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NICE decision restricts Bayer’s Xofigo to select prostate cancer patients

Published on 19/11/15 at 10:10am

NICE has issued its Final Appraisal Determination (FAD) recommending Bayer’s 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.

The decision came after Bayer submitted extra clinical trial data to the regulator, showing the therapy significantly extended median overall survival to 14.9 months.

However, the limited group of patients covered by the acceptance raised issues over disparity in available options for advanced prostate cancer patients, following the Scottish Medicines Consortium’s recent decision to approve the drug for all patients, before or after docetaxel treatment.

Bayer said 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, and noted that if the CDF maintained its recent decision to remove radium-223, only Scottish patients would have the option to receive radium-223 on the NHS pre-docetaxel.

Dr Alexander Moscho, CEO Bayer UK & Ireland, says: “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.

“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.”

Hugh Gunn, of Tackle Prostate Cancer, while welcoming that a certain level of access had been granted on the NHS, also bemoaned the disparity between Scotland and the rest of the UK, saying: “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.”

Prostate cancer is the most common cancer affecting men in the UK. In 2011, approximately 41,700 men were diagnosed with prostate cancer, equalling more than 110 every day. In some cases, prostate cancer may spread to other parts of the body, particularly the bones, sometimes leading to debilitating pain, and/or bone fractures.

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 patients and the availability of radium-223 on the NHS will enable doctors and physicians to better manage the disease.

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.

Joel Levy

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