pegvaliase


( Last Updated : July 1, 2022)
Generic Name:
pegvaliase
Project Status:
Active
Therapeutic Area:
Phenylketonuria
Manufacturer:
BioMarin Pharmaceutical Inc.
Brand Name:
Palynziq
Project Line:
Reimbursement Review
Project Number:
SR0712-000
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 µmol/L) on existing management.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 µmol/L) on existing management.
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones

Call for patient/clinician input open02-Nov-21
Call for patient/clinician input closed05-Jan-22
Clarification:

- Patient input submission received from the Canadian PKU and Allied Disorders (CanPKU)

Submission received23-Dec-21
Submission accepted14-Jan-22
Review initiated17-Jan-22
Draft CADTH review report(s) provided to sponsor for comment31-Mar-22
Deadline for sponsors comments11-Apr-22
CADTH review report(s) and responses to comments provided to sponsor12-May-22
Expert committee meeting (initial)25-May-22
Draft recommendation issued to sponsor07-Jun-22
Draft recommendation posted for stakeholder feedback16-Jun-22
End of feedback period30-Jun-22