Pegvaliase (Palynziq®) HTA ID: 21057

For further details of previous submission see:  Pegvaliase (Palynziq®) HTA ID: 20001

Assessment Status Assessment process complete
HTA ID 21057
Drug Pegvaliase
Brand Palynziq®
Indication for the treatment of patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
Assessment Process
Full submission received from Applicant 18/11/2021
Preliminary review sent to Applicant 21/03/2022
NCPE assessment re-commenced 22/04/2022
Follow-up to preliminary review sent to Applicant 02/06/2022
NCPE assessment re-commenced 24/06/2022
Factual accuracy sent to Applicant 08/08/2022
NCPE assessment re-commenced 16/08/2022
NCPE assessment completed 29/09/2022
NCPE assessment outcome The NCPE recommends that pegvalisae (Palynziq®) be considered for reimbursement if 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.