Pegunigalsidase alfa (Elfabrio®). HTA ID: 23020

Assessment Status Rapid Review Complete
HTA ID 23020
Drug Pegunigalsidase alfa
Brand Elfabrio®
Indication Pegunigalsidase alfa (Elfabrio®) is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
Assessment Process
Rapid review commissioned 19/04/2023
Rapid review completed 24/05/2023
Rapid review outcome A full HTA is not recommended. The NCPE recommends that pegunigalsiadase alfa not be considered for reimbursement at the submitted price*.

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

The HSE has approved reimbursement following confidential price negotiations. September 2023