PBAC's latest decision on Dronedarone hydrochloride: Not recommended (2010). Considered for Treatment of patients with paroxysmal or persistent atrial fibrillation or flutter and at least one additional cardiovascular risk factor, in addition to standard care. Treatment should only be initiated in consultation with a specialist.
PBAC outcome
Not recommended
Authority Required (Streamlined)
ICER (AUD/QALY)
—
Submissions
1
first 2010
Submissions
1
2010 → 2010
Eligible population
patients with paroxysmal or persistent atrial fibrillation or flutter and at least one additional cardiovascular risk factor
Therapy area
Cardiovascular
Line of therapy
Second-line
Evidence base
RCT, Meta-analysis
Primary endpoint
OS
Key trials
ATHENA, DIONYSOS, DAFNE, EURIDIS/ADONIS, ERATO
Comparator
amiodarone
Economic model
Cost-effectiveness and cost-utility analyses
Budget impact
$160M
ICER note
ICER was modelled but not explicitly stated in the PSD. Document states 'the incremental cost per extra quality adjusted life year (QALY) gained was less than $15,000' for all three economic evaluations, but PBAC did not recommend based on clinical grounds, not economic grounds.
Why PBAC said no
Reasons cited in the latest PSD: dronedarone is less effective than amiodarone in preventing AF recurrence (63.5% vs 42% AF recurrence; OR 2.4 [95% CI: 1.65, 3.49]); uncertain clinical superiority claim not accepted by PBAC; proposed restriction based on additional cardiovascular risk factor not consistent with treatment guidelines and not effectively administrable by Medicare Australia