Patients in the UK will this week get access to Novartis’ annual postmenopausal osteoporosis drug Aclasta, following its European approval last Friday.
The intravenous bisphosphonate Aclasta (zoledronic acid) offers the important benefit of once-yearly dosing, compared to rival oral bisphosphonate therapies on the market that are administered daily, weekly or monthly. This provides obvious benefits to the patient as well as potentially improving treatment compliance, an important target in the fight against the condition.
As Novartis points out, numerous studies have found that poor compliance reduces the benefit therapy and presents a major challenge for health professionals. A number of studies have found that around half of patients stop taking osteoporosis therapy within 12 months, primarily because of difficult dosing regimens and side effects.
According the company, more than 70% of patients taking part in one study said they prefer a once-yearly infusion of Aclasta to a weekly tablet. But, aside from its patient-friendly dosing, Novartis’ drug is also the only one approved in Europe and the USA to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip and spine, and experts are excited about its potential.
“The convenience of a once-yearly dose should improve compliance and bone protection among patients while reducing fracture-related hospitalisation and healthcare costs,” explained Steven Boonen, Professor of Medicine at the Centre for Metabolic Bone Diseases & Division of Geriatric Medicine at the Leuven University in Belgium.
Aclasta’s approval was based on data from the three-year Pivotal Fracture Trial involving more than 7,700 women, in which it demonstrated its ability to boost bone strength and cut the risk of spine fractures by 70% and hip fractures by 41%. The reduction in spine fractures was sustained over three years, Novartis said, and bone mineral density increased significantly in the spine by 6.7% and in the hip by 6% compared to patients taking a placebo.
According to the National Osteoporosis Society, over 60,000 hip fractures occur each year in the UK, but this looks set to soar to 117,000 per year by 2016, due to the ageing population, and so any product offering a reduction in fractures will be a welcome addition to the treatment arsenal.
As Professor David Reid, Professor of Rheumatology at the University of Aberdeen, explained: “Preventing hip fractures remains one of the main aims of treating osteoporosis, as we know that three months after a hip fracture, nearly one in five elderly patients will die. Reducing hip fractures by 41% is therefore highly clinically significant.”
A spokeswoman for the company told PharmaTimes that, in the UK, Aclasta will be priced at £283.74 per shot. Although this is more expensive that rival generic therapies on the market, she stressed that, because its unique, once-yearly dosing guarantees treatment compliance, the drug should actually help save on costs related to complications associated with the condition, such as hip fractures, which cost the National Health Service £20,000 each.
Consequently, she said the company is confident that Aclasta will be adopted by the UK’s cost-effectiveness body, the National Institute for Health and Clinical Excellence.
Aclasta is now approved in more than 30 countries for the treatment of post-menopausal osteoporosis and in more than 60 countries including the US, Canada and the EU for the treatment of Paget's disease, the second most common metabolic bone disorder.
Its clearance in Europe should certainly give sales a boost, and a number of analysts believe Aclasta can reach blockbuster status, especially as already over 200 million people across the globe are affected by osteoporosis and the market is expanding substantially. By 2020, the cost of treating all osteoporotic fractures in post-menopausal women in the UK could overshoot £2.1 billion, the company warns.