Last Updated : July 3, 2019
Details
FilesGeneric Name:
cysteamine
Project Status:
Complete
Therapeutic Area:
Corneal cystine crystal deposits
Manufacturer:
Recordati Rare Diseases Canada Inc.
Call for patient/clinician input open:
Brand Name:
Cystadrops
Project Line:
Reimbursement Review
Project Number:
SR0595-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Corneal cystine crystal deposits
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 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 | November 02, 2018 |
| Patient group input closed | December 20, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | December 10, 2018 |
| Submission accepted for review | December 24, 2018 |
| Review initiated | January 02, 2019 |
| Draft Canada's Drug Agency review report(s) sent to applicant | March 25, 2019 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | April 03, 2019 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | April 10, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | May 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | May 15, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | May 28, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | June 11, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | June 18, 2019 |
| CDEC Final Recommendation posted | June 20, 2019 |
| Final Canada's Drug Agency review report(s) posted | July 03, 2019 |
Files
Last Updated : July 3, 2019