Romosozumab(Evenity) is being made available for the treatment of postmenopausal women with severe osteoporosis who have experienced a major fracture within the previous 24 months and who are at imminent risk of another fragility fracture. The announcement was made on 6/2/2024 by Dr Colm Henry- Chief Medical Officer with the HSE.
About 32,000 people suffer fragility fractures every year, with the number projected to increase as Ireland’s population ages. Fractures cause substantial pain and disability, and ultimately lead to earlier deaths.
“This reimbursement agreement will target a very specific, at-risk subgroup of postmenopausal women,” said Dr Henry. “It’s a first-in-class medication and could prevent these women from requiring additional care. It’s also been shown that severe fractures in older age can result in morbidity within one year. Providing these medications could have a significant benefit for this population in the future.”
Romosozumab is a monoclonal antibody that binds and inhibits the effect of sclerostin. It is licensed for treatment of severe osteoporosis in postmenopausal women at high risk of fracture. It is administered as two subcutaneous injections (105mg each) each month for a maximum of 12 months after which it is recommended that patients begin antiresorptive therapy. Romosozumab has been shown to be more effective than placebo in reducing the incidence of new vertebral fractures in postmenopausal women with low bone mineral density but the difference in non-vertebral fractures was not statistically significant. In a trial in which women with osteoporosis who had previously had a fracture were treated with romosozumab or alendronic acid for 12 months followed by open-label alendronic acid, those in the romosozumab group had a lower rate of new vertebral fractures (number needed to treat [NNT] 25 over 2 years) and clinical fracture (NNT 30 over a median of 2.7 years). There have been reports of osteonecrosis of the jaw, atypical femoral fractures and serious cardiovascular events in people treated with romosozumab. Other adverse effects include nasopharyngitis, arthralgia, headache, sinusitis and injection site reactions.
Although romosozumab has shown some benefit over alendronic acid on clinical fractures in women with postmenopausal osteoporosis who were at high risk of a further fracture, the long-term effects it might have are not known, and there are ongoing concerns over the risk of serious adverse cardiovascular effects and its high cost compared with other drugs used to treat osteoporosis. Given such reservations, its use will be limited to postmenopausal women with severe osteoporosis who are at very high risk of another fracture and who are not able to tolerate other drugs used to treat osteoporosis.
