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 €€

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 femoro-popliteal artery is associated with improved patient outcomes and overall cost-savings to payers in the Dutch healthcare system, rendering it a dominant treatment strategy.