Last Updated : June 1, 2023
Details
FilesGeneric Name:
foslevodopa foscarbidopa
Project Status:
Active
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
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.
- 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.
| 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 | |
| Review initiated | December 08, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | March 08, 2023 |
| Deadline for sponsors comments | March 20, 2023 |
| CADTH 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 |
Files
Last Updated : June 1, 2023