Last Updated : July 3, 2020
Details
FilesGeneric Name:
brolucizumab
Project Status:
Complete
Therapeutic Area:
Macular degeneration, age-related
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Beovu
Project Line:
Reimbursement Review
Project Number:
SR0632-000
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 neovascular (wet) age-related macular degeneration.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Macular degeneration, age-related
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 input posted | August 28, 2019 |
| Patient group input closed | October 18, 2019 |
| Clarification:
- Patient input submission received from Canadian Council of the Blind, CNIB Foundation, Fighting Blindness Canada, Vision Loss Rehabilitation Canada (Joint Submission) |
|
| Patient input summary sent for review to patient input groups | December 04, 2019 |
| Patient group comments on input summary closed | December 11, 2019 |
| Clarification:
- No patient input summary feedback received |
|
| Submission received | September 26, 2019 |
| Submission accepted | November 28, 2019 |
| Clarification:
- Submission was not accepted for review on 10-Oct-2019 - Revised category 1 requirements received on 25-Nov-2019 |
|
| Review initiated | November 29, 2019 |
| Draft CADTH review report(s) sent to sponsor | February 20, 2020 |
| Comments from sponsor on draft CADTH review report(s) received | March 02, 2020 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | April 02, 2020 |
| Canadian Drug Expert Committee (CDEC) meeting | April 15, 2020 |
| CDEC recommendation sent to sponsor and drug plans | April 29, 2020 |
| Embargo period ended | May 13, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | May 21, 2020 |
| CDEC Final Recommendation posted | May 25, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | June 04, 2020 |
| Clarification:
- No redactions requested by the sponsor |
|
| Final CADTH review report(s) posted | July 03, 2020 |
Files
Last Updated : July 3, 2020