Romosozumab is licensed for the treatment of severe osteoporosis in postemenopausal women at high risk of fracture and is one of only two treatments licensed by the MHRA which induces new bone formation, and the first of these to simultaneously reduce bone loss.
In draft guidance issued in November 2021, NICE advised against the use of romosozumab for severe osteoporosis stating that the most likely cost-effectiveness estimates for romosozumab followed by alendronic acid compared with alendronic acid alone were higher than what NICE normally considers an acceptable use of NHS resources. NICE also stated that the company (UCB Pharma) had not presented clinical-effectiveness evidence for people at imminent fracture risk.
Romosozumab was approved for use in Scotland and Northern Ireland which led to calls from more than 100 clinicians, led by the Royal Osteoporosis Society, for NICE and UCB Pharma to work with them to ensure equal access to the drug for patients in England and Wales. This led to further discussion and review culminating in a reversal of the original decision by NICE.
The final guidance recommends romosozumab as an option in people after the menopause 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 the drug according to the commercial arrangement.
Romosozumab is administered by subcutaneous injection (2 x 105mg) into the abdomen, thigh or upper arm, once monthly for 12 months. The prescribing information states that patients should be adequately supplemented with calcium and vitamin D before and during romosozumab treatment and should be transferred to antiresorptive therapy (eg, alendronic acid) following completion of therapy in order to extend the benefit of treatment beyond 12 months.