Brand: Fosamax Once Weekly; Fosamax Plus; Fosamax Plus D-Cal
PBAC's latest decision on Alendronate sodium: Recommended with restriction (2011). Considered for Treatment of osteoporosis in patients aged 70 years and older with a bone mineral density (BMD) T-score of -2.5 or less.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
2
first 2008
Submissions
2
2008 → 2011
Eligible population
Patients 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.
Therapy area
Musculo-skeletal
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Fracture reduction (any clinical fracture, hip fracture)
Key trials
Fracture Intervention Trial (FIT-CFA)
Comparator
watchful waiting (patient monitoring and standard management with calcium and vitamin D)
Economic model
CUA
Budget impact
$10M
Eligible patients/year
50,000
ICER basis
Range aggregates 2 submissions (2008–2011) — not a single base case.
Submission history
Mar 2008: Not recommended · Restricted — ICER $105k/QALY