Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA Board of Directors approves the reimbursability of 7 medicines - AIFA Board of Directors approves the reimbursability of 7 medicines

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AIFA Board of Directors approves the reimbursability of 7 medicines

A new medicine for moderate to severe ulcerative colitis and new medicine indications for multiple sclerosis and cystic fibrosis. These are some of the treatments that will be reimbursed by the National Health Service (SSN) following the decisions taken by the AIFA Board of Directors at its meeting on 8 July 2025.

A total of 7 medicines are affected: 1 new chemical molecule, 1 generic medicine and 5 medicines already reimbursed for other indications.

The new medicine that will be eligible for reimbursement is Velsipity (etrasimod), indicated for the treatment of patients aged 16 years or older with moderate to severe ulcerative colitis (UC) with inadequate response, habituation or intolerance to conventional therapy or a biological agent.

The therapeutic indication extensions concern the multiple sclerosis (MS) medicine Aubagio (teriflunomide), the antithrombotic Ceprotin (protein C), the monoclonal antibody Evkeeza (evinacumab) for homozygous familial hypercholesterolaemia (two indication extensions) and two medicines for cystic fibrosis, Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor and Kalydeco (ivacaftor) as monotherapy or in combination with ivacaftor/tezacaftor/elexacaftor.

The reimbursement-eligible generic is Dalbavancin Teva (dalbavancin), an antibiotic indicated in acute bacterial skin and soft tissue infections (ABSSSI) in adults and paediatric patients aged 3 months and older.


Published on: 09 July 2025

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