NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC

The National Institute for Health and Care Excellence (NICE) has recommended Sanofi and Regeneron’s Libtayo (cemiplimab) for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC). The drug is the first and only systemic treatment option available for CSCC patients in England.

The treatment recommendation is specifically for eligible adults for whom surgery or radiation treatment is not appropriate. NICE’s decision means eligible patients will be able to gain full NHS access to the drug in England via routine commissioning.

Around 28,000 people are diagnosed with CSCC every year, and out of this group, an estimated 2% will be at risk of developing metastatic disease.

As the second most common skin cancer in the UK, CSCC accounts for 23% of all non-melanoma skin cancers. Diagnoses of non-melanoma skin cancer are increasing and have been forecast to continue until 2040.

For the majority of patients with CSCC, a good prognosis is possible if it is diagnosed and managed early. However, the cancer can be particularly difficult to treat when it progresses to advanced stages, presenting a median overall survival rate of less than two years for metastatic cases.

NICE’s decision was based on positive results from the EMPOWER-CSCC-1 trial. The multicentre, non-randomised phase 2 trial assessed the safety and efficacy of Libtayo in 816 patients with advanced solid malignancies who received cemiplimab monotherapy in four clinical studies.

NICE first recommended that Libtayo should be made available through the Cancer Drugs Fund (CDF) in 2019. The CDF was created to enable patients to gain access to treatments more quickly, within spending limitations.

NICE has since gathered additional real-world data to evaluate the clinical and financial effectiveness of Libtayo, further supporting its decision to grant routine funding for the drug within the NHS.

Fleur Chandler, head of market access, Sanofi UK and Ireland, commented: “We’re thrilled to have worked closely with NICE and NHS England to reach this point whereby cemiplimab has transitioned from interim CDF funding into routine NHS commissioning, a move that ensures eligible patients in England have long-term access to this innovative treatment.

“The increasing incidence of non-melanoma skin cancer forecast over the coming decades makes it essential that we provide patients with viable treatment options at every stage of disease, as we look to improve outcomes whilst maintaining quality of life. We look forward to continuing discussions with other devolved nations throughout the UK.”