Pietzsch JB, Garner AM, DeBrouwer B, Manda B, Geisler BP, Reijnen MM. Drug-coated balloon therapy for treatment of critical limb ischemia in femoropopliteal artery disease: economic analysis for the Netherlands. [Research Posters II, abstract PMD54]. Poster presented at the 2018 European Congress of the International Society for Pharmacoeconomics and Outcomes Research, Barcelona, 10–14 November 2108. Available at: https://tools.ispor.org/scientificpresentationsdatabase/presentation/88598?pdfid=57004. Accessed November 4, 2018.

Objectives. Drug-coated balloons (DCBs) for femoropopliteal peripheral artery disease (PAD) have been shown to be clinically superior and cost-effective compared to percutaneous transluminal balloon angioplasty (PTA). However, most studies focused on patients without critical limb ischemia (CLI). Our objective was to study the cost-effectiveness of DCB therapy vs. PTA in a CLI patient population in the Dutch healthcare system.

Methods. Target lesion revascularization (TLR) and amputation rates were extracted from the CLI subgroup of the IN.PACT Global study, in which a urea-excipient DCB was used. PTA outcomes were obtained from a systematic search of studies published through 2017. Costs were based on average radiology and surgery reimbursement PTA rates with additional cost of €480 assumed per DCB device. A Markov model computed costs and cost-effectiveness, considering in the base case a two-year time horizon and up to one reintervention. QALY computations were based on an estimated TLR-associated QALY decrement of 0.06, posttreatment utility of 0.82, and postamputation utility of 0.68, and Dutch general population mortality adjusted by a hazard ratio of 5.0 to reflect increased mortality in CLI patients. Costs and effects were discounted at 4% and 2.5% per annum; a willingness-to-pay threshold of €50,000 per QALY was assumed. Sensitivity analyses were performed.

Results. Model-projected 24-month probabilities of TLR were 26.2% and 41.0% for DCB and PTA, respectively, and amputation rates 2.8% and 6.5%. DCB was cost-saving, adding 0.0130 QALYs while saving €357. DCB was found dominant or cost-effective across a wide range of assumptions, including for a comparative TLR effect size of only one-fourth of the base case.

Conclusions. Urea-excipient drug-coated balloon therapy for treating CLI in the femoropopliteal artery is associated with improved patient outcomes and overall cost-savings to payers in the Dutch healthcare system, rendering it a dominant treatment strategy.