Exploring Off-Label Drug Coding Trends in French Hospitals: A Descriptive and Stratified Analysis 2020-2024
Author(s)
Pierre-Yves de Reviers de Mauny, PHD1, Marion TANO, PharmD2, VIRGINIE SIORAT, PharmD1, MATTHIEU RIBAULT, MSc1, PASCAL PAUBEL, PharmD2, OLIVIER PARENT DE CURZON, PharmD1, ALBANE DEGRASSAT THEAS, PharmD2.
1AGEPS - APHP, PARIS, France, 2AGEPS - APHP, Health Law and Health Economics Department, Faculty of Pharmacy, Université Paris Cité, Health Law Institute, Inserm UMR S 1145, Université Paris Cité, PARIS, France.
1AGEPS - APHP, PARIS, France, 2AGEPS - APHP, Health Law and Health Economics Department, Faculty of Pharmacy, Université Paris Cité, Health Law Institute, Inserm UMR S 1145, Université Paris Cité, PARIS, France.
OBJECTIVES: The increasing cost of the national out-of-DRG list (ODRL) in hospitals raises growing concerns. While pricing regulation and oversight mechanisms for reimbursable indications exist, off-label use, that is coded “I999999” and tolerated in both exceptional and default cases, accounts for €920 million in 2024 (€609 million in 2020). This generic code may serve various purposes: compassionate care, established off-label indications, or reflecting coding complexity. Therefore, describing the variability of off-label coding (OLc) use appears necessary.
METHODS: ScanSante data were collected in unit volumes by indication code for each international nonproprietary name (INNs) listed on the ODRL between 2020 and 2024. The percentage of I999999-coded INNs (%_I999999) was stratified by year, region and hospital legal status. Several explanatory variables were added: INNs usage intensity (consumption and admission), coding complexity (number of pharmaceutical presentation and indication), time on the ODRL, therapeutic class and regulatory status (early access, orphan designation). A descriptive univariate analysis (DUA) was performed; dispersion indicators were assessed and medians reported.
RESULTS: The median range of %_I999999 decreases from 17.5% (2020) to 13.9% (2024). The DUA demonstrates a variability in OLc by therapeutic class (led by antithrombotics with a median at 49.0%) and by hospital legal status (32.8% for non-profit private hospital versus 7.3% for private hospitals). In contrast, regional disparities are limited (medians ranging from 9.4% to 19.4%). INNs granted early access status show higher OLc rates (median at 30.2% versus 13.4%) as does long-standing INNs on the ODRL (21.0% versus 9.4%), whereas orphan designation had no significant impact.
CONCLUSIONS: While I999999 provides a budgetary safeguard for hospitals addressing reimbursable therapeutic gaps in patient care, heterogeneity by hospital type and by therapeutic class combined with regional homogeneity suggest that Olc is linked to the type of patients being cared for, and to coding difficulties for drugs with several indications under different statuses.
METHODS: ScanSante data were collected in unit volumes by indication code for each international nonproprietary name (INNs) listed on the ODRL between 2020 and 2024. The percentage of I999999-coded INNs (%_I999999) was stratified by year, region and hospital legal status. Several explanatory variables were added: INNs usage intensity (consumption and admission), coding complexity (number of pharmaceutical presentation and indication), time on the ODRL, therapeutic class and regulatory status (early access, orphan designation). A descriptive univariate analysis (DUA) was performed; dispersion indicators were assessed and medians reported.
RESULTS: The median range of %_I999999 decreases from 17.5% (2020) to 13.9% (2024). The DUA demonstrates a variability in OLc by therapeutic class (led by antithrombotics with a median at 49.0%) and by hospital legal status (32.8% for non-profit private hospital versus 7.3% for private hospitals). In contrast, regional disparities are limited (medians ranging from 9.4% to 19.4%). INNs granted early access status show higher OLc rates (median at 30.2% versus 13.4%) as does long-standing INNs on the ODRL (21.0% versus 9.4%), whereas orphan designation had no significant impact.
CONCLUSIONS: While I999999 provides a budgetary safeguard for hospitals addressing reimbursable therapeutic gaps in patient care, heterogeneity by hospital type and by therapeutic class combined with regional homogeneity suggest that Olc is linked to the type of patients being cared for, and to coding difficulties for drugs with several indications under different statuses.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR86
Topic
Health Policy & Regulatory, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Public Spending & National Health Expenditures, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas