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IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous
Jan B Pietzsch1, Benjamin P Geisler2, Bharati Manda3
1Wing Tech Inc., Menlo Park, California.
Insights
Drug-coated balloons (DCB) offer cost savings for treating hemodialysis arteriovenous fistula stenosis compared to standard angioplasty (PTA). This endovascular therapy is projected to be cost-effective, particularly with longer follow-up data.
Area of Science:
- Vascular Surgery
- Health Economics
- Interventional Nephrology
Background:
- Dysfunctional hemodialysis arteriovenous fistulae (AVF) present a significant clinical and economic challenge.
- Percutaneous transluminal angioplasty (PTA) is a common treatment, but restenosis rates can be high.
- Drug-coated balloons (DCB) offer a potential alternative to improve outcomes and reduce reintervention rates.
Purpose of the Study:
- To evaluate the economic consequences of using DCB versus standard PTA for stenotic lesions in dysfunctional hemodialysis AV fistulae.
- To analyze cost-effectiveness from a U.S. payer's perspective.
Main Methods:
- Two cost calculation methods were employed: one based on reintervention rates and another on primary patency rates.
- Data from clinical trials on access circuit reinterventions and primary patency at 12 months were utilized.
- Projected treatment outcomes to 3 years, with sensitivity analyses on DCB device prices.
Main Results:
- The DCB strategy demonstrated significant per-patient cost savings: $1,632 at 1 year and $4,263 at 3 years (reintervention method).
- Primary patency approach showed savings of $2,152 at 1 year and $3,894 at 2.5 years.
- The number needed to treat (NNT) for DCB compared to PTA was 2.48 at one year.
Conclusions:
- Endovascular therapy with the IN.PACT AV DCB is anticipated to be cost-saving for AV access stenosis.
- Cost-effectiveness is contingent on longer-term follow-up data confirming sustained clinical effectiveness.
- DCB presents a potentially more economical treatment option for dysfunctional hemodialysis fistulae.
Purpose:
To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae.
Materials And Methods:
Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated.
Results:
Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48.
Conclusions:
Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.
