Last Updated : September 12, 2019
Details
FilesGeneric Name:
baricitinib
Project Status:
Complete
Therapeutic Area:
Arthritis, Rheumatoid
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
Olumiant
Project Line:
Reimbursement Review
Project Number:
SR0597-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule A
Indications:
Arthritis, Rheumatoid
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 22, 2018 |
| Patient group input closed | January 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 groups | February 20, 2019 |
| Patient group comments on input summary closed | February 27, 2019 |
| Clarification: - Patient input summary feedback received | |
| Submission received | December 20, 2018 |
| Submission accepted for review | January 18, 2019 |
| Clarification: - Submission was not accepted for review on 11 Jan 2019 - Revised category 1 requirements received on 11 Jan 2019 | |
| Review initiated | January 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 Canada's Drug Agency review report(s) sent to sponsor | April 29, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | May 08, 2019 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | May 15, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | June 07, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | June 19, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | July 02, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | July 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 plans | August 02, 2019 |
| CDEC Final Recommendation posted | August 07, 2019 |
| Final Canada's Drug Agency review report(s) posted | September 10, 2019 |
Files
Last Updated : September 12, 2019