#SFHS2611955AFrance Adds Afinitor and Cotellic to Public-Sector Approved Medicines List
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order adds two medicines, Afinitor 10 mg and Cotellic 20 mg, to France’s list of pharmaceutical products approved for use by public healthcare institutions and public services. Health insurance coverage is limited to the stated approved treatment uses. For Afinitor, these include certain advanced kidney cancer, pancreatic neuroendocrine tumors, hormone receptor-positive advanced breast cancer, and some gastrointestinal or lung neuroendocrine tumors. For Cotellic, coverage applies only to the indication covered by its marketing authorization on the publication date.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Adds Afinitor 10 mg to the approved medicines list for public-sector use
- Adds Cotellic 20 mg to the approved medicines list for public-sector use
- Limits health insurance coverage to specified approved therapeutic indications
Obligations
What this law requires
Public healthcare institutions and public services may treat AFINITOR 10 mg (everolimus), CIP 34009 495 018 9 2, as approved for collective/public-service use because it is added to the approved specialties list.
Health insurance coverage for AFINITOR 10 mg must be limited to the listed therapeutic indications: advanced kidney cancer after anti-VEGF targeted therapy progression; unresectable or metastatic pancreatic neuroendocrine tumors with disease progression in adults; hormone receptor-positive, HER2/neu-negative advanced breast cancer in combination with exemestane in eligible postmenopausal women; and unresectable or metastatic non-functional gastrointestinal or lung neuroendocrine tumors, grade 1 or 2, progressing in adults.
Public healthcare institutions and public services may treat COTELLIC 20 mg (cobimetinib), CIP 34009 495 019 5 3, as approved for collective/public-service use because it is added to the approved specialties list.
Health insurance coverage for COTELLIC 20 mg must be limited to the therapeutic indication contained in its marketing authorization on the publication date of this order.