June 13, 2020

Economic Analyses Assess Medtronic's In.Pact AV DCB Versus PTA

June 13, 2020—An analysis assessing the economic impact of using the company's In.Pact AV drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) in the United States healthcare system was presented by Robert Lookstein, MD, at SIR 2020 Virtual, the Society of Interventional Radiology’s 2020 annual scientific meeting held online June 13–14.

The analysis was based on 12-month clinical data from the IN.PACT AV Access study, which supported FDA approval of the In.Pact AV DCB for the treatment of failing arteriovenous (AV) fistula access in patients with end-stage renal disease (ESRD) undergoing dialysis, which Medtronic announced in November 2019.

The findings complement an earlier budget impact analysis presented by Dr. Lookstein at LINC 2020, the Leipzig Interventional Course held January 28–31 in Leipzig, Germany. The two analyses compared the potential economic implications of using In.Pact AV DCB versus PTA using two different analytic approaches.

In the SIR presentation, a cost analysis approach consisted of using the access circuit primary patency rates from the In.Pact AV Access study and published data on comprehensive vascular access costs from an analysis of Medicare patients (n = 2,704) with maintained versus failed AV access primary patency. Using this approach, the In.Pact AV DCB strategy (before consideration of DCB device cost per case) was associated with potential savings of $2,152 at 1 year and $3,893 at 2.5 years after the index procedure.

In the budget impact analysis presented at LINC, an analytic Markov model was used to estimate total costs per patient 12 months after treatment with In.Pact AV DCB versus PTA, based on the costs of the index procedure and reinterventions needed to maintain access circuit patency. This analysis showed meaningful potential per case reductions in reintervention costs and savings of $1,386 at 1 year, and potential projected savings of $3,619 at 3 years. Assuming DCB device cost of $2,214 per case, the In.Pact AV DCB strategy would break even within 2 years and achieve savings of approximately $1,400 at 3 years, according to the presented analysis.

Medtronic stated that the two independent approaches show that treatment with the In.Pact AV DCB could lead to meaningful per-patient and health system savings at 1 year and over a longer timeframe. Potential savings to Medicare are estimated to be $160 million to $250 million over 1 year and > $420 million over 3 years if just half of the current 233,000 annual AV access maintenance procedures were performed with In.Pact AV DCB instead of PTA. Beyond economic savings, reductions in reinterventions could lead to reduced patient morbidity, improved quality of life, and less time spent in a hospital setting.

Dr. Lookstein, who served as National Principal Investigator of the trial, commented to Endovascular Today, “This is an incredible result with significantly improved patency and fewer reinterventions but also dramatic cost savings to the US healthcare system. The benefit to all hemodialysis patients is seen in terms of improved quality of life and a significant cost reduction…it’s truly a victory for our ESRD patients.”


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