Last Updated : September 18, 2024
Details
FilesGeneric Name:
cemiplimab
Project Status:
Complete
Therapeutic Area:
Locally advanced or metastatic NSCLC (first line)
Manufacturer:
sanofi-aventis Canada Inc.
Call for patient/clinician input open:
Brand Name:
Libtayo
Project Line:
Reimbursement Review
Project Number:
PC0331-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Libtayo (cemiplimab for injection): in combination with platinumbased chemotherapy for the firstline treatment of adult patients with NSCLC whose tumours have no EGFR, ALK or ROS1 aberrations and is:- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or - metastatic NSCLC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Libtayo (cemiplimab for injection):• in combination with platinum‐based chemotherapy for the first‐line treatment of adult patients with NSCLC whose tumours have no EGFR, ALK or ROS1 aberrations and is:- locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or - metastatic NSCLC.
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 | August 16, 2023 |
|---|---|
| Call for patient/clinician input closed | October 10, 2023 |
| Clarification: - Patient input submission received from Canadian Cancer Survivor Network, Lung Cancer Canada - Patient Group, and Lung Health Foundation / The Ontario Lung Association | |
| Submission received | September 27, 2023 |
| Submission accepted | October 13, 2023 |
| Review initiated | October 16, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | January 17, 2024 |
| Deadline for sponsors comments | January 29, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | March 01, 2024 |
| Expert committee meeting (initial) | March 13, 2024 |
| Draft recommendation issued to sponsor | March 26, 2024 |
| Draft recommendation posted for stakeholder feedback | April 04, 2024 |
| End of feedback period | April 18, 2024 |
| Final recommendation issued to sponsor and drug plans | May 02, 2024 |
| Final recommendation posted | May 21, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 16, 2024 |
| CADTH review report(s) posted | September 18, 2024 |
Files
Last Updated : September 18, 2024