#SFHS2610598AFrance Adds WINREVAIR to the List of Reimbursable Medicines
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order adds eight WINREVAIR presentations, containing sotatercept, to France’s list of medicines reimbursed by health insurance. The patient co-payment is removed for these products, meaning eligible patients can receive coverage without the usual out-of-pocket share. The reimbursement applies only to the therapeutic indication approved in the marketing authorization on the publication date. The products are also treated as “exception medicines,” so prescribing and reimbursement will follow stricter conditions. The change takes effect 15 days after publication in the French Official Journal.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Adds eight WINREVAIR presentations to France’s reimbursable medicines list
- Removes the patient co-payment for these listed products
- Limits reimbursement to the approved therapeutic indication and applies exception-medicine rules
Obligations
What this law requires
Apply reimbursement coverage for the eight listed WINREVAIR 45 mg and 60 mg sotatercept presentations only for the therapeutic indication included in the marketing authorization on the publication date of the order.
Remove the insured patient co-payment for the listed WINREVAIR sotatercept presentations when they are reimbursed under the applicable approved indication.
Treat the listed WINREVAIR sotatercept presentations as “médicaments d’exception,” meaning prescription and reimbursement must follow the stricter exception-medicine regime under Article R. 163-2 of the Social Security Code.