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In 2017, Medtronic, C. R. Bard, and Philips raked in approximately $300 million in revenue from the U.S. drug-coated balloon (DCB) market. Launched in the United States in late 2014, DCBs have quickly secured an important place in the endovascular specialist’s arsenal for treating lower-limb peripheral arterial disease (PAD) and, more recently, dysfunctional dialysis fistulae. However, recent reimbursement changes, new product launches, and broadening indications for established platforms leave the future of the DCB market uncertain.
The Transitional Pass-Through Payment Expires
The Centers for Medicare and Medicaid Services (CMS) transitional pass-through (TPT) payment temporarily provides additional reimbursement for new, innovative technologies in order to facilitate adoption and data collection. A TPT payment for DCBs used in the hospital outpatient setting was established in April 2015. On December 31, 2017, the TPT payment expired, despite considerable opposition from industry and end users alike.
As of January 1, 2018, the cost of DCBs has been packaged into payments for associated procedures. As a result, plain-old balloon angioplasty (POBA), a procedure often performed using standard PTA balloons, and DCB procedures are now reimbursed at the same rate. The price differential between the standard PTA balloons (~$110) and DCBs (~$1500) threatens to price some cost-sensitive facilities out of the DCB market, limiting access to DCB technology and causing DCB unit sales to decline in 2018. The reimbursement cut is also expected to accelerate ASP erosion in the DCB market. However, annual declines are anticipated to remain in the low-single digits over the near term.
This article was originally published on MDDI/Qmed, to read more please visit https://www.mddionline.com/us-drug-coated-balloons-market-threatened-reimbursement-cuts-and-competitive-pressure
For Further Market Information
More can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Peripheral Vascular Devices and Accessories 2018. The U.S. market for peripheral vascular devices includes peripheral vascular stents, PTA balloon catheters, drug-coated balloons, atherectomy devices, CTO devices, embolic protection devices, peripheral thrombus management, carotid shunts, stent grafts, surgical grafts, diagnostic and interventional catheters and guidewires, introducer sheaths, inferior vena cava filters, AV access thrombectomy devices, vascular closure devices, transcathether embolization devices and peripheral IVUS catheters.
iData’s suite of reports on this subject covers the United States and 15 countries in Europe. These include a comprehensive analysis on units sold, market values, average selling prices, procedure volumes, forecasts, as well as detailed competitive market shares and analysis of all major players.
Email us at [email protected] or register online for a U.S. Market Report Suite for Peripheral Vascular Devices 2018 brochure and synopsis.