#SFHS2608349ADecree of 30 March 2026 amending the list of pharmaceutical specialties approved for use by public authorities and various public services
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This French decree adds Posaconazole Arrow 100 mg gastro-resistant tablets (CIP 34009 303 275 5) to the official list of medicines approved for use by public hospitals, collectivités and public services. It approves specific therapeutic indications for treatment of invasive fungal infections in adults and paediatric patients aged 2 years and over weighing more than 40 kg who are refractory or intolerant to amphotericin B, itraconazole or fluconazole. Covered infections include invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma and coccidioidomycosis. The decree also approves its use for prophylaxis of invasive fungal infections in high-risk patients undergoing induction chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome, and in haematopoietic stem cell transplant recipients receiving high-dose immunosuppressive therapy for graft-versus-host disease. Refractoriness is defined as progression or lack of improvement after at least 7 days of adequate antifungal treatment.
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Key Changes
- Addition of POSACONAZOLE ARROW 100 mg gastro-resistant tablets (CIP 34009 303 275 5, pack of 96) to the approved public medicines list
- Approval for treatment of invasive aspergillosis in patients refractory or intolerant to amphotericin B or itraconazole
- Approval for fusariosis in patients refractory or intolerant to amphotericin B
+ 5 more changes with Pro
Obligations
What this law requires
Public hospitals, collectivities and public services must add Posaconazole Arrow 100 mg gastro-resistant tablets (CIP 34009 303 275 5) to their list of approved pharmaceutical specialties for use
Health insurance (assurance maladie) must provide coverage for Posaconazole Arrow 100 mg for treatment of invasive fungal infections (invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, coccidioidomycosis) in pediatric patients aged 2+ years weighing >40 kg and adults who are refractory or intolerant to amphotericin B, itraconazole, or fluconazole
Verify refractoriness is defined as infection progression or lack of improvement after minimum 7 days of adequate antifungal treatment at therapeutic doses before approving coverage for Posaconazole Arrow
Health insurance must provide coverage for Posaconazole Arrow 100 mg for prophylaxis of invasive fungal infections in pediatric patients aged 2+ years weighing >40 kg and adults undergoing induction chemotherapy for acute myeloid leukemia or myelodysplastic syndrome
Health insurance must provide coverage for Posaconazole Arrow 100 mg for prophylaxis of invasive fungal infections in hematopoietic stem cell transplant recipients receiving high-dose immunosuppressive therapy for graft-versus-host disease