Health

#SFHS2612372AFrance Adds Evrysdi Tablets to Reimbursable Medicines List

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

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

🇬🇧 English

Evrysdi 5 mg tablets, a Roche medicine containing risdiplam, are added to France’s list of medicines reimbursed by public health insurance. The reimbursed use is limited to treatment of 5q spinal muscular atrophy in patients diagnosed with SMA type 1, 2 or 3, or with one to four copies of the SMN2 gene. Coverage depends on a case-by-case treatment decision by multidisciplinary teams in FILNEMUS neuromuscular disease reference or competence centers. Use of the medicine is reserved for SMA specialists, and patients do not have to pay the usual insured-person contribution for this reimbursed indication.

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

Key Changes

  • Adds Evrysdi 5 mg risdiplam tablets to the list of medicines reimbursed by French public health insurance
  • Limits reimbursement to defined 5q spinal muscular atrophy patients
  • Requires case-by-case multidisciplinary approval in FILNEMUS neuromuscular disease centers and specialist use

Obligations

What this law requires

medium

Public health insurance reimbursement for EVRYSDI 5 mg risdiplam tablets must be limited to treatment of 5q spinal muscular atrophy in patients clinically diagnosed with SMA type 1, 2 or 3, or with one to four copies of the SMN2 gene.

French public health insurance bodies
From the fourth day after publication in the Journal officiel de la République française
operational
medium

Coverage of EVRYSDI 5 mg for the reimbursed SMA indication must be granted only where the treatment decision is made case by case during multidisciplinary consultation meetings within FILNEMUS neuromuscular disease reference or competence centers.

FILNEMUS neuromuscular disease reference centersFILNEMUS neuromuscular disease competence centersFrench public health insurance bodies
From the fourth day after publication in the Journal officiel de la République française
operational
medium

Use of EVRYSDI 5 mg for the reimbursed SMA indication must be reserved to physicians who are specialists in spinal muscular atrophy.

physicians prescribing EVRYSDISMA specialist physicianshealthcare providers
From the fourth day after publication in the Journal officiel de la République française
licensing
low

The insured-person contribution must be waived for EVRYSDI 5 mg when used within the reimbursed SMA indication specified in the annex.

French public health insurance bodiespharmacies processing reimbursement
From the fourth day after publication in the Journal officiel de la République française
operational

Affected Parties

Patients with eligible 5q spinal muscular atrophySMA specialist physicians+3 more…

Tags

pharmaceutical reimbursement,spinal muscular atrophy,Evrysdi