Last Updated : December 12, 2022
Details
FilesGeneric Name:
semaglutide
Project Status:
Complete
Therapeutic Area:
Weight management
Manufacturer:
Novo Nordisk Canada Inc.
Call for patient/clinician input open:
Brand Name:
Wegovy
Project Line:
Reimbursement Review
Project Number:
SR0725-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Novo Nordisk Canada Inc. requests that Wegovy (semaglutide injection) 2.4 mg is listed as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 35 kg/m2 or greater AND prediabetes.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Wegovy (semaglutide injection) 2.4 mg is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of: • 30 kg/m2 or greater (obesity), or • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.
Recommendation Type:
Do not reimburse
Final Recommendation:
- 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 | February 09, 2022 |
| Call for patient/clinician input closed | April 01, 2022 |
| Clarification: - Patient input submission received from Obesity Canada and the Canadian Liver Foundation (joint), Gastrointestinal Society, Diabetes Canada, and Obesity Matters | |
| Submission received | March 10, 2022 |
| Submission accepted | March 24, 2022 |
| Review initiated | March 25, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 10, 2022 |
| Deadline for sponsors comments | June 21, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 15, 2022 |
| Expert committee meeting (initial) | July 27, 2022 |
| Draft recommendation issued to sponsor | August 10, 2022 |
| Draft recommendation posted for stakeholder feedback | August 18, 2022 |
| End of feedback period | September 02, 2022 |
| Clarification: Deadline for patient groups and clinician groups to provide feedback on the draft recommendations is 06-Sep-2022 | |
| Final recommendation issued to sponsor and drug plans | September 16, 2022 |
| Final recommendation posted | October 04, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 30, 2022 |
| CADTH review report(s) posted | December 09, 2022 |
Files
Last Updated : December 12, 2022