Amgen wins NICE draft approval for bone drug Xgeva

Amgen has received a draft recommendation from the UK's National Institute of Health and Clinical Excellence (NICE) for the use of its bone drug Xgeva (denosumab).

The initial guidance says the drug should be available for use on the NHS in England and Wales to treat patients with solid tumours whose cancer has spread from its original location to the bone, but only if Amgen provides the drug at a discounted rate as agreed in a patient access scheme.

This means the drug would come in at a lower cost to the NHS than the standard £4,028 rate for a full year's treatment, although exact details of the scheme are confidential.

The recommendation would cover the drug's use in people with bone metastasis from breast cancer, as well as people with painful bone metastasis from hormone-refractory prostate cancer for whom other treatments, such as analgesics and palliative radiotherapy, have failed.

People with bone metastasis from other solid tumours who had previously been prescribed Novartis' Aclasta (zoledronic acid) to treat skeletal fractures would also be allowed to undergo treatment with Xgeva, after NICE decided the drug's patient access scheme would make it a cost-effective treatment option in this setting.

Elswhere Xgeva has struggled to win over health technology assessment bodies and regulators. NICE's Scottish equivalent, the Scottish Medicines Consortium, did not recommend Xgeva for the same indication.

Meanwhile, in the US the Food and Drug Administration (FDA) declined to approve the drug to treat bone metastases in prostate cancer patients, with the agency's advisory committee stating that Xgeva had not shown any significant impact on survival or altered the course of the disease.

However, the director of NICE's Centre for Health Technology Evaluation Professor Carole Longson said the Institute had concluded Xgeva was a viable treatment option.

She said: “Bone metastasis is associated with increased pain and skeletal-related events such as fractures and spinal cord compression. It can have a major impact on quality of life and we are therefore pleased to be able to recommend denosumab.”

Bone metastases can occur in people with a variety of cancers, including breast, prostate, lung or kidney, and commonly affect the spine, pelvis, hip, upper leg bones and skull.

It is estimated 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 per cent.