1.1 Romosozumab is recommended as an option for treating severe osteoporosis in people after menopause who are at high risk of fracture, only if:
they have had a major osteoporotic fracture (spine, hip, forearm or humerus fracture) within 24 months (so are at imminent risk of another fracture) and
the company provides romosozumab according to the commercial arrangement.
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 medicines, 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 a person has severe osteoporosis and has had a major osteoporotic fracture within 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. Comparing romosozumab indirectly with other bisphosphonates and other medicines for this condition suggests that romosozumab 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.
The most likely cost-effectiveness estimates for romosozumab followed by alendronic acid, compared with alendronic acid alone, are within what NICE normally considers an acceptable use of NHS resources. So, romosozumab is recommended.