The National Institute for Health and Clinical Excellence (NICE) has launched a second consultation on the use of Amgen's XGEVA (denosumab) to prevent bone metastases in some cancer patients.

Following a consultation on the first draft of NICE's guidance on this use of XGEVA, the Institute received "very helpful comments from clinical experts that shed new light on the original draft recommendations," says Professor Carole Longson, director of the centre for health technology evaluation at NICE.

In particular, the consultation feedback provided NICE's independent appraisal committee with more information on current UK clinical practice concerning the comparators in the appraisal. As a result, the panel reconsidered the evidence and revised the draft guidance, said Prof Longson, adding: “we are now welcoming comments from stakeholders on this revised draft."

The Institute's appraisal of XGEVA in this use is considering it as an alternative to bone-strengthening bisphosphonate drugs, where they are prescribed in clinical practice, and as an alternative to best supportive care where they are not used.

Following the appraisal committee's reconsideration of evidence in light of further information received about the use of these comparators, the latest draft guidance recommends XGEVA;

- for adults with bone metastases from breast cancer; and

- for adults with bone metastases from solid tumours other than breast and prostate only if Zometa (zoledronic acid) and Aredia (disodium pamidronate), both made by Novartis, would otherwise be prescribed for these patients.

However, the draft guidance stipulates that, where XGEVA is recommended, it should only be prescribed if Amgen provides it at the discounted rate agreed with the Department of Health as part of a patient access scheme (PAS).

NICE’s appraisal committee concluded that, based on current prices and with the PAS in place, XGEVA has been shown to be a cost-effective option in people who would be treated with Zometa, or other bisphosphonates in the case of metastatic breast cancer. For patients with bone metastases from solid tumours other than breast and prostate who would otherwise be prescribed Zometa or Aredia, the PAS reduced the Incremental Cost Effectiveness Ratio (ICER) for XGEVA, compared with Zometa, to less than £16,000 per Quality-Adjusted Life Year (QALY) gained and to less than £6,000 per QALY gained for patients with bone metastasis from non-small cell lung cancer (NSCLC).

The panel also concluded that, in people with bone metastases from breast cancer, XGEVA is a cost-effective option, as long as it is given in accordance with current NICE recommendations.

However, in comparison with best supportive care, and even with the PSA in place, XGEVA was associated with high ICERs, the lowest of which remained above £70,000 per QALY gained. Therefore, it could not be considered cost-effective when compared with best supportive care, the panel concluded.

NICE also points out that the latest draft does not recommend XGEVA as an option for preventing skeletal-related events in adults with bone metastases from prostate cancer.

In the UK, there are estimated to be more than 150,000 patients with solid tumours and bone metastases, according to Amgen.