MARKET ACCESS AGREEMENTS IN EUROPE- TYPOLOGY AND RATIONALE

Author(s)

Toumi M1, Jaroslawski S2, Lamure M31University Claude Bernard Lyon 1, Lyon, France, 2Creativ Ceutical, Paris, Ile de France, France, 3University Claude Bernard Lyon 1, Lyon cedex 08, Rhone Alpes, France

OBJECTIVES: Achieving Market Access for new products has become complex for pharmaceutical companies. Faced with growing expenditure, health care authorities accept or propose various Market Access Agreements (MAA) (risk-sharing/performance-based/commercial schemes) but often with little experience and knowledge. We performed in-depth analysis of their design and we formulate recommendations to stakeholders. METHODS: MAA is a formalized compromise between payers and industry to achieve: Price and Reimbursement, HTA recommendation and Formulary listing. We reviewed published and grey literature from major health insurers in France, Italy, Germany and UK. We conceptualize MAA typology according to the nature of uncertainty perceived by stakeholders and their motivations. RESULTS: We identified above 30 MAAs and classified them as follows: 1) Value for money not questioned: a) Conditional Market Access Agreement: Evidence development agreement->Aim: address actual uncertainty; b) Health Outcome Boostering Agreement: Disease Management Initiative->Aim: improve competitive advantage; 2) Value for money questioned: a) Cost Containment Agreement: Basic commercial agreement->Aim: reduce/control drug bill; b) Health Outcomes Agreement: Value based agreement->Aim: link payment to performance.  Motivations of public payers: Main: Buy health production; Other: Control expenditure; Improve ICER of expensive products; Prevent media coverage of negative decision; Provide patient access; Expand benefits basket. Motivations of the industry: Main: Achieve Market Access for a product at high price in all markets; Other: Mitigate development failure; Reassure share holders; Improve company publicity; Fulfil requirements of authorities. In UK the design of MAA was a direct consequence of formalized HTA, in Italy there was no apperent rationale. CONCLUSIONS: Commonly used nomenclature needs to be revisited. Applying our typology framework should allow health care payers and the industry to design and implement MAAs rationally and with transparence. MAAs in UK are a direct repercussion of a not favorable primary HTA.

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PHP61

Topic

Economic Evaluation, Health Policy & Regulatory, Organizational Practices, Real World Data & Information Systems

Topic Subcategory

Academic & Educational, Cost/Cost of Illness/Resource Use Studies, Health & Insurance Records Systems, Reimbursement & Access Policy

Disease

Multiple Diseases

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