Cross Analysis of HAS Conclusions Amongst Products With an Economic Opinion Posted in 2023

OBJECTIVES: In France, for innovative treatments, the price negotiations are based on the conclusion of two independent HAS committees:

- The CT provides recommendations on reimbursement decision and an assessment of the ASMR. An ASMR of I to III is a driver for negotiating a higher list price than that of relevant comparators.

- The CEESP gives an opinion on the economic value of the health products based on the methodological acceptability of the health-economic assessment.

The objective is to describe the situations in which the economic opinions published in 2023 are a key issue in the price negotiation, i.e. invalidated economic evaluation with an ASMR I to III or a demonstration of the dominance of the product.

METHODS: Using the Vyoo Agency database, opinions published between January 1^st and December 31^st, 2023, were reviewed to cross the conclusions of both commissions.

RESULTS: In 2023, 25 treatments had been appraised. The evaluation of one treatment is attached to two ASMRs (26 ASMR) and the evaluation of three others to two RDCR due to sub-population (28 ICER). The CEESP invalidated 35% of the economic assessment including 19% with ASMR IV-V and 15% with ASMR I-III.

The average ICER, regardless of CEESP's opinion on their validity were higher for treatments with an obtained ASMR I-III than for treatments with an obtained ASMR IV-V (€620,774/QALY versus €208,378/QALY). One product was dominant in a subpopulation with an ASMR III.

CONCLUSIONS: Treatments that demonstrated an innovative value, rated by an ASMR I-III from the CT, were associated with an 300% higher average ICER than treatments with an ASMR IV-V. It shows a link between expected higher incremental benefits and higher price expectations. Considering the advantages of a valid ICER for the price negotiation, stronger efforts should be made to avoid the invalidation of the economic assessment.