Analysis of the Impact of Early Access Decisions on Pricing and Reimbursement Decisions in France

OBJECTIVES: The revised French early access (EA) program was introduced in July 2021 to ensure derogatory access to innovative products before pricing and reimbursement decisions.This study aims to investigate the impact of EA decisions on pricing and reimbursement in France.

METHODS: Products evaluated under the revised EA program (1 July 2021–30 April 2023) were identified from the French National Health Authority (HAS) website. The EA eligibility criteria and decisions were analysed in addition to available corresponding Transparency Commission opinions. Products EA prices and available negotiated list prices were extracted from the French Ministry of Health and health insurance websites respectively and compared.

RESULTS: Fifty-one products applied to both EA and reimbursement in France for ≥1 indication(s) (67 EA requests, 60 reimbursement decisions). The same clinical data package was submitted for EA and reimbursement requests in most cases (89%). The products approved for EA were reimbursed in France and were mostly granted an “important” clinical value (SMR) (81%). Products denied EA were either not reimbursed (n=5) or granted a “weak” SMR with indication restriction (n=3). Presumed innovativeness of products under EAP was validated for 98% of the products granted an “important” SMR and for all the decisions with a clinical added value (ASMR) level II, III, or IV (No ASMR I reported). This criterion was not validated in 4 out of 5 negative reimbursement decisions. Eight products had publicly available prices under EA and after reimbursement decision. Price variation after negotiation ranged from -15% (discount) to +7% (premium).

CONCLUSIONS: EA approval, especially presumption of innovativeness, is a positive indicator of added value and a potential predictor of clinical added value. Price negotiation is a complex process based on multiple factors (clinical added value, population size, previous reimbursement in other indications). More cases are needed to better understand the potential impact of each factor.