CADTH | Evidence Driven
CADTH | Evidence Driven

foslevodopa foscarbidopa

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Generic 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
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:
  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 Milestones2
Call for patient/clinician input open18-Oct-22
Call for patient/clinician input closed08-Dec-22
Clarification:

- Patient input submission received from the Parkinson Association of Alberta

Submission received23-Nov-22
Submission accepted
Review initiated08-Dec-22
Draft CADTH review report(s) provided to sponsor for comment08-Mar-23
Deadline for sponsors comments20-Mar-23
CADTH review report(s) and responses to comments provided to sponsor14-Apr-23
Expert committee meeting (initial)26-Apr-23
Draft recommendation issued to sponsor11-May-23
Draft recommendation posted for stakeholder feedback18-May-23
End of feedback period02-Jun-23
Final recommendation issued to sponsor and drug plans16-Jun-23
Final recommendation posted05-Jul-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)30-Jun-23
CADTH review report(s) posted13-Sep-23

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : September 18, 2023