|Assessment Status||Rapid Review Complete|
|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).|
|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