cysteamine

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Generic 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:
  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 postedNovember 02, 2018
Patient group input closedDecember 20, 2018
Clarification:

- No patient input submission received

Submission receivedDecember 10, 2018
Submission accepted for reviewDecember 24, 2018
Review initiatedJanuary 02, 2019
Draft CADTH review report(s) sent to applicantMarch 25, 2019
Comments from applicant on draft CADTH review report(s) receivedApril 03, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedApril 10, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantMay 03, 2019
Canadian Drug Expert Committee (CDEC) meetingMay 15, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansMay 28, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedJune 11, 2019
CDEC Final Recommendation issued to applicant and drug plansJune 18, 2019
CDEC Final Recommendation postedJune 20, 2019
Final CADTH review report(s) postedJuly 03, 2019