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