Last Updated : March 16, 2021
Details
FilesGeneric 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
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:
- 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 | 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 |
Files
Last Updated : March 16, 2021