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    Romosozumab for treating severe osteoporosis

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    1 Recommendations

    1.1 Romosozumab is not recommended, within its marketing authorisation, for treating severe osteoporosis after menopause in people at high risk of fracture.

    1.2 This recommendation is not intended to affect treatment with romosozumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

    Why the committee made these recommendations

    Current treatments for people with severe osteoporosis after menopause include bisphosphonates, such as alendronic acid, and other types of medicine, such as denosumab or teriparatide. The company proposes that romosozumab would only be used when there is an imminent fracture risk. It defines this as when there is severe osteoporosis and the person has had a major fracture in the past 24 months. This is narrower than the marketing authorisation.

    Clinical trial evidence suggests that romosozumab followed by alendronic acid is more effective at reducing the risk of fractures than alendronic acid alone. But there is uncertainty because the population in the clinical trial is different to the proposed population. Comparing romosozumab indirectly with other bisphosphonates and other medicines for this condition suggests that it is likely to be at least as effective at reducing the risk of fractures in people with osteoporosis after menopause. But the extent of the benefit is uncertain because of differences between the trial populations in the indirect comparisons. Also, the company did not present clinical-effectiveness evidence for people at imminent fracture risk.

    The most likely cost-effectiveness estimates for romosozumab followed by alendronic acid compared with alendronic acid alone are higher than what NICE normally considers an acceptable use of NHS resources. Also, the company's economic model could not be fully reviewed by the ERG and may not be suitable for decision making. So, romosozumab is not recommended.