Amgen wins over NICE after agreeing to discount Xgeva

Amgen has persuaded the National Institute for Health and Clinical Excellence (NICE) to reverse its stance on Xgeva and back the bone cancer drug.

In final draft guidance NICE recommends Xgeva (denosumab) as a treatment for people with bone metastases from most solid cancer tumours, but the ruling comes at a cost.

An annual course of treatment with 13 doses of Xgeva costs just over £4,000 per patient and Amgen must provide the drug to the NHS in England at the discounted rate.

This discount forms part of the patient access scheme Amgen agreed with the Department of Health, details of which are confidential.

NICE also stressed that its recommendation does not apply to Xgeva as either an anti-cancer drug or a pain relief treatment.

The recommendation, which follows a review of available evidence and two stages of public consultation, is for the prevention of skeletal related events in people with bone metastases that have spread from breast cancer or solid tumours (other than breast or prostate), who would otherwise be prescribed bisphosphonates. 

Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said: “Bone metastasis can severely affect a person's quality of life, stopping them from doing things so many of us take for granted. 

“We are therefore pleased that our draft guidance recommends denosumab for those patients who are most likely to benefit from the treatment.”

The drug company has endured a number of recent setbacks in its approval attempts for denosumab. In June NICE reversed its earlier positive guidance on the drug as a treatment for prostate cancer, on the bases that it was not cost-effective.

While in April the US Food and Drug Administration (FDA) rejected Amgen's bid to extend Xgeva's licence so that it could be used as a preventative treatment for bone metastases in patients with castration-resistant prostate cancer. 

If no appeals are submitted to NICE the cost-effectiveness body will publish its final guidance on Xgeva later this year and the NHS in England will then have a legal obligation to begin funding the treatment for eligible patients.