Alendronate Sodium, Tablet
Recommended EndocrinologyAuthority RequiredFirst-line line
Initial treatment as the sole PBS-subsidised anti-resorptive agent for osteoporosis in patients aged 70 years of age or older and with a BMD T-score of -3.0 or less; Initial treatment as the sole PBS-subsidised anti-resorptive agent for established osteoporosis in patients with fracture due to minimal trauma
1
Submissions
1 resub
2006–06
On the record
$15k–75k
ICER range
1 sourced ICER · 2006
ICER stated
Cost basis
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
- Jul 2006Recommended · restricted
vs placebo or 'watchful waiting' (patient monitoring and…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
The Committee noted that the same economic model was presented as in the March 2005 submission but with updated unit costs, re-analysed baseline fracture risks, revised health state utilities and BMD screening costs included. Although the economic model in the submission was initially for the 60+ age group with a T score ≤ -2.5 which resulted in cost effectiveness ratios that were uncertain and high, the data from the narrower indication (age ≥70, T-score < -3.0) resulted in acceptable cost effectiveness, with the cost per QALY ranging from less than $15,000 to between $45,000 and $75,000 in females in the 80 – 84 and 70 – 74 age brackets respectively, and from $15,000 to $45,000 in males in the 80 – 84 and 70 – 74 age brackets respectively. PBAC · 2006
ICER uncertainICER / price too highSurrogate endpointCost-effectiveness accepted
Decision context
Populationpatients aged 70 years of age or older and with a BMD T-score of -3.0 or less; patients with fracture due to minimal trauma
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2006 | Recommended · restricted | placebo or 'watchful waiting' (patient monitoring and standard management with calcium and vitamin D) | $15k–75k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age ≥70 years and BMD T-score ≤-3.0; TGA label requires only T-score ≤-2.0 without age restriction.