tepotinib

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Generic 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:
  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 openJuly 29, 2021
Call for patient/clinician input closedSeptember 20, 2021
Clarification:

- Patient input submission received from Lung Health Foundation/The Ontario Lung Association.

Submission receivedAugust 30, 2021
Submission acceptedSeptember 14, 2021
Review initiatedSeptember 15, 2021
Draft CADTH review report(s) provided to sponsor for commentNovember 29, 2021
Deadline for sponsors commentsDecember 08, 2021
CADTH review report(s) and responses to comments provided to sponsorJanuary 28, 2022
Expert committee meeting (initial)February 09, 2022
Draft recommendation issued to sponsorFebruary 23, 2022
Draft recommendation posted for stakeholder feedbackMarch 03, 2022
End of feedback periodMarch 17, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingAugust 10, 2022
Final recommendation issued to sponsor and drug plansAugust 24, 2022
Final recommendation postedSeptember 12, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 08, 2022
CADTH review report(s) postedDecember 08, 2022