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Prostate cancer: NICE issues full guidance for Xofigo (radium-223 dichloride)

The National Institute for Health and Care Excellence (NICE) has issued its final guidance recommending Xofigo® (radium-223 dichloride) for use on the NHS in England and Wales as an option for treating adult men, with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, who have received previous docetaxel therapy.1

Bayer is pleased with this recommendation and that a pragmatic way forward has been found to ensure that for patients needing radium-223 in the post-chemotherapy setting there will be no gap when the funding stream switches from the Cancer Drugs Fund (CDF) to baseline commissioning in April. Additionally, radium-223 will also continue to be available in the pre-chemotherapy setting through the CDF.2

However, this news means that there are clear disparities in access to treatment across the UK for some patients. The Scottish Medicines Consortium has accepted the use of radium-223 for all eligible patients in Scotland pre or post docetaxel, but patients in Wales and Northern Ireland will still not be able to receive radium-223 pre-chemotherapy.3

“Bayer is pleased that NICE has recommended radium-223 to patients after treatment with docetaxel and that eligible patients will also be able to receive this treatment pre-docetaxel through the CDF and the ability for clinicians to provide this treatment should therefore not be compromised.” says Dr Alexander Moscho, CEO Bayer UK & Ireland. “There still remains uncertainty around the CDF and funding for cancer therapies going forward and we remain committed to work with the relevant authorities to ensure all suitable patients have access across whole of UK.”

Prostate cancer is the most common cancer affecting men in the UK. In 2011 there were approximately 41,700 men diagnosed with prostate cancer, which is more than 110 every day.4

In some cases prostate cancer may spread to other parts of the body, particularly the bones, in certain cases leading to debilitating pain 5,6 and/or bone fractures.7

Radium-223 is the first alpha-particle emitting radioactive therapeutic agent recommended for use for the treatment of adult men with metastatic hormone relapsed prostate cancer within the NHS. Bone metastases are one of the main causes of mortality in these patients8 and the availability of radium-223 on the NHS will enable doctors and physicians to better manage the disease.

“It is great news that patients now have access to radium-223 on the NHS and will also continue to have access through the CDF. It will allow them to spend more time with loved ones in less pain”, says Hugh Gunn, Tackle Prostate Cancer.

In the phase III ALSYMPCA study, radium-223 dichloride was shown to significantly extend median overall survival (OS), the primary endpoint of the study. Median OS was 14.9 months for radium-223 dichloride compared to 11.3 months for placebo (HR=0.70 [95% CI, 0.58-0.83]; p<0.001).9 In addition, there was a delay in the time to first symptomatic skeletal event for patients treated with radium-223 dichloride compared to placebo (HR=0.66 [95% CI, 0.52-0.83] p<0.001).9

The most frequently observed adverse reactions (?10%) in patients receiving radium-223 dichloride were diarrhoea, nausea, vomiting and thrombocytopenia.10

Radium-223 dichloride was approved for the treatment of adult men with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, in November 2013 in the European Union.11