upadacitinib


( Last Updated : April 1, 2020)
Generic Name:
upadacitinib
Project Status:
Complete
Therapeutic Area:
Arthritis, Rheumatoid
Manufacturer:
AbbVie
Call for patient/clinician input open:
Brand Name:
Rinvoq
Project Line:
Reimbursement Review
Project Number:
SR0614-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Reimburse in a similar manner to other bDMARD and tsDMARD treatments for moderate to severely active RA.Upadacitinib to be listed for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs), as monotherapy or in combination with methotrexate or other conventional synthetic DMARDs (csDMARDs).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Arthritis, Rheumatoid
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 posted May 31, 2019
Patient group input closed July 22, 2019
Clarification:

- Patient input submission received from the Arthritis Consumer Experts, Canadian Arthritis Patient Alliance (CAPA) & The Arthritis Society

Patient input summary sent for review to patient input groups July 30, 2019
Patient group comments on input summary closed August 07, 2019
Clarification:

- Patient input summary feedback received

Submission received July 04, 2019
Submission accepted July 18, 2019
Review initiated July 22, 2019
Draft CADTH review report(s) sent to sponsor October 04, 2019
Comments from sponsor on draft CADTH review report(s) received October 16, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor November 08, 2019
Canadian Drug Expert Committee (CDEC) meeting November 20, 2019
CDEC recommendation sent to sponsor and drug plans January 14, 2020
Embargo period ended January 28, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans February 04, 2020
CDEC Final Recommendation posted February 06, 2020
Redaction requests from sponsor on draft CADTH review report(s) received February 19, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans -
Validation of redacted CADTH review report(s) received -
Final CADTH review report(s) posted March 31, 2020