OBJECTIVES: Access to reimbursement in France requires manufacturers to submit a dossier to the National Authority for Health (HAS), responsible for health technology assessment (HTA). When manufacturers claim a high added therapeutic value and anticipate an impact on social health insurance (SHI) spending, they are required to submit a budget impact analysis (BIA) for the next 3 or 5 years. In addition to value-based price regulation of health products following the HTA process, and to help control SHI spending, the parliament sets an annual healthcare expenditure envelope (ONDAM). This analysis uses BIAs assessed by HAS to estimate the proportion of the ONDAM growth which is allocated to the adoption of new health products between 2020 and 2022.

METHODS: This analysis was performed using data extracted from HAS databases and publicly available information. As manufacturers’ dossiers are submitted with “claimed prices”, estimated rebates by class were considered to obtain more relevant budget impact results. These data were compared with the observed annual growth of ONDAM that reflects actual SHI expenses on the past year. To account for the covid crisis, a supplementary analysis was performed removing costs associated to the pandemic from the ONDAM.

RESULTS: Health products with high budget impacts from 2020 to 2022 were estimated based on 85 BIAs assessed and validated by HAS between 2015 and 2022. This analysis suggests that the share of budget impact in total ONDAM growth was variable across the years. In 2020, it represented 9% of the ONDAM growth compared to previous year, in 2021, 14% and in 2022, 35%. When covid costs were excluded from the ONDAM, the variability was reduced: 25%, 20% and 19% in 2020, 2021 and 2022 respectively.

CONCLUSIONS: This study suggests that the adoption of innovative health products with a BIA assessment by HAS represents approximately 20% of the ONDAM annual growth.