CADTH | Evidence Driven
CADTH | Evidence Driven

fedratinib

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Generic Name:
fedratinib
Project Status:
Complete
Therapeutic Area:
Myelofibrosis
Manufacturer:
Celgene Inc., a Bristol Myers Squibb Company
Brand Name:
Inrebic
Project Line:
Reimbursement Review
Project Number:
PC0205-000
Tumour Type:
Leukemia
Biosimilar:
No
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
Fee Schedule:
Schedule A
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.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open07-Oct-20
Call for patient/clinician input closed26-Nov-20
Clarification:

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

Submission received05-Nov-20
Submission accepted19-Nov-20
Review initiated20-Nov-20
Draft CADTH review report(s) provided to sponsor for comment11-Feb-21
Deadline for sponsors comments23-Feb-21
CADTH responses on draft review report(s) provided to sponsor05-Apr-21
Expert committee meeting (initial)15-Apr-21
Draft recommendation issued to sponsor29-Apr-21
Draft recommendation posted for stakeholder feedback07-May-21
End of feedback period21-May-21
Final recommendation issued to sponsor and drug plans02-Jun-21
Final recommendation posted21-Jun-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)16-Jun-21
CADTH review report(s) posted28-Jul-21

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Stakeholder feedback on Draft Recommendation View PDF
Clinician Input View PDF
Last Updated : May 5, 2022