Pegvaliase (Palynziq®). HTA ID: 20001

Assessment Status Submission Withdrawn. See Pegvaliase (Palynziq®) HTA ID: 21057
HTA ID 20001
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
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 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 21/12/2020
Full re-submission received from Applicant 18/11/2021
Assessment Status Submission Withdrawn Pegvaliase (Palynziq®) HTA ID: 21057
HTA ID 20001
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
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 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 21/12/2020