#SFHS2606973ADecree 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 three presentations of the medicine VYLOY (zolbetuximab) to the official list of pharmaceutical products approved for use by public hospitals, collectivités and various public services. The drug is approved exclusively for reimbursement by French health insurance when used in first-line treatment in combination with fluoropyrimidine- and platinum-based chemotherapy for adult patients with locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive gastric or gastro-oesophageal junction adenocarcinoma. The three new presentations are 100 mg single vial, 100 mg pack of 3 vials, and 300 mg single vial, all as powder for concentrate for solution for infusion. The decree was signed on 27 March 2026 and published on 31 March 2026.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Addition of VYLOY (zolbetuximab) 100 mg powder for concentrate for solution for infusion, 1-vial pack (CIP 34009 551 039 9 8)
- Addition of VYLOY (zolbetuximab) 100 mg powder for concentrate for solution for infusion, 3-vial pack (CIP 34009 551 040 0 1)
- Addition of VYLOY (zolbetuximab) 300 mg powder for concentrate for solution for infusion, 1-vial pack (CIP 34009 551 072 0 0)
+ 3 more changes with Pro
Obligations
What this law requires
Public hospitals, collectivités, and various public services must add the three presentations of VYLOY (zolbetuximab) to their approved pharmaceutical products list
Health insurance must restrict reimbursement of VYLOY to first-line treatment only in combination with fluoropyrimidine- and platinum-based chemotherapy
VYLOY reimbursement is limited to treatment of adult patients with locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive gastric or gastro-oesophageal junction adenocarcinoma
Only the three specified presentations with CIP codes 34009 551 039 9 8, 34009 551 040 0 1, and 34009 551 072 0 0 are approved for use and reimbursement