Last Updated : February 26, 2025
Details
FilesGeneric Name:
momelotinib
Project Status:
Active
Therapeutic Area:
Myelofibrosis
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Ojjaara
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 |
|---|---|
| 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 |
| Draft recommendation posted for stakeholder feedback | December 05, 2024 |
| End of feedback period | December 19, 2024 |
| Final recommendation issued to sponsor and drug plans | January 08, 2025 |
| Final recommendation posted | February 12, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 22, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 26, 2025