#SFHS2608516AOrder of April 8, 2026, Modifying the List of Pharmaceutical Specialties Approved for Use by Communities and Various Public Services
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law updates the list of pharmaceutical drugs approved for public sector use in France. The main change is that some medications are now covered by health insurance for children and adolescents aged 6 to 17 with specific lung diseases. This affects pharmaceutical companies, healthcare providers, and families of affected children.
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Key Changes
- Updates drugs approved for public sector use in France
- Includes insurance coverage for specific lung diseases in children and adolescents
- Pharmaceutical companies must adjust to new regulations
Obligations
What this law requires
Pharmaceutical companies must ensure OFEV 25 mg (nintédanib) capsules in B/120 and B/180 presentations (CIP codes 34009 303 089 3 6 and 34009 303 089 4 3) are only covered by health insurance for children and adolescents aged 6-17 years with fibrosing, progressive, clinically significant interstitial lung disease (ILD) or for children and adolescents aged 6+ years with ILD associated with systemic sclerosis (ILD-SSc).
Pharmaceutical companies must ensure OFEV 100 mg and 150 mg (nintédanib) capsules in B/60 presentations (CIP codes 34009 300 060 2 3 and 34009 300 060 4 7) are only covered by health insurance for children and adolescents aged 6-17 years with fibrosing, progressive, clinically significant interstitial lung disease (ILD) or for children and adolescents aged 6+ years with ILD associated with systemic sclerosis (ILD-SSc).
Healthcare providers must limit prescriptions of OFEV medications to the specified age groups (6-17 years for fibrosing PID; 6+ years for PID-SSc) and approved indications only when seeking health insurance reimbursement.
Health insurance systems (Assurance Maladie) must only reimburse OFEV medications when prescribed for the specified therapeutic indications and age groups as defined in the annex.
Public services and communities using these pharmaceutical specialties must update their approved medication lists in accordance with the modifications specified in this order's annex.