Last Updated : September 1, 2022
Details
FilesGeneric Name:
cemiplimab
Project Status:
Complete
Therapeutic Area:
Non-small cell lung cancer
Manufacturer:
Sanofi Genzyme, a division of Sanofi-Aventis Canada Inc.
Brand Name:
Libtayo
Project Line:
Reimbursement Review
Project Number:
PC0262-000
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who 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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 09-Sep-21 |
| Call for patient/clinician input closed | 29-Oct-21 |
| Clarification: - Patient input submission received from Lung Cancer Canada and Lung Health Foundation | |
| Submission received | 13-Oct-21 |
| Submission accepted | 24-Nov-21 |
| Clarification: - Submission was not accepted for review on 27 Oct 21 | |
| Review initiated | 25-Nov-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 24-Feb-22 |
| Deadline for sponsors comments | 07-Mar-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 01-Apr-22 |
| Expert committee meeting (initial) | 13-Apr-22 |
| Draft recommendation issued to sponsor | 26-Apr-22 |
| Draft recommendation posted for stakeholder feedback | 05-May-22 |
| End of feedback period | 19-May-22 |
| Final recommendation issued to sponsor and drug plans | 02-Jun-22 |
| Final recommendation posted | 20-Jun-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 16-Jun-22 |
| CADTH review report(s) posted | 31-Aug-22 |
Files
Last Updated : September 1, 2022