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

- The CT (Transparency Committee) provides recommendations on reimbursement decision through the ASMR (Clinical Added Value). An ASMR of I to III is a prerequisite for negotiating a higher list price than that of relevant comparators.

- The CEESP (Economic & Public Health Assessment Committee) gives an opinion on the methodological acceptability of the health-economic evaluation. A valid evaluation brings key information for price stability and net price negotiation.

No correlation is expected a priori between the ASMR level and the methodological acceptability of the economic evaluation.

The objective of the study is to determine the situations in which the economic opinions disclosed in 2022 are a key issue in the price negotiation.

METHODS: Using Vyoo Agency efficiency database, all available Health Economic appraisal published between January 1 and until December 31, 2022, were reviewed to cross the conclusions of each commission.

RESULTS: In 2022, both a CT and a CEESP opinion was disclosed for 27 treatments. The CEESP invalidated 50% of the economic dossiers irrespective of the obtained ASMR: 10/19 with ASMR I-III and 4/8 with ASMR IV-V.

In parallel, a higher 243,142€/QALY average ICER was observed for treatments with an ASMR I-III versus a 106,351€/QALY average ICER for treatments with an ASMR IV-V and one product was dominant.

CONCLUSIONS: If Economic dossier invalidation was not correlated to final ASMR granted, treatments with an ASMR I-III were associated to a 250% higher average ICER than treatments with an ASMR IV-V. It shows how useful a valid ICERs could be for price negotiation in situation where expected higher incremental benefits seemed counterbalanced by even higher price expectations. Stronger efforts should be made to both avoid invalidation of the economic dossier.