The anabolic drug romosozumab (Evenity) has been recommended for PBS listing for the treatment of severe osteoporosis in patients who have experienced a prior fracture while on anti-resorptive therapy.
The Pharmaceutical Benefits Advisory Committee (PBAC) made the recommendation at its March 2020 meeting, saying there is a clinical need for additional treatment options for severe osteoporosis in the later-line setting.
The recommendation for listing applies to the monoclonal antibody drug given as a subcutaneous injection for 12 months.
The PBAC noted that the application for a PBS subsidy was supported by the Therapeutics Committee of the Australian and New Zealand Bone and Mineral Society (ANZBMS) and Osteoporosis Australia.
“Both groups consider romosozumab is an advance in the treatment of osteoporosis, providing clinicians and patients with an effective treatment option that has a different mechanism of action and reduced injection burden compared to teriparatide,” it said in its initial application.
“The ANZBMS consider the cardiovascular adverse event profile to be a concern but are of the opinion that the risk can be managed in clinical practice.
The drug was recently recommended by the Endocrine Society for treatment of postmenopausal women with osteoporosis at very high risk of fracture, such as those with severe osteoporosis (ie, low T-score < ?2.5 and fractures) or multiple vertebral fractures.
In an update to guidelines the Society recommend romosozumab treatment for up to one year for the reduction of vertebral, hip, and nonvertebral fractures. ?The guidelines noted there was good evidence that romosozumab increased bone density and reduced vertebral fractures.
However it advised that women at high risk of cardiovascular disease and stroke should not be considered for romosozumab pending further studies on cardiovascular risk associated with this treatment. High risk includes prior myocardial infarction or stroke.
The guidelines also advised that in postmenopausal women who have completed a course of romosozumab, treatment should be continued with antiresorptive osteoporosis therapies to maintain bone mineral density gains and reduce fracture risk.