Halobetasol propionate and tazarotene


( Last Updated : December 18, 2020)
Generic Name:
Halobetasol propionate and tazarotene
Project Status:
Complete
Therapeutic Area:
Psoriasis, moderate to severe plaque
Manufacturer:
Bausch Health, Canada Inc.
Call for patient/clinician input open:
Brand Name:
Duobrii
Project Line:
Reimbursement Review
Project Number:
SR0638-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details

Manufacturer Requested Reimbursement Criteria1:
Improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 Milestones2
Call for patient input open December 19, 2019
Call for patient input closed February 14, 2020
Clarification:

- Patient input submission received from Canadian Psoriasis Network (CPN), Canadian Skin Patient Alliance (CSPA) and the Canadian Association of Psoriasis Patients (CAPP)
Submission received January 24, 2020
Submission accepted February 07, 2020
Review initiated February 10, 2020
Draft CADTH review report(s) provided to sponsor for comment April 24, 2020
Deadline for sponsors comments May 05, 2020
CADTH responses on draft review report(s) provided to sponsor June 05, 2020
Expert committee meeting (initial) June 17, 2020
Draft recommendation issued to sponsor June 30, 2020
End of embargo period August 13, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested
Expert committee meeting October 21, 2020
Final recommendation issued to sponsor and drug plans October 28, 2020
Final recommendation posted October 30, 2020
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) November 11, 2020
CADTH review report(s) posted December 17, 2020

Files

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions