MD2 - Economic Analysis of Urea-Excipient Drug-Coated Balloon Therapy for Treatment of Femoropopliteal Artery Disease in Japan

Abstract

In recent years, numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease (PAD) of the upper leg. Our objective was to study the cost-effectiveness of DCB therapy vs. plain balloon angioplasty (PTA), bare metal stents (BMS), and drug-eluting stents (DES) for femoropopliteal artery disease in the Japanese healthcare system. Target lesion revascularization (TLR) rates post PTA, BMS, DES, and DCB, as the relevant clinical effectiveness measure, were pooled from studies published through 2017 that were identified through systematic search. Only urea-excipient DCB TLR rates were utilized based on regulatory approval in Japan and improved performance compared to non-urea excipient DCB devices. Costs were based on detailed resource-based accounting and current reimbursement tariffs (JPY 170,000 per DCB device). A Markov model computed strategy-specific costs and comparative cost-effectiveness, considering a 3-year time horizon and up to one reintervention. QALY computations were based on an estimated TLR-associated QALY decrement of 0.06. Costs and effects were discounted at 2% per annum, and extensive sensitivity analyses performed. Pooled 36-month probabilities of TLR were 16.3%, 25.5%, 36.9%, and 48.4% for DCB, DES, BMS, and PTA, based on evidence of n= 358, 1,959, 3,009, and 892 lesions treated, respectively. Over three years, DCB added 0.0047, 0.0107, and 0.0167 QALYs compared to DES, BMS, and PTA, at concurrent cost savings of JPY 135,067, 167,210, and 118,914, respectively. These savings are primarily a result of reduced TLR costs, and of lower DCB index procedure cost compared to DES and BMS (JPY 1,008,740 vs. 1,076,640, and 1,015,140). Across a wide range of assumptions, DCB was found dominant or cost-effective. Urea-excipient drug-coated balloon therapy for femoropopliteal disease is associated with improved patient outcomes and overall cost-savings to payers in the Japanese healthcare system, rendering it a dominant treatment strategy.