OBJECTIVES

: In order to reinforce the support for public decision-making, the accord-cadre of 2015 signed between the CEPS (Comité Economique des Produits de Santé) and the pharmaceutical companies (Leem) provided for a budget impact model (BIM) to be carried out in addition to an efficiency analysis for medicinal products with a projected turnover in the second year of marketing of more than 50 million euros. The main objective of the study is to analyze methodological criticisms made by the CEESP (Commission Evaluation Economique et de Santé Publique) on BIM.

METHODS

: Based on publicly available opinions published by the HAS/CEESP a database was built to extract and analyze all relevant health-economic information about efficiency analysis and BIM. Data on the following items were collected: number of BIM objections, level of objections, BIM objections formulation/wording, categorization of BIM objections.

Our analysis was performed from December 2014 – the publishing date of the first economic opinion – until June 1^st, 2020.

RESULTS

: Currently, 124 health-economic opinions have been published, 50 of which include budget impact model (medical devices were excluded).

Among those opinions, BIM objections concern the choice of population, comparators, costs, market share evaluation and sensitivity analysis. In total, in only 12 opinions no BIM-specific objections were found. Major BIM objections were found in 5 opinions.

CONCLUSIONS

: Many of the objections made on the budget impact model are the same made on the cost-effectiveness model because some structuring choices are identical. The results of this retrospective analysis of the CEESP opinions will be discussed with CEPS and pharmaceutical manufacturers in order to understand the impact of BIM on the drug price negotiation process.