fedratinib


( Last Updated : July 28, 2021)
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

Details


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 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 29, 2021
Draft recommendation posted for stakeholder feedbackMay 07, 2021
End of feedback periodMay 21, 2021
Final recommendation issued to sponsor and drug plansJune 02, 2021
Final recommendation postedJune 21, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)June 16, 2021
CADTH review report(s) postedJuly 28, 2021