Resource impact statement
NICE has recommended pegunigalsidase alfa, within its marketing authorisation, as an option for treating Fabry disease (also known as alpha-galactosidase deficiency) in adults. It is recommended only if the company provides it according to the commercial arrangement.
We expect the resource impact of implementing the recommendations in England will be less than £5 million per year (or approximately £8,800 per 100,000 population, based on a population for England of 56.6 million people).
This is because the technology is a further treatment option and the overall cost of treatment for this patient group will be similar.
Evidence shows pegunigalsidase alfa is similarly clinically effective and similarly tolerable as the treatments currently used in the NHS. Economic evidence suggests that pegunigalsidase alfa is cost saving when compared with other enzyme replacement therapies and migalastat.
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.
This technology is commissioned by NHS England. Providers are NHS hospital trusts.
The payment mechanism for the technology is determined by the responsible commissioner and depends on the technology being classified as high cost.
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