Medicare approves transitional pass-through payment for outpatient use of Medtronic’s drug-coated balloon

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Medtronic plc has announced that the US Centers for Medicare and Medicaid Services has approved a transitional pass-through payment for the company’s IN.PACT Admiral drug-coated balloon under the Medicare hospital outpatient prospective payment system, removing a potential barrier to patient access to this new medical device, which may represent a significant improvement to the standard of care for peripheral arterial disease in the upper leg.

This supplemental reimbursement provision takes effect on 1 April 2015 and will remain in effect for the following two to three years. It aims to cover the additional cost to US hospitals for treating Medicare beneficiaries with the IN.PACT Admiral drug-coated balloon in the outpatient setting. The Healthcare Common Procedure Coding System code for this new device category will be C2623 (catheter, transluminal angioplasty, drug-coated, non-laser).

A similar supplemental payment to hospitals that treat Medicare beneficiaries with the device on an inpatient basis is currently under review by the US Centers for Medicare and Medicaid Services, with a decision on a new technology add-on payment for the hospital inpatient prospective payment system expected over the summer.

Recently approved by the US Food and Drug Administration (FDA) on the strength of clinical and economic data from multiple studies, the IN.PACT Admiral drug-coated balloon offers patients a new therapy option that has demonstrated the best clinical outcomes ever reported for this disease state and has been proven to reduce the need for costly repeat procedures that are commonly associated with other available interventional therapies.

US Centers for Medicare and Medicaid Services agreed to establish a transitional pass-through payment for the IN.PACT Admiral after determining that “use of the new device significantly improves clinical outcomes for a patient population as compared to currently available treatments.”

The drug-coated balloon arm of the IN.PACT SFA Trial demonstrated the lowest clinically-driven target lesion revascularisation rate ever reported for an interventional treatment of peripheral artery disease in the superficial femoral artery, with only 2.4% of patients treated with the IN.PACT Admiral requiring a repeat procedure at one year, compared to one in five patients (20.6%) treated with percutaneous transluminal angioplasty.

The data also revealed the highest reported rates of primary patency, which measures sustained restoration of adequate blood flow through the treated segment of the artery. Based on Kaplan-Meier survival estimates for primary patency at 360 days, the data showed an 89.8% sustained restoration of blood flow in the drug-coated balloon group compared to 66.8% for the percutaneous transluminal angioplasty group. Using the trial’s protocol definition, primary patency assessed at 12 months of follow up was 82.2% for the drug-coated balloon group and 52.4% for the transluminal angioplasty group.

Subset analyses of data from the IN.PACT SFA Trial and the IN.PACT Global Study show consistent performance of the device in women, patients with diabetes and those with long lesions.

By reducing the need for repeat procedures, the new device is also proving to be economically attractive. Results from an interim economic analysis of the IN.PACT SFA Trial revealed that treatment with the IN.PACT Admiral is cost-effective compared to balloon angioplasty from discharge through one-year of follow-up, indicating the potential to lower overall healthcare costs over the longer term.

The IN.PACT Admiral balloon is designed to reopen superficial femoral and popliteal arteries that have been narrowed or blocked by plaque. Once deployed in the artery, the balloon delivers a proven, safe and effective dose of the anti-restenotic drug paclitaxel to the artery walls. The drug aims to prevent the artery from narrowing again by minimising scar tissue formation. The IN.PACT Admiral received the CE mark in 2009 and has been widely adopted by European physicians, with nearly 100,000 patients treated.