On 17 August, the UK’s National Institute for Health and Clinical Excellence (NICE) published final draft guidance recommending denosumab (Xgeva, Amgen) as a treatment for people with bone metastases from most solid cancer tumours.
Denosumab is licensed to prevent skeletal-related events from occurring and is being appraised as such, not as an anticancer or pain relief treatment.
The draft guidance has been produced after a review of available evidence and two stages of public consultation. It provisionally recommends denosumab for the prevention of skeletal-related events in:
- people with bone metastases from breast cancer and
- people with bone metastases from solid tumours (other than breast or prostate) who would otherwise be prescribed bisphosphonates*.
The draft guidance also stipulates that denosumab should be prescribed to these patients if the manufacturer provides denosumab at the discounted rate agreed with the Department of Health as part of a patient access scheme.
“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 We are therefore pleased that our draft guidance recommends denosumab for those patients who are most likely to benefit from the treatment,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
NICE announced that there is an opportunity for consultees to request a factual change to the draft guidance or to lodge an appeal against the recommendations if they believe there are reasonable grounds to do so (the criteria for which are explained can be found here). If no appeals are submitted, the guidance will be published later this year and the NHS will then have a legal obligation to begin funding the treatment for eligible patients. However, until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments.
*The recommendation wording ‘if bisphosphonates would otherwise be prescribed’ is not intended to exclude adults who would be advised against taking bisphosphonates because of medical reasons (medical contra-indications). Patients with medical contra-indications to disallow bisphosphonates but not denosumab (e.g. renal impairment) would be able to receive denosumab.