maribavir

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Generic 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:
  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 openFebruary 09, 2022
Call for patient/clinician input closedApril 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 receivedMarch 31, 2022
Submission acceptedApril 14, 2022
Review initiatedApril 18, 2022
Draft CADTH review report(s) provided to sponsor for commentJuly 06, 2022
Deadline for sponsors commentsJuly 15, 2022
CADTH review report(s) and responses to comments provided to sponsorAugust 12, 2022
Expert committee meeting (initial)August 24, 2022
Draft recommendation issued to sponsorSeptember 28, 2022
Draft recommendation posted for stakeholder feedbackOctober 06, 2022
End of feedback periodOctober 21, 2022
Final recommendation issued to sponsor and drug plansNovember 04, 2022
Final recommendation postedNovember 22, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 18, 2022
CADTH review report(s) postedJanuary 25, 2023