The National Institute for Health and Care Excellence (NICE) has today (Wednesday 7 October) said yes to pembrolizumab for treating advanced skin cancer after treatment with ipilimumab in final guidance.

NICE recommends that the drug pembrolizumab (also called Keytruda and manufactured by Merck, Sharp & Dohme) is made available on the NHS as a treatment for some patients with advanced melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body). Pembrolizumab has a marketing authorisation in the UK as monotherapy 'for the treatment of advanced (unresectable or metastatic) melanoma in adults'. This is broader than the indication covered by this appraisal which looked at using pembrolizumab in people who had already had ipilimumab.

Pembrolizumab is recommended for the indication covered by the company evidence submission, that is:

  • after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or MEK inhibitor (such as dabrafenib or vemurafenib [BRAF inhibitors] or tramentinib or cobimetinib [MEK inhibitors]), and
  • when the company provides pembrolizumab with the discount agreed in the patient access scheme.

Pembrolizumab was the first drug to be approved through the Medicines and Healthcare Products Regulatory Agency's Early Access to Medicine Scheme (EAMS). The scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director said: "We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final guidance. There were over 13,000 people diagnosed with malignant melanoma in the UK in 2011, and melanoma accounts for more deaths than all other skin cancers combinedi. This will be welcome news to patients and healthcare professionals alike."

Life Sciences Minister George Freeman MP said:

"This is good news for the thousands of patients diagnosed with malignant melanoma every year, who can now be treated with this life-enhancing medicine.

"This has been a triumph for early access, but this Government wants to go further, which is why we set up the independent Accelerated Access Review which is looking at how we can reduce the time, cost, and risk of drug development, develop a new range of flexible reimbursement models and look at barriers to roll-out of adoption across the NHS."