Latanoprostene bunod

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Generic 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:
Performance Metric:
Achieved
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:
  1. 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 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 sponsorMarch 01, 2019
Comments from sponsor on draft CADTH review report(s) receivedMarch 12, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedMarch 19, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansApril 25, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMay 09, 2019
Clarification:

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaJuly 17, 2019
CDEC Final Recommendation issued to sponsor and drug plansJuly 24, 2019
CDEC Final Recommendation postedJuly 26, 2019
Final CADTH review report(s) postedAugust 15, 2019