CDA | Evidence Driven
CDA | Evidence Driven

Cemiplimab (Libtayo) for Cutaneous Squamous Cell Carcinoma — Details

Details

Files
Generic Name:
Cemiplimab
Project Status:
Complete
Therapeutic Area:
Advanced Cutaneous Squamous Cell Carcinoma (CSCC)
Manufacturer:
Sanofi Genzyme
Brand Name:
Libtayo
Project Line:
Reimbursement Review
Project Number:
PC0187-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Strength:
50mg/mL
Tumour Type:
Skin & Melanoma
Indications:
Cutaneous Squamous Cell Carcinoma
Funding Request:
For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Sponsor:
Sanofi Genzyme
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

Cemiplimab (Libtayo) CSCC – pERC Final Recommendation Final Recommendation January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Final Economic Guidance Report Guidance Reports January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Final Clinical Guidance Report Guidance Reports January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – pERC Initial Recommendation Initial Recommendation January 3, 2020 View PDF
Cemiplimab (Libtayo) CSCC – PAG Feedback on Initial Recommendation Feedback January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Manufacturer Feedback on Initial Recommendation Feedback January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Patient Advocacy Group Feedback on Initial Recommendation Feedback January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Clinician Feedback on Initial Recommendation Feedback January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Patient Advocacy Group COI Declarations COI Declarations January 22, 2020 View PDF
Cemiplimab (Libtayo) CSCC – Clinician COI Declarations COI Declarations January 22, 2020 View PDF

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : February 6, 2020