Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA Board Approves Reimbursement of 11 Drugs - AIFA Board Approves Reimbursement of 11 Drugs

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AIFA Board Approves Reimbursement of 11 Drugs

At its meeting of 14 May 2025, the Board of Directors of the Italian Medicines Agency decided that 11 medicines should be eligible for reimbursement by the National Health Service (NHS): 1 orphan medicinal product, 4 new medicinal products, 2 generic medicines, 1 parallel import medicinal product and 3 extensions of therapeutic indications.

The orphan drug that the NHS will reimburse is Fabhalta (iptacopan), indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. PNH is a rare chronic disease characterised by haemolytic anaemia, frequent thrombotic events, and bone marrow failure.

The new medicinal products that will be eligible for reimbursement are as follows: Fruzaqla (fruquintinib), a cancer medicine for the treatment of adults with metastatic colorectal cancer; Giapreza (angiotensin II), a vasoconstrictor indicated in an emergency setting to raise blood pressure to normal levels in adult patients with severely low blood pressure; Metalyse (tenecteplase), an antithrombotic medicine indicated in adults for the treatment of acute ischaemic stroke (AIS); and Vydura (rimegepant), a migraine medicine.

The generic medicines eligible for reimbursement are Alfacalcidol Doc (alfacalcidol), a vitamin D analogue, and Generic Beclomethasone and Formoterol Doc (Beclomethasone and Formoterol), a combination of two medicines indicated for the treatment of asthma. The parallel import medicine is Cyramza (ramucirumab), a cancer medicine used in combination or alone for advanced stomach cancer (or for gastroesophageal junction carcinoma).

The extensions of therapeutic indications concern Cosentyx (secukinumab), which will also be reimbursed for the treatment of moderate to severe active suppurative hydrosadenitis (reverse acne) in adults who show an inadequate response to conventional systemic therapy; Pirfenidone Teva (pirfenidone) for the treatment of idiopathic pulmonary fibrosis; and Xtandi (enzalutamide), used alone or in combination in adults with prostate cancer.


Published on: 14 May 2025

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