#SFHS2536930ADecree of 27 March 2026 amending the list of pharmaceutical specialties reimbursed in addition to hospitalization services under Article L. 162-22-7 of the Social Security Code
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This French decree adds the immunotherapy drug Tevimbra (tislelizumab) to the list of pharmaceutical specialties that can be billed separately from standard hospitalization fees under Article L. 162-22-7. It is now reimbursable by French social security for two specific first-line indications in adults. The first is in combination with platinum and fluoropyrimidine-based chemotherapy for HER2-negative, PD-L1 positive (TAP score ≥ 5 %) locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The second is in combination with platinum-based chemotherapy for PD-L1 positive (TAP score ≥ 5 %) unresectable locally advanced or metastatic esophageal squamous cell carcinoma. The product is listed with its 100 mg vial presentation, UCD code 3400890041201, marketed by BeOne Medicines France.
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Key Changes
- Addition of Tevimbra (tislelizumab) 100 mg concentrate for solution for infusion to the list of drugs billable in addition to hospitalization under Article L. 162-22-7
- Reimbursement approved only for first-line use in adults with PD-L1 TAP score ≥ 5 %
- Indication 1: Tevimbra + platinum + fluoropyrimidine chemotherapy for HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
+ 3 more changes with Pro
Obligations
What this law requires
BeOne Medicines France must ensure Tevimbra (tislelizumab) 100 mg vial (UCD code 3400890041201) is billed separately from hospitalization fees under Article L. 162-22-7 of the Social Security Code when dispensed.
Tevimbra reimbursement by French social security is restricted to first-line treatment of HER2-negative, PD-L1 positive (TAP score ≥ 5%) locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in adults when used in combination with platinum and fluoropyrimidine-based chemotherapy.
Tevimbra reimbursement by French social security is restricted to first-line treatment of PD-L1 positive (TAP score ≥ 5%) unresectable locally advanced or metastatic esophageal squamous cell carcinoma in adults when used in combination with platinum-based chemotherapy.
Healthcare providers must verify PD-L1 tumor area positivity (TAP) score ≥ 5% before prescribing Tevimbra for reimbursement under this decree for either approved indication.
Healthcare providers must confirm HER2-negative status in patients before prescribing Tevimbra for the gastric/gastroesophageal junction adenocarcinoma indication to qualify for social security reimbursement.