OBJECTIVES: Access to reimbursement in France requires manufacturers to submit a dossier to the National Authority for Health (HAS), responsible for health technology assessment. Since 2013, when manufacturers claim a high added value and substantial profit, they are required to submit an economic dossier. The economic assessment includes a Cost-Effectiveness Analysis (CEA) and a Budget Impact Analysis (BIA) which must be performed according to the French guidelines and is used to support pricing negotiations. This review summarizes 10 years of economic appraisals delivered by HAS.

METHODS: A database from all economic appraisals published through April, 2023 was created gathering administrative data, results, classification of HAS reservations and their reasons. HAS assesses products by indication, however results and conclusions can be expressed by sub-population, thus this study presents data for each sub-population identified.

RESULTS: Of the 206 economic dossiers submitted to HAS, 57.8% were first-time inclusions on reimbursements lists, 90.2% concerned pharmaceuticals, 8.2% medical devices and 1.5% vaccines. 53.4% were indicated in oncology explaining the use of a partitioned survival model in 36.4% of cases. Half the submissions used an indirect comparison method. 290 CEA sub-population analyses were submitted, their greatest reservations concerning uncertainty analyses and effectiveness data, leading to 44.1% of them not being approved by HAS. Incremental Cost-Effectiveness Ratio values ranged from 813€ to 4,603,785€ per quality adjusted life year for a median timeframe analysis of 15 years. 160 BIA were submitted, their value ranging from -€507 million to €77,322,321 million. 71.9% of BIA were approved by HAS and the most frequent reservations were related to modeling and uncertainty analyses.

CONCLUSIONS: An important number of economic appraisals were delivered by HAS over the last 10 years. These products demonstrate their clinical efficacy by using intricate data whose uncertainty and robustness are the most frequently criticized points in economic assessments delivered by HAS.