The National Institute for Health and Care Excellence (NICE) have recommend Sanofi's cancer treatment cemiplimab, brand name Libtayo▼, within the Cancer Drug Fund, as an option for locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate.
Treatment should be continued until disease progression or for up to 24 months.
This means that patients in England and Wales with squamous cell carcinoma will be able to receive Libtayo treatment if they meet the criteria and their doctor thinks it is appropriate. The medicine will be funded from the Cancer Drug Fund.
Squamous cell carcinoma starts in the cells lining the top of the epidermis and accounts for about 20% of skin cancers.
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Why NICE made these recommendations
Living with advanced unresectable cutaneous squamous cell carcinoma is physically and emotionally challenging, and there is a high unmet need for new treatments. Cemiplimab trial data are promising but uncertain.
The cost-effectiveness estimates for cemiplimab are above what is normally considered a cost-effective use of NHS resources. The evidence on life expectancy with current treatments and how long life might be prolonged with cemiplimab is very uncertain. Because of this it is not known for certain whether the end-of-life criteria apply. So cemiplimab cannot be recommended for routine use in the NHS.
However, if more mature data become available from an ongoing trial of cemiplimab, and more data on life expectancy with current treatments are obtained, this could confirm the expectation that the end-of-life criteria apply. If this is the case, there is plausible potential for cemiplimab to be a cost-effective treatment. Therefore, cemiplimab is recommended for use within the Cancer Drugs Fund.
About Libtayo (source EMA)
Libtayo is a cancer medicine used on its own to treat adults with a type of skin cancer called cutaneous squamous cell carcinoma when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body).
It is used in patients who cannot have surgery or treatment with radiation to cure their disease.
The active substance in Libtayo, cemiplimab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a receptor (target) called PD-1 found on certain cells of the immune system called T cells.
Cancer cells can make proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer. By attaching to the receptor, cemiplimab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Libtayo was first made available in the EU in 2019. It is manufactured by Sanofi.
European Medicines Agency website page for Libtayo
Links available in External Resources
© NICE 
Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma. Technology appraisal guidance [TA592]. Published date: 07 August 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
The information provided by NICE was accurate at the time this article was issued.
NICE information about Libtayo
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