The National Institute for Health and Care Excellence (NICE) today issued its Final Appraisal Determination (FAD) recommending Xofigo® (radium-223 dichloride) for use on the NHS in England as an option for treating adult men, with hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases, who have received previous docetaxel therapy.1
NICE's FAD coincides with a period of great uncertainty with the Cancer Drugs Fund (CDF) deliberating again whether to remove radium-223 from the list. This follows instructions to the CDF to reconsider the application after a review by the Programme of Care Board within NHS England. If the CDF stay with their recent decision to remove radium-223, then the only patients in the UK with the option to receive radium-223 on the NHS pre-docetaxel are those who live in Scotland.2
"Bayer is pleased that NICE has recommended radium-223 to patients post-docetaxel. This positive final appraisal determination marks a significant step in Bayer's ongoing dedication to addressing unmet clinical needs in prostate cancer," says Dr Alexander Moscho, CEO Bayer UK & Ireland. "However, if the CDF decide to no longer recommend further radium-223 funding, this will have a huge impact on patients who were expecting to receive radium-223 pre-docetaxel. We will continue to work with all organisations to ensure the access patients have in Scotland is also available in the rest of the 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.3 In some cases prostate cancer may spread to other parts of the body, particularly the bones, in certain cases leading to debilitating pain4,5, and/or bone fractures.6
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 patients7 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 some level of access to radium-223 on the NHS, as it will allow them to spend more time with loved ones in less pain," says Hugh Gunn, Tackle Prostate Cancer. "However, there are clear disparities in access to this treatment as the Scottish Medicines Consortium very recently accepted the use of radium-223 for all eligible patients' pre or post-docetaxel. There will be many patients who will feel let down by NICE's decision, as we continue to battle the postcode lottery that exists in advanced prostate cancer care."
The decision from NICE comes from the strength of additional data submitted by Bayer. 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]; p7 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] p8
The most frequently observed adverse reactions (≥10%) in patients receiving radium-223 dichloride were diarrhoea, nausea, vomiting and thrombocytopenia.9,2
Radium-223 dichloride was approved for the treatment of adult men with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases, in November 2013 in the European Union.10
About Xofigo (radium-223 dichloride)
Radium-223 dichloride is an alpha particle-emitting pharmaceutical. Its active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect. Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivo efficacy. The alpha particle range from radium-223 is less than 100 micrometers (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.