tebentafusp

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Generic Name:
tebentafusp
Project Status:
Complete
Therapeutic Area:
unresectable or metastatic uveal melanoma
Manufacturer:
Medison Canada
Brand Name:
Kimmtrak
Project Line:
Reimbursement Review
Project Number:
PC0290-000
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Tumour Type:
Skin & Melanoma
Indications:
​For the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
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 openMarch 23, 2022
Call for patient/clinician input closedMay 13, 2022
Clarification:

- Patient input submission received from Melanoma Canada and Save Your Skin Foundation

Submission receivedApril 21, 2022
Submission acceptedMay 05, 2022
Review initiatedMay 06, 2022
Draft CADTH review report(s) provided to sponsor for commentJuly 27, 2022
Draft CADTH review report(s) provided to sponsor for commentSeptember 22, 2022
Deadline for sponsors commentsOctober 03, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 28, 2022
Expert committee meeting (initial)November 09, 2022
Draft recommendation issued to sponsorNovember 21, 2022
Draft recommendation posted for stakeholder feedbackDecember 01, 2022
End of feedback periodDecember 15, 2022
Final recommendation issued to sponsor and drug plansJanuary 04, 2023
Final recommendation postedJanuary 20, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 18, 2023
CADTH review report(s) postedApril 21, 2023