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Introduction Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To provide additional clinical evidence in regulatory submissions for a modified-release (MR) once-daily (QD) tofacitinib formulation, we compared real-world adherence and effectiveness between patients initiating the MR QD formulation and patients initiating an immediate-release (IR) twice-daily (BID) formulation. Methods Two noninterventional cohort studies were conducted. First, adherence and two effectiveness proxies were compared between patients with RA who newly initiated tofacitinib MR 11 mg QD or IR 5 mg BID in the IBM® MarketScan® Commercial and Medicare Supplemental US insurance claims databases (March 2016–October 2018). Second, using data collected in the Corrona US RA Registry (February 2016–August 2019), two Clinical Disease Activity Index (CDAI)-based measures of effectiveness were compared between tofacitinib MR 11 mg QD and IR 5 mg BID, and against noninferiority criteria derived from placebo-controlled clinical trials of the tofacitinib IR formulation. Multiple sensitivity analyses of the registry data were conducted to reassure regulators of consistent results across different assumptions. Results In each study, approximately two-thirds of patients initiated the MR formulation. In the claims database study, improved adherence and at least comparable effectiveness were observed with tofacitinib MR vs IR over 12 months, particularly in patients without prior advanced therapy. In the registry study, the noninferiority of tofacitinib MR vs IR was demonstrated for both CDAI outcomes at ~6 months; this finding was robust across multiple sensitivity analyses. Conclusion These results demonstrate the value of real-world evidence from complementary data sources in understanding the impact of medication adherence with a QD formulation in clinical practice. These analyses were suitable for regulatory consideration as an important component of evidence for the comparability of tofacitinib MR 11 mg QD vs IR 5 mg BID in patients with RA. Trial Registration Claims database study: ClinicalTrials.gov identifier NCT04018001, retrospectively registered July 12, 2019. Corrona US RA Registry study: ClinicalTrials.gov identifier NCT04267380, retrospectively registered February 12, 2020. Electronic supplementary material The online version of this article (10.1007/s12325-020-01501-z) contains supplementary material, which is available to authorized users.

Background Thoracic endovascular aortic repair (TEVAR) first gained in popularity for repair of type B aortic dissections (TBADs) in the early 2000's. We aimed to describe patients undergoing open repair, TEVAR, and no repair and analyze factors associated with repair within 14 days of presentation in the contemporary era. Methods We used the MarketScan database to find patients with TBAD between 2014 and 2017. To assess factors associated with early repair, univariable, and multivariable log‐binomial regression were used. Results There were 2613 patients admitted with TBAD between 2014 and 2017 across the United States, of whom 38.4% underwent repair within 14 days of admission (25.3% open repair and 13.1% TEVAR). The incidence of repair within 14 days decreased over the study period (43% of the study cohort in 2014 to 26.4% in 2017) primarily due to a decrease in open repairs from 30.8% of patients in 2014 to 12.5% in 2017. In multivariable analysis, older age, Middle Atlantic location, diabetes mellitus, insulin use, antiplatelet use, and more recent year were associated with lower likelihood of early repair; male sex, peripheral vascular disease, and the presence of extremity ischemia, rupture, shock, and acidosis were associated with higher likelihood of repair. Conclusions Overall, repair of TBAD within 14 days of presentation declined from 2014 to 2017, with a steady rate of TEVAR but declining rate of open repairs. Further investigation into provider‐ and hospital‐specific factors as they relate to likelihood of repair is needed.

Introduction Information on the economic burden of focal segmental glomerulosclerosis (FSGS) is sparse. This study characterized health care resource utilization (HCRU) and costs in patients with FSGS, and evaluated the impact of nephrotic range proteinuria on these outcomes. Methods This retrospective, observational cohort study used administrative claims data from the Optum Clinformatics Data Mart Database from October 2015 to December 2019. Patients with FSGS (n = 844; first claim = index event) between April 2016 and December 2018 were matched on index date, age, sex, and race to non-FSGS controls (n = 1688). FSGS nephrotic range (urine protein/creatinine ratio >3000 mg/g or albumin/creatinine ratio >2000 mg/g) and non-nephrotic subpopulations were identified. Baseline comorbidities, 12-month post-index all-cause HCRU and costs (per patient per year [PPPY]), and immunosuppressant prescriptions were compared between matched cohorts and between FSGS subpopulations. Results Comorbidity burden was higher in FSGS. Of 308 patients with available urine protein/creatinine ratio/albumin/creatinine ratio results, 36.4% were in nephrotic range. All-cause HCRU was higher in FSGS across resource categories (all P < 0.0001); 50.6% of FSGS and 23.3% of controls were prescribed glucocorticoids (P < 0.0001). Mean total medical costs were higher in FSGS ($59,753 vs. $8431 PPPY; P < 0.0001), driven by outpatient costs. Nephrotic range proteinuria was associated with higher all-cause inpatient, outpatient, and prescription costs versus nonnephrotic patients (all P < 0.0001), resulting in higher total costs ($70,481 vs. $36,099 PPPY; P < 0.0001). Conclusions FSGS is associated with significant clinical and economic burdens; the presence of nephrotic range proteinuria increased the economic burden. New treatment modalities are needed to reduce proteinuria, help improve patient outcomes, and reduce HCRU and associated costs., Graphical Abstract

Michael J Fisch,1 Michael Grabner,2 Daniel S Mytelka,3 Amit D Raval,2 Lee Bowman,3 David M Kern,2 Collin Churchill,3 Joseph Singer,2 Stewart Wetmore,3 John Barron,2 Michael Eleff4 1AIM Specialty Health, Chicago, IL, USA; 2HealthCore, Inc., Wilmington, DE, USA; 3Eli Lilly and Company, Indianapolis, IN, USA; 4Anthem, Inc., Indianapolis, IN, USACorrespondence: Michael GrabnerHealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE 19801, USATel +1 302-230-2000Fax +1 302-230-2020Email mgrabner@healthcore.comObjective: Choosing chemotherapy for metastatic colorectal cancer (mCRC) requires balancing clinical effectiveness and risk of complications. This study characterized real-world inpatient/emergency department (ED) hospitalizations during first-line chemotherapy among individuals with mCRC.Methods: This retrospective cohort study used data from medical and pharmacy claims. All patients had mCRC with ≥ 1 claim for ≥ 1 of the 5 most frequently utilized first-line chemotherapy agents (fluorouracil, oxaliplatin, bevacizumab, irinotecan, capecitabine). The main outcome was all-cause hospitalizations (inpatient or ED setting) identified from claims via ICD-9/10-CM coding from index date until 30 days after the end of first-line chemotherapy or last available data.Results: A total of 717 individuals (mean age 55 years; 58% male; ECOG 0/1/2+/missing in 44%/39%/6%/11%; median follow-up 116 days) met study criteria. Thirty-four distinct chemotherapy regimens were used. Overall, 40% of patients had ≥ 1 hospitalization (n=285; total 415 hospitalizations); 12% (n=85) had ≥ 2 hospitalizations. The median time to first hospitalization was 52 days; median inpatient length of stay was 4 days; infections/neutropenia (21%) and bowel-related complications (17%) were the most common issues associated with inpatient hospitalizations. In univariate analyses, insurance plan type, geographical location, ECOG, and renal disease were associated with hospitalization. In multivariable analyses, ECOG ≥ 1 was associated with a 67% increase (p< 0.01) in the odds of hospitalization vs ECOG= 0.Conclusion: Approximately 40% of patients with mCRC were hospitalized during the study period. Hospital stays were typically short. Further research is needed to determine how many of these hospitalizations may be avoidable. We also observed a large amount of variation in regimens used in the first-line setting.Keywords: colorectal cancer, chemotherapy-associated hospitalization, outcomes research, observational study, claims analysis

Introduction Complex or personalized insulin regimens challenge traditional adherence measures. Our objective was to develop an improved basal insulin (BI) adherence measure using both patient-reported and administrative claims data, resulting in a more complete measure. Methods Patients’ self-reported BI utilization over the previous 12 months was linked with their claims data for the same period. Hybrid medication possession ratio (MPR) was derived by calculating expected days of insulin supply [total dispensed insulin units from claims over 12 months divided by self-reported total daily dose (TDD)]. The hybrid MPR was compared against traditional claims-based MPR, adjusted claims-based MPR, and patient-reported MPR. For all MPR measures, the adherence threshold was ≥ 0.8. A logistic model was used to predict non-adherence per hybrid MPR. The predicted model-based MPR was compared with existing measures in a larger cohort. Results The study sample consisted of 296 patients. TDD derived from claims was higher than self-reported TDD [77.9 (71.8) vs. 57.7 (38.3)], implying average dispensed insulin would last longer than claims-based days supply. Correspondingly, hybrid and MPRs adjusted for package size (56% and 71%, respectively) were higher than claims-based MPR (50%). Age, total claims-based days supply, retinopathy, adjusted MPR-based adherence, and non-insulin injectable use were key predictors of hybrid MPR-based adherence. Applying the claims-based prediction model to a larger cohort to test validity showed high correlations with predicted and adjusted MPR-based adherence. Conclusions Traditional claims-based MPR underestimated adherence while adjusted MPR overestimated adherence when self-reported total daily dose was taken as benchmark insulin dose. The predicted model may help identify patients with poor basal insulin adherence. More research is needed to further confirm the findings. Funding Eli Lilly and Company, Indianapolis, IN, USA. Electronic supplementary material The online version of this article (10.1007/s12325-018-0828-4) contains supplementary material, which is available to authorized users.

Introduction Enzalutamide and abiraterone acetate (plus prednisone) are new hormonal treatments for metastatic castration-resistant prostate cancer (mCRPC). This study compared treatment duration, healthcare resource utilization (HRU), and treatment costs for chemotherapy-naïve mCRPC patients treated with enzalutamide or abiraterone acetate in the USA. Methods Chemotherapy-naïve mCRPC patients initiating treatment with enzalutamide or abiraterone acetate were identified from administrative claims. Continuous enrollment ≥ 6 months before and ≥ 3 months after the index date (initiation date of enzalutamide or abiraterone acetate) was required. Treatment duration, all-cause and prostate cancer-related HRU, and costs were estimated during the post-index period. Multivariable analyses compared HRU and costs between cohorts, adjusting for baseline characteristics. Results Overall, 920 chemotherapy-naïve patients initiated enzalutamide and 2310 initiated abiraterone acetate (median follow-up, 10.7 and 13.5 months, respectively). More enzalutamide-treated patients had corticosteroid-sensitive comorbidities at baseline. Treatment duration was longer with enzalutamide versus abiraterone acetate (median, 10.7 vs. 8.8 months; P = 0.008). Enzalutamide was associated with fewer all-cause inpatient admissions [adjusted incidence rate ratio (95% confidence interval) 0.87 (0.76, 0.99)], days of hospitalization [0.84 (0.70, 1.02)], and outpatient visits [0.94 (0.90, 0.98)], and fewer prostate cancer-related outpatient visits [0.92 (0.87, 0.96)] compared with abiraterone acetate. Enzalutamide was also associated with lower prostate cancer-related inpatient and emergency department costs [adjusted differences, $122 (P = 0.024) and $28 (P = 0.009), respectively]. Conclusion Chemotherapy-naïve mCRPC patients treated with enzalutamide versus abiraterone acetate had longer treatment duration and incurred lower HRU and prostate cancer-related inpatient and emergency department costs. Funding Astellas Pharma Inc. Electronic supplementary material The online version of this article (10.1007/s12325-018-0774-1) contains supplementary material, which is available to authorized users.

Introduction Gender disparities in access to healthcare have been documented, including disparities in access to care for cardiovascular diseases (CVDs). Disparities in access to cardiologists could disadvantage some patients to the newer lipid-lowering proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) antibodies, as utilization management criteria for PCSK9is often require step therapy with statins and/or ezetimibe and prescription by a cardiologist. To assess whether these utilization management criteria disproportionally limit access to patients with certain characteristics, we assessed the use of cardiologist care and receipt of statin and/or ezetimibe prescriptions from a cardiologist by gender and other patient demographic and clinical characteristics. Methods This cross-sectional study used administrative claims data from Inovalon’s Medical Outcomes Research for Effectiveness and Economics Registry (MORE2 Registry®) for patients enrolled in commercial and Medicare Advantage healthcare plans from January 1, 2014, through December 31, 2014. Provider data from the registry were linked to individual demographic and administrative claims data. Logistic regression models were used to assess characteristics associated with outpatient visits to a cardiologist and receipt of a prescription for statin and/or ezetimibe from a cardiologist. Results Data from 39,322 patients in commercial plans and 261,898 patients with Medicare Advantage were analyzed. Female gender (vs male) was associated with a significantly lower likelihood of visiting a cardiologist for patients in commercial plans (odds ratio [OR] 0.85; 95% confidence limit [CL] 0.81–0.88) and in Medicare Advantage plans (OR 0.82; 95% CL 0.81–0.83). Female gender was also associated with a lower likelihood of receiving a statin and/or ezetimibe prescription from a cardiologist for patients in commercial plans (OR 0.69; 95% CL 0.65–0.74) and in Medicare Advantage plans (OR 0.78; 95% CL 0.76–0.79). Conclusions Compared with men, women were less likely to visit a cardiologist and less likely to receive a prescription for a statin and/or ezetimibe from a cardiologist. Funding Amgen Inc.

Introduction As continuous exposure to anticholinergics has been associated with adverse outcomes, accurately measuring exposure is important. However, no gold standard measure is available, and the performance of existing measures has not been compared. Our objective was to compare the properties of the Cumulative Anticholinergic Burden (CAB) measure against two existing measures of anticholinergic exposure and to assess their compatibility for use in observational studies based on claims data. Methods The average daily dose, cumulative dose and CAB measures were evaluated on: the applicability for use with anticholinergic burden scales, the ability to consider duration and/or accumulation of exposure, and consideration of anticholinergic dose, potency, and residual effect. To calculate each measure empirically, Truven MarketScan claims data from 2012 to 2015 were analyzed. Cumulative anticholinergic exposure over 1-year post-enrollment was calculated for each measure using Anticholinergic Cognitive Burden scale scores. Median [interquartile range (IQR)] and ranges of measure scores, and Spearman’s correlation coefficients between measures, were estimated. Due to the differing methods of calculation, the absolute values of each score cannot be compared. Results The properties of the different measures varied, with only the CAB considering both dose and theoretical potency. The cohort included 99,742 individuals (mean age = 73.1 years; 54.9% female). Among individuals prescribed anticholinergics (n = 55,969), 1-year median (IQR) scores based on average daily dose, cumulative dose and CAB measures were 0.9 (0.3–1.5), 16.9 (7.3–33.9) and 203 (68–500), respectively. Measures were highly inter-correlated (r2 = 0.74-0.83). Conclusions Considering both potency and dose, the CAB may prove a more comprehensive measure of anticholinergic burden; however, additional research is necessary to demonstrate whether it has any association with relevant health-related outcomes. Funding Astellas Pharma Global Development, Inc. Electronic supplementary material The online version of this article (10.1007/s12325-019-01035-z) contains supplementary material, which is available to authorized users.

This study measured rates and trends in antibiotic dispensing for emergency department (ED) and outpatient visits by age groups. This retrospective analysis used data from the National Institutes of Health Collaboratory Distributed Research Network. The analysis included children (aged > 3 months to

Jordana K Schmier,1 David W Covert,2 Carolyn K Hulme-Lowe,1 Anmol Mullins,3 Emmanuel M Mahlis4 1Health Sciences, Exponent Inc., Alexandria, VA, 2Health Economics, 3Global Market Access, 4US Pharma Medical Affairs, Alcon Inc., Fort Worth, TX, USA Purpose: The current costs of treating cystoid macular edema (CME), a complication that can follow cataract surgery, are largely unknown. This analysis estimates the treatment costs for CME based on the recently released US Medicare data. Setting: Nationally representative database. Design: Retrospective analysis of the 2011 through 2013 Medicare 5% Beneficiary Encrypted Files. Methods: Beneficiaries who underwent cataract surgery were identified and stratified by diagnosis of CME (cases) or no diagnosis of CME (controls) within 6months following surgery. Claims and reimbursements for ophthalmic care were identified. Subgroup analyses explored the rates of CME in beneficiaries based on the presence of selected comorbidities and by the type of procedure (standard vs complex). Total Medicare and ophthalmic costs for cases and controls are presented. The analysis explored the effect of considering diabetic macular edema (DME) and macular edema (ME) as exclusion criteria. Results: Of 78,949 beneficiaries with cataract surgery, 2.54% (n=2,003) were diagnosed with CME. One-third of beneficiaries had one or more conditions affecting retinal health (including diabetes), 4.5% of whom developed CME. The rate of CME, at 22.5%, was much higher for those patients with preoperative DME or ME. Ophthalmic charges were almost twice as high for cases compared with controls (US$10,410 vs $5,950); payments averaged 85% higher ($2,720 vs $1,470) (both P

Background: Irritable bowel syndrome (IBS) reduces quality of life and burdens healthcare systems. This study identified factors associated with frequent use of IBS diagnostic tests and procedures. Methods: Using a United States claims database (2001–2012), tests and procedures in IBS patients occurring in the 2-year study period (12 months before/following the first IBS diagnosis) were analyzed: endoscopy, GI transit testing, anorectal procedures, and radiologic imaging. Patients were classified based on test/procedure frequency (3+, 1–2, or 0). Multivariate logistic regression identified factors associated with more frequent tests/procedures. Results: Among 201,322 IBS patients, 41.7% had 3+ tests/procedures, 35.1% had 1–2, and 23.3% had 0. Patients with more tests/procedures were older [mean age 50.6 (3+ group), more likely to be female and had more comorbidities, including anxiety, depressive disorders, and somatization. Dyspepsia [odds ratio (95% confidence interval): 1.80 (1.72–1.87)], interstitial cystitis [1.60 (1.45–1.77)], gastroesophageal reflux disease [1.59 (1.55–1.63)], constipation [1.50 (1.45–1.54)], and dyspareunia [1.38 (1.25–1.52)] were significantly associated with more tests/procedures (3+ versus 1–2), while anxiety, depressive disorders, and somatization were not. Patients with more frequent specialist visits [emergency department (ED; 1.10 (1.09–1.11)) and gastroenterologists (1.26 (1.26–1.27))] or at least one GI-related ED visit or inpatient admission [1.95 (1.86–2.04) and 3.67 (3.48–3.87), respectively] were more likely to have more tests/procedures (all p < 0.05). Conclusions: Test frequency in patients with IBS is strongly associated with demographic and clinical characteristics, especially comorbid conditions related to IBS. Presence of common overlapping comorbid conditions should increase clinicians’ confidence in making the diagnosis of IBS, thus curtailing redundant testing and reducing healthcare costs.

Background:Studies comparing standalone real-time continuous glucose monitoring (rtCGM) to self-monitoring of blood glucose (SMBG) in patients with type 1 diabetes mellitus (T1DM) have found that rtCGM is associated with lower glycated hemoglobin (A1C) levels, yet does not increase the risk of severe hypoglycemia. However, little is known about the relationship between rtCGM and health care costs and utilization. The objective of this study was to compare health care spending, hospital admissions, and A1C levels of patients using rtCGM to that of patients not using rtCGM.Methods:This retrospective, cross-sectional analysis used a large repository of health plan administrative data to compare average health care costs (excluding durable medical equipment), hospital admissions, and A1C levels of those using rtCGM (N = 1027) versus not using rtCGM (N = 32 583). To control for potentially confounding variables, a propensity score method was used to match patients using rtCGM to those not using rtCGM, based on characteristics such as age, gender, and comorbidities.Results:Patients using rtCGM spent an average of approximately $4200 less in total health care costs, when compared to patients not using rtCGM ( P < .05). They also experienced fewer hospital admissions ( P < .05) and lower A1C ( P < .05) during the postindex year.Conclusions:Use of rtCGM by patients with T1DM is associated with lower health care costs, fewer hospital admissions, and better glycemic control.

BackgroundClinical features of Lyme disease (LD) range from localized skin lesions to serious disseminated disease. Information on risk factors for Lyme arthritis, facial palsy, carditis, and meningitis is limited but could facilitate disease recognition and elucidate pathophysiology.MethodsPatients from high-incidence states treated for LD during 2005–2014 were identified in a nationwide insurance claims database using the International Classification of Diseases, Ninth Revision code for LD (088.81), antibiotic treatment history, and clinically compatible codiagnosis codes for LD manifestations.ResultsAmong 88022 unique patients diagnosed with LD, 5122 (5.8%) patients with 5333 codiagnoses were identified: 2440 (2.8%) arthritis, 1853 (2.1%) facial palsy, 534 (0.6%) carditis, and 506 (0.6%) meningitis. Patients with disseminated LD had lower median age (35 vs 42 years) and higher male proportion (61% vs 50%) than nondisseminated LD. Greatest differential risks included arthritis in males aged 10–14 years (odds ratio [OR], 3.5; 95% confidence interval [CI], 3.0–4.2), facial palsy (OR, 2.1; 95% CI, 1.6–2.7) and carditis (OR, 2.4; 95% CI, 1.6–3.6) in males aged 20–24 years, and meningitis in females aged 10–14 years (OR, 3.4; 95% CI, 2.1–5.5) compared to the 55–59 year referent age group. Males aged 15–29 years had the highest risk for complete heart block, a potentially fatal condition.ConclusionsThe risk and manifestations of disseminated LD vary by age and sex. Provider education regarding at-risk populations and additional investigations into pathophysiology could enhance early case recognition and improve patient management.

Introduction Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have examined real-world outcomes among elderly patients with advanced renal cell carcinoma (RCC). The purpose of this retrospective claims analysis was to assess real-world overall survival (OS), healthcare resource utilization (HRU), and healthcare costs (both all-cause and associated with RCC diagnosis) among elderly advanced RCC patients starting pazopanib or sunitinib treatment. Methods Advanced RCC patients aged 65 years or older who started first-line treatment with pazopanib or sunitinib (index drug; the initiation date was the index date) were identified from the 100% Medicare database plus Part D linkage (January 1, 2006 to December 31, 2014). Patients were stratified by index drug and matched 1:1 with use of propensity scores based on baseline characteristics. OS was assessed from the index date to death and compared by Kaplan–Meier analyses and univariable Cox models; patients were censored at the end of eligibility/data. Monthly HRU and costs from an intent-to-treat perspective were compared by Wilcoxon signed-rank tests. Results Baseline characteristics were balanced after matching (both N = 522). Treatment with pazopanib was associated with significantly longer median OS compared with treatment with sunitinib (18.2 months vs 14.6 months, respectively; log-rank p = 0.015). Pazopanib was associated with significantly lower monthly all-cause costs compared with sunitinib ($8845 vs $10,416, respectively), as well as lower inpatient costs associated with RCC diagnosis ($1542 vs $2522), fewer monthly inpatient admissions (0.179 vs 0.262), and shorter length of inpatient stay (1.375 days vs 1.883 days; all p ≤ 0.004). Conclusions Among elderly Medicare patients with advanced RCC, first-line pazopanib tretament was associated with significantly longer OS, as well as lower healthcare costs and HRU, compared with first-line sunitinib treatment. Electronic supplementary material The online version of this article (doi:10.1007/s12325-017-0628-2) contains supplementary material, which is available to authorized users.

Background Newer oral antidiabetic drug classes are expanding treatment options for type 2 diabetes mellitus (T2DM); however, concerns remain. The objective was to assess relative risk of heart failure hospitalization of sodium–glucose co-transporter-2 (SGLT2) and dipeptidyl peptidase-4 (DPP4) inhibitors in T2DM patients. Methods This retrospective observational study used a national commercially insured claims database. Adults (>18 years) with T2DM newly starting SGLT2 or DPP4 medication between April 2013 and December 2014 were included. Depending on their index fill, patients were grouped into either SGLT2 or DPP4 medication class cohorts. The primary outcome was hospitalization for heart failure and the risk was assessed using Cox regression models. Propensity score matching (1:2 ratio) was used to adjust for potential confounders. Analyses were also stratified by the presence of baseline diabetes complication and age (

In the area of Robust Design Methodology (RDM) less is done on how to use and work with data from the back-end of the product development process to support upstream improvement. The purpose of this paper is to suggest RDM practices for the use of customer claims data in early design phases as a basis for improvements. The back-end data, when systematically analyzed and fed back into the product development process, aids in closing the product development loop from claims to improvement in the design phase. This is proposed through a flow of claims data analysis tied to an existing tool, namely Failure Mode and Effects Analysis (FMEA). The systematic and integrated analysis of back-end data is suggested as an upstream effort of RDM to increase understanding of noise factors during product usage based on the feedback of claims data to FMEA and to address continuous improvement in product development.

C Mel Wilcox1, Byron L Cryer2, Henry J Henk3, Victoria Zarotsky3, Gergana Zlateva41University of Alabama, Birmingham, AL, USA; 2University of Texas Southwestern Medical School, Dallas, TX; 3i3 Innovus, Eden Prairie, MN, USA; 4Pfizer, Inc., New York, NY, USA Objectives: To compare the short-term mortality rates of gastrointestinal (GI) bleeding to those of acute myocardial infarction (AMI) by estimating the 30-, 60-, and 90-day mortality among hospitalized patients.Methods: United States national health plan claims data (1999–2003) were used to identify patients hospitalized with a GI bleeding event. Patients were propensity-matched to AMI patients with no evidence of GI bleed from the same US health plan.Results: 12,437 upper GI-bleed patients and 22,847 AMI patients were identified. Propensity score matching yielded 6,923 matched pairs. Matched cohorts were found to have a similar Charlson Comorbidity Index score and to be similar on nearly all utilization and cost measures (excepting emergency room costs). A comparison of outcomes among the matched cohorts found that AMI patients had higher rates of 30-day mortality (4.35% vs 2.54%; p< 0.0001) and rehospitalization (2.56% vs 1.79%; p = 0.002), while GI bleed patients were more likely to have a repeat procedure (72.38% vs 44.95%; p< 0.001) following their initial hospitalization. The majority of the difference in overall 30-day mortality between GI bleed and AMI patients was accounted for by mortality during the initial hospitalization (1.91% vs 3.58%).Conclusions: GI bleeding events result in significant mortality similar to that of an AMI after adjusting for the initial hospitalization.Keywords: gastrointestinal, bleeding, mortality, acute myocardial infarction, claims analysis

ObjectivesThere are limited studies concerning the economic burden of osteoporosis in the Medicaid population. This study estimated the direct cost of osteoporosis-related fractures (OPFx) to state Medicaid budgets.MethodsThis retrospective analysis utilized Medicaid claims databases from three states, which included approximately 8 million Medicaid recipients. The study sample had at least one claim for an osteoporosis diagnosis (733.0x) between January 1, 2000 and December 31, 2001. Beneficiaries with a fracture and a diagnosis of osteoporosis were assigned to the case cohort. A propensity score-based matching method was used to select a cohort of controls with osteoporosis but without a fracture. An exponential conditional mean model was used to estimate the incremental annual cost associated with fractures.ResultsThe study cohort (n = 7626) and a 1:1 matched control group were identified. The study cohort was 85.8% female, had an average age of 65 years, were 53.2% white, and 48.9% were eligible for Medicare. There were significant increases (all P < 0.05) from the preperiod to study period for this cohort in the proportion that had at least one hospital admission (14.0% vs. 26.5%), nursing home admission (9.2% vs. 17.2%), home health (39.1% vs. 49.3%), or emergency room visit (21.3% vs. 31.9%). In contrast, the control cohort had very little increase in utilization. The regression-adjusted incremental cost for osteoporosis-related expenses in the year after fracture was estimated at $4007 per patient. The estimated incremental cost was $5370 for the subset of patients who were eligible for Medicare.ConclusionThe economic burden of osteoporosis-related fractures on state Medicaid budgets is substantial.

La responsabilidad del dentista acerca de las intervenciones dentales realizadas en el ejercicio de sus actividades tienen responsabilidades civil, etica, administrativa y penal. Cuando se prueba que un resultado es perjudicial para el paciente, por imprudencia, mal praxis o negligencia, el examen de la lesion puede ser ordenado por una autoridad judicial y se analiza por peritos, haciendo que el dentista este sujeto a las sanciones previstas en el Codigo Penal brasileno, siendo forzado a reparar el dano e indemnizar de acuerdo a la consecuencia causada, con base en el Codigo Civil, o ambos, pudiendo sufrir una doble accion. Debido al incremento de los procesos legales relacionados con la odontologia, el objetivo de esta investigacion es dar mayor visibilidad al tema, haciendo hincapie en los aspectos eticos y legales relacionados con la practica profesional. Para ello, llevamos a cabo un estudio de los informes odontologicos legales de lesiones maxilofaciales en el Instituto de Medicina Legal Nina Rodrigues, Salvador-BA-Brasil, durante los meses de enero 2007 a diciembre 2013. Se analizo la informacion de los procedimientos realizados, la razon para el informe del perito y su resultados, la responsabilidad profesional y la conclusion propuesta por el peritos. Se encontro que del total de examenes por injurias a pacientes, la mayoria correspondio al area de cirugia (42,9%), seguido por endodoncia y ortodoncia con 14,3% en cada uno; en el 96% de los casos se involucraron uno o mas elementos de responsabilidad profesional, siendo el 47,4% clasificados por los peritos como lesiones menores. Se concluye que el aumento de los litigios por lesiones generadas por la atencion odontologica se deben a que el dentista no toma responsabilidad sobre los malos resultados y realiza procedimientos sin tener la habilidad adecuada. Se sugiere realizar una adecuada formacion profesional para la adquirir los conocimientos tecnicos y cientificos de cada area (especializacion), lo que permitiria actuar con el maximo cuidado y profesionalismo.

Background: Expansion of virtual health care—real-time video consultation with a physician via the Internet—will continue as use of mobile devices and patient demand for immediate, convenient access to care grow. Objective: The objective of the study is to analyze the care provided and the cost of virtual visits over a 3-week episode compared with in-person visits to retail health clinics (RHC), urgent care centers (UCC), emergency departments (ED), or primary care physicians (PCP) for acute, nonurgent conditions. Methods: A cross-sectional, retrospective analysis of claims from a large commercial health insurer was performed to compare care and cost of patients receiving care via virtual visits for a condition of interest (sinusitis, upper respiratory infection, urinary tract infection, conjunctivitis, bronchitis, pharyngitis, influenza, cough, dermatitis, digestive symptom, or ear pain) matched to those receiving care for similar conditions in other settings. An episode was defined as the index visit plus 3 weeks following. Patients were children and adults younger than 65 years of age without serious chronic conditions. Visits were classified according to the setting where the visit occurred. Care provided was assessed by follow-up outpatient visits, ED visits, or hospitalizations; laboratory tests or imaging performed; and antibiotic use after the initial visit. Episode costs included the cost of the initial visit, subsequent medical care, and pharmacy. Results: A total of 59,945 visits were included in the analysis (4635 virtual visits and 55,310 nonvirtual visits). Virtual visit episodes had similar follow-up outpatient visit rates (28.09%) as PCP (28.10%, P=.99) and RHC visits (28.59%, P=.51). During the episode, lab rates for virtual visits (12.56%) were lower than in-person locations (RHC: 36.79%, P

Background Poor psychosocial workplace factors have been found to cause or exacerbate a variety of health problems, including pain. However, little work has focused on how psychosocial workplace factors, such as health-related employer support, relate to future medical expenditures after controlling for health. Health-related support has also not been well explored in previous literature as a psychosocial factor. This study estimated the association of health-related employer support and pain with future medical expenditures, after including many additional controls. Methods This study used a restricted data set comprised of medical claims and survey data for one company in the U.S. Participants were included in the sample if they had worked for their employer for at least 12 months prior to the survey and if they were continuously eligible for health insurance (N=1,570). Future medical expenditures were measured using administrative claims data covering inpatient, outpatient, mental health and pharmaceutical insurance claims during a year. Health-related employer support was measured using participants’ answers about whether the employer would support their efforts to positively change their emotional or physical health. Pain was measured as recurring pain from any condition over the previous year. Results Having any physical health-related employer support was associated with a 0.06 increase in the probability of having future medical expenditures greater than zero, 95% CI [0.01, 0.11], but not with total expenditures. Having pain was associated with a 0.06 increase, 95% CI [0.04, 0.09], in the probability of having future medical expenditures greater than zero and with $3,027 additional total expenditures, 95% CI [$1,077, $4,987]. Conclusions After controlling for health and pain, psychosocial workplace factors were not robustly associated with future medical expenditures. Pain was associated with increased medical expenditures for the self-insured employer in this study, adjusting for a variety of factors.

Michael Grabner,1 Yong Chen,2 Matthew Nguyen,3 Scott D Abbott,3 Ralph Quimbo1 1HealthCore, Inc., Wilmington, DE, USA; 2Merck and Co., Inc., Whitehouse Station, NJ, USA; 3Valeritas, Inc., Bridgewater, NJ, USA Objective: To inform the design and assess the feasibility of a prospective effectiveness study evaluating an insulin delivery device for patients with diabetes mellitus to be conducted within the membership of a large US commercial insurer. Methods: Providers who issued ≥1 insulin prescription between January 1, 2011 and September 30, 2011 were selected from administrative claims contained in the HealthCore Integrated Research DatabaseSM. Adult diabetes patients with visits to these providers were identified. Providers were dichotomized into high- [HVPs] and low-volume providers [LVPs] based on median number of diabetes patients per provider. Results: We identified 15,349 HVPs and 15,313 LVPs (median number of patients = 14). Most HVPs were located in the Midwest (6,291 [41.0%]) and South (5,092 [33.2%]), while LVPs were evenly distributed across regions. Over 80% (12,769) of HVPs practiced family or internal medicine; 6.4% (989) were endocrinologists. HVPs prescribed insulin to an average of 25% of patients. Patients of HVPs (522,527) had similar characteristics as patients of LVPs (80,669), except for geographical dispersion, which followed that of providers. Approximately 65% of patients were aged 21-64 years and 97% had type 2 diabetes. Among patients with ≥1 available HbA1C result during 2011 (103,992), 48.3% (50,193) had an average HbA1C ≥7.0%. Among patients initiating insulin, 79.6% (22,205) had an average HbA1C ≥7.0%. Conclusion: The observed provider and patient populations support the feasibility of the prospective study. Sampling of patients from HVPs is efficient while minimizing bias as patient characteristics are similar to those from LVPs. The study also highlights unmet needs for improved glycemic control since approximately half of patients with diabetes are not on goal. Keywords: diabetes mellitus, claims analysis, prospective study design, insulin delivery

Charles Ruetsch,1 Joseph Tkacz,1 Peter G Kardel,1 Andrew Howe,2 Helen Pai,2 Bennett Levitan31Health Analytics, LLC, Columbia, Maryland, 2Janssen Research & Development, Raritan, New Jersey, 3Janssen Research & Development, Titusville, New Jersey, USAIntroduction: The lack of consistency surrounding the diagnosis of chronic non-cancer pain, treatment approaches, and patient management suggests the need for further research to better characterize the chronic non-cancer pain population.Objective: The purpose of this study was to identify distinct trajectories of health care service utilization of chronic non-cancer pain patients and describe the characteristic differences between trajectory groups.Patients and methods: This study utilized the MarketScan claims databases. A total of 71,392 patients diagnosed with either low back pain or osteoarthritis between 2006 and 2009 served as the study sample. Each subject's claims data were divided into three time periods around an initial diagnosis date: pre-period, post-Year 1, and post-Year 2. Subjects were categorized as either high (H) or low (L) cost at each post period, resulting in the creation of four trajectory groups based on the post-Year 1 and 2 cost pattern: H-H, H-L, L-H, and L-L. Multivariate statistical tests were used to predict and discriminate between trajectory group memberships.Results: The H-H, L-H, and H-L groups each utilized significantly greater pre-period high-cost venue services, post-Year 1 outpatient services, and post-Year 1 opioids compared to the L-L group (P

Nicole M Engel-Nitz1, Stephen D Sander2, Carolyn Harley3, Gabriel Gomez Rey1, Hemal Shah21Health Economic and Outcomes Research, i3 Innovus, Eden Prairie, MN, USA; 2Health Economic and Outcomes Research, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 3Health Economic and Outcomes Research, i3 Innovus, Palo Alto, CA, USAPurpose: To evaluate the clinical outcomes and incremental health care costs of ischemic stroke in a US managed care population.Patients and methods: A retrospective cohort analysis was done on patients (aged 18+ years) hospitalized with noncardioembolic ischemic stroke from January 1, 2002, through ­December 31, 2003, identified from commercial health plan administrative claims. New or recurrent stroke was based on history in the previous 12 months, with index date defined as first date of ­indication of stroke. A control group without stroke or transient ischemic attack (TIA) was matched (1:3) on age, sex, and geographic region, with an index date defined as the first ­medical claim during the patient identification period. Patients with atrial fibrillation or mitral value abnormalities were excluded. Ischemic stroke and control cohorts were compared on 4-year clinical outcomes and 1-year costs.Results: Of 2180 ischemic stroke patients, 1808 (82.9%) had new stroke and 372 (17.1%) had a recurrent stroke. Stroke patients had higher unadjusted rates of additional stroke, TIA, and fatal outcomes compared with the 6540 matched controls. Recurrent stroke patients had higher rates of adverse clinical outcomes compared with new stroke patients; costs attributed to recurrent stroke were also higher. Stroke patients were 2.4 times more likely to be hospitalized in follow-up compared with controls (hazard ratio [HR] 2.4, 95% confidence interval [CI]: 2.2, 2.6). Occurrence of stroke following discharge was 21 times more likely among patients with index stroke compared with controls (HR 21.0, 95% CI: 16.1, 27.3). Stroke was also predictive of death (HR 1.8, 95% CI: 1.3, 2.5). Controlling for covariates, stroke patients had significantly higher costs compared with control patients in the year following the index event.Conclusion: Noncardioembolic ischemic stroke patients had significantly poorer outcomes and higher costs compared with controls. Recurrent stroke appears to contribute substantially to these higher rates of adverse outcomes and costs.Keywords: burden of illness, stroke⁄cerebrovascular accident, cardiovascular disease, claims analysis, costs of care, health care outcomes

BACKGROUND: Practice-based Internet communication allows patients to obtain health information, ask questions, and submit requests through a personalized Web site. While such online tools also bring great promise for educating patients with the goal of fostering behavior change, it is important to examine how individuals currently using such services differ from those who do not. OBJECTIVE: The study used administrative information to characterize a population of patients communicating with a medical practice through the Internet during the end of 1999 and through 2000. METHODS: Patient claims data generated during clinical encounters from January 1999 through May 2000 were examined to measure the relationship between patient demographics, frequency of visits, specific acute diagnoses, and specific chronic diagnoses and the use of online communication with the practice. RESULTS: Ten percent of patients, and 13.2% of patients 18 years or older, used the practice Web site. There were differences in use of the practice Web site by age and insurance status, but not by gender. Use of the practice Web site was similar or higher among patients having a diagnosis for a variety of acute and chronic conditions compared to those not having such a diagnosis. Patients with more clinic visits were more likely to use the Web-based service. CONCLUSIONS: Patients using practice-based Internet communication and having significant health risks can be identified through the use of administrative data, presenting an opportunity to test online educational efforts to improve health. [J Med Internet Res 2004;6(1):e1]

Background nab-Paclitaxel is an albumin-bound formulation of paclitaxel approved for the treatment of metastatic breast cancer (MBC). This analysis was designed to characterize the treatment patterns, efficacy, and safety of nab-paclitaxel for MBC treatment using health claims data from US health plans associated with Optum. Methods Women aged ≥ 18 years who initiated nab-paclitaxel for MBC treatment from January 1, 2005, to September 30, 2012, and who met eligibility criteria were selected from the Optum Research Database for this analysis. Patients were required to have complete medical coverage and pharmacy benefits, ≥ 6 months of continuous enrollment, and a diagnosis of MBC prior to nab-paclitaxel initiation. The pattern of use for nab-paclitaxel (eg, regimen, schedule, duration, and administration) and claims-captured toxicities were characterized by line of therapy. Overall survival (OS) and time to next therapy or death (TNTD) were described by line of therapy, regimen, and schedule. Results Of the 664 nab-paclitaxel patients, 172 (25.9 %) received it as first-line therapy, 211 (31.8 %) as second-line therapy, and 281 (42.3 %) as third-line or later therapy. Overall, the majority of patients received monotherapy (61 %) and followed a weekly (71 %) rather than an every 3 weeks treatment schedule. nab-Paclitaxel was often (31.7 %) combined with targeted therapy (57.5 % with bevacizumab and 23.9 % with trastuzumab or lapatinib). The median duration of therapy was 128 days (4.2 months). For the overall population, median OS was 17.4 months (22.7, 17.4, and 15.1 months in first-, second-, and third-line or later therapy, respectively). Median TNTD was 6.1 months (7.1, 6.6, and 5.3 months in first-, second-, and third-line or later therapy, respectively). For patients aged ≤ 50 years or with ≥ 3 metastatic sites, median OS was 15.6 months. No new safety signal was identified. Conclusions In this US healthcare system, the majority of patients received nab-paclitaxel as second-line or later therapy, monotherapy, and weekly treatment. The efficacy and safety outcomes of nab-paclitaxel observed in this real-world setting appear consistent with those from clinical trial data.

Background: This retrospective cohort study aimed to describe and quantify healthcare resource utilization and costs for patients with ulcerative colitis (UC) and Crohn’s disease (CD) following initiation of biologic therapy. Methods: Resource utilization and costs were analyzed at baseline and 1- and 2-years after initiating a biologic. Data were extracted from a US administrative health insurance claims database for adults ≥18 years. Eligible patients were continuously enrolled in a health plan with medical and pharmacy benefits for ≥12 months prior to, and 12 months (primary analysis) or 24 months (secondary analysis) after index date (biologic initiation). Results: In total, 4864 and 2692 patients with UC, and 8910 and 5227 patients with CD were identified in the 1- and 2-year follow-up cohorts, respectively. Of 1-year follow-up cohort patients, 45% received the same biologic initiated at index for ≥1 year. Infliximab and adalimumab were the most commonly initiated biologics in patients with UC or CD. The highest proportion of patients who continued with the same biologic after 1-and 2-years had initiated therapy with infliximab for both indications (although at the 1-year follow-up for CD, the highest proportion continued to use natalizumab, but this was a small sample [n=15]). Generally, the proportion of patients having inpatient admissions and emergency department (ED) visits decreased after receiving the same biologic for 1 year compared with baseline, although the proportion having outpatient visits did not change. Mean per patient all-cause costs for inpatient hospitalizations, ED visits and outpatient visits decreased for patients with UC or CD who received the same biologic for 1 year, while mean pharmacy costs per patient increased. Conclusions; This descriptive analysis shows that although biologics effectively reduced inpatient and ED resource utilization and corresponding costs in patients with UC and CD, total management costs increased, driven by increased pharmacy costs.