2 Information about pegunigalsidase alfa

Marketing authorisation indication

2.1

Pegunigalsidase alfa (Elfabrio, Chiesi) is indicated for 'long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase)'.

Dosage in the marketing authorisation

Price

2.3

The list price of pegunigalsidase alfa is £1,255.19 per 20 mg vial (excluding VAT; company submission January 2023). The annual treatment cost is £118,187 (based on an average dosing weight of 72.2 kg).

2.4

The company has a commercial arrangement. This makes pegunigalsidase alfa available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.