semaglutide

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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

Performance Metric:

Achieved

Biosimilar:

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:

June 8, 2021

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/clinician input open	29-Oct-20
Call for patient/clinician input closed	17-Dec-20
Clarification: - Patient input submission received from Diabetes Canada and Type 2 Diabetes Experience Exchange
Submission received	26-Nov-20
Submission accepted	10-Dec-20
Review initiated	11-Dec-20
Draft CADTH review report(s) provided to sponsor for comment	04-Mar-21
Deadline for sponsors comments	15-Mar-21
CADTH responses on draft review report(s) provided to sponsor	09-Apr-21
Expert committee meeting (initial)	21-Apr-21
Draft recommendation issued to sponsor	05-May-21
Draft recommendation posted for stakeholder feedback	13-May-21
End of feedback period	28-May-21
Final recommendation issued to sponsor and drug plans	08-Jun-21
Final recommendation posted	24-Jun-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	22-Jun-21
CADTH review report(s) posted	13-Sep-21