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 United Kingdom. BMJ Open. 2016;6(5):e011245; doi:10.1136/bmjopen-2016-011245.

Objectives. Our objective was to estimate the clinical and economic impact of drug-eluting endovascular treatment strategies for femoropopliteal artery disease compared with current standard of care.

Study Design. We conducted a systematic literature search to pool target lesion revascularizations (TLRs). We then developed a model-based projection of per-patient costs and quasi-cost-effectiveness over 24 months, based on pooled TLRs and current reimbursement rates.

Setting. The UK National Health Service (NHS).

Participants. Patients presenting with symptomatic femoropopliteal disease eligible for endovascular treatment.

Interventions. Current guidelines from the UK’s National Institute for Health and Care Excellence (NICE) recommend treatment with percutaneous transluminal balloon angioplasty (PTA) and bailout using a bare-metal stent (BMS). We compared this current standard of care to primary BMS placement, or treatment using a drug-coated balloon (DCB) or drug-eluting stent (DES).

Primary and Secondary Outcome Measures. The primary outcome was defined as the 24-month per-patient cost impact to NHS. Secondary outcomes included pooled 24-month TLR rates; numbers needed to treat (NNTs); cost per TLR avoided; and estimated incremental cost-effectiveness ratio (ICER) in £ per quality-adjusted life year (QALY).

Results. We identified 28 studies reporting on 5,167 femoropopliteal lesions. Over 24 months, BMS, DCB, and DES, reduced target lesion revascularization for de novo lesions from 36.2% to 26.9%, 17.6%, and 19.4%, respectively, at an increased cost of £112, £43, £44. Over the 24-month modeled timeframe, the corresponding numbers needed to treat in order to avoid one target lesion revascularization were 10.8, 5.4, and 6.0, resulting in cost per TLR avoided of £1204, £231, and £264.

Treatment with BMS was estimated to add 0.005 QALYs; DCB added 0.011 QALYs; and DES added 0.010 QALYs, correspondingly resulting in estimated ICERs of £20,719, £3,983, and £4,534 per QALY gained. A subset analysis revealed more favorable clinical and economic outcomes for a 3.5 µg/mm² DCB with urea excipient, compared with the rest of DCBs. A modest reduction of 10% in DCB and DES prices made drug-eluting treatments dominant.

Conclusions. Widespread adoption of drug-eluting endovascular therapies for femoropopliteal disease would add meaningful clinical benefit at reasonable additional costs to the NHS. Based on currently available data, DCBs offer the highest clinical and economic value.