Last Updated : September 20, 2024
Details
FilesGeneric Name:
maralixibat
Project Status:
Complete
Therapeutic Area:
Alagille syndrome
Manufacturer:
Mirum Pharmaceuticals Inc.
Call for patient/clinician input open:
Brand Name:
Livmarli
Project Line:
Reimbursement Review
Project Number:
SR0780-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Livmarli is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
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 | March 23, 2023 |
|---|---|
| Call for patient/clinician input closed | May 15, 2023 |
| Clarification: - Patient input submission received from Alagille Syndrome Alliance and Canadian Liver Foundation | |
| Submission received | May 05, 2023 |
| Submission accepted | May 19, 2023 |
| Review initiated | May 23, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | August 04, 2023 |
| Deadline for sponsors comments | August 16, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 15, 2023 |
| Expert committee meeting (initial) | September 27, 2023 |
| Draft recommendation issued to sponsor | October 12, 2023 |
| Draft recommendation posted for stakeholder feedback | October 19, 2023 |
| End of feedback period | November 02, 2023 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | February 28, 2024 |
| Draft recommendation issued to sponsor | March 11, 2024 |
| Draft recommendation posted for stakeholder feedback | March 21, 2024 |
| End of feedback period | April 08, 2024 |
| Final recommendation issued to sponsor and drug plans | April 22, 2024 |
| Final recommendation posted | May 09, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 07, 2024 |
| CADTH review report(s) posted | September 20, 2024 |
Files
Last Updated : September 20, 2024