#SFHS2608200ADecree of April 2, 2026, Amending the List of Pharmaceutical Specialties Approved for Use in Public and Various Services
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law adds a new pharmaceutical drug to the list of medications approved for use by public services in France. It specifically approves the use of pegzilarginase for treating arginase 1 deficiency in adults and children over the age of 2. Healthcare providers and public institutions managing treatment plans need to be aware of this update.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Adds pegzilarginase to the approved list of pharmaceutical specialties for public use.
- Approves treatment for arginase 1 deficiency in patients aged 2 and older.
- Enables reimbursement through health insurance for this treatment.
Obligations
What this law requires
Public institutions and healthcare services must update their pharmaceutical formularies to include pegzilarginase (LOARGYS) 5mg/ml injectable solution (CIP code 34009 302 832 8 8) on the list of approved pharmaceutical specialties
Healthcare providers must ensure pegzilarginase is available for treating arginase 1 deficiency (ARG1-D/hyperargininémie) in patients aged 2 years and older
Health insurance (assurance maladie) must provide reimbursement coverage exclusively for pegzilarginase when prescribed for the therapeutic indication of arginase 1 deficiency in patients aged 2 years and older
Applicable compliance and implementation procedures take effect fifteen (15) days after publication in the Journal Officiel de la République Française