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Last Updated: October 23, 2019
Result type: Reports
Project Number: SR0580-000
Product Line: Reimbursement Review

Generic Name: telotristat

Brand Name: Xermelo

Manufacturer: Ipsen Biopharmaceuticals Canada Inc.

Therapeutic Area: carcinoid syndrome

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: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: June 26, 2019

Recommendation Type: Do not reimburse

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 CADTH review report(s) sent to sponsorJanuary 07, 2019
Comments from sponsor on draft CADTH review report(s) receivedJanuary 16, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedJanuary 23, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorFebruary 07, 2019
Canadian Drug Expert Committee (CDEC) meetingFebruary 20, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansMarch 06, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMarch 22, 2019

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

- Target CDEC reconsideration meeting date to be determined

Sponsor's request for reconsideration placed on CDEC agendaJune 19, 2019
CDEC Final Recommendation issued to sponsor and drug plansJune 26, 2019
CDEC Final Recommendation postedJuly 03, 2019
Final CADTH review report(s) postedJuly 25, 2019