Last Updated : March 13, 2023
Details
FilesGeneric Name:
dexamethasone intravitreal implant
Project Status:
Complete
Therapeutic Area:
Diabetic macular edema
Manufacturer:
Allergan, an AbbVie Company
Brand Name:
Ozurdex
Project Line:
Reimbursement Review
Project Number:
SR0739-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with DME who
are pseudophakic and have had an inadequate response to prior anti-vascular
endothelial growth factors (VEGF) therapy.
Submission Type:
Resubmission
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with diabetic macular edema (DME) who are pseudophakic.
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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.
| Call for patient/clinician input open | May 09, 2022 |
|---|---|
| Call for patient/clinician input closed | July 04, 2022 |
| Clarification: - Patient input submission received from CNIB, Diabetes Canada, Fighting Blindness Canada, The Canadian Council of the Blind and Vision Loss Rehabilitation Canada | |
| Submission received | June 08, 2022 |
| Submission accepted | June 22, 2022 |
| Review initiated | June 23, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | September 12, 2022 |
| Deadline for sponsors comments | September 21, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | October 14, 2022 |
| Expert committee meeting (initial) | October 26, 2022 |
| Draft recommendation issued to sponsor | November 09, 2022 |
| Draft recommendation posted for stakeholder feedback | November 17, 2022 |
| End of feedback period | December 01, 2022 |
| Final recommendation issued to sponsor and drug plans | December 13, 2022 |
| Final recommendation posted | January 06, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 04, 2023 |
| CADTH review report(s) posted | March 10, 2023 |
Files
Last Updated : March 13, 2023