Bristol-Myers Squibb has announced that its breakthrough medicine Opdivo® (nivolumab) will be available from today (21 October) to NHS patients in England and Wales who have the most common form of kidney cancer.1,2 In a reversal of its draft decision, the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending nivolumab for adult patients with advanced renal cell carcinoma (RCC) after prior therapy.1 Nivolumab is the first checkpoint inhibitor immunotherapy to be recommended by NICE for this group of patients, in which it has demonstrated a significant survival benefit over currently available treatments.3 It is estimated that approximately 900 patients in the advanced and incurable stages of this disease are likely to be treated with nivolumab each year and funding will be provided as standard on the NHS in 30 days' time, but in the interim it will be funded via the Cancer Drugs Fund. Over the last 40 years, the number of new patients diagnosed with kidney cancer each year has more than doubled, rising by 166%.4 In 2013 around 11,800 people were diagnosed and, in 2014, an average of 12 people died every day from the disease.4
"This decision is a major turning point, which will bring a new wave of immunotherapy to kidney cancer patients," said Professor John Wagstaff, Professor of Medical Oncology, Swansea University. "Nivolumab has demonstrated its potential to improve survival rates in clinical trials and NICE has now recognised the importance of achieving this for patients in England and Wales. This is an aggressive disease that is on the rise and new treatment options are vital to ensure that survival rates are improved in the coming years."
The NICE decision is based on a pivotal Phase III clinical study in which patients who were treated with nivolumab, after their previous therapy was no longer effective, lived for an average of 5.4 months longer than those who received standard targeted therapy everolimus (25 months [95% CI: 21.8-NE] versus 19.6 months [95% CI: 17.6-23.1] respectively).3 Additionally, nivolumab provided an improved quality of life as patients experienced fewer serious (grade 3-4) treatment-related side effects compared to everolimus.3
"Today's landmark decision is hugely welcome news for kidney cancer patients and their families. I am delighted that NICE has reversed its recommendation so that patients now have the best possible chance for increased survival," said Nick Turkentine, CEO of Kidney Cancer UK. "This is a leap forward for cancer care in England and Wales and hopefully the rest of the UK will provide similar decisions as soon as possible."
Nivolumab is the first in an innovative class of medicines (PD-1 immune checkpoint inhibitors).5 It works by harnessing the ability of the immune system to fight advanced forms of kidney cancer, lung cancer and melanoma (a type of skin cancer).5
"Nivolumab is a game-changing medicine that has demonstrated survival benefits in a number of cancer types and we are very happy that NICE has made this recommendation for patients with advanced kidney cancer and their families," said Benjamin Hickey, General Manager, UK and Ireland, Bristol-Myers Squibb. "While this is a positive outcome for kidney cancer patients, it adds to the deepening cancer medicine disparity in the UK as those with lung cancer are still left without this innovative treatment option. Our goal is to make nivolumab available to everyone who could benefit from it and we urge NICE and NHS England to collaborate with us to find a swift solution for patients."
Currently in England, approximately one in four cases of kidney cancer (27%) are diagnosed when the patient is already at an advanced stage.6 These patients will have a poor prognosis and approximately 85% will die within five years.7