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telotristat

Last Updated: May 22, 2019
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 posted August 29, 2018
Patient group input closed October 19, 2018
Clarification:

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

Patient input summary sent for review to patient input groups October 29, 2018
Patient group comments on input summary closed November 05, 2018
Clarification:

- Patient input summary feedback received

Submission received September 27, 2018
Submission accepted for review October 12, 2018
Review initiated October 15, 2018
Draft CADTH review report(s) sent to applicant January 07, 2019
Comments from applicant on draft CADTH review report(s) received January 16, 2019
Redaction requests from applicant on draft CADTH review report(s) received January 23, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicant February 07, 2019
Canadian Drug Expert Committee (CDEC) meeting February 20, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans March 06, 2019
Embargo period ended and validation of redacted CADTH review report(s) received March 22, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

- Target CDEC reconsideration meeting date to be determined

Applicant's request for reconsideration placed on CDEC agenda June 19, 2019
CDEC Final Recommendation issued to applicant and drug plans June 26, 2019
CDEC Final Recommendation posted -
Final CADTH review report(s) posted -