Last Updated : September 18, 2024
Details
FilesGeneric Name:
momelotinib
Project Status:
Active
Therapeutic Area:
Myelofibrosis
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
PC0355-000
Call for patient/clinician input closed:
Tumour Type:
Other
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Momelotinib is indicated for the treatment of disease-related splenomegaly or symptoms, and anemia in adult patients with primary myelofibrosis, post polycythemia vera myelofibrosis or post essential thrombocythemia myelofibrosis who are Janus Kinase (JAK) inhibitor naïve or have been treated with a JAK inhibitor.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Momelotinib is indicated for
the treatment of disease-related splenomegaly or symptoms, and anemia in adult
patients with primary myelofibrosis, post polycythemia vera myelofibrosis or
post essential thrombocythemia myelofibrosis who are Janus Kinase (JAK)
inhibitor naïve or have been treated with a JAK inhibitor.
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Call for patient/clinician input open | May 09, 2024 |
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Call for patient/clinician input closed | June 28, 2024 |
Submission received | June 19, 2024 |
Submission accepted | July 04, 2024 |
Review initiated | July 05, 2024 |
Draft CADTH review report(s) provided to sponsor for comment | September 26, 2024 |
Deadline for sponsors comments | October 08, 2024 |
CADTH review report(s) and responses to comments provided to sponsor | October 31, 2024 |
Expert committee meeting (initial) | November 13, 2024 |
Draft recommendation issued to sponsor | November 25, 2024 To November 27, 2024 |
Draft recommendation posted for stakeholder feedback | December 05, 2024 |
End of feedback period | December 19, 2024 |
Files
Last Updated : September 18, 2024