OBJECTIVES: Performance-based contracts (PBS) between manufacturers and payers have gained traction to ensure access to medical innovation when uncertainty remains too high. In France, despite a legal-administrative framework that outlines PBS negotiation, experience has been mixed with some contracts not necessarily meeting the authorities’ expectations. A multidisciplinary group of 12 experts has convened to draw up concrete recommendations for the implementation of PBS.

METHODS: The experts panel was made of 3 patients organizations representatives, 2 clinicians, 4 academics (public health, health law, health economics), 1 think tank representative, 1 former member of the French HTA agency, and 1 former member of the French national pricing authority. The panel met in 4 sequential workshops: 1) Situation analysis and definitions, 2 & 3) recommendations listing, 4) practical and hypothetical cases discussion.

RESULTS: Participants acknowledged the value of PBS in supporting access to innovation. Participants agreed on the pitfalls and prerequisites of PBS, including a clear characterization of the uncertainty and a performance variable that can be easily objectivized from reliable information systems. Consensus was also reached on the need to distinguish between single-dose and repeated-dose treatments. However, the very notion of performance was not understood and defined in the same way by all. Differences in perception between stakeholders have emerged, with patients/clinicians on one side and health authorities on the other. The former embraces dynamic and real-life evaluations based notably on patient-reported outcomes and day-to-day disease management (micro-level). The latter focuses on the demonstration of efficacy, safety, and efficiency with robust methodological requirements, and on budget issues (macro-level). Reconciling the two seems challenging with the current legal-administrative framework.

CONCLUSIONS: Future legal-administrative evolutions should ensure that differences of opinion are taken into consideration, to provide information systems and negotiating frameworks that better satisfies all stakeholders and ultimately enables the efficient operationalization of PBS in France.