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Last Updated: June 17, 2020
Result type: Reports
Project Number: SR0606-000
Product Line: Reimbursement Review

Generic Name: teduglutide

Brand Name: Revestive

Manufacturer: Shire Pharmaceuticals Ireland Limited

Therapeutic Area: Short Bowel Syndrome (SBS), pediatrics

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: Initial

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 postedMarch 04, 2019
Patient group input closedApril 23, 2019

- Patient input submission received from Gastrointestinal Society

Patient input summary sent for review to patient input groupsJune 24, 2019
Patient group comments on input summary closedJuly 02, 2019

- No patient input summary feedback received

Submission receivedMay 29, 2019
Submission acceptedJune 12, 2019
Review initiatedJune 17, 2019
Draft CADTH review report(s) sent to sponsorAugust 30, 2019
Comments from sponsor on draft CADTH review report(s) receivedSeptember 11, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorOctober 03, 2019
Canadian Drug Expert Committee (CDEC) meetingOctober 16, 2019
CDEC recommendation sent to sponsor and drug plansOctober 29, 2019
Embargo period endedNovember 12, 2019
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansNovember 19, 2019
CDEC Final Recommendation postedNovember 21, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedDecember 03, 2019
Redacted CADTH review report(s) sent to sponsor and drug plansDecember 13, 2019
Validation of redacted CADTH review report(s) receivedDecember 20, 2019
Final CADTH review report(s) postedJanuary 22, 2020