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teduglutide

Last Updated: January 23, 2020
Result type: Reports
Project Number: SR0606-000
Product Line: Common Drug Review

Generic Name: teduglutide

Brand Name: Revestive

Manufacturer: Shire Pharmaceuticals Ireland Limited

Indications: Short Bowel Syndrome (SBS), pediatrics

Manufacturer Requested Reimbursement Criteria1: Revestive is proposed to be indicated for the treatment of pediatric patients 1 year of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Submission Type: New Indication

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: November 19, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule B

  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 March 04, 2019
Patient group input closed April 23, 2019
Clarification:

- Patient input submission received from Gastrointestinal Society

Patient input summary sent for review to patient input groups June 24, 2019
Patient group comments on input summary closed July 02, 2019
Clarification:

- No patient input summary feedback received

Submission received May 29, 2019
Submission accepted June 12, 2019
Review initiated June 17, 2019
Draft CADTH review report(s) sent to sponsor August 30, 2019
Comments from sponsor on draft CADTH review report(s) received September 11, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor October 03, 2019
Canadian Drug Expert Committee (CDEC) meeting October 16, 2019
CDEC recommendation sent to sponsor and drug plans October 29, 2019
Embargo period ended November 12, 2019
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans November 19, 2019
CDEC Final Recommendation posted November 21, 2019
Redaction requests from sponsor on draft CADTH review report(s) received December 03, 2019
Redacted CADTH review report(s) sent to sponsor and drug plans December 13, 2019
Validation of redacted CADTH review report(s) received December 20, 2019
Final CADTH review report(s) posted January 22, 2020