NATURE OF ENDPOINTS IN MARKET ACCESS AGREEMENTS

Author(s)

Toumi M1, Zard J2, Rémuzat C2, Ben Abdallah I2, Jaroslawski S3
1University Claude Bernard Lyon 1, Lyon, France, 2Creativ-Ceutical, Paris, France, 3, India

OBJECTIVES: Payers are strongly reluctant to value surrogate endpoints (SEP) as they carry substantial uncertainty on the final endpoint. However, it seems that SEP are common in payment for performance (P4P) agreements. The objective of this project was to Identify the proportion of SEP used in P4P and coverage with evidence development (CED). METHODS: Market access agreements (MAA) were identified from literature review, completed agencies websites, and experts input.  P4P and CED were selected. Performance endpoints were classified as SEP or hard endpoint (HEP). RESULTS: CONCLUSIONS: Although SEP are considered as not reliable from payers’ perspective to fund newly approved products, they have become widely acceptable for defining success criteria in P4P. This highlights the limitation of P4P, and more research would be needed to assess the actual predictive value of such endpoints. On the opposite, CED appears to be an appropriate tool to address payers’ uncertainty as they rely on HEP for decision making.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PHP96

Topic

Health Policy & Regulatory

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways, Reimbursement & Access Policy

Disease

Multiple Diseases

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