Last Updated : December 12, 2022
Details
FilesGeneric Name:
tepotinib
Project Status:
Complete
Therapeutic Area:
Locally advanced or metastatic non-small cell lung cancer
Manufacturer:
EMD Serono Canada, a division of EMD Inc.
Brand Name:
Tepmetko
Project Line:
Reimbursement Review
Project Number:
PC0255-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring METexon14 skipping alterations.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with locally advanced unresectable metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.
Recommendation Type:
Do not reimburse
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 | July 29, 2021 |
| Call for patient/clinician input closed | September 20, 2021 |
| Clarification: - Patient input submission received from Lung Health Foundation/The Ontario Lung Association. | |
| Submission received | August 30, 2021 |
| Submission accepted | September 14, 2021 |
| Review initiated | September 15, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | November 29, 2021 |
| Deadline for sponsors comments | December 08, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | January 28, 2022 |
| Expert committee meeting (initial) | February 09, 2022 |
| Draft recommendation issued to sponsor | February 23, 2022 |
| Draft recommendation posted for stakeholder feedback | March 03, 2022 |
| End of feedback period | March 17, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | August 10, 2022 |
| Final recommendation issued to sponsor and drug plans | August 24, 2022 |
| Final recommendation posted | September 12, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 08, 2022 |
| CADTH review report(s) posted | December 08, 2022 |
Files
Last Updated : December 12, 2022