A health watchdog has approved the first new osteoporosis drug of its kind for more than a decade, after medics urged it to perform a U-turn.
Earlier this year, more than 100 experts wrote a letter calling on the National Institute for Health and Care Excellence (Nice) to repeal its verdict that romosozumab should not be given on the NHS.
The drug, which is administered as monthly injections, induces new bone formation and is highly effective at reducing the risk of fracture in postmenopausal women with severe osteoporosis
It is one of only two treatments that help to promote bone formation, and the first to reduce bone loss at the same time.
In their letter the medics wrote: “As clinicians working in this field, we know this is one of the biggest threats to living well in later life.
“Yet the National Institute for Health and Care Excellence (Nice) has declined to recommend the first new osteoporosis medication in more than a decade.”
Now, in a final appraisal document, Nice has approved the drug for use in treating severe osteoporosis in people who are at high risk of fracture, if they have had a major osteoporotic fracture within 24 months.
Craig Jones, chief executive of the Royal Osteoporosis Society, welcomed the move, saying: “This is a major step forward for people living with severe osteoporosis.
“We’re pleased that Nice has listened to the views of clinical experts and patient advocates.
“Now, no matter where people live in the UK, healthcare professionals and eligible patients will have the same range of treatment options.
Closing the eye-watering treatment gap for osteoporosis depends on ending the inequalities in local services across the NHSCraig Jones, Royal Osteoporosis Society
“The decision to approve the new medication is a reminder that there are safe, effective therapies and treatment options available to help prevent fractures and enable people to live well with osteoporosis.
“The crucial next step is to end the postcode lottery for fracture liaison services, which remains a stubborn barrier to people’s ability to get a timely diagnosis and treatment.
“Closing the eye-watering treatment gap for osteoporosis depends on ending the inequalities in local services across the NHS.”
Osteoporosis causes bones to lose strength and break more easily, and affects an estimated 3.5 million people in the UK.
Half of women and 20% of men over 50 will break a bone because of osteoporosis.
Nice said more than 20,000 people could be eligible for the treatment, which has been agreed at a discounted price for the NHS.
Current treatments for people with severe osteoporosis after menopause include bisphosphonates, such as alendronic acid, and other types of medicines.
Helen Knight, acting director for medicines evaluation at Nice, said: “People with severe osteoporosis often have a poorer quality of life.
“Fractures due to osteoporosis can lead to hospital stays and limit people’s mobility and independence.
“Romosozumab has shown clinically significant results that could have a huge impact on the lives of people who have severe osteoporosis.”
A clinical trial showed that people who took romosozumab before alendronic acid had a 50% lower relative risk of vertebral fractures (fractures in the bones of the spine) over 24 months than people having alendronic acid alone.
The risk of other fractures was 19% lower for people who had romosozumab before alendronic acid compared with those having alendronic acid alone.