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 |
||||||
Disodium etidronate with calcium carbonate |
||||||
Raloxifene hydrochloride |
* |
|||||
Risedronate sodium |
||||||
Strontium ranelate |
* |
* | ||||
Zoledronic acid |
† |
* | ||||
* 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'.