Search

Kathryn Fitch,1 Jocelyn Lau,1 Tyler Engel,1 Joseph J Medicis,2 John F Mohr,2 William S Weintraub3 1Milliman Inc., New York, NY, USA; 2scPharmaceuticals Inc., Burlington, MA, USA; 3MedStar Washington Hospital Center, Washington, DC, USA Purpose: The aim of this study was to quantify the potential cost savings to Medicare of shifting the site of treatment for worsening heart failure (HF) from inpatient to outpatient (OP) settings for a subset of worsening HF episodes among the Medicare fee-for-service (FFS) population.Materials and methods: A cross-sectional analysis of a random 5% sample of 2014 FFS Medicare beneficiaries was conducted. Incidence and cost of worsening HF episodes in both inpatient and OP settings were identified. These results were used to calculate cost savings associated with shifting a proportion of worsening HF episodes from the inpatient to OP settings.Results: A total of 151,908 HF beneficiaries were identified. The estimated annual cost for the treatment of worsening HF across both inpatient and OP settings ranged from US$9.3 billion to US$17.0 billion or 2.4%–4.3% of total Medicare FFS spend. The cost saving associated with shifting worsening HF treatment from inpatient hospital setting to OP settings was US$667.5 million or 0.17% of total Medicare spend when 10% of HF admissions were targeted and 60% of targeted HF admissions were successfully shifted. The cost savings increased to US$2.098 billion or 0.53% of total Medicare spend when 20% of HF admissions were targeted and 90% of targeted HF admissions were successfully shifted.Conclusion: Treatment options that can shift costly hospital admissions for worsening HF treatment to less expensive OP settings potentially lead to significant cost savings to Medicare. Pursuit of OP therapy options for treating worsening HF might be considered a viable alternative. Keywords: health care resource utilization, heart failure management, hospital admission burden, administrative claims data, cost impact analysis

Judith J Stephenson,1 Mayura U Shinde,1 Winghan Jacqueline Kwong,2 An-Chen Fu,1 Hiangkiat Tan,1 William S Weintraub3 1HealthCore, Inc., Wilmington, DE, 2Daiichi Sankyo, Inc., Basking Ridge, NJ, 3Christiana Care Health System, Newark, DE, USA Objective: To compare oral anticoagulant (OAC) adherence among patients with nonvalvular atrial fibrillation (NVAF) using patient-reported and claims-based measures, and to evaluate the effect of OAC adherence on health care costs and patient satisfaction with OAC therapy.Methods: This was a hybrid US observational study consisting of a longitudinal cohort survey followed by linkage and analysis of respondents’ administrative claims data. Patients with NVAF receiving warfarin, dabigatran, rivaroxaban, or apixaban completed an initial survey and follow-up surveys at 4, 8, and 12 months. Patient-reported adherence was measured at each survey by Morisky Medication Adherence Scale (MMAS-8) and pharmacy claims-determined adherence by the proportion of days covered (PDC) for the 12-month period following the initial survey date; adherence was defined as MMAS-8 score =8 and PDC ≥80%. Patient satisfaction with OAC therapy was assessed by the Duke Anticoagulation Satisfaction Scale (DASS).Results: Overall, 675 patients completed at least the initial survey (warfarin, n=271; dabigatran, n=266; rivaroxaban, n=128; apixaban, n=10). Fewer than half (47.9%) were PDC adherent, 37.2% were MMAS-8 adherent, and 19.4% were adherent by both measures. Total medical costs of PDC-adherent patients were significantly lower vs PDC-nonadherent patients (US$640 vs $993 per-patient per-month, respectively, p

Jeffrey D Miller,1 Xin Ye,2 Gregory M Lenhart,1 Amanda M Farr,1 Oth V Tran,1 W Jackie Kwong,2 Elizabeth A Magnuson,3 William S Weintraub41Truven Health Analytics Inc, Cambridge, MA, 2Daiichi Sankyo Inc, Parsippany, NJ, 3St Luke Mid-America Heart Institute, Kansas City, MO, 4Center for Heart and Vascular Health, Christiana Care Health System, Newark, DE, USABackground: Understanding the value of new anticoagulation therapies compared with existing therapies is of paramount importance in today’s cost-conscious and efficiency-driven health care environment. Edoxaban and rivaroxaban for stroke prevention in nonvalvular atrial fibrillation (NVAF) patients with CHADS2 scores ≥2 have been evaluated in pivotal trials versus warfarin. The relative value of edoxaban versus rivaroxaban would be of interest to health care stakeholders and patients who prefer a once-daily treatment option for long-term stroke prevention in NVAF.Objective: To evaluate the relative cost-effectiveness of two once-daily regimens of novel oral anticoagulation therapy – edoxaban (60 mg/30 mg dose-reduced) versus rivaroxaban (20 mg/15 mg dose-reduced) – for stroke prevention in NVAF patients from a US health-plan perspective.Materials and methods: A Markov model simulated lifetime risk and treatment of stroke, systemic embolism, major bleeding, clinically relevant nonmajor bleeding, myocardial infarction, and death in NVAF patients treated with edoxaban or rivaroxaban. Efficacy and safety data were derived from a network meta-analysis that utilized data from patients enrolled in ENGAGE AF-TIMI 48 and ROCKET-AF. Health care cost and utility data were obtained from published sources. Incremental cost-effectiveness ratios of $150,000 per quality-adjusted life year (QALY) gained were used as thresholds for “highly cost-effective”, “cost-effective”, and “not cost-effective” treatment options, respectively, as per American Heart Association/American College of Cardiology guidelines.Results: Edoxaban was dominant relative to rivaroxaban, such that it was associated with lower total health care costs and better effectiveness in terms of QALYs in the base-case analysis. Results were supported by probabilistic sensitivity analyses that showed edoxaban as either dominant or a highly cost-effective alternative (incremental cost-effectiveness ratio

Edward Ewen,1 Zugui Zhang,1 Teresa A Simon,2 Paul Kolm,1 Xianchen Liu,3,4 William S Weintraub11Christiana Care Health System, Newark, DE, USA; 2Bristol-Myers Squibb, Princeton, NJ, USA; 3Indiana University School of Medicine, Indianapolis, IN, USA; 4Pfizer, Groton, CT, USABackground: Warfarin is recommended for stroke prevention in high-risk patients with atrial fibrillation. However, it is often underutilized and inadequately managed in actual clinical practice.Objectives: To examine the patterns of warfarin use and their relationship with stroke and bleeding in atrial fibrillation patients in community-based primary care practices.Design: Retrospective longitudinal cohort study.Participants: A total of 1141 atrial fibrillation patients were selected from 17 primary care practices with a shared electronic medical record and characterized by stroke risk, potential barriers to anticoagulation, and comorbid conditions.Main measures: Duration and number of warfarin exposures, interruptions in warfarin exposure > 45 days, stroke, and bleeding events.Results: Among 1141 patients with a mean age of 70 years (standard deviation 13.3) and mean follow-up of 3.4 years (standard deviation 3.0), 764 (67%) were treated with warfarin. Warfarin was discontinued within 1 year in 194 (25.4%), and 349 (45.7%) remained on warfarin at the end of follow-up. Interruptions in warfarin use were common, occurring in 32.6% (249 of 764) of patients. Those with two or more interruptions were younger and at lower baseline stroke risk when compared to those with no interruptions. There were 76 first strokes and 73 first-bleeding events in the follow-up period. When adjusted for baseline stroke risk, time to warfarin start, and total exposure time, two or more interruptions in warfarin use was associated with an increased risk of stroke (relative risk, 2.29; 95% confidence interval: 1.29–4.07). There was no significant association between warfarin interruptions and bleeding events.Conclusion: Warfarin was underutilized in a substantial portion of eligible atrial fibrillation patients in these community-based practices. In addition, prolonged interruptions in anticoagulation were common in this population, and multiple interruptions were associated with over twice the risk of stroke when compared to those treated continuously.Keywords: cardiovascular disease, primary care, quality assessment, outcomes

Background: Variation in outcomes after percutaneous coronary interventions (PCI) may reflect differences in quality of care. To date, however, we lack a methodology to monitor and improve national hospital 30-day mortality rates among patients undergoing PCI.Methods and Results: We developed hierarchical logistic regression models to calculate hospital risk-standardized 30-day all-cause PCI mortality rates. Due to differences in risk, patients were divided into 2 cohorts: those with ST-segment elevation myocardial infarction or cardiogenic shock, and those with no ST-segment elevation myocardial infarction and no cardiogenic shock. The models were derived using 2006 data from the CathPCI Registry linked with administrative claims data, and validated using comparable 2005 data. In the derivation cohort of the ST-segment elevation myocardial infarction or shock model (n=15 123), the unadjusted 30-day mortality rate was 9.2%. The final model included 13 variables with the observed mortality rates ranging from 1.4% to 40.3% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate were 8.5% and 9.7%, with 5th and 95th percentiles of 7.6% and 11.0%. In the derivation cohort of the no ST-segment elevation myocardial infarction and no shock model (n=110 529), the unadjusted 30-day mortality rate was 1.4%. The final model included 16 variables with the observed predicted mortality rates ranging from 0.1% to 7.0% across deciles of the predicted patient mortality rates. The 25th and 75th percentiles of the risk-standardized mortality rate across 612 hospitals were 1.3% and 1.6%, with 5th and 95th percentiles of 1.0% and 2.0%.Conclusions: These National Quality Forum endorsed registry-based models produce estimates of hospital risk-standardized mortality rates for patients undergoing PCI. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to develop a long-term model to predict mortality after percutaneous coronary intervention in both patients with ST-segment elevation myocardial infarction and those with more stable coronary disease.Methods and Results: The American College of Cardiology Foundation CathPCI Registry data were linked to the Centers for Medicare and Medicaid Services 100% denominator file by probabilistic matching. Preprocedure demographic and clinical variables from the CathPCI Registry were used to predict the probability of death over 3 years as recorded in the Centers for Medicare and Medicaid Services database. Between 2004 and 2007, 343 466 patients (66%) of 518 195 patients aged ≥65 years undergoing first percutaneous coronary intervention in the CathPCI Registry were successfully linked to Centers for Medicare and Medicaid Services data. This study population was randomly divided into 60% derivation and 40% validation cohorts. Median follow-up was 15 months, with mortality of 3.0% at 30 days and 8.7%, 13.4%, and 18.7% at 1, 2, and 3 years, respectively. Twenty-four characteristics related to demographics, clinical comorbidity, prior history of disease, and indices of disease severity and acuity were identified as being associated with mortality. The C indices in the validation cohorts for patients with and without ST-segment elevation myocardial infarction were 0.79 and 0.78. The model calibrated well across a wide range of predicted probabilities.Conclusions: On the basis of the large and nationally representative CathPCI Registry, we have developed a model that has excellent discrimination, calibration, and validation to predict survival up to 3 years after percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

The process of atherosclerosis may begin in youth and continue for decades, leading to both nonfatal and fatal cardiovascular events, including myocardial infarction, stroke, and sudden death. With primordial and primary prevention, cardiovascular disease is largely preventable. Clinical trial evidence has shown convincingly that pharmacological treatment of risk factors can prevent events. The data are less definitive but also highly suggestive that appropriate public policy and lifestyle interventions aimed at eliminating tobacco use, limiting salt consumption, encouraging physical exercise, and improving diet can prevent events. There has been concern about whether efforts aimed at primordial and primary prevention provide value (ie, whether such interventions are worth what we pay for them). Although questions about the value of therapeutics for acute disease may be addressed by cost-effectiveness analysis, the long time frames involved in evaluating preventive interventions make cost-effectiveness analysis difficult and necessarily flawed. Nonetheless, cost-effectiveness analyses reviewed in this policy statement largely suggest that public policy, community efforts, and pharmacological intervention are all likely to be cost-effective and often cost saving compared with common benchmarks. The high direct medical care and indirect costs of cardiovascular disease-approaching $450 billion a year in 2010 and projected to rise to over $1 trillion a year by 2030-make this a critical medical and societal issue. Prevention of cardiovascular disease will also provide great value in developing a healthier, more productive society. [ABSTRACT FROM AUTHOR]

BACKGROUND: A previous study of participants with prediabetes found that hemoglobin A(1c) (HbA(1c)) levels differed between black and white participants with no differences in glucose concentration. OBJECTIVE: To determine whether black-white differences in HbA(1c) level are present in other populations and across the full spectrum of glycemia. DESIGN: Cross-sectional, retrospective. SETTING: Outpatient. PARTICIPANTS: 1581 non-Hispanic black and white participants between 18 and 87 years of age without known diabetes in the SIGT (Screening for Impaired Glucose Tolerance) study and 1967 non-Hispanic black and white participants older than 40 years without known diabetes in the NHANES III (Third National Health and Nutrition Examination Survey). MEASUREMENTS: HbA(1c) levels, anthropometry, and plasma glucose levels during oral glucose tolerance testing. RESULTS: Hemoglobin A(1c) levels were higher in black than in white participants with normal glucose tolerance (0.13 percentage point [P < 0.001] in the SIGT sample and 0.21 percentage point [P < 0.001] in the NHANES III sample), prediabetes (0.26 percentage point [P < 0.001] and 0.30 percentage point [P < 0.001], respectively), or diabetes (0.47 percentage point [P < 0.020] and 0.47 percentage point [P < 0.013], respectively) after adjustment for plasma glucose levels and other characteristics known to correlate with HbA(1c) levels. LIMITATION: The mechanism for the differences is unknown. CONCLUSION: Black persons have higher HbA(1c) levels than white persons across the full spectrum of glycemia, and the differences increase as glucose intolerance worsens. These findings could limit the use of HbA(1c) to screen for glucose intolerance, indicate the risk for complications, measure quality of care, and evaluate disparities in health. [ABSTRACT FROM AUTHOR]

Background: The EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure and Survival Study) showed that the use of aldosterone blockade with eplerenone decreased mortality in patients with heart failure after acute myocardial infarction, and a subsequent analysis showed eplerenone to be highly cost effective in this population. Objective: To assess the cost effectiveness of eplerenone in an EPHESUS subgroup population who were taking both ACE inhibitors and [beta]-blockers ([beta]-adrenoceptor antagonists) at baseline. Intervention: In the EPHESUS, a total of 6632 patients were randomized to receive eplerenone 25-50 mg/day (n = 3319) or placebo (n = 3313) concurrently with standard therapy and were followed for up to 2.5 years. Of these, 4265 (64.3%) patients (eplerenone: n = 2113; placebo: n = 2152) were taking both ACE inhibitors and [beta]-blockers at baseline. Methods and Main Outcome Measures: Resource use after the initial hospitalization included additional hospitalizations, outpatient services, emergency room visits, and medications. Eplerenone was priced at an average wholesale price of $US3.60 per day (year 2004 value). Bootstrap methods were used to estimate the fraction of the joint distribution of the cost and effectiveness. A net-benefit regression model was used to derive the propensity score-adjusted cost-effectiveness curve. The incremental cost effectiveness of eplerenone in cost per life-year gained (LYG) and cost per quality-adjusted life-year (QALY) gained beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. Both costs and effectiveness were discounted at 3%. Allthough not all resource use could be accounted for, the overall perspective was societal. Results: As in the overall EPHESUS population, the total direct treatment costs were higher in the eplerenone arm than the placebo arm for patients who were taking both ACE inhibitors and [beta]-blockers ($US14 563 vs $US12 850, difference = $US1713; 95% CI 721, 2684). The number of LYGs with eplerenone compared with placebo was 0.1665 based on the Framingham data, 0.0979 using the Saskatchewan data, and 0.2172 using the Worcester data. The incremental cost-effectiveness ratio (ICER) was $US10 288/LYG with the Framingham data, $US17 506/LYG with the Saskatchewan data, and $US7888/LYG with the Worcester data (99% <$US50 000/LYG for all three sources). The ICERs were systematically higher when calculated as the cost per QALY gained ($US14 926, $US25 447, and $US11 393, respectively) as the utilities were below 1 with no difference between the treatment arms. Conclusions: As for the overall EPHESUS population, aldosterone blockade with eplerenone is effective in reducing mortality and is cost effective in increasing years of life for the EPHESUS subgroup of patients who were taking both ACE inhibitors and [beta]-blockers. [ABSTRACT FROM AUTHOR]