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Fedratinib

Last Updated: December 23, 2020
Result type: Reports
Project Number: PC0205-000
Product Line: Reimbursement Review

Generic Name: fedratinib

Brand Name: Inrebic

Manufacturer: Celgene Inc., a Bristol Myers Squibb Company

Therapeutic Area: Myelofibrosis

Indications: ​For the treatment of splenomegaly and/or disease-related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.

Manufacturer Requested Reimbursement Criteria1: For the treatment of splenomegaly and/or disease-related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.

Submission Type: Initial

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: 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/clinician input openOctober 07, 2020
Call for patient/clinician input closedNovember 26, 2020
Clarification:

- Patient input submission received from Canadian MPN Network, Canadian MPN Research Foundation and The Leukemia & Lymphoma Society of Canada

Submission receivedNovember 05, 2020
Submission acceptedNovember 19, 2020
Review initiatedNovember 20, 2020
Draft CADTH review report(s) provided to sponsor for commentFebruary 11, 2021
Deadline for sponsors commentsFebruary 23, 2021
CADTH responses on draft review report(s) provided to sponsorApril 05, 2021
Expert committee meeting (initial)April 15, 2021
Draft recommendation issued to sponsorApril 27, 2021
To
April 29, 2021
Draft recommendation posted for stakeholder feedback-