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fluocinolone acetonide intravitreal implant

Last Updated: October 22, 2019
Result type: Reports
Project Number: SR0608-000
Product Line: Common Drug Review

Generic Name: fluocinolone acetonide intravitreal implant

Brand Name: Iluvien

Manufacturer: Knight Therapeutics Inc.

Indications: diabetic macular edema

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: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: September 26, 2019

Recommendation Type: Do not reimburse

Fee Schedule: Schedule A

  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 postedMarch 06, 2019
Patient group input closedApril 25, 2019
Clarification:

- 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 groupsMay 06, 2019
Patient group comments on input summary closedMay 13, 2019
Clarification:

- Patient input summary feedback received

Submission receivedApril 03, 2019
Submission accepted for reviewApril 17, 2019
Review initiatedApril 18, 2019
Draft CADTH review report(s) sent to sponsorJuly 04, 2019
Comments from sponsor on draft CADTH review report(s) receivedJuly 15, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedJuly 22, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorAugust 09, 2019
Canadian Drug Expert Committee (CDEC) meetingAugust 21, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansSeptember 05, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedSeptember 19, 2019
CDEC Final Recommendation issued to sponsor and drug plansSeptember 26, 2019
CDEC Final Recommendation postedSeptember 30, 2019
Final CADTH review report(s) postedOctober 22, 2019