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Last Updated: December 20, 2018
Result type: Reports
Project Number: SR0580-000
Product Line: Common Drug Review

Generic Name: telotristat

Brand Name: Xermelo

Manufacturer: Ipsen Biopharmaceuticals Canada Inc.

Indications: carcinoid syndrome

Manufacturer Requested Reimbursement Criteria1: For the treatment of refractory carcinoid syndrome diarrhea, in combination with somatostatin analogue (SSA) therapy, in patients inadequately controlled by SSA therapy alone.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 Milestones2

Call for patient input postedAugust 29, 2018
Patient group input closedOctober 19, 2018

- Patient input submission received from the Carcinoid Neuroendocrine Tumour Society – Canada

Patient input summary sent for review to patient input groupsOctober 29, 2018
Patient group comments on input summary closedNovember 05, 2018

- Patient input summary feedback received

Submission receivedSeptember 27, 2018
Submission accepted for reviewOctober 12, 2018
Review initiatedOctober 15, 2018
Draft CDR review report(s) sent to applicantJanuary 07, 2019
Comments from applicant on draft CDR review report(s) receivedJanuary 16, 2019
Redaction requests from applicant on draft CDR review report(s) receivedJanuary 23, 2019
CDR review team's comments on draft CDR review report(s) sent to applicantFebruary 07, 2019
Canadian Drug Expert Committee (CDEC) meetingFebruary 20, 2019
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansMarch 04, 2019
March 06, 2019