From French Early Access to Reimbursement: A Comparison of Early Access Prices and List Prices

OBJECTIVES: French early access (EA) can be granted for innovative products targeting diseases with high unmet needs. Although EA prices (EAPs) are freely set by the manufacturer, final prices are negotiated based on factors including clinical added value (ASMR). A rebate equivalent to the difference in sales based on EAP versus negotiated list price (NP) is paid. This analysis compared EAP with NP and assessed the impact of ASMR on this difference.

METHODS: In June 2024, drugs with terminated EA after reimbursement were extracted from the National Agency for the Safety of Medicines and Health Products database. EAPs were sourced from the Ministry of Health website and NPs from a health insurance database. ASMR levels for indications covered during EA were identified from corresponding reimbursement reports.

RESULTS: Fifty-nine terminated EAs after reimbursement, with available EAPs and NPs, were identified. In most cases (83%), NPs were up to 41% lower than EAPs. Only 9 products maintained EAP, 8 of which were granted ASMR III or IV. Only 1 ASMR IV product, targeting a rare severe disease, had an NP higher (+5%) than EAP. Overall, NPs were lower than EAPs for ASMR V products: 66% had 20% to 39% lower NPs, 60% of ASMR IV products maintained EAP or had <10% lower prices, and 70% of ASMR III products maintained EAP or had <15% lower prices. However, 2 ASMR IV products had 39% and 41% lower prices than EAP.

CONCLUSIONS: Although no clear correlation between ASMR and NP versus EAP was demonstrated, a trend toward a substantial price decrease for ASMR V products was observed. ASMR III/IV products may maintain EAP level, but confidential discounts are usually systematically applied in all cases. In conclusion, EA does not guarantee EAP after reimbursement, and EAP should be carefully considered versus anticipated ASMR to avoid large rebates.