Cemiplimab recommended in the Cancer Drugs Fund following draft guidance from the National Institute for Health and Care Excellence (NICE).
NICE has issued draft guidance which recommends cemiplimab for the treatment of a type of skin cancer as part of the Cancer Drugs Fund. This decision means hundreds of patients in England will be among the first in Europe to access the drug.
Squamous cell carcinoma, or SCC, is a cancer of the keratinocyte cells in the outer layer of the skin. It’s the second most common type of skin cancer in the UK. Usually, squamous cell carcinomas are slow-growing and only spread to other parts of the body if they are left untreated for a long time. Occasionally though, they can behave more aggressively and spread at a relatively early stage which is known as cutaneous squamous cell carcinoma (CSCC).
CSCC can be cured in most people if caught early enough but a small percentage reaches an advanced state, usually in older people.
It is estimated that around 560 people per year with locally advanced or metastatic cutaneous squamous cell carcinoma in adults, where curative surgery or curative radiotherapy is not appropriate, are eligible for treatment with cemiplimab.
Although there is significant uncertainty around the evidence for cemiplimab, the committee noted that the overall response rates reported in the trials are very promising. 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.
Cemiplimab potentially provides a new treatment option for patients who currently have limited access to any life-extending treatment and is therefore considered a step-change in the treatment of advanced, unresectable CSCC.
The list price of cemiplimab is £4,650 per 350 mg vial (one treatment cycle). The list price for one year of treatment with cemiplimab is £80,877 (all prices excluding VAT, company submission).
The company has a managed access agreement (data collection arrangement including a commercial access agreement). This makes cemiplimab available to the NHS with a discount. The anticipated licenced dose of cemiplimab is 350 mg every three weeks.
Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, said: “We are happy to be able to announce the availability of cemiplimab for the treatment of cutaneous squamous cell carcinoma through the Cancer Drugs Fund.”
John Stewart, NHS England’s Director of Specialised Commissioning, said: “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.
“Cemiplimab has the potential to make a significant impact for patients when previous treatments have failed, as aggressive surgery is often the only option.”