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Last Updated: December 24, 2020
Result type: Reports
Project Number: SR0637-000
Product Line: Reimbursement Review

Generic Name: semaglutide

Brand Name: Rybelsus

Manufacturer: Novo Nordisk Canada Inc.

Therapeutic Area: diabetes mellitus, type 2

Indications: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in combination with other medicinal products for the treatment of diabetes

Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with type 2 diabetes to improve glycemic control: in combination with metformin, and in combination with metformin and sulfonylurea

Submission Type: Initial

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

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/clinician input open October 29, 2020
Call for patient/clinician input closed December 17, 2020

- Patient input submission received from Diabetes Canada and Type 2 Diabetes Experience Exchange

Submission received November 26, 2020
Submission accepted December 10, 2020
Review initiated December 11, 2020
Draft CADTH review report(s) provided to sponsor for comment March 04, 2021
Deadline for sponsors comments March 15, 2021
CADTH responses on draft review report(s) provided to sponsor April 09, 2021
Expert committee meeting (initial) April 21, 2021
Draft recommendation issued to sponsor May 03, 2021
May 05, 2021