Pegcetacoplan (Aspaveli®). HTA ID: 21064

Assessment Status NCPE Assessment Process Complete
HTA ID 21064
Drug Pegcetacoplan
Brand Aspaveli®
Indication For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least three months.
Assessment Process
Rapid review commissioned 13/12/2021
Rapid review completed 26/01/2022
Rapid review outcome Rapid Review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegcetacoplan compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.
Full pharmacoeconomic assessment commissioned by HSE 23/02/2022
Pre-submission consultation with Applicant 17/10/2022
Full submission received from Applicant 26/05/2023
Preliminary review sent to Applicant 05/12/2023
NCPE assessment re-commenced 16/01/2024
Follow-up to preliminary review sent to Applicant 02/02/2024
NCPE assessment re-commenced 09/02/2024
Factual accuracy sent to Applicant 08/03/2024
NCPE assessment re-commenced 19/03/2024
NCPE assessment completed 24/04/2024
NCPE assessment outcome The NCPE recommends that pegcetacoplan not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments*.

Technical Summary

Plain English Summary

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