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NICE reverses positive guidance on Xgeva in prostate cancer

Drug watchdog to rethink decision to recommend drug on NHS after further review

Amgen - Xgeva (denosumab)

The UK's National Institute for Health and Clinical Excellence (NICE) has reconsidered its earlier guidance on Amgen's Xgeva, saying it no longer believes the drug should be available under the National Health Service (NHS) for prostate cancer patients.

The drug cost-effectiveness watchdog said it had changed its draft guidance after reviewing comments from clinical experts "that shed new light on the original draft recommendations".

In March, the agency recommended the use of Xgeva (denosumab) for certain groups of cancer patients whose disease has spread to their bones, including patients with hormone-refractory prostate cancer for whom other treatments (including analgesics and palliative radiotherapy) have failed.

New information on the use of comparator bisphosphonate drugs such as zoledronic acid and disodium pamidronate in this indication has however prompted NICE's appraisal committee to rethink its stance on Xgeva.

Specifically, it has been pointed out that clinical guidelines on the diagnosis and treatment of prostate cancer do not support the use of bisphosphonates to prevent skeletal-related events in this form of cancer, only to provide pain relief.

"Denosumab is not currently licensed as a treatment for pain relief and so the committee concluded the most appropriate comparator for this appraisal is best supportive care," said the agency.

Recommendations that Xgeva can be used in adults with bone metastases from breast cancer and some other solid tumours suitable for treatment with zoledronic acid and disodium pamidronate still stand, provided Amgen offers a discounted rate under patient access schemes, said the NICE, whose jurisdiction covers NHS prescribing in England and Wales.

Last December, NICE's equivalent in Scotland - the Scottish Medicines Consortium - said it would not recommend the use of Xgeva for the prevention of skeletal related events in adults with bone metastases from solid tumours.

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

Once predicted as a potential blockbuster with sales of $3bn or more at peak, Xgeva has struggled to meet expectations in light of the regulatory setbacks. Last year the product brought in $351m, with another $203m coming from Amgen's Prolia brand of denosumab, which is indicated for preventing fractures in women with osteoporosis.

The latest version of NICE's guidance is now open for comment.

12th June 2012

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