Risedronate (Actonel Once-a-Month) and summary of anti-resorptive drug listings

Published in NPS RADAR

Date published: About this date

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Update on PBS-listed anti-resorptive drugs and their restrictions | Reference

A new once-monthly tablet formulation containing risedronate sodium 150 mg (Actonel Once-a-month) was listed on the PBS on 1 July 2009. The authority-required (streamlined) listing is for treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in people1:

  • with a fracture due to minimal trauma
  • aged 70 years or older with a bone mineral density (BMD) T-score ≤ –3.0
  • on long-term high-dose corticosteroid therapy (at least 7.5 mg/day of prednisolone or equivalent for ≥ 3 months) with a BMD T-score ≤ –1.5.

These restrictions are in line with other currently listed risedronate products (Actonel, Actonel Once-a-week, Actonel Combi, Actonel Combi D).

Update on PBS-listed anti-resorptive drugs and their restrictions

Since 2006 several new medicines, formulations and indications for anti-resorptive drugs have been listed on the PBS. Table 1 lists the anti-resorptive drugs currently subsidised for osteoporosis.

Table 1.
PBS listings of anti-resorptive drugs for osteoporosis (as at 1 July 2009)

Anti-resorptive drug PBS listing restriction
Established osteoporosis with fracture due to minimal trauma 70 years of age or older with BMD T-score ≤ –3.0 Long-term high-dose corticosteroid therapy with BMD T-score
≤ –1.5

Alendronate sodium
(Adronat, Alendrobell, Alendro Once Weekly, Fosamax Once Weekly, Fosamax Plus, Ossmax)

 cross

Disodium etidronate with calcium carbonate
(Didrocal)

 cross  cross

Raloxifene hydrochloride
(Evista)

*

 cross cross

Risedronate sodium
(Actonel, Actonel Once-a-month, Actonel Once-a-week, Actonel Combi, Actonel Combi D)

 

Strontium ranelate
(Protos)

*

*
 cross

Zoledronic acid
(Aclasta)

*  cross
* Postmenopausal women only
† Use in men only subsidised if they have had a hip fracture due to minimal trauma

For more information about prescribing anti-resorptive drugs, go to the NPS Health Professional webpage at www.nps.org.au/health_professionals and search for 'osteoporosis'.

References

1. Australian Government Department of Health and Ageing. March 2009 PBAC Outcomes — Positive Recommendations. http://www.health.gov.au/internet/main/publishing.nsf/Content/EE62734C748A1C12CA25759E0014357F/$File/PBACOutcomesMarch2009-Positiverecommendations.pdf (accessed 25 May 2009).