#SFHS2604853ADecree 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
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This French decree adds the monoclonal antibody Zolbetuximab (brand name Vyloy) to the list of expensive pharmaceutical products that hospitals can bill separately in addition to standard DRG hospitalization fees. The only reimbursed indication is first-line treatment, in combination with fluoropyrimidine- and platinum-based chemotherapy, of adult patients with locally advanced unresectable or metastatic HER2-negative, CLDN18.2-positive gastric or gastro-oesophageal junction adenocarcinoma. Three presentations are inscribed: 300 mg single vial, 100 mg single vial, and 100 mg pack of 3 vials, all marketed by Astellas Pharma. The measure takes effect upon publication in the Journal Officiel and allows French hospitals to obtain supplementary reimbursement when using Vyloy for the approved indication.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Addition of Zolbetuximab (Vyloy) to the Liste en sus under Article L. 162-22-7 effective upon publication in Journal Officiel
- Reimbursement limited exclusively to first-line treatment of HER2-negative, CLDN18.2-positive unresectable or metastatic gastric/GEJ adenocarcinoma in combination with fluoropyrimidine + platinum chemotherapy
- Three presentations inscribed with UCD codes: 3400890049719 (300 mg vial), 3400890043106 (100 mg 1 vial and 3-vial pack)
+ 3 more changes with Pro
Obligations
What this law requires
Add Zolbetuximab (VYLOY) in three presentations (300mg single vial, 100mg single vial, 100mg pack of 3 vials) to the list of pharmaceutical specialties billable separately from hospitalization services under Article L. 162-22-7 of the Social Security Code
Restrict reimbursement of Zolbetuximab (VYLOY) to first-line treatment only, 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
Ensure that Zolbetuximab (VYLOY) is only reimbursed as a separate billable item when used for the specified therapeutic indication and not for any other indication
Apply the decree effective immediately upon publication in the Journal Officiel de la République française
Recognize Astellas Pharma as the authorized marketing authorization holder for all three presentations of VYLOY for reimbursement purposes