#SFHS2613283AFrance Expands Public-Sector Coverage for Selected Pediatric Medicines
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The order expands the approved public-sector use of several pharmaceutical products in France. Apremilast HCS is now covered for children and adolescents aged 6 and over, weighing at least 20 kg, who have moderate to severe plaque psoriasis and need systemic treatment. It also extends coverage for mycophenolate mofetil products from Viatris/Mylan for preventing acute organ rejection in pediatric transplant patients, when used with ciclosporin and corticosteroids. Hospitals, public healthcare services, prescribing physicians, and affected pediatric patients are the main groups impacted.
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Key Changes
- Extends public-sector coverage of Apremilast HCS for moderate to severe plaque psoriasis in children and adolescents aged 6 and over who weigh at least 20 kg.
- Extends coverage of mycophenolate mofetil products for preventing acute organ rejection in certain pediatric kidney, heart, and liver transplant patients.
- Updates the official list of medicines approved for use by public healthcare institutions and public services.
Obligations
What this law requires
Public healthcare establishments and other public services using the approved collectivities medicines list must treat APREMILAST HCS 10 mg/20 mg/30 mg initiation pack and APREMILAST HCS 30 mg tablets as approved for coverage for treatment of moderate to severe plaque psoriasis in children and adolescents aged at least 6 years, weighing at least 20 kg, who require systemic treatment.
Public healthcare establishments and other public services using the approved collectivities medicines list must treat MYCOPHENOLATE MOFETIL MYLAN 500 mg and MYCOPHENOLATE MOFETIL VIATRIS 500 mg as approved for coverage, in combination with ciclosporin and corticosteroids, for prevention of acute organ rejection in pediatric renal allograft patients aged 1 to 2 years.
Public healthcare establishments and other public services using the approved collectivities medicines list must treat MYCOPHENOLATE MOFETIL MYLAN 500 mg and MYCOPHENOLATE MOFETIL VIATRIS 500 mg as approved for coverage, in combination with ciclosporin and corticosteroids, for prevention of acute organ rejection in pediatric heart or liver allograft patients aged 1 to 18 years.