semaglutide


( Last Updated : September 13, 2021)
Generic Name:
semaglutide
Project Status:
Complete
Therapeutic Area:
diabetes mellitus, type 2
Manufacturer:
Novo Nordisk Canada Inc.
Brand Name:
Rybelsus
Project Line:
Reimbursement Review
Project Number:
SR0637-000
NOC Status at Filing:
Post NOC

Details


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
Fee Schedule:
Schedule A
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
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open29-Oct-20
Call for patient/clinician input closed17-Dec-20
Clarification:

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

Submission received26-Nov-20
Submission accepted10-Dec-20
Review initiated11-Dec-20
Draft CADTH review report(s) provided to sponsor for comment04-Mar-21
Deadline for sponsors comments15-Mar-21
CADTH responses on draft review report(s) provided to sponsor09-Apr-21
Expert committee meeting (initial)21-Apr-21
Draft recommendation issued to sponsor05-May-21
Draft recommendation posted for stakeholder feedback13-May-21
End of feedback period28-May-21
Final recommendation issued to sponsor and drug plans08-Jun-21
Final recommendation posted24-Jun-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)22-Jun-21
CADTH review report(s) posted13-Sep-21