Last Updated : December 16, 2021
Details
FilesGeneric Name:
liraglutide
Project Status:
Complete
Therapeutic Area:
Chronic weight management in adults
Manufacturer:
Novo Nordisk Canada Inc.
Brand Name:
Saxenda
Project Line:
Reimbursement Review
Project Number:
SR0668-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
An adjunct to a reduced calorie diet and increased physical
activity for chronic weight management in adult patients who have been
diagnosed with:
Obesity (BMI 30 kg/m2) AND prediabetes, or
Overweight (BMI 27 kg/m2 and 30 kg/m2) with one or
more weight-related comorbidity AND prediabetes.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Saxenda® (liraglutide) 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 (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.
Date NOC Issued:
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 Milestones | |
|---|---|
| Call for patient/clinician input open | 26-Nov-20 |
| Call for patient/clinician input closed | 22-Jan-21 |
| Clarification: - Patient input submission received from Diabetes Canada, Gastrointestinal Society and Obesity Canada | |
| Submission received | 23-Dec-20 |
| Submission accepted | 14-Jan-21 |
| Review initiated | 15-Jan-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 09-Apr-21 |
| Deadline for sponsors comments | 20-Apr-21 |
| CADTH responses on draft review report(s) provided to sponsor | 07-May-21 |
| Expert committee meeting (initial) | 19-May-21 |
| Draft recommendation issued to sponsor | 02-Jun-21 |
| Draft recommendation posted for stakeholder feedback | 10-Jun-21 |
| End of feedback period | 24-Jun-21 |
| Clarification: - Reconsideration: major revisions requested by sponsor. | |
| Expert committee meeting | 18-Aug-21 |
| Final recommendation issued to sponsor and drug plans | 01-Sept-21 |
| Final recommendation posted | 20-Sept-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 16-Sept-21 |
| CADTH review report(s) posted | 16-Dec-21 |
Files
Last Updated : December 16, 2021