PBAC's latest decision on Dabigatran etexilate: Recommended with restriction (2012). Considered for Prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation who are at moderate-to-high risk of developing stroke or systemic embolism, as evidenced by one or more of the following risk factors: age ≥75 years; hypertension; diabetes mellitus; heart failure or left ventricular dysfunction (ejection fraction <40%) or a history of coronary artery disease; previous stroke or transient ischaemic attack or systemic embolism.
PBAC outcome
Recommended with restriction
Authority Required (STREAMLINED)
ICER (AUD/QALY)
$15k/QALY
—–$15k/QALY · across 2 submissions
Submissions
2
first 2011
Submissions
2
2011 → 2012
Eligible population
patients with non-valvular atrial fibrillation who are at moderate-to-high risk of developing stroke or systemic embolism
Therapy area
Cardiovascular
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null
Key trials
RE-LY
Comparator
adjusted-dose warfarin and aspirin
Economic model
CUA
Budget impact
$100M
ICER basis
Range aggregates 2 submissions (2011–2012) — not a single base case.
Submission history
Mar 2011: Recommended · Authority Required — ICER $15k/QALY