From 1 December 2013 the PBS listing of the anti-resorptive agent denosumab is extended to include the treatment of osteoporosis in men.1 The extended Authority required (Streamlined) listing subsidises the use of denosumab (60 mg/mL) for men with established osteoporosis who are 70 years or older with a BMD T-score of –2.5 or less.1
Other than the extension of the restriction to include men, the criteria for PBS-subsidised listing of denosumab as the sole agent for the treatment for primary and secondary prevention of fracture in osteoporosis remains unchanged.
At its July 2013 meeting the PBAC recommended extending the PBS listing for denosumab based on non-inferior efficacy, safety and equivalent cost to that of zoledronic acid.2
A recent placebo-controlled clinical trial demonstrated that denosumab (60 mg/mL) every 6 months in men with osteoporosis who have low BMD was well tolerated and resulted in reduced bone resorption and significant increases in BMD at all skeletal sites assessed.3
Denosumab is an alternative to existing therapies for osteoporosis for men who are at risk of fractures.
Currently recommended treatments for osteoporosis in men include:4
- bisphosphonates (alendronate, risedronate, zoledronic acid and teriparatide)
- strontium ranelate
- teriparatide for severe established osteoporosis.
Read the full NPS RADAR article on denosumab to review the evidence on its use for postmenopausal osteoporosis in women.5 For more information about the management of osteoporosis, read the NPS News on reducing fracture risk in osteoporosis.6
- Australian Government Department of Health and Ageing. July 2013 PBAC Outcomes – Positive Recommendations. 2013. http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes (accessed 30 August 2013).
- Australian Government Department of Health and Ageing. Public Summary Document: Denosumab, injection, 60 mg/ml, Prolia. 2013. http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd (accessed 13 November 2013).
- Orwoll E, Teglbjaerg CS, Langdahl BL, et al. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab 2012;97:3161–9. [PubMed]
- Therapeutic Guidelines. Treatment of osteoporosis. eTG complete: 2013. http://etg.hcn.com.au/desktop/index.htm (accessed 3 October 2013).
- National Prescribing Service Limited. Denosumab (Prolia) for postmenopausal osteoporosis. NPS RADAR, December 2010. http://www.nps.org.au/publications/health-professional/nps-radar/2010/december-2010/denosumab (accessed 3 October 2013).
- National Prescribing Service Limited. Reducing fracture risk in osteoporosis. NPS News 73, 2011. http://www.nps.org.au/publications/health-professional/nps-news/2011/reducing-fracture-risk-in-osteoporosis (accessed 20 August 2013).