The UK’s NICE has reversed its previous standing on Bristol-Myers Squibb’s Opdivo and backed the immunotherapy for the treatment of advanced renal cell cancer (RCC) in final draft guidance.
Opdivo (nivolumab) is now set to be recommended as a second-line treatment on the NHS in England and Wales almost immediately as the Cancer Drugs Fund will support the drug while the NICE process is finalised.
The cost-effectiveness watchdog initially turned down the PD-1 inhibitor due to “substantial uncertainty about the extent of the survival benefit of nivolumab when measured over the long term”.
But BMS has since swayed it with longer-term data from recently published phase I and II trials, as well as a patient access scheme discount for the drug, which has a typical list price of £1,097 per 100mg vial.
Benjamin Hickey, BMS’ UK and Ireland’s general manager, said: “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.”
In a phase III clinical study, patients treated with Opdivo lived for an average of 5.4 months longer than the group who received Novartis’ Afinitor (everolimus), the standard therapy, and with less adverse side effects.
Kidney cancer accounts for 4% of all new cases of cancer diagnosed in men and 2% in women, with renal cell cancer the most common form.
8,505 people were diagnosed with kidney cancer in England in 2013, and with the number growing rapidly over the last few years, an estimated 10,000 people could have the cancer this year.
Nick Turkentine, chief executive of Kidney Cancer UK, said: “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 change for increased survival.
“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.”