script.reportAU
Endocrinology

Risedronate sodium

Brand: Actonel® EC

PBAC's latest decision on Risedronate sodium: Deferred (2023). Considered for Primary prevention of fractures in patients with osteoporosis aged less than 70 years with a BMD T-score of -2.5 or less, without a history of minimal trauma fracture.

PBAC outcome
Deferred
Restricted
ICER (AUD/QALY)
ICER not stated
Submissions
6
first 2006
Submissions
6
2006 → 2023

Eligible population

Patients aged less than 70 years with osteoporosis (BMD T-score of -2.5 or less) without a history of minimal trauma fracture

Therapy area
Endocrinology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Fracture prevention
Key trials
BMD-MN, BMD-NA, HIP, VERT-MN, VERT-NA, Harrington 2004, Heaney 2002
Comparator
placebo or 'watchful waiting' (patient monitoring and standard management with calcium and vitamin D)
Economic model
CEA
ICER note
Document appears truncated; economic model details not fully available in provided text.
ICER (historical)
$15k/QALY–$45k/QALY across 2 submissions (2006–2008) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.

Submission history

Similar precedents

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