CDA | Evidence Driven
CDA | Evidence Driven

dexamethasone intravitreal implant

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Generic 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
Performance Metric:
Achieved
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:
  1. 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 open09-May-22
Call for patient/clinician input closed04-Jul-22
Clarification:

- Patient input submission received from CNIB, Diabetes Canada, Fighting Blindness Canada, The Canadian Council of the Blind and Vision Loss Rehabilitation Canada

Submission received08-Jun-22
Submission accepted22-Jun-22
Review initiated23-Jun-22
Draft CADTH review report(s) provided to sponsor for comment12-Sep-22
Deadline for sponsors comments21-Sep-22
CADTH review report(s) and responses to comments provided to sponsor14-Oct-22
Expert committee meeting (initial)26-Oct-22
Draft recommendation issued to sponsor09-Nov-22
Draft recommendation posted for stakeholder feedback17-Nov-22
End of feedback period01-Dec-22
Final recommendation issued to sponsor and drug plans13-Dec-22
Final recommendation posted06-Jan-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Jan-23
CADTH review report(s) posted10-Mar-23

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : July 23, 2024