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
- 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 | |
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Call for patient/clinician input open | October 29, 2020 |
Call for patient/clinician input closed | December 17, 2020 |
Clarification: - 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 To May 05, 2021 |