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cyclosporine

Last Updated: January 14, 2020
Result type: Reports
Project Number: SR0615-000
Product Line: Common Drug Review

Generic Name: cyclosporine

Brand Name: Verkazia

Manufacturer: Santen Canada Inc.

Indications: Severe vernal keratoconjunctivitis, pediatric (≥4 years)

Manufacturer Requested Reimbursement Criteria1: For the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age through adolescence.

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: November 18, 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 postedApril 23, 2019
Patient group input closedJune 12, 2019
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groupsJuly 04, 2019
Patient group comments on input summary closedJuly 10, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 22, 2019
Submission acceptedJune 05, 2019
Review initiatedJune 06, 2019
Draft CADTH review report(s) sent to sponsorAugust 28, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 09, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to sponsor and drug plansOctober 28, 2019
Embargo period endedNovember 11, 2019
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansNovember 18, 2019
CDEC Final Recommendation postedNovember 20, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedDecember 02, 2019
Redacted CADTH review report(s) sent to sponsor and drug plansDecember 12, 2019
Validation of redacted CADTH review report(s) receivedDecember 19, 2019
Final CADTH review report(s) postedJanuary 14, 2020