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NICE Makes a U-turn on Romosozumab, Recommends it for Postmenopausal Osteoporosis

In draft guidance published last week, the National Institute for Health and Care Excellence (NICE) has recommended romosozumab for the treatment of osteoporosis in postmenopausal women.

With this decision, more than 20,000 individuals in England and Wales with severe osteoporosis who are at high risk of fracture are likely to become eligible to receive the drug.

Chief executive of the Royal Osteoporosis Society, Craig Jones, said, "This is a major step forward for people living with severe osteoporosis. 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."

Burden of Osteoporosis

Osteoporosis poses a significant healthcare burden globally, with nearly 9 million fractures reported each year. More than 300,000 individuals in the UK attend hospitals with osteoporotic fractures annually.

The risk of osteoporosis is more pronounced in women than in men, particularly due to menopause-related hormone changes that cause bone loss. The prevalence of osteoporosis in women rises from 2% at 50 years to more than 25% at 80 years.

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 is the only drug available that can help to form bone as well as increase existing bone strength. It is the first new treatment for osteoporosis for several years and I'm delighted we have been able to recommend this drug as an option for people with severe osteoporosis," she added.

U-turn by NICE

In draft guidance published in November 2021, NICE had failed to recommend romosozumab, within its marketing authorisation, for the treatment of severe osteoporosis following menopause.

Earlier this year, several NHS clinicians led by the Royal Osteoporosis Society drafted a letter urging NICE to reconsider their decision of not approving the drug. Since then, NICE has reversed its decision, offering potential benefit to thousands of patients.

"We're pleased that NICE has listened to the views of clinical experts and patient advocates," said Mr Jones.


A clinical trial found that initiating romosozumab before alendronic acid was associated with a 50% lower relative risk of vertebral fractures over 24 months compared with alendronic acid alone. Additionally, there was 19% reduction in the risk of non-vertebral fractures among romosozumab users compared with those using alendronic acid alone.

Guideline Updated

The positive recommendation for romosozumab was shortly followed by publication of the new UK National Osteoporosis Guideline endorsed by NICE. The guideline carries a conditional recommendation of considering teriparatide or romosozumab as first-line treatment options in postmenopausal women with high risk of fractures, particularly vertebral fractures. Romosozumab may also be considered as a second-line option in postmenopausal women, who are refractory to bisphosphonate treatment. The guideline states that treatment with romosozumab should be initiated by secondary care clinicians.

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