OBJECTIVES: This research explores the use of risk-sharing agreements as a pricing scheme for innovative therapies in France. There is conceptual interest in this type of agreement, which stands out as an exception in the landscape of market access for medicines and determination of therapeutic value. Although they represent an attempt to price disruptive innovations, they are characterised by difficulties in implementation, particularly regarding the use of real-life data. The objective is to investigate the applicability of these agreements for innovative drug pricing and to clarify the framework surrounding the use of clinical evidence.

METHODS: A qualitative approach examined the barriers and opportunities associated with the subject. Semi-structured interviews were conducted using a thematic interview grid to gather data from the relevant stakeholders. The interviews were recorded and transcribed, then the data was analysed using interview coding. An open and then axial coding analysis was employed to group the responses into themes and categories to obtain an in-depth understanding of the respondents' perceptions.

RESULTS: Semi-structured interviews were conducted with nine stakeholders (out of 13 contacted, response rate =62%): two patient association representatives, four pharmaceutical industry employees responsible for market access and pricing, four public stakeholders (French Ministry of Health and French Ministry of the Economy), two researchers in health economics and law, one pharmaceutical industry union representative. Risk-sharing agreements are seen by stakeholders as an opportunity for providing contributory funding for innovative drugs and as leverage for price negotiation. However, major structural limitations were highlighted concerning the use of real data, the lack of budgetary predictability and divergences over their very purpose.

CONCLUSIONS: The study highlights the need for structural changes in the use of such agreements, including improved management of medico-administrative databases and clarification of their ambitions regarding innovative health products, to guarantee the economic sustainability of healthcare expenditure.