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baricitinib

Last Updated: September 12, 2019
Result type: Reports
Project Number: SR0597-000
Product Line: Common Drug Review

Generic Name: baricitinib

Brand Name: Olumiant

Manufacturer: Eli Lilly Canada Inc.

Indications: Arthritis, Rheumatoid

Manufacturer Requested Reimbursement Criteria1: In combination with methotrexate (MTX), indicated for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs).Olumiant may be used as monotherapy in cases of intolerance to MTX.

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: August 2, 2019

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 postedNovember 22, 2018
Patient group input closedJanuary 18, 2019
Clarification:

- Patient input submission received from Arthritis Consumer Experts and The Arthritis Society & Canadian Arthritis Patient Alliance

Patient input summary sent for review to patient input groupsFebruary 20, 2019
Patient group comments on input summary closedFebruary 27, 2019
Clarification:

- Patient input summary feedback received

Submission receivedDecember 20, 2018
Submission accepted for reviewJanuary 18, 2019
Clarification:

- Submission was not accepted for review on 11 Jan 2019

- Revised category 1 requirements received on 11 Jan 2019

Review initiatedJanuary 30, 2019
Clarification:

- Submission temporarily suspended pending receipt of information

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) sent to sponsorApril 29, 2019
Comments from sponsor on draft CADTH review report(s) receivedMay 08, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedMay 15, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansJuly 02, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedJuly 26, 2019
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

CDEC Final Recommendation issued to sponsor and drug plansAugust 02, 2019
CDEC Final Recommendation postedAugust 07, 2019
Final CADTH review report(s) postedSeptember 10, 2019