An Incremental Cost Analysis of Orbital Atherectomy Plus Angioplasty Compared To Angioplasty Alone for the Treatment of Critical Limb Ischemia

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treatment and rehabilitation while the other was also receiving naftidrofuryl in addition to standard treatment and rehabilitation. Both direct and indirect costs were accounted. The source of data on the clinical effectiveness was taken from randomized controlled trials and meta-analyzes, which examined the efficacy, safety and tolerability of naftidrofuryl. Analysis of data sources has found that, while there is not enough information to ascertain naftidrofuryl effect on hard clinical endpoints, naftidrofuryl demonstrates an ability to reduce time required to obtain clinical results, thus reducing treatment time and hospital stay. Existing standards were used to calculate expenditures associated with diagnosing, treating, and rehabilitating stroke patients in each simulated group. CMA, BIA and sensitivity analysis were performed.  Results: The CMA index for naftidrofuryl was found to be minus 250,630 millions, indicating significant cost reduction. BIA indicated budget savings of 7,59% in the naftidrofuryl group, which amounts to 59,471 mln rubles per 100,000 of population. Sensitivity analysis has confirmed result robustness, indicating result stability both in case of price increase and in case of negative alteration of assumptions underlying the model.  Conclusions: Including naftidrofuryl in Russian national standards for treatment and rehabilitation of patients with ischemic strokes would allow reducing healthcare organization spending as well as overall budgetary burden. PCV33 Impact of a Limb Salvage Program on the Economic Burden of Amputation in The United States Palli S1, Gunnarsson C1, Kotlarz H2, Martinsen BJ2, Zhao R3, Rizzo JA4 1CTI Clinical Trial and Consulting Services, Cincinnati, OH, USA, 2Cardiovascular Systems, Inc., St. Paul, MN, USA, 3Cardiovascular Systems, Inc., Saint Paul, MN, USA, 4Stony Brook University, Stony Brook, NY, USA

Objectives: Critical limb ischemia (CLI) is a severe complication of peripheral artery disease (PAD). Many CLI patients receive a lower extremity amputation (LEA) as a first line treatment. Limb salvage programs provide an alternative treatment pathway aimed at the prevention of LEAs. The objective of this analysis was to estimate the potential lifetime economic savings to a national payer from the implementation of a limb salvage program in the United States (US).  Methods: A simulation model was developed in MS Excel to estimate the direct healthcare cost of implementing a limb salvage program in the US for all CLI patients. The model was from the perspective of Centers for Medicare & Medicaid Services (CMS). Clinical endpoints were the number of amputations and the LEA reduction rate associated with a limb salvage program. Cost parameters included lifetime amputation burden and limb salvage program cost estimates. All parameter values were obtained from the published literature and adjusted to 2015 dollars using the Medical Care Component of the Consumer Price Index.  Results: LEAs have been reported at 73,000 annually. The estimated lifetime direct healthcare cost for an amputee patient is $640,849. When aggregated, the expected lifetime cost is estimated at $46.7 billion. In the published literature, comprehensive limb salvage programs are shown to reduce the rate of amputations from 36% to 86%. Using the midpoint of this reduction (61%) and accounting for the estimated cost of a limb salvage program ($1.7 billion) yields a cost savings of $26.8 billion. The reduction in amputations from a formal limb salvage program is expected to save CMS from $15.2 billion assuming a 36% salvage rate to $38.5 billion assuming an 86% salvage rate.  Conclusions: The lifetime economic burden of amputees is substantial. A national limb salvage program may reduce this burden by $15.2 to $38.5 billion. PCV34 An Incremental Cost Analysis of Orbital Atherectomy Plus Angioplasty Compared To Angioplasty Alone for the Treatment of Critical Limb Ischemia Zhao R1, Gunnarsson C2, Kotlarz H3, Martinsen BJ3, Palli S2, Bell E4, Rizzo JA5 Systems, Inc., Saint Paul, MN, USA, 2CTI Clinical Trial and Consulting Services, Cincinnati, OH, USA, 3Cardiovascular Systems, Inc., St. Paul, MN, USA, 4One Tall Tree Consulting LLC, Seattle, WA, USA, 5Stony Brook University, Stony Brook, NY, USA 1Cardiovascular

Objectives: To perform an incremental cost analysis of the Cardiovascular Systems Inc. Orbital Atherectomy System in conjunction with angioplasty (OAS+BA) compared to angioplasty alone for the treatment of critical limb ischemia (CLI) from the hospital perspective. Methods: A deterministic decision tree simulation model was constructed using MS Excel. The perspective of the model was a United States (US) hospital. Clinical and healthcare utilization data were obtained from the CALCIUM 360 randomized clinical trial. Cost data were obtained from the published literature. All costs were adjusted to 2015 dollars using the Medical Care Component of the Consumer Price Index. The simulation model estimated the incremental cost due to adverse events and BA and/or OAS-related unit costs. The following utilization measures were included in the simulation model: OAS device, balloon(s), and bailout stent(s) (bare metal or drug eluting). The model computed the incremental cost to the hospital of performing OAS+BA versus angioplasty alone at 1 year. Oneway sensitivity analysis was performed.  Results: Based on a hospital performing 100 procedures annually, the incremental costs to the hospital at 1 year were $290,230 lower with OAS+BA compared to angioplasty alone. These cost savings primarily reflected a reduction in target lesion and/or vessel revascularization and end of life care. Sensitivity analyses revealed these findings to be robust to the specified parameter value ranges.  Conclusions: This analysis suggests that OAS+BA is associated with cost savings to the hospital of $290,230 at 1 year. PCV35 Costs Associated with Choice of Perioperative Intravenous Crystalloid among Adults Undergoing Cardiac Surgery Raghunathan K1, Khangulov VS2, Peyerl FW2, Shaw AD3 Medical Center, Duke University Medical Center, Durham, NC, USA, 2Boston Strategic Partners, Inc., Boston, MA, USA, 3Vanderbilt University School of Medicine, Nashville, TN, USA 1Durham VA

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Objectives: Patients undergoing cardiac surgery (CS) routinely receive intravenous (IV) crystalloids perioperatively (during and immediately post-surgery). A study using a large US electronic health record database, reported an association between the use of low-chloride IV crystalloids and improved outcomes. Here we examine the association between perioperative crystalloid choice and treatment costs among adults undergoing CS.  Methods: Patients who underwent CS between January 2009-June 2013 and received ≥ 500 mL of IV crystalloids within 1 day post-surgery, survived ≥ 1 day, and had recorded data on charges were included. Main exclusion criteria were hospital stay > 30 days and receipt of > 1 L IV fluids on the day before surgery. Patients were categorized as receiving either 0.9% saline exclusively as their primary IV fluid, Lactated Ringer’s (LR), or a calcium-free balanced crystalloid (Plasma-Lyte (CF-BAL)). Outcomes were compared in three propensity-matched cohorts and included total cost, cost/day/patient, and length-of-stay (LOS). Costs were calculated using published cost-to-charge ratios.  Results: In the propensitymatched cohorts (CF-BAL versus saline (n= 298 patients); CF-BAL versus LR (n= 516); LR versus saline (n= 2,930)), CF-BAL was associated with significantly lower total costs than either saline ($231,651 ± $112,215 versus $341,956 ± $284,124; p< 0.0001) or LR ($235,392 ± $127,256 versus $360,582 ± $231,038; p< 0.0001). Saline was associated with significantly lower costs than LR ($304,732 ± $235,832 versus $331,712 ± $249,530; p= 0.0027). The same statistically significant trends were observed for cost/ day/patient. LOS was significantly shorter with LR than saline (223 ± 126 h versus 235 ± 136 h; p= 0.0098) and CF-BAL (213 ± 103 h versus 245 ± 126 h; p= 0.0018), with no significant difference between CF-BAL and saline (239 ± 124 h versus 245 ± 146 h; p= 0.71), suggesting that cost differences were not attributable to differences in LOS.  Conclusions: Perioperative use of calcium-free balanced IV crystalloids was associated with lower costs among CS patients. PCV36 Clinical and Economic Burden of Peripheral Artery Disease Among Patients Receiving Endovascular Interventions: A Retrospective Cohort Study of Commercially Insured Patients in the United States Meyers J1, Chaudhari P2, Madhwani S1, Candrilli SD1 Health Solutions, Research Triangle Park, NC, USA, 2Takeda Pharmaceuticals, Deerfield, IL, USA

1RTI

Objectives: Evaluate patients with newly diagnosed peripheral artery disease (PAD) undergoing angioplasty or stent in a United States commercially insured population.  Methods: Patients with a PAD diagnosis (ICD-9-CM codes 440.xx or 443.9x) from 01/01/2010 to 12/31/2011, were identified in the MarketScan Commercial and Medicare databases. Patients were required to have ≥ 1 year of continuous plan enrollment before the 1st observed PAD diagnosis. Patients were also required to have an endovascular procedure (i.e., stent or angioplasty) on or after the 1st observed PAD diagnosis (1st procedure defined the index date) and ≥ 2 years of continuous enrollment post-index date. Study measures included clinical characteristics and costs. Measures were reported by type of procedure received on the index date. Generalized linear models (GLM) with a log-link and gamma distribution were estimated to adjust for the effect of demographic and clinical characteristics on costs.  Results: In total, 7,452 patients met the study inclusion criteria (23.7% angioplasty only, 62.9% stent only, and 13.4% both). Approximately 23% of patients had another endovascularization procedure performed in the 2-years post-index date. In year-1 post-index date, unadjusted costs for patients with angioplasty only were over twice (mean (SD) $120,586 [$164,419]) those for patients with stent only ($50,516 [$60,623]). Costs decreased in year-2 post-index date, with costs approximately 3 times greater for patients with angioplasty only ($86,412 [$164,087]) versus stent only ($26,464 [$53,149]). GLM analyses found during the 2-year follow-up, mean (SD) costs were $206,015 ($101,163) for patients with angioplasty only and $76,834 ($24,097) for patients with stent only.  Conclusions: Patients with PAD undergoing endovascularization procedures have a high rate of repeat procedures in the 2 years after their initial procedure. Costs are substantial during the 2 years after the initial endovascularization procedure and are greater for patients receiving angioplasty only versus patients receiving stent only. PCV37 Health Care Costs among Patients Diagnosed with Deep Vein Thrombosis in the Outpatient Setting and Treated with Rivaroxaban Versus Low-Molecular-Weight Heparin and Warfarin Deitelzweig S1, Laliberté F2, Raut R3, Germain G2, Bookhart BK3, Olson WH3, Schein J3, Lefebvre P4 1Ochsner Medical Center, New Orleans, LA, USA, 2Groupe d’analyse, Ltée, Montréal, QC, Canada, 3Janssen Scientific Affairs, LLC, Raritan, NJ, USA, 4Groupe d’analyse, Ltée, Montreal, QC, Canada

Objectives: The anticoagulant rivaroxaban has advantages such as simplified care compared with low-molecular-weight heparin (LMWH) and warfarin that may be easily managed in outpatient (OP) setting and lead to lower healthcare costs. The objective of this study was to compare costs among deep vein thrombosis (DVT) patients treated with rivaroxaban or LMWH/warfarin in the outpatient setting.  Methods: A retrospective propensity score matching analysis was conducted using the Truven Health Analytic MarketScan Claims database from 1/2011-12/2013. Adult patients with a primary diagnosis of DVT during an OP/emergency room (ER) visit after November 2012, and who initiated treatment on the same day with rivaroxaban or LMWH/warfarin (index date) were identified. All-cause and VTE-related healthcare costs were evaluated over 1, 2, 3, and 4 weeks after their DVT diagnosis. Mean healthcare costs were evaluated using Lin’s method and compared using non-parametric bootstrap procedure methods.  Results: All of the 512 rivaroxaban patients were well-matched with LMWH/warfarin patients. Mean all-cause total cost was significantly lower for rivaroxaban users compared to LMWH/warfarin users over 1 week ($2,332 vs. $3,428; P< .001) and over 2 weeks ($3,108 vs. $4,524; P< .001), and numerically lower over 3 weeks ($4,551 vs. $5,468; P= 0.167) and 4 weeks ($5,140 vs. $6,394; P= 0.102); all-cause hospitalization costs followed similar trends. Pharmacy costs were statistically lower by $432, $461, $418, and $366 within 1, 2,