CDA | Evidence Driven
CDA | Evidence Driven

momelotinib

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Generic 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:
Ojjaara is indicated for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera myelofibrosis or post essential thrombocythemia MF who have moderate to severe anemia.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Ojjaara is indicated for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera myelofibrosis or post essential thrombocythemia MF who have moderate to severe anemia.
  1. 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.
Key Milestones2
Call for patient/clinician input open09-May-24
Call for patient/clinician input closed28-Jun-24
Submission received19-Jun-24
Submission accepted04-Jul-24
Review initiated05-Jul-24
Draft CADTH review report(s) provided to sponsor for comment26-Sep-24
Deadline for sponsors comments08-Oct-24
CADTH review report(s) and responses to comments provided to sponsor31-Oct-24
Expert committee meeting (initial)13-Nov-24
Draft recommendation issued to sponsorNovember 25, 2024
To
November 27, 2024
Draft recommendation posted for stakeholder feedback05-Dec-24
End of feedback period19-Dec-24

Files

Patient and Clinician Group input View PDF
Last Updated : November 14, 2024