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naltrexone hydrochloride and bupropion hydrochloride

Last Updated: June 12, 2020
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: Active

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: May 27, 2020

Recommendation Type: Do not reimburse

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 acceptedMay 15, 2019
Review initiatedMay 16, 2019
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) sent to sponsorNovember 21, 2019
Comments from sponsor on draft CADTH review report(s) receivedDecember 02, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJanuary 03, 2020
Canadian Drug Expert Committee (CDEC) meetingJanuary 15, 2020
CDEC recommendation sent to sponsor and drug plansJanuary 27, 2020
Embargo period endedMarch 10, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaMay 20, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansMay 27, 2020
CDEC Final Recommendation postedJune 05, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJune 10, 2020
Clarification:

- No redactions requested by the sponsor

Final CADTH review report(s) posted-