cemiplimab

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Generic 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:
  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 openAugust 16, 2023
Call for patient/clinician input closedOctober 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 receivedSeptember 27, 2023
Submission acceptedOctober 13, 2023
Review initiatedOctober 16, 2023
Draft CADTH review report(s) provided to sponsor for commentJanuary 17, 2024
Deadline for sponsors commentsJanuary 29, 2024
CADTH review report(s) and responses to comments provided to sponsorMarch 01, 2024
Expert committee meeting (initial)March 13, 2024
Draft recommendation issued to sponsorMarch 26, 2024
Draft recommendation posted for stakeholder feedbackApril 04, 2024
End of feedback periodApril 18, 2024
Final recommendation issued to sponsor and drug plansMay 02, 2024
Final recommendation postedMay 21, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 16, 2024
CADTH review report(s) postedSeptember 18, 2024