#SFHS2612373AFrance Adds Evrysdi Tablets to the Approved Medicines List for Public Healthcare Use
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order adds Evrysdi 5 mg tablets, a risdiplam medicine made by Roche, to the list of medicines approved for use by public healthcare institutions and other public services in France. Health insurance coverage is limited to treatment of 5q spinal muscular atrophy in patients with type 1, type 2, or type 3 SMA, or patients with one to four copies of the SMN2 gene. Treatment must be decided case by case in specialist multidisciplinary meetings within FILNEMUS neuromuscular disease centers, and use is reserved for SMA specialist doctors.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Adds Evrysdi 5 mg film-coated tablets to France’s approved list for public healthcare use
- Limits health insurance coverage to specified 5q spinal muscular atrophy patients
- Requires case-by-case specialist review and restricts use to SMA specialist doctors
Obligations
What this law requires
Public healthcare institutions and other public services may use EVRYSDI 5 mg (risdiplam) film-coated tablets only as a pharmaceutical specialty approved on the collectivités list in accordance with the annexed listing.
Health insurance coverage for EVRYSDI 5 mg is limited to treatment of 5q spinal muscular atrophy in patients with a clinical diagnosis of SMA type 1, type 2, or type 3, or with one to four copies of the SMN2 gene.
Treatment with EVRYSDI 5 mg for the covered indication must be decided case by case during multidisciplinary consultation meetings within FILNEMUS neuromuscular disease reference and competence centers.
Use of EVRYSDI 5 mg for the covered indication must be reserved to physicians who are specialists in spinal muscular atrophy.