#SFHS2608351ADecree of 30 March 2026 on the conditions of coverage for pharmaceutical specialties with marketing authorization listed under Article L. 5126-6 of the Public Health Code
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This French decree adds Posaconazole Arrow 100 mg gastro-resistant tablets (POSACONAZOLE ARW 100MG CPR by Arrow Generiques) to the list of reimbursable medicines under social security. It defines the exact therapeutic indications for which the product is covered by French health insurance. Coverage applies to treatment of specific invasive fungal infections (invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, and coccidioidomycosis) in adults and pediatric patients ≥2 years and >40 kg who are refractory or intolerant to first-line antifungals after at least 7 days of treatment. It is also covered for prophylaxis of invasive fungal infections in high-risk patients undergoing induction chemotherapy for AML/MDS with prolonged neutropenia or in HSCT recipients on high-dose immunosuppression for graft-versus-host disease. The decree specifies that only these listed indications qualify for reimbursement.
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Key Changes
- Posaconazole Arrow 100 mg gastro-resistant tablets added to the reimbursable list under Article L. 162-17 of the Social Security Code
- Coverage for treatment of invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma and coccidioidomycosis in refractory or intolerant adults and pediatric patients ≥2 years weighing >40 kg
- Refractory status defined as progression or lack of improvement after minimum 7 days of effective antifungal therapy at therapeutic doses
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Obligations
What this law requires
Reimburse POSACONAZOLE ARW 100MG CPR (Arrow Generiques, UCD 34008 900 524 1 2) only when prescribed for treatment of invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, or coccidioidomycosis in patients refractory or intolerant to first-line antifungals after minimum 7 days of treatment.
Restrict reimbursement of POSACONAZOLE ARW 100MG CPR to pediatric patients aged ≥2 years weighing >40 kg and adult patients only; deny claims for patients outside these age/weight criteria.
Reimburse POSACONAZOLE ARW 100MG CPR for prophylaxis of invasive fungal infections only in: (1) patients receiving induction chemotherapy for AML/MDS with prolonged neutropenia at high risk, or (2) HSCT recipients on high-dose immunosuppression for graft-versus-host disease.
Define and verify 'refractory' status as infection progression or lack of improvement after minimum 7 days of treatment with an effective antifungal at therapeutic doses before approving reimbursement.
Apply copayment (participation de l'assuré) rates determined by UNCAM (Union nationale des caisses d'assurance maladie) to all reimbursements of POSACONAZOLE ARW 100MG CPR.