Merck, Sharp & Dohme’s anti-PD therapy Keytruda has won backing for routine use on the National Health Service in England and Wales to treat certain patients with skin cancer.
Final draft guidelines released by the National Institute for Health and Care Excellence permit the drug to be considered an option for NHS patients with advanced melanoma which is either unresectable or metastatic - but only if the disease has progressed following treatment with Bristol-Myers Squibb’s Yervoy (ipilimumab), or a BRAF or MEK inhibitor in BRAF V600 mutation-positive disease.
NICE backing is also contingent upon MSD providing Keytruda (pembrolizumab) with the discount agreed in the confidential patient access scheme. With this, the Committee concluded that the most plausible incremental cost effectiveness ratio for the drug compared with best supportive care was likely to be less than £50,000 per QALY gained.
Back in March Keytruda became the first drug to be approved through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme, which aims to give patients with life threatening or seriously debilitating conditions access to promising new treatments yet to receive official marketing approval when there is a clear unmet medical need.
European approval followed in July on the back of data from the Phase III KEYNOTE-006 study, which showed one-year survival for Keytruda was 74% versus 58% for Yervoy, while the risk of death was cut by 37%.
The Scottish Medicine’s Consortium is due to publish its advice on the immunotherapy for unresectable or metastatic melanoma in patients previously treated with Yervoy in November.