Trientine Hydrochloride


( Last Updated : November 29, 2021)
Generic Name:
Trientine Hydrochloride
Project Status:
Active
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

Details


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:
  1. 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 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