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naltrexone hydrochloride and bupropion hydrochloride

Last Updated: July 3, 2019
Result type: Reports
Project Number: SR0610-000
Product Line: Common Drug Review

Generic Name: naltrexone hydrochloride and bupropion hydrochloride

Brand Name: Contrave

Manufacturer: Bausch Health, Canada Inc.

Indications: Chronic weight management in adults

Manufacturer Requested Reimbursement Criteria1: Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults 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., controlled hypertension, type 2 diabetes mellitus, or dyslipidemia)

Submission Type: New

Project Status: Suspended

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 input postedMarch 28, 2019
Patient group input closedMay 17, 2019
Clarification:

- Patient input submission received from the Canadian Spondylitis Association and Obesity Canada

Patient input summary sent for review to patient input groupsMay 31, 2019
Patient group comments on input summary closedJune 07, 2019
Clarification:

- Patient input summary feedback received

Submission receivedMay 01, 2019
Submission accepted for reviewMay 15, 2019
Review initiatedMay 16, 2019
Clarification:

- Submission temporarily suspended pending receipt of information

Draft CADTH review report(s) sent to applicant-
Comments from applicant on draft CADTH review report(s) received-
CADTH review team's comments on draft CADTH review report(s) sent to applicant-
Canadian Drug Expert Committee (CDEC) meeting-
CDEC recommendation sent to applicant and drug plans-