Last Updated : October 23, 2019
Details
FilesGeneric Name:
fluocinolone acetonide intravitreal implant
Project Status:
Complete
Therapeutic Area:
diabetic macular edema
Manufacturer:
Knight Therapeutics Inc.
Call for patient/clinician input open:
Brand Name:
Iluvien
Project Line:
Reimbursement Review
Project Number:
SR0608-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule A
Indications:
diabetic macular edema
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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 input posted | March 06, 2019 |
| Patient group input closed | April 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 groups | May 06, 2019 |
| Patient group comments on input summary closed | May 13, 2019 |
| Clarification:
- 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 |
Files
Last Updated : October 23, 2019