#SFHS2607630ADecree of 27 March 2026 amending the list of pharmaceutical specialties approved for use by public authorities and various public services
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This French decree adds Tevimbra (tislelizumab) 100 mg concentrate for solution for infusion to the official list of medicines approved for use by public hospitals, prisons, military health services and other public entities. Reimbursement by French social security is restricted to two specific first-line indications in adults: (1) in combination with platinum and fluoropyrimidine chemotherapy for HER2-negative, PD-L1 TAP ≥ 5 % locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma; and (2) in combination with platinum-based chemotherapy for PD-L1 TAP ≥ 5 % unresectable locally advanced or metastatic oesophageal squamous cell carcinoma. The product is supplied as 100 mg/10 mL vials (CIP 34009 551 016 2 8) by BeOne Medicines France SARL. The decree was published on 31 March 2026.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Addition of Tevimbra (tislelizumab) 100 mg/10 mL vial (CIP 34009 551 016 2 8) to the approved public-collectivity medicines list
- Reimbursement limited to first-line PD-L1 TAP ≥ 5 % HER2-negative gastric/GEJ adenocarcinoma with platinum + fluoropyrimidine chemotherapy
- Reimbursement limited to first-line PD-L1 TAP ≥ 5 % unresectable locally advanced or metastatic oesophageal squamous cell carcinoma with platinum chemotherapy
+ 2 more changes with Pro
Obligations
What this law requires
Add Tevimbra (tislelizumab) 100 mg concentrate for solution for infusion to the official list of medicines approved for use by public hospitals, prisons, military health services and other public entities
Restrict reimbursement by French social security for Tevimbra to first-line indication: combination with platinum and fluoropyrimidine chemotherapy for HER2-negative, PD-L1 TAP ≥ 5% locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma in adults
Restrict reimbursement by French social security for Tevimbra to first-line indication: combination with platinum-based chemotherapy for PD-L1 TAP ≥ 5% unresectable locally advanced or metastatic oesophageal squamous cell carcinoma in adults
Supply Tevimbra only in the approved formulation: 100 mg/10 mL vials (CIP 34009 551 016 2 8) manufactured by BeOne Medicines France SARL
Verify PD-L1 TAP score ≥ 5% in patient tumors before approving reimbursement for either approved indication