ertugliflozin

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Generic Name:

ertugliflozin

Project Status:

Complete

Therapeutic Area:

Diabetes mellitus, Type 2

Manufacturer:

Merck Canada Inc.

Call for patient/clinician input open:

April 2, 2018

Brand Name:

Steglatro

Project Line:

Reimbursement Review

Project Number:

SR0565-000

Call for patient/clinician input closed:

May 22, 2018

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

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

Fee Schedule:

Schedule A

Indications:

Diabetes mellitus, Type 2

Recommendation Type:

Do not reimburse

Final Recommendation:

January 23, 2019

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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
Clarification: - 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
Clarification: - 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