Health

#SFHS2608737AOrder of April 2, 2026, Amending the List of Pharmaceutical Specialties Covered Beyond Hospital Services

🇫🇷France··Other·Medium Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This law adds the medication PEGZILARGINASE (Loargys 5 mg/mL) to the list of pharmaceuticals covered by France's national health insurance beyond hospital services. It specifically supports treatment for a rare metabolic disorder, arginase 1 deficiency, for patients over the age of two. Hospitals and health insurers need to update their billing and coverage systems accordingly.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Addition of PEGZILARGINASE to the reimbursable pharmaceuticals list
  • Focus on treating arginase 1 deficiency
  • Implementation effective 15 days after publication

Obligations

What this law requires

high

Add PEGZILARGINASE (LOARGYS 5 mg/mL, solution injectable pour perfusion) with UCD code 3400890037068 to the list of pharmaceutical specialties billable beyond hospitalization services under article L. 162-22-7 of the social security code

Health insurers, Hospital billing departments, Healthcare reimbursement bodies
operational
high

Update billing and coverage systems to recognize PEGZILARGINASE as a covered medication effective from the fifteenth day following publication in the Journal officiel de la République française

Health insurers, Hospital billing departments, Healthcare IT systems administrators
operational
high

Limit reimbursement coverage of PEGZILARGINASE exclusively to the therapeutic indication of treatment for arginase 1 deficiency (ARG1-D/hyperargininemia in patients aged 2 years and older

Health insurers, Hospital billing departments, Healthcare providers
operational
high

Ensure PEGZILARGINASE is only covered for patients aged 2 years and above; deny coverage for patients under 2 years of age

Health insurers, Healthcare providers, Hospital billing departments
operational
high

Implement the coverage modifications as of the fifteenth day following publication in the Journal officiel de la République française (effective date: April 17, 2026)

Health insurers, Hospital billing departments, All healthcare facilities
operational

Affected Parties

HospitalsHealth insurers

Tags

pharmaceuticals,health insurance,hospital services