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Last Updated: March 31, 2020
Result type: Reports
Project Number: SR0614-000
Product Line: Reimbursement Review

Generic Name: upadacitinib

Brand Name: Rinvoq

Manufacturer: AbbVie

Therapeutic Area: Arthritis, Rheumatoid

Indications: Arthritis, Rheumatoid

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

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: February 4, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 postedMay 31, 2019
Patient group input closedJuly 22, 2019

- 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 groupsJuly 30, 2019
Patient group comments on input summary closedAugust 07, 2019

- Patient input summary feedback received

Submission receivedJuly 04, 2019
Submission acceptedJuly 18, 2019
Review initiatedJuly 22, 2019
Draft CADTH review report(s) sent to sponsorOctober 04, 2019
Comments from sponsor on draft CADTH review report(s) receivedOctober 16, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 08, 2019
Canadian Drug Expert Committee (CDEC) meetingNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansJanuary 14, 2020
Embargo period endedJanuary 28, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansFebruary 04, 2020
CDEC Final Recommendation postedFebruary 06, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedFebruary 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) postedMarch 31, 2020