#SFHS2608808AOrder of April 8, 2026, regarding the terms for coverage of pharmaceutical specialties with a marketing authorization listed in Article L. 5126-6 of the Public Health Code
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This law specifies how a particular antifungal pharmaceutical, authorized for marketing, will be covered by health insurance in France. It outlines the medical conditions under which this medication will be reimbursed, focusing on specific fungal infections and considerations for renal impairment. Key affected groups include adults and children with these medical conditions.
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Key Changes
- Defines insurance coverage conditions for a specific antifungal drug
- Outlines medical conditions eligible for reimbursement
- Focuses on fungal infections and renal impairment
Obligations
What this law requires
Include the pharmaceutical specialty (Amphotericin B Liposomal 50mg, UCD code 34008 900 518 7 3) on the health insurance coverage list in accordance with Article L. 162-17 of the French Social Security Code
Reimburse or cover the pharmaceutical specialty only for invasive Aspergillus fungal infections as a therapeutic alternative in cases of voriconazole failure or intolerance in adults and children
Reimburse or cover the pharmaceutical specialty for neuro-meningeal cryptococcosis treatment in HIV-infected subjects and invasive Candida fungal infections only when renal impairment develops during amphotericin B treatment (serum creatinine >220 micromol/l or creatinine clearance <25 ml/min)
Reimburse or cover the pharmaceutical specialty for invasive Candida fungal infections when preexisting and persistent renal function impairment exists (serum creatinine >220 micromol/l or creatinine clearance <25 ml/min)
Reimburse or cover the pharmaceutical specialty for empirical treatment of presumed fungal infections in febrile neutropenic patients, specifically those who are allogeneic bone marrow transplant recipients or adults with neutropenia ≥7 days receiving concurrent nephrotoxic agents