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NICE Changes Stance on Kidney Cancer Immunotherapy, Opdivo



The endorsement will likely prompt the National Health Service (NHS) in the UK and Wales to begin offering Bristol-Myers Squibb’s immunotherapy to patients.

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October 24, 2016 | by Sarah Hand, M.Sc.

UK pharmaceutical cost regulator, the National Institute for Health and Care Excellence (NICE), has reversed its previous decision and announced it supports the use of Opdivo (nivolumab) as a cost-effective treatment option for patients with advanced renal cell carcinoma. The endorsement will likely prompt the National Health Service (NHS) in the UK and Wales to begin offering Bristol-Myers Squibb’s immunotherapy to patients.

“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.”

Opdivo is approved for use in patients who have received prior therapy – which was ineffective – for their kidney cancer. If the NHS decides to cover the treatment, the immunotherapy will become the first checkpoint inhibitor drug for patients with advanced renal cell carcinoma.

A Phase III clinical trial of Opdivo revealed that the immunotherapy was able to extend patient lives by an average of 5.4 months, compared to the standard treatment, Novartis' Afinitor. Patients receiving Opdivo immunotherapy also reported fewer treatment-related side effects, according to Bristol-Myers Squibb, leading to improved quality of life.

Opdivo is expected to be used to treat approximately 900 patients with advanced and incurable kidney cancer, each year. At present, the drug is funded under the Cancer Drugs Fund, however the NHS will begin covering costs in about a month.

“This decision is a major turning point, which will bring a new wave of immunotherapy to kidney cancer patients,” said John Wagstaff, Professor of Medical Oncology, Swansea University. “Nivolumab has demonstrated its potential to improve survival rates in clinical trials and NICE has now recognized 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 number of new patients diagnosed with kidney cancer has risen by 166 percent in the last 40 years. This increase in cases has been attributed to lifestyle factors – including smoking and obesity – which could raise a person’s risk of developing kidney cancer.

“We were very concerned with the initial news that NICE were not recommending the drug,” said Nick Turkentine, CEO 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.”

Keywords: Kidney Cancer, Immunotherapy, NICE


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