Last Updated : May 1, 2023
Details
FilesGeneric 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:
- 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, 2022 |
|---|---|
| Call for patient/clinician input closed | May 13, 2022 |
| Clarification: - Patient input submission received from Melanoma Canada and Save Your Skin Foundation | |
| Submission received | April 21, 2022 |
| Submission accepted | May 05, 2022 |
| Review initiated | May 06, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | July 27, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | September 22, 2022 |
| Deadline for sponsors comments | October 03, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | October 28, 2022 |
| Expert committee meeting (initial) | November 09, 2022 |
| Draft recommendation issued to sponsor | November 21, 2022 |
| Draft recommendation posted for stakeholder feedback | December 01, 2022 |
| End of feedback period | December 15, 2022 |
| Final recommendation issued to sponsor and drug plans | January 04, 2023 |
| Final recommendation posted | January 20, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 18, 2023 |
| CADTH review report(s) posted | April 21, 2023 |
Files
Last Updated : May 1, 2023