Last Updated : July 10, 2020
Details
FilesGeneric Name:
naltrexone hydrochloride and bupropion hydrochloride
Project Status:
Complete
Therapeutic Area:
Chronic weight management in adults
Manufacturer:
Bausch Health, Canada Inc.
Call for patient/clinician input open:
Brand Name:
Contrave
Project Line:
Reimbursement Review
Project Number:
SR0610-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
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
Fee Schedule:
Schedule A
Indications:
Chronic weight management in adults
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 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 |
Files
Last Updated : July 10, 2020