The Board of Directors of the Italian Medicines Agency, which met on 29 January for the first session of 2025, has re-admitted to reimbursement, in all Regions, the drug BAQSIMI (glucagon nasal spray), a treatment for severe hypoglycaemia in adult and paediatric patients with diabetes mellitus. Among the new therapies that will be reimbursed by the National Health Service, there is also an antitumor medicine for metastatic prostate cancer (PLUVICTO), a medicine for osteoporosis in post-menopausal women (ELADYNOS) and two medicines for the treatment of diabetes mellitus (MOUNJARO and AWIQLI).

PLUVICTO (Lutetium (177lu) Vipivotide Tetraxetan) is a radiopharmaceutical indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer, which is administered intravenously in hospital. It is a precision therapy that combines a radioisotope with a molecule capable of recognizing and binding to a receptor expressed on tumour cells. The medicine, now reimbursed by the NHS, represents a new therapeutic option for prostate cancer, one of the most widespread cancers in the world.

ELADYNOS (abaloparatide) is a new medicine in injectable solution for subcutaneous use indicated for osteoporosis in postmenopausal women at increased risk of fracture.

MOUNJARO (tirzepatide) is indicated for the treatment of type 2 diabetes mellitus and AWIQLI (insulin icodec) is a weekly human insulin analogue.

The Board of Directors approved the admission to reimbursement by the NHS of 13 medicines, including orphan drugs for rare diseases (1), new medicines of chemical origin (3), generic medicines (2), extensions of therapeutic indications (6 medicine for 12 new therapeutic indications) and biosimilars (1). Furthermore, 16 price renegotiations were approved, the majority of which involved price reductions while small increases were decided on for medicines at risk of shortages.

The therapeutic extensions of medicines already reimbursed by the NHS mainly fall into the area of oncological diseases and concern the medicines JEMPERLI (ostarlimab), KEYTRUDA (pembrolizumab), OPDIVO (nivolumab), TRODELVY (sacituzumab govitecan) e XALKORI (crizotinib).

Among the generics, an anticoagulant and an antipsychotic indicated for the treatment of schizophrenia were admitted to reimbursement. A biosimilar indicated for plaque psoriasis and Crohn's disease has also been admitted to reimbursement.