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Latanoprostene bunod

Last Updated: August 15, 2019
Result type: Reports
Project Number: SR0590-000
Product Line: Common Drug Review

Generic Name: latanoprostene bunod

Brand Name: Vyzulta

Manufacturer: Bausch Health, Canada Inc.

Indications: Open-angle glaucoma or ocular hypertension

Manufacturer Requested Reimbursement Criteria1: For the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: July 24, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 postedOctober 24, 2018
Patient group input closedDecember 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 groupsDecember 19, 2018
Patient group comments on input summary closedJanuary 07, 2019
Clarification:

- Patient input summary feedback received

Submission receivedNovember 23, 2018
Submission accepted for reviewDecember 07, 2018
Review initiatedDecember 10, 2018
Draft CADTH review report(s) sent to applicantMarch 01, 2019
Comments from applicant on draft CADTH review report(s) receivedMarch 12, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedMarch 19, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansApril 25, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMay 09, 2019
Clarification:

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agendaJuly 17, 2019
CDEC Final Recommendation issued to applicant and drug plansJuly 24, 2019
CDEC Final Recommendation postedJuly 26, 2019
Final CADTH review report(s) posted-