Last Updated : May 15, 2023
Details
FilesGeneric 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:
- 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 Lung Health Foundation / The Ontario Lung Association and Lung Cancer Canada | |
| 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 29, 2022 |
| Deadline for sponsors comments | August 10, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 01, 2022 |
| Expert committee meeting (initial) | September 14, 2022 |
| Draft recommendation issued to sponsor | September 26, 2022 |
| Draft recommendation posted for stakeholder feedback | October 06, 2022 |
| End of feedback period | October 21, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | January 11, 2023 |
| Draft recommendation issued to sponsor | January 24, 2023 |
| Draft recommendation posted for stakeholder feedback | February 02, 2023 |
| End of feedback period | February 16, 2023 |
| Final recommendation issued to sponsor and drug plans | March 01, 2023 |
| Final recommendation posted | March 20, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 15, 2023 |
| CADTH review report(s) posted | May 10, 2023 |
Files
Last Updated : May 15, 2023