NICE recommends Xgeva for bone metastasis
pharmafile | March 29, 2012 | News story | Sales and Marketing | Amgen, NICE, Xgeva, Zytiga, denosumab, prostate cancer
NICE has issued draft guidance recommending Amgen’s Xgeva (denosumab) for certain groups of cancer patients whose disease has spread to their bones.
Xgeva looks set to gain approval as a treatment for bone metastases from solid tumours, which cause pain, weakening and eventual destruction of the bone.
The decision has been welcomed in particular by prostate cancer groups, who have been disappointed by recent NICE rulings.
The draft guidance recommends denosumab as a treatment option for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) for:
- People with bone metastasis from breast cancer
- People with painful bone metastasis from hormone-refractory prostate cancer for whom other treatments (including analgesics and palliative radiotherapy) have failed
- People with bone metastasis from other solid tumours for whom zoledronic acid is indicated.
All recommendations stipulate the drug should only be prescribed if the manufacturer provides denosumab at the discounted rate agreed with the Department of Health, as part of a patient access scheme.
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, 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.”
Consultees are now able to comment on the preliminary recommendations. The consultation is open until Tuesday 24 April 2012.
The Prostate Cancer Charity has welcomed the decision to recommend the drug for men with advanced prostate cancer which has spread to the bone.
Owen Sharp, chief executive of The Prostate Cancer Charity said it sent an “encouraging message to men in the final stages of the disease that their needs have not been forgotten”.
He added: “This treatment is key in helping to minimise the risk of complications once prostate cancer has spread to a man’s bones. Although it will not extend lives, this simple injection gives these men the chance of a much better quality of life. We commend NICE for provisionally recommending that this treatment be made widely available.”
In January this year NICE rejected two other new treatments for prostate cancer – Sanofi’s Jevtana (cabazitaxel) and Janssen’s Zytiga (abiraterone) on grounds of cost effectiveness.
Owen Sharp said these had been a “string of bitter disappointments,” and hoped to see the Zytiga draft decision reversed.
Andrew McConaghie
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