Alendronate Sodium With ColecalciferolAlendronate Plus D3-DRLA
Recommended EndocrinologyAuthority RequiredFirst-line line
Initial and continuing treatment of established osteoporosis in patients with fracture due to minimal trauma who require supplemental intake of vitamin D.
2
Submissions
2006–06
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2009 Recommended Osteoporosis no PSD
- Meeting Jul 2008 Recommended Osteoporosis no PSD
- Meeting Mar 2008 Deferred Osteoporosis
Access path
- TGA registered · Alendronate Plus D3-DRLA
TGA label narrower than the PBS population
- Mar 2006Recommended · restricted
vs alendronate 70 mg once weekly
- Mar 2006Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation submission; no economic evaluation presented as Fosamax Plus requested same price as alendronate 70 mg with no premium.
The submission did not present an economic evaluation as the submission requested the same price as alendronate 70 mg without a premium component for the addition of vitamin D. PSD · 2006
Decision context
PopulationPatients with established osteoporosis and fracture due to minimal trauma who require supplemental intake of vitamin D.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2006 | Recommended · restricted | alendronate 70 mg once weekly | — | RCT |
| Mar 2006 | Recommended · restricted | alendronate 70 mg once weekly | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to established osteoporosis with fracture due to minimal trauma; TGA label includes broader select patients without fracture requirement.