Kidney cancer patients are now likely to get access to Bristol-Myers Sqiubb's immunotherapy on the NHS in England and Wales after all, after cost regulators had a change of heart and recommended the drug as a cost-effective treatment option.
In a reversal of its draft decision, the National Institute for Health and Care Excellence has published a Final Appraisal Determination endorsing Opdivo (nivolumab) for adult patients with advanced renal cell carcinoma (RCC) after prior therapy, paving the way for 'routine' access to the first checkpoint inhibitor immunotherapy for this patient subset.
Data from a pivotal Phase III clinical study showed that patients who were treated with Opdivo after their previous therapy was no longer effective lived for an average of 5.4 months longer than those who received standard targeted therapy, Novartis' Afinitor (everolimus; 25 months versus 19.6 months, respectively). BMS said its drug also provided an improved quality of life as patients experienced fewer serious treatment-related side effects.
Around 900 patients in the advanced and incurable stages of this disease are likely to be treated with the drug each year, which will continue to be funded via the Cancer Drugs Fund until it is provided under normal NHS channels (in 30 days' time).
"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."
Over the last 40 years, the number of new patients diagnosed with kidney cancer each year has more than doubled, rising by 166 percent - mainly because of lifestyle factors such as obesity and smoking - highlighting the urgent need for new treatment options.
"We were very concerned with the initial news that NICE were not recommending the drug," said Nick Turkentine, chief executive of Kidney Cancer UK. "Data, personal statements, public opinion and various negotiations seem to have won the day and we could not be happier at this outcome for kidney cancer patients".
"The facts are there in the research, we have also spoken first-hand to patients who have been involved in trials and the benefits of making nivolumab available through the NHS are blindingly clear. This is a red letter day for kidney cancer patients; present and future."
"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, BMS.
"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."