In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) says it is continuing to recommend Amgen's XGEVA (denosumab) as a treatment for people with bone metastases from solid cancer tumours.

Bone metastases occur when the cancer spreads from its original site to bones, which can then be weakened, ultimately leading to skeletal-related events such as pathological fractures, spinal cord compression or the need for radiation or surgery to the bone. 

XGEVA is licensed to prevent skeletal-related events and NICE points out that it is being appraised as such - not as an anticancer or pain relief treatment.

In the final draft guidance, which was produced after a review of available evidence and two stages of public consultation, NICE says it is continuing to recommend the product for the prevention of skeletal-related events in: - people with bone metastases from breast cancer; and - people with bone metastases from solid tumours, other than breast or prostate, who would otherwise be prescribed bisphosphonates.

The draft guidance also stipulates that XGEVA should be prescribed to these patients if the manufacturer provides it at the discounted rate agreed with the Department of Health as part of a patient access scheme (PAS). While the cost of a 120mg vial of the drug is £309.86, excluding value-added tax (VAT), costs may vary in different settings because of negotiated procurement discounts. The level of discount provided under the PAS agreed between Amgen and the Department is commercial-in-confidence.

Amgen estimates that 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. Breast cancer patients with bone metastases have an average life expectancy of approximately two years, it says.

Amgen's submission to NICE also reports that 11% of patients with prostate cancer have bone metastases at the time of diagnosis, and that for men with prostate cancer, the presence of bone metastases reduces five-year survival from 56% to 3%.

The final draft guidance has been welcomed by the charity Breast Cancer Care as "a positive milestone for secondary breast cancer patient choice and quality of life."

People whose breast cancer has spread to their bones can experience a reduction in quality of life and they currently have limited treatment options, so making XGEVA available throughout the NHS means there is another option for people for whom bisphosphonates are not appropriate. And, as it can be given subcutaneously, it offers patients a different route of administration, which may be more convenient, noted Tara Beaumont, clinical nurse specialist for secondary breast cancer at Breast Cancer Care.

"We hope that this announcement paves the way for similar positive developments in secondary breast cancer treatment and raises awareness of the importance of quality of life and symptom management for those living with incurable cancer," she added.