Alendronate SodiumAlendronate Sandoz
Treatment of osteoporosis in patients aged 70 years and older with a bone mineral density (BMD) T-score of -2.5 or less.
Decisions on record
- Meeting Jul 2016 Recommended Osteoporosis no PSD
- Meeting Mar 2014 Recommended Fosamax Plus D-Cal® Merck Sharp and Dohme (Australia) Pty Ltd Osteoporosis To request listing as General Schedule Authority Required (STREAMLINED) benefit of a new presentation of alendronate + colecalciferol + calcium. In making this recommendation, the PBAC noted it could only recommend listing of no PSD
- Meeting Jul 2011 Recommended Osteoporosis
- Meeting Jul 2010 Recommended Osteoporosis
- Meeting Mar 2008 Not recommended Osteoporosis
Access path
- TGA registered · Alendronate Sandoz
TGA label narrower than the PBS population
- Jul 2006Recommended · restricted
vs placebo or watchful waiting (patient monitoring and…
- Mar 2008Recommended
ICER rose $75,000 → $105,000 (+40%)
- Jul 2010Recommended · restricted
Comparator changed: watchful waiting (patient monitoring and standard management with…
- Jul 2011Recommended · restricted
Comparator changed: risedronate → watchful waiting (patient monitoring and standard…
- PBS listing · Authority Required
Cost-effectiveness
The base case incremental cost effectiveness ratio (ICER) per QALY was between $15,000 and $45,000 for the alendronate combination products and lower but within the same range for the alendronate only product. PSD · 2011
Decision context
PopulationPatients aged 70 years and older with a bone mineral density (BMD) T-score of -2.5 or less, specifically those with T-scores between -3.0 and -2.5 from the pivotal trial analysis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2011 | Recommended · restricted | watchful waiting (patient monitoring and standard management with calcium and vitamin D) | $15k–45k | RCT · Fracture reduction (any clinical fracture, hip fracture) |
| Jul 2010 | Recommended · restricted | risedronate | — | Meta-analysis |
| Mar 2008 | Recommended | watchful waiting (patient monitoring and standard management with calcium and vitamin D, i.e. placebo) | $15k–105k | RCT · Fracture rate reduction |
| Jul 2006 | Recommended · restricted | placebo or watchful waiting (patient monitoring and standard management with calcium and vitamin D) | $15k–75k | RCT · Clinical fracture |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to patients aged ≥70 years with BMD T-score ≤-2.5; TGA label covers all osteoporosis patients without age or BMD restrictions.