Alendronic Acid
Treatment of osteoporosis in patients aged 70 years and above with a BMD T-score of -2.5 or less; corticosteroid-induced osteoporosis in patients with a BMD T-score of -1.5 or less; and established osteoporosis in patients who have had a fracture due to minimal trauma.
Decision on record
- Meeting Nov 2021 Withdrawn Osteoporosis no PSD
Access path
- Jul 2010Recommended · restricted
vs risedronate
- Jul 2011Recommended · restricted
Comparator changed: risedronate → watchful waiting (patient monitoring and standard…
- Jul 2016Recommended · restricted
Comparator changed: watchful waiting (patient monitoring and standard management with…
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the Restricted Benefit listing of alendronic acid in the form of 70 mg effervescent tablets (as alendronate sodium) for the treatment of osteoporosis, on the basis that it is bioequivalent to alendronate tablets.PSD · Jul 2016
6.2 The PBAC recommended that alendronate effervescent tablets have the same restriction as alendronate tablets on the basis the two forms are bioequivalent. The PBAC noted that there would be potential for leakage into the general osteoporosis patient population if alendronate effervescent tablets were restricted to patients with dysphagia or other swallowing difficulties.PSD · Jul 2016
5.6 The submission requested an approved ex-manufacturer price (AEMP) for alendronate effervescent tablets of $''''''''''''''. The current AEMP for alendronate tablets is $4.56.PSD · Jul 2016
5.7 The submission stated that the increased price of alendronate effervescent tablets compared with conventional tablets is justifiable as it is a superior product and will be used in a smaller subset of people. No evidence was provided to support this claim.PSD · Jul 2016
5.4 The submission claimed that alendronate effervescent tablets are superior to alendronate tablets. No clinical evidence was provided to support this claim.PSD · Jul 2016
5.5 The PBAC considered that the claim of superior comparative effectiveness and superior comparative safety was not adequately supported in the absence of any clinical data.PSD · Jul 2016
Cost-effectiveness
Minor submission with no clinical trials presented; economic analysis not applicable as listing recommended to be cost-neutral
The PBAC considered that, as per the original recommendation for primary prevention, the benefit of alendronate depends on the baseline risk of the patients and that there will likely be a smaller benefit in this new subgroup, based on the clinical evidence presented. However, the comparable ICERs in this submission to those which formed the basis of the previous recommendations, particularly with the lower priced alendronate monotherapy, alleviate some of the uncertainty in the model. PBAC · 2011
Decision context
PopulationPatients with osteoporosis meeting current PBS restrictions for alendronate tablets, particularly those with dysphagia or other swallowing difficulties
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Recommended · restricted | alendronate tablets | — | Cost-minimisation |
| Jul 2011 | Recommended · restricted | watchful waiting (patient monitoring and standard management with calcium and vitamin D) | $15k–45k | RCT · Other |
| Jul 2010 | Recommended · restricted | risedronate | — | RCT, Meta-analysis |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age ≥70 years and/or specific BMD T-score thresholds; TGA label covers all osteoporosis diagnosed by low bone mass criteria.