Budget Impact of Appropriate Low-Dose Aspirin Use for Primary and Secondary Cardiovascular Event Prevention in the Managed Care Setting.

BACKGROUND: Cardiovascular disease remains the leading cause of death in adults in the United States and constitutes a substantial portion of overall national health expenditures. Aspirin is generally recommended for primary cardiovascular event prevention based on a given patient's underlying cardiovascular event risk profile, particularly for those aged 50-69 years with a 10-year risk of coronary heart disease of ≥ 10%. Evidence-based clinical guidelines are in agreement for secondary prevention consisting of lifelong, low-dose aspirin therapy following a cardiovascular event. Despite these recommendations, research suggests suboptimal concordance between guidelines and clinical practice. OBJECTIVE: To evaluate the budget impact of appropriate low-dose aspirin use for primary and secondary cardiovascular event prevention compared with current rates of low-dose aspirin use. METHODS: An economic model measuring budget spend for cardiovascular events, aspirin, and aspirin-related adverse events was developed from the perspective of a U.S. payer. The model compared current rates of aspirin use to appropriate rates of aspirin use according to guideline recommendations for both primary and secondary cardiovascular event prevention. RESULTS: For a hypothetical plan with 1 million members, an estimated 18,026 patients were on aspirin therapy for primary cardiovascular event prevention, while guidelines recommend that 55,788 patients should have been on aspirin therapy for this indication. Optimal aspirin use in the primary cardiovascular event prevention population reduced the number of nonfatal myocardial infarctions (MIs; -367), ischemic strokes (-232), and deaths (-60), with an increase in the number of gastrointestinal bleeds (169) and hemorrhagic strokes (98). Evidence-based guideline-compliant use of aspirin for primary cardiovascular event prevention resulted in total cost savings of approximately $4.2 million over a 5-year time horizon. For secondary cardiovascular event prevention, an estimated 48,663 patients were on aspirin, while clinical guidelines recommend that 71,316 patients should have been on aspirin therapy for this indication. Optimal aspirin use in secondary cardiovascular event prevention reduced the number of nonfatal MIs (-515), ischemic strokes (-375), and deaths (-217), with an increase in the number of gastrointestinal bleeds (98) and hemorrhagic strokes (58). Evidence-based guideline-compliant use of aspirin for secondary cardiovascular event prevention resulted in total cost savings of approximately $11 million over a 5-year time horizon. CONCLUSIONS: Appropriate low-dose aspirin use for primary and secondary cardiovascular event prevention can result in improved patient outcomes with significant cost savings for U.S. payers. As a simple and inexpensive prophylactic measure for cardiovascular event prevention, aspirin use should be carefully considered in all appropriate at-risk adult patients. DISCLOSURES: Development of this manuscript and the corresponding budget impact analysis was funded by Bayer. Coppolecchia, Williamson, and Cameron are employees of Bayer. Carlton, Lennert, and Moradi are employees of Xcenda, a consulting firm that received funding from Bayer to assist in the completion of this study. Khalaf-Gillard was an employee of Xcenda at the time of the study. The corresponding poster was presented at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.

Multispecialty Rating of Evidence-Based Conditions for Intravenous Immunoglobulin Therapy Using a 3-Axis Prioritization Algorithm.

BACKGROUND: A 3-axis prioritization algorithm was proposed and was evaluated in a US multispecialist pilot study to obtain uniform consensus regarding effective practices for the use of intravenous immunoglobulin (IVIG) therapy. OBJECTIVE: The primary objective was to use consensus-building methodologies to rate disease states for IVIG utilization while considering disease severity and the efficacy of alternative therapeutic options to IVIG from the perspective of US multispecialists. METHODS: A 7-member multispecialty physician expert panel was surveyed to rate 50 disease states and to determine their level of agreement with the American Academy of Allergy, Asthma & Immunology (AAAAI) evidence-based medicine (EBM) ratings. The disease states were then rated across the 2 domains of disease severity and the perceived efficacy of therapeutic alternatives. An interquartile deviation (IQD) of ≤0.5 was used to determine consensus for disease states within each domain. Disease states reaching consensus across both domains were ranked according to a 2 × 4 algorithmic scale to establish priority for IVIG utilization. RESULTS: Overall, a high level of agreement was found with the AAAAI ratings for EBM. Based on an IQD of ≤0.5, the panel reached consensus on the severity of all 50 disease states. Of the 50 disease states, consensus was reached on the efficacy of therapeutic alternatives for 39 disease states. Using the same panel of experts, the 11 disease states without consensus in the first survey were resurveyed, and consensus was subsequently reached on 4 of them. Discussion among the experts, and the resurvey, resulted in expert consensus increasing from 78% to 86% postdiscussion and a change in the overall rating of IVIG on 4 conditions. CONCLUSIONS: Multispecialty input of 7 experts on evidence-based IVIG use, augmented with disease severity and efficacy of therapeutic alternatives, enables a balanced perspective on IVIG therapy prioritization. Moreover, multispecialty dialogue improved consensus building among panel members on the effective use of IVIG therapy in several clinical conditions.

Impact of Dry Eye Disease on Work Productivity, and Patients' Satisfaction With Over-the-Counter Dry Eye Treatments.

PURPOSE: To assess the effect of dry eye disease on work productivity and performance of non-work-related activities, and patients' satisfaction with over-the-counter (OTC) dry eye treatments. METHODS: In this prospective, noninterventional, cross-sectional study, conducted at 10 U.S. optometry/ophthalmology practices, 158 symptomatic dry eye patients naïve to prescription medication underwent standard dry eye diagnostic tests and completed Work Productivity and Activity Impairment (WPAI) and Ocular Surface Disease Index (OSDI) questionnaires. Use of OTC dry eye medication, and satisfaction with OTC medication and symptom relief were also assessed. RESULTS: On average, dry eye resulted in loss of 0.36% of work time (∼5 minutes over 7 days) and ∼30% impairment of workplace performance (presenteeism), work productivity, and non-job-related activities. Presenteeism and productivity impairment scores showed significant correlation with OSDI total (r = 0.55) and symptom domain (r = 0.50) scores, but not with dry eye clinical signs. Activity impairment score showed stronger correlation with OSDI total (r = 0.61) and symptom domain (r = 0.53) scores than with clinical signs (r ≤ 0.20). Almost 75% of patients used OTC dry eye medication. Levels of patient satisfaction with OTC medication (64.2%) and symptom relief from OTC (37.3%) were unaffected by administration frequency (≥3 vs. ≤2 times daily). CONCLUSIONS: Dry eye causes negligible absenteeism, but markedly reduces workplace and non-job-related performances. Impairment of work performance is more closely linked to dry eye symptoms than to clinical signs. Patients' perceptions of OTC dry eye medication tend to be more positive than their perceptions of symptom relief.

Resource utilization in children with tuberous sclerosis complex and associated seizures: a retrospective chart review study.

Seizures are a hallmark manifestation of tuberous sclerosis complex, yet data characterizing resource utilization are lacking. This retrospective chart review was performed to assess the economic burden of tuberous sclerosis complex with neurologic manifestations. Demographic and resource utilization data were collected for 95 patients for up to 5 years after tuberous sclerosis complex diagnosis. Mean age at diagnosis was 3.1 years, with complex partial and infantile spasms as the most common seizure types. In the first 5 years post-diagnosis, 83.2% required hospitalization, 30.5% underwent surgery, and the majority of patients (90.5%) underwent ≥3 testing procedures. In 79 patients with a full 5 years of data, hospitalizations, intensive care unit stays, diagnostic testing, and rehabilitation services decreased over the 5-year period. Resource utilization is cost-intensive in children with tuberous sclerosis complex and associated seizures during the first few years following diagnosis. Improving seizure control and reducing health care costs in this population remain unmet needs.

Assessment of Treatment Patterns and Patient Outcomes in Levodopa-Induced Dyskinesias (ASTROID): A US Chart Review Study.

BACKGROUND: No curative therapy is available for Parkinson's disease; therefore, one of the main goals of treatment is to control motor symptoms, often via the use of levodopa (also known as L-dopa). However, prolonged levodopa treatment in Parkinson's disease has been associated with the development of motor fluctuations and the occurrence of levodopa-induced dyskinesias (LIDs). OBJECTIVE: To gain a clear, empirical understanding of the current real-world approach to treatment and patient outcomes associated with Parkinson's disease and LIDs. METHODS: This study used a mixed methodology, combining a cross-sectional survey of neurologists practicing in the United States, a retrospective chart review of patients with Parkinson's disease and LIDs, and cross-sectional surveys of health-related quality of life (QOL) and physical functioning in patients with Parkinson's disease. The surveys included the 39-item Parkinson's Disease Questionnaire, the Unified Parkinson's Disease Rating Scale, the Parkinson Disease Dyskinesia 26-item Scale, and the modified Abnormal Involuntary Movement Scale (mAIMS). Survey and chart data were collected between May 2010 and July 2011. Descriptive analyses were used to evaluate the distribution of study variables, treatment patterns, patient QOL, and patient physical functioning. RESULTS: Data from 7 neurologists and from 172 patients with Parkinson's disease and LIDs were collected. Results from the physician survey indicate that prescribing patterns depend largely on the severity of LIDs, assessed via mAIMS. Most patients (88%) received pharmacologic therapy as first-line treatment for LIDs, with monotherapy favored in patients with mild LIDs and combination therapy in patients with moderate-to-severe LIDs. The mean time from the diagnosis of LID to the administration of first-line treatment for the condition was 10.7 months (standard deviation, 14.0 months). The study population reflects a mean time from levodopa initiation to the onset of LIDs of slightly more than 5 years, regardless of the levodopa dosage. Results from the chart review and the physician survey suggest a strong alignment in severity classification among the assessment scales used. CONCLUSION: These findings indicate that the diagnosis and the treatment of Parkinson's disease and LIDs are not optimal, because of the length of time from diagnosis to treatment, and because of the variability in treatment selection and response. Additional real-world studies are recommended to better understand treatment patterns, compliance with guidelines, and their potential impact on patient outcomes.

Anticoagulant use for prevention of stroke in a commercial population with atrial fibrillation.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and patients with AF are at an increased risk for stroke. Thromboprophylaxis with vitamin K antagonists reduces the annual incidence of stroke by approximately 60%, but appropriate thromboprophylaxis is prescribed for only approximately 50% of eligible patients. Health plans may help to improve quality of care for patients with AF by analyzing claims data for care improvement opportunities. OBJECTIVES: To analyze pharmacy and medical claims data from a large integrated commercial database to determine the risk for stroke and the appropriateness of anticoagulant use based on guideline recommendations for patients with AF. METHODS: This descriptive, retrospective claims data analysis used the Anticoagulant Quality Improvement Analyzer software, which was designed to analyze health plan data. The data for this study were obtained from a 10% randomly selected sample from the PharMetrics Integrated Database. This 10% sample resulted in almost 26,000 patients with AF who met the inclusion criteria for this study. Patients with a new or existing diagnosis of AF between July 2008 and June 2010 who were aged ≥18 years were included in this analysis. The follow-up period was 1 year. Demographics, stroke risk level (CHADS2 and CHA2DS2-VASc scores), anticoagulant use, and inpatient stroke hospitalizations were analyzed through the analyzer software. RESULTS: Of the 25,710 patients with AF (CHADS2 score 0-6) who were eligible to be included in this study, 9093 (35%) received vitamin K antagonists and 16,617 (65%) did not receive any anticoagulant. Of the patients at high risk for stroke, as predicted by CHADS2, 39% received an anticoagulant medication. The rates of patients receiving anticoagulant medication varied by age-group-16% of patients aged <65 years, 22% of those aged 65 to 74 years, and 61% of elderly ≥75 years. Among patients hospitalized for stroke, only 28% were treated with an anticoagulant agent in the outpatient setting before admission. CONCLUSIONS: Our findings support the current literature, indicating that many patients with AF are not receiving appropriate thromboprophylaxis to counter their risk for stroke. Increased use of appropriate anticoagulation, particularly in high-risk patients, has the potential to reduce the incidence of stroke along with associated fatalities and morbidities.