Scottish cost regulators have given the thumbs-up to Amgen's Prolia for the treatment of postmenopausal osteoporosis.
The Scottish Medicines Consortium has accepted Prolia (denosumab) for restricted use on the National Health Service in the country. The watchdog says that treatment with the drug, which is administered as an injection every six months, significantly reduces the risk of vertebral, non-vertebral and hip fractures in postmenopausal women.
However, the approval is based on the stipulation that doctors should only prescribe Prolia to patients with a bone mineral density T-score between -2.5 and -4.0 for whom oral bisphosphonates are unsuitable. The news has gone down well with Amgen and GlaxoSmithKline, which will co-market the drug.
The latter's medical director, Pim Kon, said that following positive guidance on denosumab from the National Institute for Health and Clinical Excellence in October, "we are delighted that women in Scotland unable to tolerate other treatments for postmenopausal osteoporosis now have access to an alternative, efficacious treatment option". Dr Kon added that "the recognition by the SMC of the cost-effectiveness of denosumab could significantly reduce the financial burden of fragility fractures.” Prolia is expected to cost the NHS around £366 per patient per year.
Stephen Gallacher of the Southern General Hospital in Glasgow, said the discovery of "a biochemical pathway that controls the way bones are built and broken down has meant we are able to tackle osteoporosis at the root cause of the disease". Osteoporosis-related fractures affect around 200,000 women in Scotland, with one in three women over the age of 50 suffering a fracture.
Amgen and GSK noted that the average cost of treating a hip fracture is £13,000 in the first year and £7,000 for the subsequent year. Despite the fact that osteoporosis treatments have been available for more than 10 years, 68% of patients in the UK are no longer taking their medication after one year, according to figures from the National Osteoporosis Society.