fluocinolone acetonide intravitreal implant


Generic Name:
fluocinolone acetonide intravitreal implant
Project Status:
Therapeutic Area:
diabetic macular edema
Knight Therapeutics Inc.
Call for patient/clinician input open:
Brand Name:
Project Line:
Reimbursement Review
Project Number:
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Manufacturer Requested Reimbursement Criteria1:
Indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
Submission Type:
Fee Schedule:
Schedule A
diabetic macular edema
Date NOC Issued:
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input posted March 06, 2019
Patient group input closed April 25, 2019

- Patient input submission received from the Canadian Association for Retired Persons (CARP), Canadian Council of the Blind (CCB), Diabetes Canada (DC) and the International Federation on Ageing (IFA)

Patient input summary sent for review to patient input groups May 06, 2019
Patient group comments on input summary closed May 13, 2019

- Patient input summary feedback received

Submission received April 03, 2019
Submission accepted for review April 17, 2019
Review initiated April 18, 2019
Draft CADTH review report(s) sent to sponsor July 04, 2019
Comments from sponsor on draft CADTH review report(s) received July 15, 2019
Redaction requests from sponsor on draft CADTH review report(s) received July 22, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor August 09, 2019
Canadian Drug Expert Committee (CDEC) meeting August 21, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans September 05, 2019
Embargo period ended and validation of redacted CADTH review report(s) received September 19, 2019
CDEC Final Recommendation issued to sponsor and drug plans September 26, 2019
CDEC Final Recommendation posted September 30, 2019
Final CADTH review report(s) posted October 22, 2019