New guidance published today (24 October) by the National Institute for Health and Care Excellence (NICE) commits the NHS to funding the drug denosumab (XGEVA, Amgen) for cancer patients whose disease has spread from most solid tumour sites (e.g. breast, lung, liver) to their bones. This is known as bone metastasis.

The NICE guidance covers the use of denosumab as a treatment to delay or prevent 'skeletal-related events' which are caused by bone metastases. These ‘events' include pathological fractures, spinal cord compression, or the need for radiation or surgery to the bone. People who are recommended to receive denosumab are those with bone metastases from:

• Breast cancer or,
• Solid tumours other than prostate who would otherwise be prescribed bisphosphonates[a]

However, the treatment should only be prescribed on the proviso that the manufacturer makes denosumab available to the NHS under terms agreed with the Department of Health as part of a patient access scheme. The guidance also states that any other patients with bone metastases from other types of solid tumours who are currently receiving denosumab for the prevention of skeletal-related events should continue to receive it until they and their doctor decide that it is appropriate to stop.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: "We're pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours. This type of metastasis can reduce a person's mobility and quality of life in general, increasing the risk of complications from bone weakness. Denosumab is a welcome addition to the current treatment options available for the people in whom it has been shown to be clinically and cost effective."

Ends

Notes to Editors

About the guidance

1. The guidance will be available at ta265 from Wednesday 24 October 2012.

2. Denosumab is licensed to prevent skeletal-related events from occurring in people with bone metastases from solid tumours and has being appraised as such, not as an anticancer or pain relief treatment.

3. The NHS now has a legal obligation to begin funding denosumab (XGEVA) to prevent skeletal-related events in eligible cancer patients with bone metastases from solid tumours within the next three months.

4. The manufacturer has agreed a patient access scheme with the Department of Health which makes denosumab more cost-effective. The details of the patient access scheme are confidential at the request of the manufacturer.

5. The manufacturer estimates there are over 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%. In patients with breast cancer, approximately 0.5% will have bone metastases at diagnosis, while 4.7% will develop bone metastases within five years.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.