[Off-label coding in the out-of-diagnosis related group reimbursement list: Nationwide assessment]

The full reimbursement of drugs listed on the "out of diagnosis-related groups" list and coded as off-label use, which has shown continuous growth, is being reconsidered. The objective of this study was to provide a nationwide overview of this practice and to identify the determinants of its dynamics. The percentage of dispensing units coded as off-label use, calculated from the Scan Santé database between 2020 and 2024, was stratified by year, region (metropolitan France), and type of healthcare institution (university hospital, general hospital, cancer center, private non-profit hospital, private for-profit hospital). The explanatory variables included: consumption volume, number of indications, duration of listing on the out of diagnosis related groups list, therapeutic class, and early access status. A descriptive analysis and a variance analysis were performed using R software. Over the study period, the percentage of off-label use ranged from 10.4% to 17.5% depending on the year (median 14.3%). Median values of off-label use differed by region (9.9% to 19.4%) and by type of healthcare institution (7.3% to 32.8%). The type of institution, the international nonproprietary names, and the region had a significant impact on this use (P<0.001). By contrast, the duration of listing on the out-of-DRG list had no impact. This prescribing freedom is granted by exception and by default. It raises the question of revising reimbursement modalities and of the risk of financial losses for hospital, in a context of hospital expenditure control.