OBJECTIVES: Health economics is playing a greater role in pharmaceuticals pricing in France since the 2012 Social Security Funding Law established the Commission for Economic Evaluation and Public Health (CEESP), which sits within the Haute Authorite de Sante (HAS). Two criteria define the eligibility for a CEESP assessment: (1) improvement of the Medical Benefit (ASMR) or improvement of the Benefit (ASA) claimed by the company (ASMR or ASA I, II, or III); and (2) significant impact of the product on the health insurance budget (turnover > €20m). Both criteria have to be met. This study aims to discuss retrospectively the relevance of the CEESP assessment which is based on the ASMR claimed by the company as opposed to the ASMR granted by the Transparency Committee (TC).

METHODS: Secondary research was performed to analyse eligibility opinions since the first CEESP assessment in 2014, until December 2015. ASMR and ASA scores were retrieved from TC opinions. For each case, the study questioned the rationale for a CEESP assessment as detailed by the manufacturer in the submission dossier, in light of the actual ASMR granted by the TC in parallel.

RESULTS: CONCLUSIONS: The CEESP assessment is meant to inform the price negotiation with the pricing committee (CEPS). The decision to conduct a CEESP assessment is based on the ASMR claimed by the manufacturer. However, the TC may eventually grant the drug a lower ASMR, meaning that the CEESP assessment that was conducted was not justified. This has an economic impact on the overall HAS budget as CEESP is potentially assessing drugs unnecessarily.