trientine hydrochloride

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Generic Name:
trientine hydrochloride
Project Status:
Complete
Therapeutic Area:
Wilson's Disease
Manufacturer:
Waymade PLC
Brand Name:
Waymade-Trientine
Project Line:
Reimbursement Review
Project Number:
SR0696-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Waymade-Trientine (trientine hydrochloride) is indicated for the treatment of patients with Wilson's Disease who are intolerant of penicillamine.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Waymade-Trientine (trientine hydrochloride) is indicated for the treatment of patients with Wilson's Disease who are intolerant of penicillamine.
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/clinician input openJune 02, 2021
Call for patient/clinician input closedJuly 23, 2021
Clarification:

- Patient input submission received from Canadian Liver Foundation

Submission receivedJuly 21, 2021
Submission acceptedAugust 05, 2021
Review initiatedAugust 06, 2021
Draft CADTH review report(s) provided to sponsor for commentNovember 04, 2021
Deadline for sponsors commentsNovember 15, 2021
CADTH review report(s) and responses to comments provided to sponsorDecember 03, 2021
Expert committee meeting (initial)December 15, 2021
Draft recommendation issued to sponsorJanuary 04, 2022
Draft recommendation posted for stakeholder feedbackJanuary 13, 2022
End of feedback periodJanuary 27, 2022
Final recommendation issued to sponsor and drug plansFebruary 08, 2022
Final recommendation postedFebruary 25, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 23, 2022
CADTH review report(s) postedApril 04, 2022