Last Updated : January 13, 2023
Details
FilesGeneric Name:
faricimab
Project Status:
Complete
Therapeutic Area:
Diabetic Macular Edema
Manufacturer:
Hoffmann-La Roche Canada
Brand Name:
Vabysmo
Project Line:
Reimbursement Review
Project Number:
SR0729-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of Diabetic Macular Edema (DME).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
For the treatment of Diabetic Macular Edema (DME).
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | February 24, 2022 |
| Call for patient/clinician input closed | April 14, 2022 |
| Clarification: - Patient input submission received from Fighting Blindness Canada, The Canadian Council of the Blind, CNIB, Vision Loss Rehabilitation Canada, Diabetes Canada | |
| Submission received | March 24, 2022 |
| Submission accepted | April 07, 2022 |
| Review initiated | April 08, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 23, 2022 |
| Deadline for sponsors comments | July 05, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | August 12, 2022 |
| Expert committee meeting (initial) | August 24, 2022 |
| Draft recommendation issued to sponsor | September 07, 2022 |
| Draft recommendation posted for stakeholder feedback | September 15, 2022 |
| End of feedback period | September 29, 2022 |
| Final recommendation issued to sponsor and drug plans | October 13, 2022 |
| Final recommendation posted | October 31, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 27, 2022 |
| CADTH review report(s) posted | January 12, 2023 |
Files
Last Updated : January 13, 2023