Last Updated : January 26, 2023
Details
FilesGeneric Name:
maribavir
Project Status:
Complete
Therapeutic Area:
Post-transplant cytomegalovirus infection
Manufacturer:
Takeda Canada Inc.
Brand Name:
Livtencity
Project Line:
Reimbursement Review
Project Number:
SR0720-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are ref ractory (with or without genotypic resistance) to one or more prior antiviral therapies.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
Treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are ref ractory (with or without genotypic resistance) to one or more prior antiviral therapies.
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | February 09, 2022 |
| Call for patient/clinician input closed | April 01, 2022 |
| Clarification: - Patient input received from LLSC, Myeloma Canada, CLL Canada, AAMAC, Lymphoma Canada, MPN Canadian Research Foundation, Canadian MPN Network, Canadian CML Network (joint), Canadian Liver Foundation, and Kidney Foundation of Canada | |
| Submission received | March 31, 2022 |
| Submission accepted | April 14, 2022 |
| Review initiated | April 18, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | July 06, 2022 |
| Deadline for sponsors comments | July 15, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | August 12, 2022 |
| Expert committee meeting (initial) | August 24, 2022 |
| Draft recommendation issued to sponsor | September 28, 2022 |
| Draft recommendation posted for stakeholder feedback | October 06, 2022 |
| End of feedback period | October 21, 2022 |
| Final recommendation issued to sponsor and drug plans | November 04, 2022 |
| Final recommendation posted | November 22, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 18, 2022 |
| CADTH review report(s) posted | January 25, 2023 |
Files
Last Updated : January 26, 2023