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||Complete|
|For further details of previous submission see: Pegvaliase (Palynziq®) HTA ID: 20001|
|Full re-submission received from Applicant||18/11/2021|
|Preliminary review sent to Applicant||21/03/2022|
|NCPE assessment re-commenced||22/04/2022|
|Preliminary review II sent to Applicant||02/06/2022|
|NCPE assessment re-commenced||24/06/2022|
|Factual accuracy check sent to Applicant||08/08/2022|
|NCPE assessment recommenced||16/08/2022|
|NCPE assessment completed||29/09/2022|
|NCPE assessment outcome||
The NCPE recommends that pegvaliase (Palynziq®) be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments.*
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.