Last Updated : January 23, 2025
Details
FilesGeneric Name:
foslevodopa foscarbidopa
Project Status:
Complete
Therapeutic Area:
Parkinson’s disease
Manufacturer:
AbbVie Canada Inc.
Call for patient/clinician input open:
Brand Name:
Vyalev
Project Line:
Reimbursement Review
Project Number:
SR0768-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of motor fluctuations in patients with advanced Parkinson’s disease who are not adequately controlled on oral therapies
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
foslevodopa foscarbidopa is indicated for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson's disease who do not have satisfactory control of severe, debilitating motor fluctuations and hyper- /dyskinesia despite optimized treatment with available combinations of Parkinson's medicinal products.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | October 18, 2022 |
|---|---|
| Call for patient/clinician input closed | December 08, 2022 |
| Clarification: - Patient input submission received from the Parkinson Association of Alberta | |
| Submission received | November 23, 2022 |
| Submission accepted | December 07, 2022 |
| Review initiated | December 08, 2022 |
| Draft Canada's Drug Agency review report(s) provided to sponsor for comment | March 08, 2023 |
| Deadline for sponsors comments | March 20, 2023 |
| Canada's Drug Agency review report(s) and responses to comments provided to sponsor | April 14, 2023 |
| Expert committee meeting (initial) | April 26, 2023 |
| Draft recommendation issued to sponsor | May 11, 2023 |
| Draft recommendation posted for stakeholder feedback | May 18, 2023 |
| End of feedback period | June 02, 2023 |
| Final recommendation issued to sponsor and drug plans | June 16, 2023 |
| Final recommendation posted | July 05, 2023 |
| Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s) | June 30, 2023 |
| Canada's Drug Agency review report(s) posted | September 13, 2023 |
Files
Last Updated : January 23, 2025