Last Updated : September 6, 2019
Details
FilesGeneric Name:
latanoprostene bunod
Project Status:
Complete
Therapeutic Area:
Open-angle glaucoma or ocular hypertension
Manufacturer:
Bausch Health, Canada Inc.
Call for patient/clinician input open:
Brand Name:
Vyzulta
Project Line:
Reimbursement Review
Project Number:
SR0590-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Open-angle glaucoma or ocular hypertension
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | October 24, 2018 |
| Patient group input closed | December 12, 2018 |
| Clarification: - Patient input submission received from Canadian Council of the Blind, Canadian National Institute for the Blind and The Foundation Fighting Blindness | |
| Patient input summary sent for review to patient input groups | December 19, 2018 |
| Patient group comments on input summary closed | January 07, 2019 |
| Clarification: - Patient input summary feedback received | |
| Submission received | November 23, 2018 |
| Submission accepted for review | December 07, 2018 |
| Review initiated | December 10, 2018 |
| Draft CADTH review report(s) sent to sponsor | March 01, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | March 12, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | March 19, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | April 25, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | May 09, 2019 |
| Clarification: - Reconsideration requested | |
| Sponsor's request for reconsideration placed on CDEC agenda | July 17, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | July 24, 2019 |
| CDEC Final Recommendation posted | July 26, 2019 |
| Final CADTH review report(s) posted | August 15, 2019 |
Files
Last Updated : September 6, 2019