Last Updated : February 1, 2022
Details
FilesGeneric Name:
Trientine Hydrochloride
Project Status:
Complete
Therapeutic Area:
Wilson's Disease
Manufacturer:
Marcan Pharmaceuticals Inc.
Brand Name:
MAR-Trientine
Project Line:
Reimbursement Review
Project Number:
SR0680-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
MAR-Trientine (trientine hydrochloride) to be reimbursed for the treatment of patients with Wilson's Disease who are intolerant to penicillamine.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
MAR-Trientine (trientine hydrochloride) is indicated for the treatment of patients with Wilson's Disease who are intolerant to penicillamine. MAR-Trientine should only be initiated by physicians experienced in the management of Wilson’s Disease.
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 Milestones |
|
|---|---|
| Call for patient/clinician input open | March 18, 2021 |
| Call for patient/clinician input closed | May 07, 2021 |
| Clarification:
- Patient input submission received from the Canadian Liver Foundation |
|
| Submission received | April 19, 2021 |
| Submission accepted | May 03, 2021 |
| Review initiated | May 04, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | July 19, 2021 |
| Deadline for sponsors comments | July 28, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | September 10, 2021 |
| Expert committee meeting (initial) | September 22, 2021 |
| Draft recommendation issued to sponsor | October 05, 2021 |
| Draft recommendation posted for stakeholder feedback | October 14, 2021 |
| End of feedback period | October 28, 2021 |
| Final recommendation issued to sponsor and drug plans | November 11, 2021 |
| Final recommendation posted | November 29, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 25, 2021 |
| CADTH review report(s) posted | February 01, 2022 |
Files
Last Updated : February 1, 2022