CMS Decision May Threaten DCB Utilization

Hello and welcome to the November edition of Vascular Disease Management. There are excellent articles in this edition, but I’ve chosen to deviate from the standard practice of commenting on one of these articles. I have instead decided to comment on drug-coated balloon (DCB) technology as there are now 3 FDA-approved devices, with many others presently in trials.

Centers for Medicare & Medicaid Services (CMS) has ruled that the pass-through code will end on December 31, 2017. CMS is considering creating new Ambulatory Payment Classifications (APCs) for endovascular procedures. These new APCs could enable a differentiated reimbursement for DCBs versus existing technologies. There is a risk that CMS may decide not to create these new classifications. At present, CMS does not provide reimbursement for office-based laboratories that utilize DCBs. Historically, the utilization of DCBs has fallen significantly when incremental hospital reimbursement was not provided (in other countries), as there is a direct negative impact on the operating margins of the interventional laboratories.

Large randomized controlled trials^1-3 have demonstrated improved short- and long-term patency, as well as safety, in the treatment of de novo femoral and popliteal arterial obstructions, femoral-popliteal in-stent restenosis,⁴ and recently in the interventional therapy of arteriovenous (AV) fistulas.⁵ Based on these large trials, DCBs have received FDA approval for the treatment of superficial femoral artery (SFA)/popliteal obstructive disease, femoral-popliteal in-stent restenosis, and AV fistulas. The THUNDER trial⁶ demonstrated restenosis benefit in SFA/popliteal interventions at 5 years, but this technology was never studied in a large randomized US trial and never received FDA approval. 

DCBs have been enthusiastically embraced by the interventional community as a means to decrease restenosis rates and decrease the need for repeat interventions. Repeat interventions are costly and are associated with additional risk to patients such as bleeding complications, pain, embolization, contrast allergic reactions, vascular obstruction, and radiation exposure. Most interventionists view DCBs as one of the greatest breakthroughs in the treatment of peripheral vascular disease. Clinical data on the treatment of infrapopliteal disease have been mixed, with small center trials showing benefit but no benefit and a potential safety risk noted in the randomized controlled IN.PACT DEEP trial.⁷ Continued research is ongoing with DCBs for the treatment of infrapopliteal arterial disease.

Presently, FDA-approved DCBs utilize paclitaxel in varying doses, an excipient, (each of which is different) to facilitate drug delivery, and a balloon angioplasty catheter to which the drug and excipient are applied. Recommended technique is that the vessel is crossed and then treated with balloon inflation for 2 to 3 minutes, after which angiography is performed. If there is a good angioplasty result without major flow limiting dissection, the patient is considered a candidate for DCB treatment. Treatment with the DCBs should utilize a balloon that is fully sized to the vessel (or .1 mm larger) with no touching of the balloon by the operator, a rapid transit time to the lesion, and inflation at nominal or greater pressures for at least 2 minutes. The objective is to first create an adequate initial lumen and then to evenly apply paclitaxel to the vessel wall, following which transits into the vessel wall where it remains for a period of time to inhibit subsequent restenosis. Dense calcium and thrombus have been reported to have a negative prognostic effect. DCBs are presently being evaluated following atherectomy to determine if the combination can further diminish risk of restenosis.

There have been no large randomized head-to-head clinical trials of the 3 presently FDA-approved DCBs to determine which is most effective, but all have shown superiority to standard balloon angioplasty at 1 year, and several have demonstrated benefit at 2 years or longer. These balloons also vary in available shaft length, size of required sheath, and balloon lengths. There are balloons with indication for lesions from 180 to 300 mm.

There have been several articles demonstrating that these DCBs have slightly higher initial procedural cost but result in cost savings over time by reducing restenosis rates and need for repeat intervention.^8,9 DCBs have been reported to be cost effective as compared to other treatments utilized in the areas that have been approved for treatment by the FDA.¹⁰

DCBs have become mainstream therapy amongst most interventionists treating de novo SFA/popliteal artery obstructive disease, SFA/popliteal artery in-stent restenosis, and AV fistula intervention. I believe that failure to cover the incremental costs of these devices is a grave mistake that will decrease DCB utilization. This will limit initial costs but will result in increased overall long-term costs and expose patients to the unnecessary risk of additional procedures. 

I am also concerned that the development of future life- and limb-saving innovations will be discouraged as trials and device development are extremely expensive and are not always positive resulting in FDA approval. The costs of those unsuccessful trials are also absorbed by device innovators. DCBs have been proven in large randomized trials to be effective. In my opinion, coverage of the incremental cost of these balloons should not only be maintained but should be extended to the office-based laboratories and ambulatory centers.

References 

1. Laird JR, Schneider PA, Tepe G, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66(21):2329-2338.

2. Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145-153.

3. Krishnan P, Faries P, Niazi K, et al. Stellarex drug coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136(12):1102-1113.

4. Tepe G, Ansel G, Bosiers M, et al, IN.PACT Global Clinical Study (ISR Cohort). ClinicalTrials.gov. Oct 2017.

5. Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012;19(2);263-272.

6. Tepe G, Schnorr B, Albrecht T, et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiolvasc Interv. 2015;8(1 Pt A):102-108.

7. Zeller T, Baumgartner I, Scheinert D, et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64(15):1568-1576.

8. Salisbury A, Li H, Vilain KR, et al. Cost-effectiveness of endovascular femoropopliteal intervention using drug-coated balloons versus standard percutaneous transluminal angioplasty. JACC Cardiovasc Interv. 2016;9(22):2343-2352.

9. Micari A, Vadalà G, Corbo M, D’Alessandro G, Castriota F, Cremonesi A. An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease. International Cardiovascular Forum Journal.3;2015. https://doi.org/10.17987/icfj.v3i0.115.

10. Katsanos, K, Geisler BP, Garner AM, Zayed H, Cleveland T, Pietzsch JB. Economic analysis of endovascular drug-eluting treatments for femoropopliteal artery disease in the UK. BMJ Open. 2016;6(5):e011245.