Dronedarone Hydrochloride

Not recommended CardiovascularAuthority Required (Streamlined)Second-line line

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.

Submissions

2010–10

On the record

—

ICER range

ICER stated

Cost basis

Decision on record

1 decision

Meeting Nov 2010 Not recommended Abnormal heart rhythm

Cost-effectiveness

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.

Decision context

Populationpatients with paroxysmal or persistent atrial fibrillation or flutter and at least one additional cardiovascular risk factor

Why it was knocked back

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

Submission history

1 entries

Decided	Outcome	Comparator	ICER	Evidence
Nov 2010	Not recommended	amiodarone	—	RCT, Meta-analysis · OS

Clinical evidence

Trials cited in the PSDs · ClinicalTrials.gov

Trial	Phase	N	Primary outcome	Status
ATHENA	Ph 3	4,628	First Hospitalization for Cardiovascular Reason or Death From Any Cause	completed
DIONYSOS	Ph 3	504	Treatment Failure	completed
EURIDIS/ADONIS	Ph 3	615	The primary endpoint of the study is the time from randomisation to first documented AF/AF…	completed
ERATO	Ph 3	174	Change from baseline in mean ventricular rate at rest and during exercise	completed

Similar precedents

By decision profile

Warfarin63%Dabigatran Etexilate62%Rivaroxaban61%Zoledronic Acid61%Apixaban61%Dutasteride60%Cladribine60%Ivabradine58%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to second-line use requiring specialist consultation; TGA label permits first-line use on top of standard therapy.