Last Updated : November 21, 2024
Details
FilesGeneric Name:
aflibercept 8mg/0.07mL
Project Status:
Complete
Therapeutic Area:
diabetic macular edema
Manufacturer:
Bayer Inc.
Call for patient/clinician input open:
Brand Name:
Eylea HD
Project Line:
Reimbursement Review
Project Number:
SR0813-000
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 diabetic macular edema (DME), with reimbursement criteria similar to those used for other approved and reimbursed anti-vascular endothelial growth factor (VEGF) therapies.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
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.
| Call for patient/clinician input open | 07-Jul-23 |
|---|---|
| Call for patient/clinician input closed | 01-Sep-23 |
| Clarification: - Patient input submission received from Fighting Blindness Canada, The Cdn Council of the Blind, CNIB, Vision Loss Rehabilitation Canada, International Federation on Ageing, International Federation on Ageing (IFA) and Diabetic macular edema | |
| Submission received | 18-Aug-23 |
| Submission accepted | 05-Sep-23 |
| Clarification: - Submission was not accepted for review on 01 Sep 2023 | |
| Review initiated | 06-Sep-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 30-Nov-23 |
| Deadline for sponsors comments | 11-Dec-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 12-Jan-24 |
| Expert committee meeting (initial) | 24-Jan-24 |
| Draft recommendation issued to sponsor | 08-Feb-24 |
| Draft recommendation posted for stakeholder feedback | 15-Feb-24 |
| End of feedback period | 01-Mar-24 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Request for minor reconsideration not accepted - Reconsideration: major revisions requested by sponsor | |
| Final recommendation issued to sponsor and drug plans | 05-Jun-24 |
| Final recommendation posted | 21-Jun-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 19-Jun-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : November 21, 2024