amivantamab

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Generic Name:
amivantamab
Project Status:
Complete
Therapeutic Area:
Non-small cell lung cancer
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Rybrevant
Project Line:
Reimbursement Review
Project Number:
PC0289-000
Call for patient/clinician input closed:
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 locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on, or after platinum-based chemotherapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Tumour Type:
Lung
Indications:
​For the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal-growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on, or after platinum-based chemotherapy.
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 Lung Health Foundation / The Ontario Lung Association and Lung Cancer Canada

Submission receivedApril 21, 2022
Submission acceptedMay 05, 2022
Review initiatedMay 06, 2022
Draft CADTH review report(s) provided to sponsor for commentJuly 29, 2022
Deadline for sponsors commentsAugust 10, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 01, 2022
Expert committee meeting (initial)September 14, 2022
Draft recommendation issued to sponsorSeptember 26, 2022
Draft recommendation posted for stakeholder feedbackOctober 06, 2022
End of feedback periodOctober 21, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingJanuary 11, 2023
Draft recommendation issued to sponsorJanuary 24, 2023
Draft recommendation posted for stakeholder feedbackFebruary 02, 2023
End of feedback periodFebruary 16, 2023
Final recommendation issued to sponsor and drug plansMarch 01, 2023
Final recommendation postedMarch 20, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 15, 2023
CADTH review report(s) postedMay 10, 2023