cemiplimab


( Last Updated : May 24, 2022)
Generic Name:
cemiplimab
Project Status:
Active
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

Details


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.
  1. 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 open09-Sep-21
Call for patient/clinician input closed29-Oct-21
Clarification:

- Patient input submission received from Lung Cancer Canada and Lung Health Foundation

Submission received13-Oct-21
Submission accepted24-Nov-21
Clarification:

- Submission was not accepted for review on 27 Oct 21

Review initiated25-Nov-21
Draft CADTH review report(s) provided to sponsor for comment24-Feb-22
Deadline for sponsors comments07-Mar-22
CADTH review report(s) and responses to comments provided to sponsor01-Apr-22
Expert committee meeting (initial)13-Apr-22
Draft recommendation issued to sponsor26-Apr-22
Draft recommendation posted for stakeholder feedback05-May-22
End of feedback period19-May-22
Final recommendation issued to sponsor and drug plans02-Jun-22
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)
CADTH review report(s) posted