cyclosporine

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Generic Name:
cyclosporine
Project Status:
Complete
Therapeutic Area:
Severe vernal keratoconjunctivitis, pediatric (≥4 years)
Manufacturer:
Santen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Verkazia
Project Line:
Reimbursement Review
Project Number:
SR0615-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age through adolescence.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Indicated for the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age through adolescence.
Date NOC Issued:
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 posted April 23, 2019
Patient group input closed June 12, 2019
Clarification:

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

Patient input summary sent for review to patient input groups July 04, 2019
Patient group comments on input summary closed July 10, 2019
Clarification:

- Patient input summary feedback received

Submission received May 22, 2019
Submission accepted June 05, 2019
Review initiated June 06, 2019
Draft CADTH review report(s) sent to sponsor August 28, 2019
Comments from sponsor on draft CADTH review report(s) received September 09, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor October 03, 2019
Canadian Drug Expert Committee (CDEC) meeting October 16, 2019
CDEC recommendation sent to sponsor and drug plans October 28, 2019
Embargo period ended November 11, 2019
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans November 18, 2019
CDEC Final Recommendation posted November 20, 2019
Redaction requests from sponsor on draft CADTH review report(s) received December 02, 2019
Redacted CADTH review report(s) sent to sponsor and drug plans December 12, 2019
Validation of redacted CADTH review report(s) received December 19, 2019
Final CADTH review report(s) posted January 14, 2020