CADTH | Evidence Driven
CADTH | Evidence Driven

roflumilast

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Generic Name:
roflumilast
Project Status:
Complete
Therapeutic Area:
Plaque psoriasis
Manufacturer:
Arcutis Biotherapeutics, Inc.
Call for patient/clinician input open:
Brand Name:
Zoryve
Project Line:
Reimbursement Review
Project Number:
SR0771-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
ZORYVE (roflumilast cream, 0.3%) is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
ZORYVE™ (roflumilast cream, 0.3%) is indicated for topical treatment of plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients 12 years of age and older.
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/clinician input open04-Jan-23
Call for patient/clinician input closed27-Feb-23
Clarification:

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

Submission received02-Feb-23
Submission accepted
Review initiated17-Feb-23
Draft CADTH review report(s) provided to sponsor for comment09-May-23
Deadline for sponsors comments18-May-23
CADTH review report(s) and responses to comments provided to sponsor16-Jun-23
Expert committee meeting (initial)28-Jun-23
Draft recommendation issued to sponsor11-Jul-23
Draft recommendation posted for stakeholder feedback20-Jul-23
End of feedback period03-Aug-23
Final recommendation posted01-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)30-Aug-23
CADTH review report(s) posted01-Nov-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 3, 2023