dexamethasone intravitreal implant


( Last Updated : December 6, 2022)
Generic Name:
dexamethasone intravitreal implant
Project Status:
Active
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

Details


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.
  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 openMay 09, 2022
Call for patient/clinician input closedJuly 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 receivedJune 08, 2022
Submission acceptedJune 22, 2022
Review initiatedJune 23, 2022
Draft CADTH review report(s) provided to sponsor for commentSeptember 12, 2022
Deadline for sponsors commentsSeptember 21, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 14, 2022
Expert committee meeting (initial)October 26, 2022
Draft recommendation issued to sponsorNovember 09, 2022
Draft recommendation posted for stakeholder feedbackNovember 17, 2022
End of feedback periodDecember 01, 2022
Final recommendation issued to sponsor and drug plansDecember 13, 2022
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 04, 2023
CADTH review report(s) posted