More than 14,000 postmenopausal women in England could benefit from a new drug that helps prevent bone fractures.
Osteoporosis weakens bones and affects 3.8 million people in the UK. It particularly affects older women because during the menopause oestrogen, the hormone that is important for maintaining bone density and strength, decreases and bone density reduces.
This can lead to osteoporosis, making broken bones more common. The condition is linked to more than half a million fractures a year in UK, at a cost of more than £4.5bn.
Fractures can be very painful and limit a person’s independence, and they are also associated with increased mortality. Until now, women with osteoporosis after menopause at very high risk of fracture have been treated with romosozumab or teriparatide, followed by bisphosphonates such as alendronic acid. But some patients do not respond to or cannot tolerate these drugs.
On Wednesday, the National Institute for Health and Care Excellence (Nice) announced it had approved a new drug, Abaloparatide, for use by the health service. It will be available for use on the NHS in England within three months.
Abaloparatide – which is sold as Eladynos and made by Theramex – increases bone density by stimulating the cells that make new bones.
The drug has been recommended for patients at high risk of bone fractures, with Nice estimating that it could benefit more than 14,000 women who have gone through menopause. Abaloparatide is administered via a pre-filled pen, which is injected at home once a day.
Prof Jonathan Benger, chief medical officer and deputy chief executive of Nice, said: “The independent committee heard from patients about how debilitating osteoporosis can be and how it impacts all aspects of day-to-day life, such as not going out for a walk because they are fearful of falling and having a fracture.
“This can impair mental and physical health. Our focus is on enabling access to care that improves quality of life while offering value to the taxpayer. Abaloparatide has been found by our independent committee to be clinically and cost effective at reducing the risk of fracture, giving people more independence and, therefore, a better quality of life.”
The Royal Osteoporosis Society (ROS) welcomed Nice’s announcement. Given the prevalence of bone fractures among women over 50 and the extent of disability these breaks cause, the “paucity of new treatments over the last decade and a half has been a huge cause for concern”, said Craig Jones, chief executive of the ROS.
“We are very pleased that Nice have recommended a new drug treatment for postmenopausal women at the greatest risk of breaking bones. This will change many thousands of lives for the better and we’re looking forward to seeing the impact it makes in communities across the country.”
Prof Kamila Hawthorne, chair of the Royal College of GPs, said: “GPs will always do our best to develop a treatment plan with patients based on all the various factors impacting on their health – and sometimes first line treatments won’t be appropriate or effective – so it’s positive to see a new treatment option has been approved by Nice for us to consider. We hope that this will help patients who have osteoporosis but have not responded to other treatments.”
But menopause expert and campaigner Kate Muir said that women needed earlier intervention, adding: “It’s great that new drugs like abaloparatide are available, but this is shutting the door after the osteoporotic horse has bolted.”
Studies show hormone replacement therapy can increase bone density by up to 8% and reduce the risk of fractures, she said. “But this public health message is not getting out to women, who should be informed that body-identical transdermal HRT is much safer than previous forms, and it helps to keep bones healthy.”
