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
- 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 |
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|---|---|
| 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 | - |