Last Updated : March 13, 2023
Details
FilesGeneric Name:
pegvaliase
Project Status:
Complete
Therapeutic Area:
Phenylketonuria
Manufacturer:
BioMarin Pharmaceutical Inc.
Brand Name:
Palynziq
Project Line:
Reimbursement Review
Project Number:
SR0712-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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.
Procedural review: CADTH accepted a procedural review request from BioMarin Pharmaceutical Inc. (Canada) for the final recommendation from the CADTH Canadian Drug Expert Committee (CDEC) for SR0712-000 Palynziq.
Status: Concluded.
Description: This matter was concluded following adjudication by a procedural review panel (“the panel”). In its decision, the panel found that CADTH and CDEC acted in accordance with the Procedures for CADTH Reimbursement Reviews for the review of Palynziq.
The panel’s decision was provided in a memorandum report to CADTH . CADTH has prepared a response to the findings of the procedural review.
Outcome: The CDEC final recommendation of “Reimburse With Conditions” is upheld for Palynziq.
| Call for patient/clinician input open | November 02, 2021 |
|---|---|
| Call for patient/clinician input closed | January 05, 2022 |
| Clarification: - Patient input submission received from the Canadian PKU and Allied Disorders (CanPKU) | |
| Submission received | December 23, 2021 |
| Submission accepted | January 14, 2022 |
| Review initiated | January 17, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | March 31, 2022 |
| Deadline for sponsors comments | April 11, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | May 12, 2022 |
| Expert committee meeting (initial) | May 25, 2022 |
| Draft recommendation issued to sponsor | June 07, 2022 |
| Draft recommendation posted for stakeholder feedback | June 16, 2022 |
| End of feedback period | June 30, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | October 26, 2022 |
| Final recommendation issued to sponsor and drug plans | November 09, 2022 |
| Final recommendation posted | November 25, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 23, 2022 |
| CADTH review report(s) posted | February 14, 2023 |
| Procedural review concluded | March 13, 2023 |
| Clarification:
- Final recommendation upheld |
|
Files
Last Updated : March 13, 2023