CDA | Evidence Driven
CDA | Evidence Driven

Halobetasol propionate and tazarotene

Details

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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
Performance Metric:
Achieved
Biosimilar:
No
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 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 open19-Dec-19
Call for patient input closed14-Feb-20
Clarification:

- Patient input submission received from Canadian Psoriasis Network (CPN), Canadian Skin Patient Alliance (CSPA) and the Canadian Association of Psoriasis Patients (CAPP)

Submission received24-Jan-20
Submission accepted07-Feb-20
Review initiated10-Feb-20
Draft CADTH review report(s) provided to sponsor for comment24-Apr-20
Deadline for sponsors comments05-May-20
CADTH responses on draft review report(s) provided to sponsor05-Jun-20
Expert committee meeting (initial)17-Jun-20
Draft recommendation issued to sponsor30-Jun-20
End of embargo period13-Aug-20
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Expert committee meeting21-Oct-20
Final recommendation issued to sponsor and drug plans28-Oct-20
Final recommendation posted30-Oct-20
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-Nov-20
CADTH review report(s) posted17-Dec-20

Files

Recommendation and Reasons View PDF
Clinical Report View PDF
Pharmacoeconomic Report View PDF
Patient Group Input Submissions View PDF
Last Updated : May 2, 2024