Patients with cutaneous squamous cell carcinoma (CSCC) stand to gain access to Sanofi's newly approved Libtayo (cemiplimab) via the NHS in England, after funding for the drug was backed by cost regulators.

The National Institute for Health and Care Excellence has issued preliminary guidelines recommending that the treatment be funded by the Cancer Drug Fund, giving hundreds of patients in England the chance to be among the first in Europe to access the drug.

Around 560 people per year with locally advanced or metastatic CSCC in adults, where curative surgery or curative radiotherapy is not appropriate, are eligible for treatment with Libtayo.

CSCC accounts for 20% of skin cancers and 23% of non-melanoma skin cancers. Although death is rare, the median overall survival rate of metastatic CSCC is poor at less than two years.

While there is significant uncertainty around the evidence for Libtayo, the committee noted that the overall response rates reported in the trials are “very promising”.

The drug – a fully-human monoclonal antibody that targets the immune checkpoint receptor PD-1 –  has been given a conditional approval by the European Commission for use in patients who are not candidates for curative surgery or curative radiation.

“Cemiplimab has the potential to make a significant impact for patients when previous treatments have failed, as aggressive surgery is often the only option,” noted John Stewart, NHS England’s director of specialised commissioning.

“NHS England has worked closely with Sanofi and NICE to reach a deal to make this hugely promising innovative drug available, meaning NHS patients in England will be among the first in Europe to benefit,” he added.

The list price of Libtayo is £4,650 per 350mg vial (one treatment cycle), while for one year it is £80,877 (all prices excluding VAT, company submission). However, Sanofi has a managed access agreement (data collection arrangement including a commercial access agreement), which makes the drug available to the NHS with a discount.