Regulatory, Reimbursement, and Economic Challenges Impacting the Uptake of Drug-Coated Balloons Worldwide

Abstract

Drug-coated balloons (DCBs) have emerged as a significant technological innovation in the field of interventional cardiology and peripheral vascular therapy. Designed to deliver antiproliferative drugs directly to the vessel wall during angioplasty, DCBs offer a promising alternative to permanent implant-based devices such as drug-eluting stents. Their clinical potential lies in reducing restenosis while avoiding long-term complications associated with implanted foreign materials. Despite favorable clinical outcomes in selected indications and increasing technological refinement, the global adoption of drug-coated balloons remains uneven and relatively limited when compared to other cardiovascular devices. This disparity raises critical questions about the non-clinical factors influencing their uptake.

This paper examines the regulatory, reimbursement, and economic challenges that shape the global diffusion of drug-coated balloon technology. Regulatory frameworks governing cardiovascular devices vary widely across regions, influencing approval timelines, post-market surveillance requirements, and manufacturer compliance costs. These variations often create barriers to market entry, particularly in low- and middle-income countries. Additionally, reimbursement policies play a decisive role in determining whether healthcare providers adopt new technologies. Inconsistent coverage decisions, lack of standardized reimbursement codes, and uncertainty regarding long-term cost-effectiveness frequently discourage hospitals and clinicians from using DCBs, even when clinical evidence supports their use.

Economic considerations further complicate adoption patterns. High device costs, budgetary constraints in public healthcare systems, and limited health economic data comparing DCBs with established therapies restrict widespread implementation. While some high-income regions have demonstrated growing acceptance of DCBs in specific clinical scenarios, many healthcare systems continue to prioritize lower-cost or better-established alternatives.