Libtayo has been approved for adults when curative surgery or radiation is not appropriate

The Nationail Institute for Health and Care Excellence (NICE) has published a positive final appraisal determination recommending Sanofi and Regeneron’s Libtayo, also known as cemiplimab. The therapy becomes the first and only systemic treatment option in England for metastatic or locally advanced cutaneous squamous cell carcubina (CSCC).

Libtayo has been approved for adults when curative surgery or curative radiation is not appropriate, meaning eligible patients will have full NHS access in England via routine commissioning.

“I am delighted to hear of NICE’s decision to recommend cemplimab via NHS routine commissioning,” Dr Andrew Sykes, consultant clinical oncologist from The Christie NHS Foundation Trust, commented. “Locally advanced and metastatic cutaneous squamous cell carcinoma remains particularly challenging to treat, and there are limited options for patients when surgery or radiotherapy haven’t been successful, resulting in a poor prognosis.”

Approximately 28,000 people are diagnosed with CSCC every year, of which around 2% will be at risk of developing metastatic disease.

Dr Sykes continued: “NICE’s recommendation in this setting is really important and provides clarity for healthcare professionals and certainty of this treatment continuing to be available in the future. Having routine NHS access to cemiplimab is vital as we attempt to improve outcomes and is welcome news for hundreds of eligible English patients and the wider skin cancer community.”

CSCC is the second most common skin cancer in the UK and accounts for 23% of all non-melanoma skin cancers. The incidence of non-melanoma skin cancer is rising and is estimated to continue doing so until 2040.

Patients diagnosed with CSCC have a good prognosis if detected early, however, the cancer can be especially difficult to treat when it progresses to advanced stages. The median overall survival rate stands at less than two years for metastatic cases.

Fleur Chandler, head of market access at Sanofi UK and Ireland, said: “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 while maintaining quality of life.”

“We look forward to continuing discussions with other devolved nations throughout the UK,” she added.

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.