Cancer patients whose disease has spread from a solid tumour to their bones have now been given a new treatment option after NICE backed the use of Amgen’s Xgeva (denosumab).

Xgeva has been recommended to treat the condition known as bone metastases in people suffering from breast cancer or solid tumours other than prostate who would otherwise be prescribed bisphosphonates.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said Xgeva was a “welcome addition” alongside existing treatment options.

Final guidance states that Xgeva should only be prescribed under the terms agreed between the Department of Health and Amgen as part of a patient access scheme.

Amgen estimates there are around 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

“We’re pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours,” said Professor Longson. “This type of metastasis can reduce a person’s mobility and quality of life in general, increasing the risk of complications from bone weakness.”

NICE has again backed Amgen’s Xgeva (denosumab) as a treatment option for patients with bone metastases from the majority of solid cancer tumours.

The final draft guidance recommends the treatment after NICE produced a review of available evidence and two separate stages of public consultation.

It continues to recommend Xgeva for the prevention of skeletal-related events in:

· people with bone metastases from breast cancer, and

· people with bone metastases from solid tumours who would otherwise be prescribed bisphosphonates.

The guidance also states that Xgeva must only be prescribed under the terms agreed in a Patient Access Scheme between Amgen and the DH.

Bone metastases occur when cancer spreads from its original tumour to the bone. This can lead to bones losing their strength and ultimately lead to skeletal-related events.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the condition “can severely affect a person’s quality of life” and stop individuals from completing everyday tasks.

NICE has now given consultees another opportunity to request a factual change to the draft guidance or lodge an appeal against its recommendation. If no appeals are received, final guidance will be issued later this year.

NICE has launched a second consultation on the use of Xgeva (denosumab) for the treatment of cancer patients with bone metastases after again recommending its use on the NHS.

An independent Appraisal Committee heard evidence from clinical experts during the original consultation on the draft guidance on current UK clinical practice concerning its comparison to existing options.

As a result, the latest draft guidance now recommends Xgeva for adults with bone metastases from breast cancer and those with solid tumours other than breast and prostate only if certain other bisphosphonates would otherwise be prescribed.

The updated guidance also states the treatment must be supplied under the terms of an agreed Patient Access Scheme, and that Xgeva is not recommended for preventing skeletal-related events in those with bone metastases from prostate cancer.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said feedback from clinical experts “shed new light on the original recommendations”.

Earlier draft guidance recommended the treatment in people with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

The appraisal is considering the treatment as an alternative to bisphosphonates and as an alternative to best supporting care where they are not used.

Comments are now being invited by NICE and its Appraisal Committee on the updated draft guidance.

NICE has launched a second consultation on the use of Xgeva (denosumab) for the treatment of cancer patients with bone metastases after again recommending its use on the NHS.

An independent Appraisal Committee heard evidence from clinical experts during the original consultation on the draft guidance on current UK clinical practice concerning its comparison to existing options.

As a result, the latest draft guidance now recommends Xgeva for adults with bone metastases from breast cancer and those with solid tumours other than breast and prostate only if certain other bisphosphonates would otherwise be prescribed.

The updated guidance also states the treatment must be supplied under the terms of an agreed Patient Access Scheme, and that Xgeva is not recommended for preventing skeletal-related events in those with bone metastases from prostate cancer.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said feedback from clinical experts “shed new light on the original recommendations”.

Earlier draft guidance recommended the treatment in people with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

The appraisal is considering the treatment as an alternative to bisphosphonates and as an alternative to best supporting care where they are not used.

Comments are now being invited by NICE and its Appraisal Committee on the updated draft guidance.

NICE has recommended the use of Xgeva (denosumab) in draft guidance for certain cancer patients whose disease has spread to their bones.

The recommendation covers patients with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, says the condition can have a “major impact on quality of life” and is therefore “pleased” to recommend the treatment.

The guidance stipulates that Xgeva should only be prescribed under the terms of an agreed Patient Access Scheme between Amgen and the DH.

Amgen estimates there are more than 150,000 patients in the UK with solid tumours or bone metastases, of which breast and prostate cancer account for more than 80%.

The spine, pelvis, hip, upper leg bones and skull are most commonly affected by bone metastases with symptoms including pain, and weakening and eventual destruction of the bone.

The majority of patients with the condition are currently treated with bisphosphonates. NICE’s independent Appraisal Committee considered Xgeva as an alternative to standard treatment options where bisphosphonates are not used.

It noted that in clinical trials where Xgeva was directly compared to standard treatment options it improved skeletal-related outcomes. It was also shown to be more clinically effective in patients with breast, prostate and non-small cell lung cancer.

The initial recommendation is now open for consultation.

Hexal AG has formally notified the EMA of its decision to withdraw the application for a centralised marketing authorisation for Ibandronic acid Hexal (ibandronic acid).

The move is based on the fact that the European Commission considers that the co-marketing reasons were not acceptable in this case.

The application for the tablet was submitted to the EMA in December 2010 as a duplicate to Iasibon, which was authorised on 21 January 2011.

Ibandronic acid Hexal was intended to be used as a treatment option for the prevention of skeletal events in patients with breast cancer and bone metastases.

The CHMP adopted a positive opinion for the medicine in February, and, at the time of the withdrawal, the EC was considering the adoption of a marketing authorisation.