National Centre for Pharmacoeconomics

National Centre for
Pharmacoeconomics

NCPE Ireland

Pegvaliase (Palynziq®) HTA ID: 20001

Pegvaliase is indicated 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.

NCPE Assessment Process Ongoing
Rapid review commissioned 13/01/2020
Rapid review completed 24/02/2020
Rapid Review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of pegvaliase compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by the HSE 26/02/2020
Pre-submission consultation with Applicant 27/04/2020
Full submission received from Applicant 02/11/2020
Preliminary review sent to Applicant/Re-submission requested 21/12/2020
Current status Re-submission requested