpitaux de Paris, France
Wills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Belgium
In the context of growing requirements from health authorities, the theme aims
to examine the possibilities of increasing the consistency between European
Health Technology Assessment (HTA) agencies. It will also explore the
potential to reconcile the different requirements for Marketing Authorisation
and actual market access, as determined by reimbursement decisions. The
second part of the theme focuses in on clinical endpoints. It will examine
differences and similarities in the FDA and European Medicines Agency
approaches for the assessment of Patient-Reported Outcomes (PROs). It will
explore opportunities for further interaction between the agencies themselves
and with industry. It will discuss the factors for a successful scientific advice
and review the potential of Scientific Advice in the future. Lastly, it will present
an update on the different initiatives undertaken by European and US Public-
Private Partnerships, to reach consensus on Patient-Reported endpoints.
Tuesday, 29 March 2011
09:00-10:30 Session 0401
UPDATE ON HOW AGENCIES ASSESS THERAPEUTIC VALUE OF A PRODUCT
AND – INCREASINGLY – THE THERAPEUTIC ADDED VALUE
Session Chair:
Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU
Marketing Authorisation is no longer the 'key to the market'. Without a
successful demonstration that the product can actually add value, reimbursed
market access, or at least, reimbursed market access at a price that makes
sense to the manufacturer might be a just a dream. This session will examine
the approaches that different countries take to not only the value that the
product brings to the patients, but also what added value it brings, in relation
to existing therapeutic options.
Service Medical Rendered (SMR) and Added Service Medical Rendered
(ASMR)
Anne d’Andon, Head of Medicines Assessment, Haute Autorité de Santé (HAS),
France
AIFA’s System
Guido Rasi, General Director, Italian Medicines Agency (AIFA), Italy
11:00-12:30 Session 0402
CAN WE MERGE TWO DIFFERENT WORLDS: REGULATORY REVIEW FOR
MARKET AUTHORISATION AND HTA ASSESSMENT FOR REIMBURSEMENT
DECISION?
Session Chair:
Wills Hughes-Wilson, Senior Director, Health Policy Europe, Genzyme, Belgium
As regulatory review becomes just one stage in the process, there is a drive
to bring together the scientific reviewers for the regulatory approval and
the scientific reviewers for the HTA assessment. The European Medicines
Agency sees this as one way forward to address the current fragmentation of
the single EU Marketing Authorisation caused by 27 or more post-Marketing
Authorisation reviews. But how do the national agencies see it? Is it possible
in practice and will it address the communication gap?
‘Not Really’
Industry speaker invited
‘Maybe’
Regulator invited
‘Yes’
Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU
14:00-15:30 Session 0403
COMPARISON OF ENDPOINTS FOR MARKET AUTHORISATION AND
REIMBURSEMENT: HOW CAN WE HARMONISE ASSESSMENT?
Session Chair:
Mira Pavlovic, Deputy Director, DEMESP, HAS Haute Autorité de Santé, France
The endpoints needed to achieve regulatory approval might not be the same
as those that an HTA body is looking for. What are the differences and what
needs to be added? Will the two always be different?
Increasing the interaction between Regulators and HTA Bodies: Towards
easier access for innovative drugs or an increased burden to industry?
Karim Benslimane, Regulatory Intelligence & Policy Manager, Lundbeck, France
Integrating HTA Requirements into Drug Development
Adam Lloyd, Senior Principal, Health Economics and Outcomes Research, IMS,
UK
View from the European Medicines Agency
Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU
16:00-17:30 Session 0404
CAN WE REACH SOME HARMONISATION AMONG EUROPE ON HTA
REVIEW ASSESSMENT OF VALUE PRODUCT, ADDED VALUE PRODUCT AND
REIMBURSEMENT DECISION PROCESS
Session Chair:
Yann Le Cam, Chief Executive Officer, EURORDIS, France
The EUNetHTA project has 'earned its stripes' – it has gone from being a
trial project to a full 'Joint Action', 50% funded by the Member States. Will
it lead to potential alignment of relative effectiveness, the creation of relative
effectiveness guidelines and, ultimately a shared long-term assessment, to
support conditional pricing and reimbursement as foreseen by the EU High
Level Pharmaceutical Forum?
View from the Commission
Jérôme Boehm, Head of Pharmaceuticals Sector, Health and Consumers
(SANCO), European Commission, EU
Can Clear Understanding of Individual EU National HTA Evaluations and
Decision-Making Processes Lead to More Predictable, Transparent and
Consistent Outcomes?
Franz Pichler, Manager, HTA Programmes, CMR International Institute for
Regulatory Science, UK
From HTA to Reimbursement and Pricing: Situation in France and European
perspective
François Meyer, Director, Health Technology Assessment Division, HAS Haute
Autorité de Santé, France