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Mariam Hassan,1 Machaon M Bonafede,2 Brendan L Limone,2 Paul Hodgkins,1 Gregory S Sawicki3 1Global Health Economics and Outcomes Research, Vertex Pharmaceuticals Incorporated, Boston, MA, USA; 2Life Sciences, Truven Health Analytics, Cambridge, MA, USA; 3Division of Respiratory Diseases, Boston Children’s Hospital, Harvard Medical School, Boston, MA, USA Purpose: To conduct an analysis describing clinical characteristics, pulmonary exacerbation (PEx) events, and health care resource utilization among Medicaid-insured patients with cystic fibrosis (CF). Patients and methods: A retrospective analysis of the Truven Health MarketScan® Medicaid Multi-State administrative claims database (2010–2014) was undertaken. Patients aged ≥6 years with a CF diagnosis, continuously enrolled for 12 months, were identified. Demographics, comorbidities, PEx events, and health care resource utilization and costs over a 12-month enrollment period were analyzed for all patients and by age groups. Results: In total, 1196 patients with CF aged ≥6 years were identified from a sample size of approximately 10 million Medicaid patients. Mean (SD) age was 16.1 (8.8) years. A greater proportion of patients were in younger age groups (6–11 years: 35.5%, 12–17 years: 29.1%, 18–26 years: 25.6%, 27–34 years: 6.7%, ≥35 years: 3.2%). Across all age groups, approximately 90% of patients had at least 1 PEx event; 50.7% of those had a PEx event involving treatment with intravenous antibiotics, and 42.8% required hospitalization. PEx recurrence was frequent: 55.7% of all patients experienced ≥3 PEx events during 1 year. Mean (SD) health care expenditures during a PEx event rose with increasing age, ranging from US$44,589 (US$139,024) to US$116,169 (US$387,752). Overall health care resource utilization was high among patients with CF; 47.2% of the population required an inpatient admission, and 26.8% had subsequent hospitalizations totaling 29.1 days per year in hospital. Conclusion: High rates of PEx, hospitalizations, and time spent in hospital demonstrate the significant health care burden of CF among Medicaid beneficiaries. Keywords: resource utilization, length of stay, pulmonary exacerbations

Barbara H Johnson,1 Machaon M Bonafede,1 Crystal Watson2 1Outcomes Research, Truven Health Analytics, Cambridge, MA, USA; 2Health Economics and Outcomes Research, Biogen, Cambridge, MA, USA Objectives: The mean lifetime cost of ischemic stroke is approximately $140,048 in the United States, placing stroke among the top 10 most costly conditions among Medicare beneficiaries. The objective of this study was to describe the health-care resource utilization and costs in the year following hospitalization for acute ischemic stroke (AIS).Methods: This retrospective claims analysis quantifies utilization and costs following inpatient admission for AIS among the commercially insured and Medicare beneficiaries in the Truven Health databases. Patients who were 18 years or older and continuously enrolled for 12 months before and after an AIS event occurring (index) between January 2009 and December 2012 were identified. Patients with AIS in the year preindex were excluded. Demographic and clinical characteristics were evaluated at admission and in the preindex, respectively. Direct costs, readmissions, and inpatient length of stay (LOS) were described in the year postindex.Results: The eligible populations comprised 20,314 commercially insured patients and 31,037 Medicare beneficiaries. Average all-cause costs were $61,354 and $44,929 (commercial and Medicare, respectively) in the first year after the AIS. Approximately 50%–55% of total 12-month costs were incurred between day 31 and day 365 following the incident AIS. One quarter (24.6%) of commercially insured patients and 38.8% of Medicare beneficiaries were readmitted within 30 days with 16.6% and 71.7% (commercial and Medicare, respectively) of those having a principal diagnosis of AIS. The average AIS-related readmission length of stay was nearly three times that of the initial hospitalization for both commercially insured patients (3.8 vs 10.8 days) and Medicare beneficiaries (4.0 vs 10.8 days).Conclusion: In addition to the substantial costs of the initial hospitalization of an AIS, these costs double within the year following this event. Given the high cost associated with AIS, new interventions reducing either the acute or longer-term burden of AIS are needed. Keywords: acute ischemic stroke, health-care resource utilization, health-care costs, readmissions

Machaon M Bonafede,1 Barbara H Johnson,1 Akshara Richhariya,2 Shravanthi R Gandra2 1Outcomes Research, Truven Health Analytics, Cambridge, MA, USA; 2Global Health Economics, Amgen, Thousand Oaks, CA, USA Objectives: This study descriptively examined acute and longer term direct medical costs associated with a major cardiovascular (CV) event among high-risk coronary heart disease risk-equivalent (CHD-RE) patients. It also gives a firsthand look at fatal versus nonfatal CV events. Methods: The MarketScan® Commercial Claims and Encounters Database was used to identify adults with a CV event in 2006–2012 with hyperlipidemia or lipid-lowering therapy use in the 18 months prior to one of the following inpatient CV events: myocardial infarction, ischemic stroke, unstable angina, transient ischemic attack, percutaneous coronary intervention, or coronary artery bypass graft (CABG). Patients were required to have a preindex diagnosis of at least one of the following: peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, or diabetes. A subset analysis was conducted with patients with data linkable to the Social Security Administration Master Death File. Direct medical costs were reported for each quarter following a CV event, for up to 36 months after the first CV event. Results: In total, 38,609 CHD-RE patients were included, mean age 57 years, 31% female. CABG, myocardial infarction, and percutaneous coronary intervention were the most frequent and most expensive first CV events, accounting for >75% of all first CV events with mean first quarter costs ranging from $17,454 (nonfatal transient ischemic attack) to $125,690 (fatal CABG). Overall, 15% of those with a first CV event went on to have a second event during the 36-month study period with mean first quarter nonfatal and fatal costs similar to first event levels. Third CV events were rare, happening in less than 3% of patients. Conclusion: CV events among CHD-RE patients were costly regardless of sequence, averaging $47,433 in the first 90 days following an event and remaining high, never returning to preevent levels. When fatal, first CV event costs were 1.2 to 2.9 times higher than when nonfatal. Keywords: coronary heart disease risk equivalent, economic burden, subsequent CV event, fatal CV event

Jeffrey D Miller,1 Gregory M Lenhart,1 Machaon M Bonafede,1 Cindy M Basinski,2 Andrea S Lukes,3 Kathleen A Troeger4 1Truven Health Analytics, Cambridge, MA, 2Basinski, LLC, Newburgh, IN, 3Carolina Women’s Research and Wellness Center, Durham, NC, 4Hologic, Inc, Marlborough, MA, USA Objectives: Abnormal uterine bleeding (AUB) interferes with physical, emotional, and social well-being, impacting the quality of life of more than 10 million women in the USA. Hysterectomy, the most common surgical treatment of AUB, has significant morbidity, low mortality, long recovery, and high associated health care costs. Global endometrial ablation (GEA) provides a surgical alternative with reduced morbidity, cost, and recovery time. The NovaSure® system utilizes unique radiofrequency impedance-based GEA technology. This study evaluated cost effectiveness of AUB treatment with NovaSure ablation versus other GEA modalities and versus hysterectomy from the US commercial and Medicaid payer perspectives. Methods: A health state transition (semi-Markov) model was developed using epidemiologic, clinical, and economic data from commercial and Medicaid claims database analyses, supplemented by published literature. Three hypothetical cohorts of women receiving AUB interventions were simulated over 1-, 3-, and 5-year horizons to evaluate clinical and economic outcomes for NovaSure, other GEA modalities, and hysterectomy. Results: Model analyses show lower costs for NovaSure-treated patients than for those treated with other GEA modalities or hysterectomy over all time frames under commercial payer and Medicaid perspectives. By Year 3, cost savings versus other GEA were $930 (commercial) and $3,000 (Medicaid); cost savings versus hysterectomy were $6,500 (commercial) and $8,900 (Medicaid). Coinciding with a 43%–71% reduction in need for re-ablation, there were 69%–88% fewer intervention/reintervention complications for NovaSure-treated patients versus other GEA modalities, and 82%–91% fewer versus hysterectomy. Furthermore, NovaSure-treated patients had fewer days of work absence and short-term disability. Cost-effectiveness metrics showed NovaSure treatment as economically dominant over other GEA modalities in all circumstances. With few exceptions, similar results were shown for NovaSure treatment versus hysterectomy. Conclusion: Model results demonstrate strong financial favorability for NovaSure ablation versus other GEA modalities and hysterectomy from commercial and Medicaid payer perspectives. Results will interest clinicians, health care payers, and self-insured employers striving for cost-effective AUB treatments. Keywords: NovaSure, abnormal uterine bleeding, menorrhagia, hysterectomy, global endometrial ablation, cost-effectiveness analysis

Machaon M Bonafede,1 Vivek B Kalra,2 Jeffrey D Miller,1 Laurie L Fajardo3 1Truven Health Analytics, Cambridge, MA, 2Yale University School of Medicine, New Haven, CT, 3Department of Radiology, University of Iowa College of Medicine, Iowa City, IA, USA Purpose: The objective of this study was to conduct a value analysis of digital breast tomosynthesis (DBT) for breast cancer screening among women enrolled in US commercial health insurance plans to assess the potential budget impact associated with the clinical benefits of DBT. Methods: An economic model was developed to estimate the system-wide financial impact of DBT as a breast cancer screening modality within a hypothetical US managed care plan with one million members. Two scenarios were considered for women in the health plan who undergo annual screening mammography, ie, full field digital mammography (FFDM) and combined FFDM + DBT. The model focused on two main drivers of DBT value, ie, the capacity for DBT to reduce the number of women recalled for additional follow-up imaging and diagnostic services and the capacity of DBT to facilitate earlier diagnosis of cancer at less invasive stages where treatment costs are lower. Model inputs were derived from published sources and from analyses of the Truven Health MarketScan® Research Databases (2010–2012). Comparative clinical and economic outcomes were simulated for one year following screening and compared on an incremental basis. Results: Base-case analysis results show that 4,523 women in the hypothetical million member health plan who are screened using DBT avoid the use of follow-up services. The overall benefit of DBT was calculated at $78.53 per woman screened. Adjusting for a hypothetical $50 incremental cost of the DBT examination, this translates to $28.53 savings per woman screened, or $0.20 savings per member per month across the plan population and an overall cost savings to the plan of $2.4 million per year. Conclusion: The results of this study demonstrate clinical and economic favorability of DBT for breast cancer screening among commercially-insured US women. Wider adoption of DBT mammography presents an opportunity to deliver value-based care in the US health care system. Keywords: breast cancer screening, mammography, digital breast tomosynthesis, cost analysis, value analysis, economic model

Machaon M Bonafede,1 Jeffrey D Miller,1 Shannon K Laughlin-Tommaso,2 Andrea S Lukes,3 Nicole M Meyer,1 Gregory M Lenhart1 1Truven Health Analytics, Cambridge MA, 2Mayo Clinic, Department of Obstetrics and Gynecology, Rochester, MN, 3Women's Wellness Clinic and Research Center, Durham, NC, USA Background: Women with abnormal uterine bleeding (AUB) may be treated surgically with hysterectomy or global endometrial ablation (GEA), an outpatient procedure. We compared the costs and clinical outcomes of these surgical procedures for AUB among women in Medicaid programs.Methods: The Truven Health MarketScan® Medicaid Multi-State Database was used to identify Medicaid women aged 30–55 years with AUB who newly initiated GEA or hysterectomy (index event) during 2006–2010. Patients were required to have 12 months of continuous enrollment pre-index and post-index. Baseline characteristics were assessed in the pre-index period; health care utilization and costs (2011 USD), treatment complications, and reinterventions were assessed in the post-index period.Results: Of 1,880 women who met the study criteria (mean age 40.7 years), 53.4% were Caucasian, 33.1% were African-American, and 2.3% were Hispanic; many (42.8%) received their Medicaid eligibility due to disability. Similar proportions received GEA (50.9%) or hysterectomy (49.1%). At baseline, both groups also had similar Deyo-Charlson Comorbidity scores (0.65), and use of antibiotics (69.4%), nonsteroidal anti-inflammatory drugs (56.3%), and oral contraceptives (5.3%). More hysterectomy patients than GEA patients had a treatment-related complication (52% versus 36%, respectively, P

Machaon M Bonafede,1 Barbara H Johnson,1 Crystal Watson2 1Truven Health Analytics, Cambridge, MA, USA; 2Biogen Idec, Weston, MA, USA Objectives: To evaluate multiple sclerosis (MS)-related health care-resource utilization and costs prior to and after initiating natalizumab in the US. Materials and methods: A retrospective administrative claims analysis was conducted using the Truven Health MarketScan Databases to identify adults diagnosed with MS who initiated natalizumab (index date) between January 1, 2007 and December 31, 2010. Patients had ≥24 months of continuous enrollment (12 months before [preperiod] and 12 months after [postperiod] the index date) and remained on natalizumab for the 12-month postperiod. Patients with and without other disease-modifying treatment (DMT) during the preperiod were examined. Patient characteristics, MS-related inpatient stays, and corticosteroid use were compared in the pre- and postperiods using paired statistical tests, where appropriate. Results: The study comprised 1,458 patients, mean age 45.2 years (standard deviation 10.5), 74.2% female. The majority (70.3%) used a DMT during the preperiod. After initiating natalizumab, there was a significant reduction in the percentage of patients with MS-related inpatient stays (7.6% versus 2.4%, P