PBAC's latest decision on Warfarin: Not recommended (2016). Considered for Prophylaxis and/or treatment of venous thrombosis and its extension and pulmonary embolism; prophylaxis and/or treatment of thromboembolic complications associated with atrial fibrillation; and as an adjunct in the treatment of coronary occlusion.
PBAC outcome
Not recommended
Unrestricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Patients requiring warfarin for prophylaxis and/or treatment of venous thrombosis, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, or as an adjunct in coronary occlusion treatment.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Bioequivalence
Pivotal trial size
7 patients
Key trials
WA8300, WATB02, WATB03, WATB04, WATB05, WA6231, WA6232, Pereira et al 2005
Comparator
Warfarin Coumadin®
Economic model
Cost-minimisation
ICER note
No formal economic analysis presented; cost-minimisation approach implied.
Why PBAC said no
Reasons cited in the latest PSD: Potential safety and quality use of medicines (QUM) issues; narrow therapeutic index with risk of confusion and adverse outcomes; 'a' flagging would contradict risk management plan and enable brand substitution without prescriber notification; no clinical need for a third brand of warfarin; increased risk of confusion given existing two brands (Coumadin® and Marevan®) are not bioequivalent; potentially vulnerable patient population with decreasing warfarin utilisation.