OBJECTIVES: The self-expandable paclitaxel DES represents a major development in endovascular treatments for lower limb PAD. Clinical data show improved clinical outcomes compared to bare metal stents (BMS). This budget impact analysis assessed the impact of introducing reimbursement for a paclitaxel DES in France. METHODS: An Excel-based model was developed to estimate the impact of a transition from BMS to DES over a 5-year horizon (15% in 2011 to 35% in 2015). Hospital episode statistics were used to estimate the 2011-2015 patient population. The analysis was conducted from the payer perspective and only direct costs of procedures were considered, based on GHM 2009 tariffs (stenting and revascularization) and LPPR tariffs (BMS and grafts). The main outcome was target lesion revascularization (TLR) in the superficial femoral artery (SFA) after primary stent placement: angioplasty, re-stenting, or bypass surgery. TLR rates were based on the paclitaxel drug-eluting SFA stent registry study and on BMS TLR rates reported in the literature (Years 1 and 2: 6% and 9% for the DES; 16% and 22% for average BMS) and extrapolated for years 3 to 5. Net budget impact was expressed as the difference in cost between the scenario where the DES is progressively adopted versus the status quo (patients treated with BMS only). RESULTS: The base-case results show an incremental cost of €278,526 in year 1, which is more than offset by increasing cost savings in all subsequent years (year 2: -€35,901; year 5: -€510,025), resulting in a cumulative 5-year net budget impact of -€727,649. One-way sensitivity analyses on key inputs continued to show cumulative 5-year cost savings. CONCLUSIONS: Reimbursement and consequent adoption of the paclitaxel DES would result in cost savings for the French health care payer, despite requiring an initial investment. This is due to savings associated with fewer SFA revascularization events after the primary intervention.