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Last Updated: January 25, 2019
Result type: Reports
Project Number: SR0565-000
Product Line: Reimbursement Review

Generic Name: ertugliflozin

Brand Name: Steglatro

Manufacturer: Merck Canada Inc.

Therapeutic Area: Diabetes mellitus, Type 2

Indications: Diabetes mellitus, Type 2

Manufacturer Requested Reimbursement Criteria1: As monotherapy for patients who have inadequate glycemic control and for whom metformin or a sulfonylurea is inappropriate due to contraindications or intolerance. Add-on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea.

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: January 23, 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 posted April 02, 2018
Patient group input closed May 22, 2018

- Patient input submission received

Patient input summary sent for review to patient input groups -
Patient group comments on input summary closed -
Submission received April 30, 2018
Submission accepted for review May 14, 2018
Review initiated May 15, 2018
Draft CDR review report(s) sent to applicant August 07, 2018
Comments from applicant on draft CDR review report(s) received August 16, 2018
Redaction requests from applicant on draft CDR review report(s) received August 23, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant September 07, 2018
Canadian Drug Expert Committee (CDEC) meeting September 19, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 03, 2018
Embargo period ended and validation of redacted CDR review report(s) received October 29, 2018

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agenda January 16, 2019
CDEC Final Recommendation issued to applicant and drug plans January 23, 2019
CDEC Final Recommendation posted January 25, 2019
Final CDR review report(s) posted February 08, 2019