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Last Updated: October 16, 2019
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: Active

Biosimilar: No

Companion Diagnostics: No

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 accepted for reviewJune 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 28, 2019
October 30, 2019