Cemiplimab (Libtayo®). HTA ID: 21007

Assessment Status NCPE Assessment Process Complete
HTA ID 21007
Drug Cemiplimab
Brand Libtayo®
Indication Is indicated as monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.
Assessment Process
Rapid review commissioned 15/03/2021
Rapid review completed 23/03/2021
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of cemiplimab (Libtayo®) compared with the current standard of care.
Full pharmacoeconomic assessment commissioned by HSE 31/03/2021
Pre-submission consultation with Applicant 29/11/2021
Full submission received from Applicant 23/01/2023
Preliminary review sent to Applicant 08/06/2023
NCPE assessment re-commenced 26/07/2023
Factual accuracy sent to Applicant 25/09/2023
NCPE assessment re-commenced 03/10/2023
NCPE assessment completed 24/10/2023
NCPE assessment outcome The NCPE recommends that cemiplimab (Libtayo®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.*

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.