Green light for the reimbursement of the first subcutaneous treatment for paroxysmal nocturnal haemoglobinuria and the first three biosimilars of denosumab, the monoclonal antibody indicated for osteoporosis and bone loss.

At its meeting on 8 October, the AIFA Board of Directors gave the green light for the reimbursement of two new medicines: the monoclonal antibody Piasky (crovalimab) and Beyonttra (acoramidis), a small molecule for oral administration.

Piasky is the first subcutaneous treatment (for doses following the first intravenous infusion) available in the European Union for paroxysmal nocturnal haemoglobinuria (PNH), a rare acquired blood disorder characterised by haemolytic anaemia, bone marrow failure and frequent thrombotic events.

Beyonttra is a medicine indicated for transthyretin cardiac amyloidosis (ATTR-CM), a serious and progressive disease that causes restrictive cardiomyopathy, leading to heart failure.    
Izamby, Junod and Osvyrti, the first biosimilars of denosumab, 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, will also be reimbursed by the NHS.

The AIFA Board of Directors also approved the reimbursement by the National Health Service of three generic medicines:

• Glicopirronio Doc (glycopyrronium bromide), a medicine indicated as maintenance bronchodilator therapy to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD);
• Prosoptima (tafluprost+timolol) and Taflofim (tafluprost+timolol), indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension.

Finally, the reimbursement of Reblozyl (luspatercept) will be extended to the treatment of transfusion-dependent anaemia due to very low, low and intermediate risk myelodysplastic syndromes.