Presentation (CTI)

OBJECTIVES: In France, innovative hospital therapies rely on exceptional add-on funding outside the standard DRG framework (innovative and high-cost drugs included in the 'liste en sus', and early access). While the Economic Committee for Health Products (CEPS) uses confidential rebates as a central regulatory lever, the growing gap between public list prices (PFHT) and actual net prices—reaching €3.9bn in 2024 for out-of-DRG drugs—creates multiple downstream inefficiencies. To assess both the efficiency and limitations of this regulatory mechanism by modelling the microeconomic (hospitals), macroeconomic (national health budget known as “ONDAM”), and international vulnerabilities induced by this expanding price differential.
METHODS: Focusing on the French hospital market, this study combines financial flow mapping with a Failure Mode and Effects Analysis (FMEA) framework applied to every transactional touchpoint within the out-of-DRG reimbursement circuit.
RESULTS: At hospital level, three major critical failure modes were identified:

1. A transitional cash-flow burdens on hospitals fronting procurement costs at PFHT;
2. Drastic reduction in hospital bargaining space for innovative drugs;
3. Heightened risk of inventory devaluation when the CEPS converts rebates into list-price reductions.

Macroeconomically, rebate concentration obscures ONDAM governance, particularly within the hospital care envelope. Between 2021 and 2024, gross out-of-DRG expenditure surged by 59.6% (€5.9bn to €9.4bn), whereas net expenditure grew by 42.2%, creating a major blind spot in public accounting. At the international level, this artificial gap introduces a bias in the assessment of countries that use External Reference Pricing, thereby contributing to the inflationary impact of spending on medicines.
CONCLUSIONS: While confidential rebates effectively secure immediate patient access to innovation at a contained macroeconomic cost, they nevertheless shift the financial risks to hospitals. Optimizing financial compensation circuits is imperative to preserve the sustainability of this regulatory model.