At its meeting on 12 February 2025, the Board of Directors of the Italian Medicines Agency (AIFA) approved the reimbursability by the National Health Service of 6 medicines including orphan drugs for rare diseases (1), generic medicines (3) and extensions of therapeutic indications (2).

The orphan drug that will be reimbursed by the National Health Service is TALVEY (talquetamab), indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 3 previous therapies and who showed disease progression during the last therapy.

The generics eligible for reimbursement are the oral anticoagulant APIXABAN MYLAN (apixaban) – which may be marketed at the cost of the NHS once the originator (ELIQUIS) patent expires – the chemotherapy medicine HYDROXYCARBAMIDE AUROBINDO (hydroxycarbamide) and the antiviral MARAVIROC WAYMADE (maraviroc).

The therapeutic indication extensions concern the anticancer medicine TALZENNA (talazoparib) and IMCIVREE (setmelanotide), a medicine for obesity and hunger control in adults and children with rare genetic deficiencies.