CADTH | Evidence Driven
CADTH | Evidence Driven

upadacitinib

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Generic Name:
upadacitinib
Project Status:
Complete
Therapeutic Area:
ankylosing spondylitis
Manufacturer:
AbbVie Corporation
Brand Name:
Rinvoq
Project Line:
Reimbursement Review
Project Number:
SR0759-000
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults with active ankylosing spondylitis who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Rinvoq is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable. Rinvoq may be used as monotherapy or in combination with nonsteroidal anti-inflammatory drugs (NSAIDs).
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 open16-Sep-22
Call for patient/clinician input closed11-Nov-22
Clarification:

- Patient input submission received from the Canadian Arthritis Patient Alliance, Canadian Spondylitis Association, Arthritis Society, CreakyJoints Canada

Submission received17-Oct-22
Submission accepted31-Oct-22
Review initiated01-Nov-22
Draft CADTH review report(s) provided to sponsor for comment02-Feb-23
Deadline for sponsors comments13-Feb-23
CADTH review report(s) and responses to comments provided to sponsor09-Mar-23
Expert committee meeting (initial)22-Mar-23
Draft recommendation issued to sponsor03-Apr-23
Draft recommendation posted for stakeholder feedback13-Apr-23
End of feedback period27-Apr-23
Final recommendation issued to sponsor and drug plans11-May-23
Final recommendation posted30-May-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)26-May-23
CADTH review report(s) posted28-Aug-23

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : August 28, 2023