Extended PBS listings for zoledronic acid 5mg (Aclasta)

From 1 April 2010, zoledronic acid 5 mg (Aclasta) can be prescribed on the PBS as the sole anti-resorptive agent for:

• osteoporosis in men without hip fracture
• people with corticosteroid-induced osteoporosis
• people with symptomatic Paget's disease.^1,2
  

The authority-required listing for zoledronic acid was previously restricted to:

• women with osteoporosis and any fracture due to minimal trauma
• women aged > 70 years with a bone mineral density (BMD) T-score of ≤ –3.0
• men with a hip fracture due to minimal trauma.
  

(See the NPS RADAR review: Zoledronic acid (Aclasta) for osteoporosis for more information.³)

No longer restricted to men with hip fracture only

The extended PBS listing for osteoporosis allows zoledronic acid to be prescribed for men with any type of minimal trauma fracture and for men aged > 70 years with a BMD T-score of ≤ –3.0. This is similar to the listings for alendronate and risedronate — other PBS-listed bisphosphonates for osteoporosis (see Box 1).⁴

Box 1: PBS-listed bisphosphonates for osteoporosis, corticosteroid-induced osteoporosis and symptomatic Paget's disease*⁴

*Streamlined authority listings except for zoledronic acid (which is authority required)

^† Restricted to when calcitonin has been found to be unsatisfactory due to either lack of efficacy or unacceptable side effects

Corticosteroid-induced osteoporosis

Zoledronic acid may now be prescribed for people on long-term high-dose (≥ 3 months at ≥ 7.5 mg daily prednisolone or equivalent) corticosteroid therapy and with a BMD T-score ≤ –1.5. Until now, risedronate was the only other PBS-listed medicine for corticosteroid-induced osteoporosis (see the NPS RADAR In Brief news item: Risedronate [Actonel and Actonel Once-a-Week] for corticosteroid-induced osteoporosis⁵ and Box 1 for more information).⁴ The PBAC recommended extending the listing of zoledronic acid on a cost-minimisation basis — that is, similar efficacy and cost — compared with risedronate. The equi-effective doses for this comparison were zoledronic acid 5 mg once yearly and risedronate 5 mg once daily.¹

Symptomatic Paget's disease

This extended PBS listing is similar to those of alendronate, pamidronate, risedronate and tiludronate — the other PBS-listed bisphosphonates for symptomatic Paget's disease (see Box 1).⁴ The PBAC recommended this listing on a cost-minimisation basis compared with pamidronate. The equi-effective doses for this comparison were 1 infusion of zoledronic acid 5 mg once yearly and 2 infusions of pamidronate 60 mg per year.¹

References

1. Pharmaceutical Benefits Advisory Committee. Positive recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC) in November 2009 relating to the listing of drugs on the Pharmaceutical Benefits Scheme (PBS). Canberra: Australian Government Department of Health and Ageing, 2009. http://www.health.gov.au/internet/main/publishing.nsf/Content/pbacrec-nov09-positive (accessed 6 January 2010).
2. Australian Drug Evaluation Committee. ADEC 264^th meeting resolutions: resolution 9306. Canberra: Australian Government Department of Health and Ageing, 2009. http://www.tga.gov.au/docs/html/adec/adec0264.htm (accessed 13 January 2010).
3. National Prescribing Service. Zoledronic acid (Aclasta) for osteoporosis. NPS RADAR March 2009. Sydney: National Prescribing Service, 2009. http://nps.org.au/__data/assets/pdf_file/0006/69936/OKA7018_NPS_RADAR_ZoledronicAcid_V3.pdf (accessed 7 January 2010).
4. Department of Health and Ageing. PBS for Health Professionals. Canberra, 2010. www.pbs.gov.au (accessed 6 January 2010).
5. National Prescribing Service. Risedronate (Actonel and Actonel Once-a-Week) for corticosteroid-induced osteoporosis. NPS RADAR In Brief February 2009. Sydney: National Prescribing Service, 2009. http://nps.org.au/health_professionals/publications/nps_radar/2009/march_2009/brief_item_risedronate (accessed 7 January 2010).