Italian Medicines Agency Agenzia Italiana del Farmaco

Board of Directors meeting of October 28, 2025, medicines eligible for reimbursement - Board of Directors meeting of October 28, 2025, medicines eligible for reimbursement

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Board of Directors meeting of October 28, 2025, medicines eligible for reimbursement

Two new molecules, one extension of therapeutic indication, one parallel import medicine, one generic medicine, and seven biosimilars.

An orphan drug for hemophilia A and an antineoplastic for breast cancer are the two new medicines that will be eligible for reimbursement by the National Health Service (NHS). This was decided by the AIFA Board of Directors at its meeting on October 28, giving the green light to Altuvoct (efanesoctocog alfa), a long-acting factor VIII replacement therapy for the treatment and prophylaxis of bleeding in patients with hemophilia A, and Truqap (capivasertib), an oral medicine used in locally advanced or metastatic breast cancer, in combination with fulvestrant.

A new therapeutic indication for the antineoplastic Breyanzi (lisocabtagene maraleucel), a genetically modified cell immunotherapy (CAR-T) used to treat certain forms of lymphoma, will also be reimbursed by the NHS.

Also eligible for reimbursement are the generic Emtricitabine/Tenofovir Alafenamide Viatris, a combined antiviral for the treatment of HIV-1 infection, two biosimilars of aflibercept (Afqlir and Mynzepli), an intravitreal drug for exudative macular degeneration and vision impairment due to macular edema or myopic choroidal neovascularization, and five biosimilars of denosumab (Jubereq, Osenvelt, Wyost, Xbryk, Yaxwer), a monoclonal antibody used primarily for osteoporosis in postmenopausal women and men at high risk of fractures, but also for bone loss associated with certain oncological diseases.

Finally, a parallel import drug, Akynzeo (netupitant/palonosetron hydrochloride), an antiemetic for the prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy, will be reimbursed by the NHS.


Published on: 29 October 2025

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