PAYERS’ ACCEPTANCE OF SURROGATE AND PATIENT-RELEVANT END POINTS IN OUTCOMES-BASED MARKET ACCESS AGREEMENTS

Author(s)

Toumi M1, Jaroslawski S1, Jadot G2, Rémuzat C3, Kornfeld Å3
1Aix-Marseille University, Marseille, France, 2Lyon 1 University, Villeurbanne, France, 3Creativ-Ceutical, Paris, France

OBJECTIVES:  Costly drugs are often not reimbursed by health care payers via the regular pathway but can be subject specific arrangements called Market Access Agreements (MAAs). MAAs are financial (Commercial Agreements) or outcomes-based (Payment-for-Performance Agreements or Coverage-with-Evidence-Development Agreements). Outcomes in outcomes-based MAAs are assessed through changes in surrogate end points (EPs) or patient-relevant EPs. METHODS:  We reviewed published and grey literature on MAAs between manufacturers and payers from all geographies in May 2015. We classified the schemes by MAA type. Outcomes-based MAAs were further categorized by the EP used. RESULTS:  We identified 143 MAAs. 56 (39,2%) were pure Commercial Agreements, 53 (37,1%) were Coverage-with-Evidence-Development Agreements and 34 (23,8%) were Payment-for-Performance Agreements. Among Coverage-with-Evidence-Development Agreements, 49 were patient-relevant EP Coverage-with-Evidence-Development Agreements and four were surrogate EP Coverage-with-Evidence-Development Agreements. In 34 Payment-for-Performance Agreements, there were 29 surrogate EP Payment-for-Performance Agreements for 30 drugs and five patient-relevant EP Payment-for-Performance Agreements for at least six drugs. Among 87 outcomes-based MAAs (Coverage-with-Evidence-Development Agreements + Payment-for-Performance Agreements), patient-relevant EP Coverage-with-Evidence-Development Agreements were the most common (56,3%), followed by surrogate EP Payment-for-Performance Agreements (34,1%). CONCLUSIONS:  Payers have high acceptance for surrogate EPs when used in Payment-for-Performance Agreements. In contrast, patient-relevant EPs are predominantly accepted for use in Coverage-with-Evidence-Development Agreements. Therefore, Payment-for-Performance Agreements are not used by payers to reduce uncertainty about real-life effectiveness. They can constitute an outcome guarantee for payers if they are based on patient-relevant EPs or validated surrogate EPs. In contrast, Coverage-with-Evidence-Development Agreements employ patient-relevant EPs and can be used by payers to reduce uncertainty about a drug’s clinical outcomes or real-life use. They can enable payers to align a product’s price with its value.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PHP15

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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