liraglutide

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Generic 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
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:
  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 Milestones

Call for patient/clinician input open26-Nov-20
Call for patient/clinician input closed22-Jan-21
Clarification:

- Patient input submission received from Diabetes Canada, Gastrointestinal Society and Obesity Canada

Submission received23-Dec-20
Submission accepted14-Jan-21
Review initiated15-Jan-21
Draft CADTH review report(s) provided to sponsor for comment09-Apr-21
Deadline for sponsors comments20-Apr-21
CADTH responses on draft review report(s) provided to sponsor07-May-21
Expert committee meeting (initial)19-May-21
Draft recommendation issued to sponsor02-Jun-21
Draft recommendation posted for stakeholder feedback10-Jun-21
End of feedback period24-Jun-21
Clarification:

- Reconsideration: major revisions requested by sponsor.

Expert committee meeting18-Aug-21
Final recommendation issued to sponsor and drug plans01-Sept-21
Final recommendation posted20-Sept-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)16-Sept-21
CADTH review report(s) posted16-Dec-21