OBJECTIVES:

French legal framework has imposed budget impact analyses under certain conditions since January 2016 and methodological guidelines have been available since November 2016. To assess the publicly available French health-economic opinions about those analyses, an exhaustive retrospective analysis was conducted on methodological objections delivered by the HAS.

METHODS:

Based on publicly available opinions published by the HAS/CEESP (Comité d’Evaluation Economique et Santé publique) an electronic database was built to extract and analyze all relevant health-economic information. Data were collected and sorted in the following items: structural choices, results, sensitivity analysis and methodological objections.

Our analysis was performed from December 2014 – the publishing date of the first economic opinion – until June 16^th, 2017. (34 health-economic opinions available)

RESULTS:

Currently, 34 health-economic opinions have been published, six of which include budget impact analyses. Evaluations took place between February 2014 and October 2015. Other evaluations took place but are not published yet.

Among those analyses, the methods of four were not acceptable. Major limitations concern the choice of population, comparators, and absence of sensitivity analysis. Only two of the opinions included an overview of their limitations.

CONCLUSIONS:

The published French budget impact analyses were evaluated before the publication of the guideline, and many were of a low methodological quality (four out of six are methodologically unacceptable). The majority of analyses did not include adequate information concerning their limitations.

According to these results, French health economic evaluation is focusing on cost-effectiveness analyses at the expense of the budget impact analyses. But with the evolution of the legal framework and the publication of the French guideline, improvements in the quality of budget impact analyses are expected.