WWW.LESECHOS-ETUDES.FR JUNE 2016 Market access of pharmaceuticals in Europe Benchmark of the market access conditions in the top 5 European pharmaceutical markets An exclusive survey to Learn how each country understands the major issues of innovation funding, the increasing role of real life data, the medico-economic assessment and the place of performance contracts Identify key success factors and best practices to promote the market access of new products and innovative therapies Have a comparative access to market analysis of pharmaceuticals in Germany, UK, Spain, Italy and France Know the national specificities and axes of convergence between these five countries
Transcript
WWW.LESECHOS-ETUDES.FR
JUNE 2016
Market access of pharmaceuticals in Europe
Benchmark of the market access conditions in the top 5 European pharmaceutical markets
An exclusive survey to
Learn how each country understands the major issues of innovation funding, the increasing role of real life data, the medico-economic assessment and the place of performance contracts
Identify key success factors and best practices to promote the market access of new products and innovative therapies
Have a comparative access to market analysis of pharmaceuticals in Germany, UK, Spain, Italy and France
Know the national specificities and axes of convergence between these five countries
TOWARDS A CONVERGENCE PROCESS OF THE HTA ASSESSMENT IN EUROPE AND AN INCREASED
EXCHANGE OF INFORMATION BETWEEN HTA AGENCIES AND BETWEEN PAYERS
More than ten years ago, the European Commission and the EU Council had identified the assessment of health technologies (HTA) as a "political priority", considering there was an urgent need to foster cooperation between European countries and to strengthen the impact of "HTA" assessments on the pricing and reimbursement process. It is to meet this priority that the EUnetHTA network was established and a number of projects have been implemented, of which the development of the "Core Model" (evaluation of the comparative effectiveness) and the SEED project (Shaping European Early Dialogues) which set up early dialogues between health products manufacturers and fourteen European assessment agencies.
In a growing interconnection context, pharmaceutical companies must optimize market access in the different European countries taking into account, on one hand the specific and national issues (even at a regional level for the decentralized countries) and on the other hand, the convergence process with EUnetHTA.
Therefore, MA scenarios by country must integrate many parameters, including pricing negotiations with the "risk sharing" contracts, reimbursement terms, time to market issues and "real life" studies.
ABOUT THE AUTOR
Gilles Chalanson, consultant specialized in Market Access. Gilles has held senior positions in the Pharmaceutical Industry before starting as Consultant specialized in the Market Access of Pharmaceuticals and Devices, capitalizing on a large experience in Pricing & Reimbursement.
He successively held the positions of Market Access Director at Rhône-Poulenc Rorer France (1996-2000), Aventis France (2000-2004) and Sanofi-Aventis France
(2004-2005) before being appointed Market Access Senior Director at Sanofi-Aventis Europe until December 2009.
Market access of pharmaceuticals in Europe
> A qualitative study based on in-depth interviews with officials from LEEM (France), VFA (Germany), OHE (United Kingdom), Farmindustria (Italy), Farmaindustria (Spain) and EFPIA
> An analysis of recent communications and works from EUnetHTA
> Extensive desk research on Market Access conditions in the first five European pharmaceutical markets
METHODOLOGY
BENCHMARK OF THE MARKET ACCESS CONDITIONS IN THE TOP 5 EUROPEAN PHARMACEUTICAL MARKETS
01 The analytical framework of market access conditions Market access evolutions in Europe since the 1980s, and the EUnetHTA targets
Structural choices and key parameters: centralized systems or not, automatic reimbursement or not, pricing conditions, clinical effectiveness assessments or health economic assessments...
02 Cross analysis of market access conditions in 5 countries Market access mapping in the 5 countries covered by this benchmark, based on about ten key criteria: place of pharmaco-economics, pricing and risk sharing agreements, specific measures to promote therapeutic innovations, financing terms in hospitals, time to market estimations...
3 case studies: Benchmark of the access to market sofosbuvir (Gilead Sciences), trastuzumab emtansine (Roche) and empagliflozine (Boehringer Ingelheim)
03 Monographs of 5 countries studiedGermany
Spain
France
Italy
United-Kingdom (focus on England)
04 Outlook of market access conditionsKey issues> Innovation funding> The multiplicity of payers > Intensifying exchanges between HTA agencies and payers> Development and management of "therapeutic solutions" (combined offers, connected solutions)
"HTA" assessment outlook at a European level, the increasing role of real-life data
The increasing role of performance contracts (risk sharing)
05 Market access strategy for a new medication: best practices and key success factors at european and national levels
What are the best practices to promote the access to innovation?
What are the success factors for successful market access of a new drug?
Country monographs framework
• Reminder of health systems organizations (centralized vs regionalized, number of funding agencies, importance of the hospital sector ...)• Pricing and reimbursement systems fundamentals • Time to market estimations• Medicines evaluation and reevaluation phases • Pharmaco-economic evaluation procedures• Risk sharing contracts procedures• Role of real life studies • Innovation funding in hospitals• Specific cases of orphan drugs and biosimilars
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THE PHARMACY HEALTH DEPARTMENT of Les Echos Etudes is animated by Hélène CHARRONDIÈRE
OTHERS FRENCH STUDIES :
Visite médicale - Mai 2016
Le marché des objets connectés dans la santé - Mai 2016
Cartographie du système de santé - Janvier 2016
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