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Fedratinib

Last Updated: November 20, 2020
Result type: Reports
Project Number: PC0205-000
Product Line: Reimbursement Review

Generic Name: fedratinib

Brand Name: Inrebic

Manufacturer: Celgene Inc.

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 open October 07, 2020
Call for patient/clinician input closed November 26, 2020
Submission received November 05, 2020
Submission accepted November 19, 2020
Review initiated November 20, 2020
Draft CADTH review report(s) provided to sponsor for comment February 10, 2021
Deadline for sponsors comments February 22, 2021
CADTH responses on draft review report(s) provided to sponsor April 05, 2021
Expert committee meeting (initial) April 15, 2021
Draft recommendation issued to sponsor April 27, 2021
To
April 29, 2021
Draft recommendation posted for stakeholder feedback -