A new immunotherapy treatment for certain advanced skin cancer patients is to be made available on the NHS in England.
The decision came immediately after the drug received European approval. This means patients in England will be among the first in Europe to receive the treatment, which will be paid for by the Cancer Drugs Fund.
Cancer Research UK’s Rose Gray said the National Institute for Health and Care Excellence’s (NICE) recommendation of cemiplimab (Libtayo) was significant.
The drug will be used to treat adults with an advanced form of skin cancer called cutaneous squamous cell carcinoma (CSCC) when surgery or radiotherapy to cure their cancer aren’t an option.
“This decision is excellent news for people affected by this type of skin cancer,” said Gray.
“Patients and clinicians told NICE new treatments were needed for this disease, so it’s great that NICE have approved it.”
New treatment option
The director of the centre for health technology evaluation at NICE, Meindert Boysen, said: “CSCC can be cured in most people if caught early enough but a small percentage reaches an advanced state, usually in older people.”
There is no single established way to treat these patients, but those who are fit enough may receive chemotherapy, while others get supportive care.
NICE estimates that around 560 of these people per year will now be eligible for treatment with cemiplimab.
Boysen acknowledged that there is significant uncertainty around how long the drug can extend survival, but said that “the overall response rates reported in the trials are very promising”.
Out of the 59 patients that took part in a phase 2 trial, 28 patients saw their cancer shrink in response to the treatment, with 4 cancers completely disappearing. 23 of these were still responding 6 months after treatment when the trial finished.
The most common reported side effects were diarrhoea and fatigue.
According to NICE, CSCC accounts for around 20 in 100 skin cancers and around 23 in 100 cases of non-melanoma skin cancer. Boysen added that although death is rare, average survival once the disease has spread is poor.
Gray said that “because trials testing this treatment are in their early stages, we don’t know for sure how much longer this drug could give patients before their cancer gets worse, or how much it will extend patients’ survival”. But she agreed clinical trial results looked positive.
“Experts told NICE that cemiplimab is likely to be more effective and have fewer side effects than current treatment options,” she added.
More long-term evidence to be collected
Cemiplimab is an immunotherapy treatment that works by making a patient’s own immune system recognise and attack cancer cells.
Its inclusion in the Cancer Drugs Fund, which allows early patient access to innovative drugs on the NHS, will mean patients can receive the treatment while more data on the drug’s long-term benefits is collected.
This will give more time for research to assess whether there are benefits to continuing with cemiphlimab treatment beyond two years, which the NICE guidance sets as a cutoff.
Medicines in the Cancer Drugs Fund are usually available to eligible patients in England, Wales and Northern Ireland.
NHS patients to receive new drugs faster
The decision follows approval of the drug by the European Medicines Agency (EMA) on Tuesday. The EMA regulates which drugs can be sold in Europe by certifying their safety and effectiveness, and puts measures in place to make sure they are manufactured to a consistently high quality.
NICE has recently changed the way it assesses new medicines to better align its timelines with the EMA. This will reduce the time between a drug receiving its European license and NICE’s decision on whether or not to make it available for patients on the NHS. This change means patients can access drugs more quickly if the treatment is recommended.
Migen M, R. et al. (2018) PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med DOI: 10.1056/NEJMoa1805131