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naltrexone hydrochloride and bupropion hydrochloride

Last Updated: July 9, 2020
Result type: Reports
Project Number: SR0610-000
Product Line: Reimbursement Review

Generic Name: naltrexone hydrochloride and bupropion hydrochloride

Brand Name: Contrave

Manufacturer: Bausch Health, Canada Inc.

Therapeutic Area: Chronic weight management in adults

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: Initial

Project Status: Complete

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 posted March 28, 2019
Patient group input closed May 17, 2019
Clarification:

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

Patient input summary sent for review to patient input groups May 31, 2019
Patient group comments on input summary closed June 07, 2019
Clarification:

- Patient input summary feedback received

Submission received May 01, 2019
Submission accepted May 15, 2019
Review initiated May 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 sponsor November 21, 2019
Comments from sponsor on draft CADTH review report(s) received December 02, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor January 03, 2020
Canadian Drug Expert Committee (CDEC) meeting January 15, 2020
CDEC recommendation sent to sponsor and drug plans January 27, 2020
Embargo period ended March 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 agenda May 20, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans May 27, 2020
CDEC Final Recommendation posted June 05, 2020
Redaction requests from sponsor on draft CADTH review report(s) received June 10, 2020
Clarification:

- No redactions requested by the sponsor

Final CADTH review report(s) posted July 09, 2020