Last Updated : September 18, 2023
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 | 18-Oct-22 |
---|---|
Call for patient/clinician input closed | 08-Dec-22 |
Clarification: - Patient input submission received from the Parkinson Association of Alberta | |
Submission received | 23-Nov-22 |
Submission accepted | |
Review initiated | 08-Dec-22 |
Draft CADTH review report(s) provided to sponsor for comment | 08-Mar-23 |
Deadline for sponsors comments | 20-Mar-23 |
CADTH review report(s) and responses to comments provided to sponsor | 14-Apr-23 |
Expert committee meeting (initial) | 26-Apr-23 |
Draft recommendation issued to sponsor | 11-May-23 |
Draft recommendation posted for stakeholder feedback | 18-May-23 |
End of feedback period | 02-Jun-23 |
Final recommendation issued to sponsor and drug plans | 16-Jun-23 |
Final recommendation posted | 05-Jul-23 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 30-Jun-23 |
CADTH review report(s) posted | 13-Sep-23 |
Files
Last Updated : September 18, 2023