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Latanoprostene bunod

Last Updated: May 22, 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: Active

Biosimilar: No

Companion Diagnostics: No

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 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 applicant March 01, 2019
Comments from applicant on draft CADTH review report(s) received March 12, 2019
Redaction requests from applicant on draft CADTH review report(s) received March 19, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicant March 29, 2019
Canadian Drug Expert Committee (CDEC) meeting April 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans April 25, 2019
Embargo period ended and validation of redacted CADTH review report(s) received May 09, 2019
Clarification:

- Reconsideration requested

- Reconsideration request under assessment by CADTH