Health Plan Claims Data Research Articles

SUN-597 Healthcare Utilization Patterns Among Commercially Insured Patients with Prader-Willi Syndrome: A Retrospective Analysis of Administrative Claims

Prader-Willi syndrome (PWS) is a complex orphan endocrine disease characterized by hyperphagia and abnormal food-related behaviors that contribute to severe morbidity and early mortality along with a significant burden on patients and caregivers. Life-long medical care is required but the consistency of services rendered to this population has not been evaluated. This study characterized use of US hospital care, specialty physician care, and growth hormone (GH) therapy for PWS patients at different life stages. Methods: PWS ICD-9 codes in the IQVIA™ Health Plan Claims Data from 1/2006 to 9/2015 were used to identify PWS patients. Inclusion criteria considered patients <65 years of age with ≥12 months of continuous enrollment who received ≥2 PWS diagnostic codes. Observation time was segmented into 12-month patient-years for analysis. Standardized billing code conventions were used to identify and categorize services of interest from 1/2006 to 11/2018. Results: A total of 5,060 PWS patient years representing 1,461 unique patients were eligible. Mean annual visits to inpatient, emergency department, and physician office settings ranged by age-cohort in years from 0.2-1.6, 0.5-1.3, and 9.2-26.0, respectively. Younger (0-17) and older (50-64) age-cohorts utilized more services than early-mid adulthood age-cohorts. Use of pediatricians or endocrinologists ranged from 76% to 88% among patients under 18 years of age. Utilization of cardiologists, orthopedists, physical therapists, and otolaryngologists ranged by age-cohort from 8-44%, 7-21%, 3-21%, and 7-38%, respectively, with highest utilization among younger patients. GH use increased from 37% to 46% of PWS patients between 2007 and 2018. GH users <18 years of age were 3.0, 0.6, 1.9, 1.7, and 1.4 times as likely to utilize endocrinologists, cardiologists, orthopedists, physical therapists, and otolaryngologists, respectively, compared with non-GH users. Conclusions: Use of hospital services for PWS patients was bimodal with higher use among the youngest and oldest age-cohorts. Change in the utilization level of select specialists reflects the complexity of care for age-related clinical sequelae, such as orthopedic concerns in infancy and early-onset cardiovascular disease due to hyperphagia and obesity in adolescents, as well as syndrome-specific treatment protocols (e.g., specialty consults needed for GH treatment). That less than half of PWS patients <18 years of age received GH therapy despite growing clinical evidence on the benefits and tolerability of GH suggests a potential gap in provider knowledge of the standard of care for PWS. Our analysis suggests that GH use may be a surrogate for better access to a multidisciplinary care team and specialty services. Considerable variation of services indicates that more effort is required to optimize care in PWS.

SUN-595 Comparative Comorbidity Burden Among Patients with Prader-Willi Syndrome: A Population-Level Cohort Study

Prader-Willi syndrome (PWS) is a rare, complex multi-system genetic disorder characterized by hyperphagia and abnormal food-related behaviors that contribute to severe morbidity and early mortality and to a significant burden on patients and caregivers. The hyperphagia seen in people with PWS can result in significant obesity. This study assessed rates of comorbidities associated with obesity, including type II diabetes (T2D), cardiovascular disease (CVD), and sleep apnea (SA) in a large US PWS vs. a non-PWS cohort. Methods: T2D, CVD, and SA conditions for privately insured PWS and non-PWS patients aged <65 years were identified via ICD diagnosis codes in deidentified medical claims provided by IQVIA™ Health Plan Claims Data (1/2006 - 11/2018). Patients were grouped into age-bands of 0–2, 3–8, 9–17, 18–26, 27–34, 35–49, and 50–64 years. Patients were required to have ≥12 months of enrollment, and observations were segmented into 12-month patient years. Due to patient privacy, figures that represent fewer than 11 patients are not shared and are represented as a non-zero figure (NZF). Results: 5,060 PWS and 31,093 non-PWS patient years representing 1,461 and 9,656 unique patients were eligible for analysis. T2D was detected in 8% of PWS patients age 9–17 (vs a NZF in non-PWS), 19% (vs 1%) in ages 18–26, and 27% in ages 27–34, 35–49, and 50–64 (vs 2, 5, and 13%, respectively). Comorbid CVD was detected in 25% of PWS patients age 0–2 (vs 1% in non-PWS), 11% (vs 1%) in ages 3–8, 15% (vs 1%) in ages 9–17, 29% (vs 4%) in ages 18–26, 44% (vs 11%) in ages 27–34, 60% (vs 27%) in ages 35–49, and 78% (vs 53%) in ages 50–64. Sleep apnea was detected in a NZF of non-PWS patients aged 0–2 and in all age groups 3–8, 9–17, and 18–26, compared to 37%, 22%, 17%, and 18% of PWS patients, respectively. Sleep apnea prevalence in PWS patients was 18% (vs 1% in non-PWS) in ages 27–34, 15% (vs 3%) in ages 35–49, and 16% (vs 4%) in ages 50–64.The largest disparities between PWS and non-PWS T2D prevalence was observed in the 9–17 and 18–26 age groups. Manifestations of CVD in PWS patients ages 0–2 was characterized by high rates of congenital atrial septal and patient ductus arteriosus defects, and in adolescent and adult PWS patients featured markedly higher rates of hypertension and hyperlipidemia than non-PWS cohorts. The proportion of PWS patients with SA that also received continuous positive airway pressure or oxygen monitoring ranged from 38% to 71%. Conclusions: Across all age groups, compared to non-PWS subjects, individuals with PWS experience markedly higher rates of CVD, T2D, and SA. The increased rate of CVD in the earliest age groups is consistent with previously observed increases in congenital heart defects with PWS. The frequency and early age of onset of hypertension, hyperlipidemia, T2D and SA emphasize the need for even more aggressive management of underlying drivers such as hyperphagia and the resulting obesity and metabolic dysfunction.

SUN-604 U.S. Prevalence &amp; Mortality of Prader-Willi Syndrome: A Population-Based Study of Medical Claims

Prader-Willi syndrome (PWS) is a complex developmental genetic disorder associated with hypotonia, poor feeding in neonates, onset of hyperphagia in early childhood, and shorter overall life expectancy. Prior epidemiology studies of PWS have examined smaller populations, with limited research in a US population. The aim of this study was to provide a contemporary estimate of PWS prevalence and annual all-cause mortality in the US using a large administrative medical claims dataset. Methods: PWS patients were identified between 2012-2014 via the presence of ≥2 claims with a diagnosis code for PWS on medical claims provided by IQVIA™ Health Plan Claims Data and CMS Medicare fee-for-service claims. Patients were grouped into age bands including: 0-2, 3-8, 9-17, 18-26, 27-49, and ≥50. PWS prevalence and mortality rates were calculated for 2014, then 2018 US census data was used to project rates for the total US population. The presence of select diagnoses and procedures suggestive of a life-threatening event (e.g., mechanical ventilation) with a patient’s prompt disenrollment defined as death in the IQVIA data; vital status is indicated in Medicare data. Results: Overall US diagnosed PWS prevalence was 2.7 per 100k persons (or 1 per 37,037), a prevalence of 8,870 patients in the US in 2018. Diagnosed PWS prevalence 3.9, 5.2, 4.5, 4.2, 2.5, and 1.1 per 100k persons respectively for age bands 0-2, 3-8, 9-17, 18-26, 27-49, and ≥50. The median age of PWS patients was 21 years. The mortality rate was highest among diagnosed PWS patients aged 0-2 years and lowest among those aged 9-17 years and the overall mortality rate was 2.7%. For all respective age bands 0-2, 3-8, 9-17, 18-26, 27-49, and ≥50, the all-cause mortality rate was 5.4%, 3.0%, 1.4%, 2.1%, 2.4%, and 4.5%. The observed median age of death was 23 years (IQR 6-36) Conclusions: The diagnosed PWS prevalence of 1 per 37,037 persons estimated for the 2018 US population is comparable to the other reported US prevalence estimate. As the current study describes diagnosed patients, it likely represents a lower bound of true PWS prevalence. Annual PWS mortality is ≥3 times higher than the overall US population (2.7% vs 0.8%). This rate appears unchanged from mortality estimates reported for PWS populations in the last several decades despite significant advances in genetic testing and the availability of growth hormone therapies in the US. Aggressive management of serious comorbid conditions, especially in younger PWS patients, should be a clinical priority.

PRO22 COST OF CARE ANALYSIS FOR U.S. PATIENTS WITH PRADER-WILLI SYNDROME (PWS)

This study analyzed direct medical costs of PWS patients compared to non-PWS patients; cost variation between those receiving growth hormone (GH) and those not was also evaluated. Costs for commercially-insured PWS and non-PWS patients (<65 years of age) were identified via ICD diagnosis codes in IQVIA™ Health Plan Claims Data (1/2006 – 11/2018). Patients were required to have ≥12 months of continuous enrollment with observation limited to the first 12 months. Controls were matched based on age, sex, length of continuous enrollment, and payer type. Observable medical expenditures were captured for 1,621 PWS and 8,105 non-PWS patients. The direct medical costs for PWS were 10 times higher than non-PWS overall. These differences peaked in infancy and adolescence ranging from 12.1 to 14.7 times higher for PWS patients <18 years of age compared to non-PWS. Across ages, the primary cost driver was inpatient care (∼48% of PWS patient costs), followed by outpatient-based care and prescription costs (∼21% and ∼31% of costs, respectively). The mean annualized costs per PWS patient per year overall were $35,197 and $3,529 for PWS and non-PWS, respectively; ranges by age group were $7,960 - $97,673 and $1,589 - $8,724, respectively. Costs were higher among PWS patients taking GH (driven primarily by the cost of GH itself). PWS patients require life-long care, reflected in higher costs relative to non-PWS patients. Because infancy and adolescence appear to be a critical period for intervention, preventative care should be a priority. Quantitation of direct medical costs may stoke awareness of PWS and heighten calls to investigate effective disease management, particularly for patients <18 years old. Future research should seek to elucidate long-term quality of life implications of access to select services (including GH).

The Patient-Centered Outcomes Research Network Antibiotics and Childhood Growth Study: Implementing Patient Data Linkage.

PCORnet, the Patient-Centered Outcomes Research Network, is comprised of health systems and health plans that transform electronic health records (EHRs) and claims data to a common data model (CDM) to facilitate real-world clinical research. Because patients receive health care in multiple care delivery settings, linking health records across systems and health plan claims would provide a more comprehensive and accurate picture of health care for patients. The current study expanded on a PCORnet Antibiotics and Childhood Growth (ABX) study to (1) identify and implement a privacy-preserving patient linkage solution among a clinical data research network and a health plan network within the ABX Study, and (2) assess overlap in prescribed and dispensed antibiotics and additional data gained from claims among the linked patients. This manuscript describes the linkage process and resulting overlap analysis. The authors identified 549 patients from the EHR record study cohort who had claims records with the health plan. Sixty percent (n = 329) of patients had consistent antibiotic exposure data across the 2 sources, indicating antibiotic exposure (44.3%) or nonexposure (15.7%). Among total antibiotic prescribing records, 43.1% had a matched claims record for dispensing within 60 days. Among antibiotic dispense records 26.5% were not associated with a prescribing record in the linked health systems. These findings showcase the feasibility of linking health plan claims data to PCORnet CDM in a privacy-preserving manner while also demonstrating continued gaps in data that may occur. The study highlights the importance of combining multiple health data sources for comprehensive clinical research.

Real-World Economic Outcomes of Brexpiprazole and Extended-Release Quetiapine Adjunctive Use in Major Depressive Disorder.

PurposeMajor depressive disorder (MDD) is a chronic mental disorder with a substantial clinical and economic burden. Despite the efficacy of adjunctive atypical antipsychotics (AAP) for augmentation in patients with major depressive disorder (MDD) who failed first-line antidepressant therapy (ADT), little is known of the impact of AAP choices on healthcare resource use and costs in real-world practice. Therefore, this study compared real-world healthcare utilization and costs in patients with MDD treated with brexpiprazole or extended-release (XR) quetiapine as adjunctive treatment to ADT.Patients and methodsAdults with MDD starting adjunctive treatment with brexpiprazole (n=844) or extended-release (XR) quetiapine (n=688) were identified in the adjudicated health plan claims data (07/2014 – 09/2016). Resource use and healthcare costs in the 6 months following treatment initiation were compared between non-matched populations, and between propensity score-matched groups, and by multivariable regression analyses.ResultsDuring follow-up, unadjusted all-cause hospitalization (6.6% vs 12.5%) and ED visits (17.0% vs 27.5%) were lower with brexpiprazole compared to quetiapine XR (both p<0.001). Brexpiprazole-treated patients had significantly lower mean medical costs (US$6,421 vs US$8,545, p=0.0123) but higher mean pharmacy costs (US$7,401 vs US$4,691, p<0.0001) than quetiapine XR-treated patients did. Total healthcare costs were not significantly different between the two cohorts. Propensity score-matched comparisons of 397 patients in each cohort showed no statistically significant difference in all-cause hospitalization, ED visits, and total healthcare costs; and significantly lower medical costs (US$5,719 vs US$8,602, p=0.0092) but higher pharmacy costs (US$7,091 vs US$5,091, p=0.0007) in brexpiprazole compared to quetiapine XR. In multivariable regressions, brexpiprazole was associated with 16.1% lower medical costs (p=0.0186) and 9.4% higher total healthcare costs (p=0.0463) as compared to quetiapine XR.ConclusionSignificantly lower medical costs were observed in patients with MDD treated with brexpiprazole vs quetiapine XR.

Changes in Opioid Utilization Following Tumor Necrosis Factor Inhibitor Initiation in Patients with Rheumatoid Arthritis.

IntroductionPain control is one of the most important aspects of rheumatoid arthritis (RA) management from the patient’s perspective. Newer generations of RA treatment including tumor necrosis factor inhibitor (TNFi) have the potential to alleviate pain and thus reduce opioid utilization. However, patterns of opioid utilization before and after TNFi initiation have not been well characterized. This study aims to examine multiple measures of change in opioid utilization after the initiation of TNFi.MethodsPatients aged ≥ 18 years with RA and 24 months continuous enrollment between January 2007 and December 2015 who newly initiated a TNFi in IQVIA™ Health Plan Claims Data were included in our study. Opioid utilization at baseline and during follow-up were identified and compared.ResultsOf 2330 patients with RA that were included in the study, 38.8% of patients used opioids in both baseline and follow-up periods. From pre-index to post-index, the proportion of patients receiving any opioid decreased from 54.0 to 51.0%. In addition, the proportion of those who received ≥ 50 mg median daily MED decreased from 12.6 to 10.6% during pre-post periods.ConclusionsThis real-world study of commercially insured patients with RA suggests that opioid use among these patients is prevalent. There was a small decrease in overall opioid utilization after TNFi initiation.

Medication adherence in patients with asthma using once-daily versus twice-daily ICS/LABAs

Objective This real-world observational study compared medication adherence and persistence among patients with asthma receiving the once-daily inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fluticasone furoate/vilanterol (FF/VI) versus the twice-daily ICS/LABAs budesonide/formoterol (B/F) and fluticasone propionate/salmeterol (FP/SAL). Methods This retrospective cohort study conducted using IQVIATM Health Plan Claims Data included patients with asthma ≥18 years of age initiating ICS/LABA therapy with FF/VI, B/F, or FP/SAL between January 1, 2014 and June 30, 2016 (index date). Patients had ≥12 months and ≥3 months of continuous eligibility pre- and post-index date, respectively. Patients receiving FF/VI were separately matched 1:1 with patients receiving B/F or FP/SAL using propensity score matching (PSM) and multivariable regression to balance baseline covariates between cohorts. The primary endpoint was medication adherence, measured by proportion of days covered (PDC). Secondary endpoints included proportion of patients achieving PDC ≥ 0.5 and PDC ≥ 0.8 and persistence with index medication, measured by time to discontinuation (>45-day gap in therapy). Results After PSM, 3,764 and 3,339 patients receiving FF/VI were matched with patients receiving B/F or FP/SAL, respectively. Mean PDC was significantly higher for FF/VI versus B/F (0.453 vs 0.345; adjusted p < 0.001) and FP/SAL (0.446 vs 0.341; adjusted p < 0.001). The proportion of patients achieving PDC ≥ 0.5 or PDC ≥ 0.8, and treatment persistence were significantly higher for FF/VI versus B/F and FP/SAL (all p < 0.001). Conclusions In this real-world study, patients initiating FF/VI had better adherence and lower risk of discontinuing treatment versus B/F or FP/SAL, suggesting that once-daily ICS/LABA treatment might improve adherence and persistence compared with twice-daily alternatives.

Characterizing Real-World Use Of Tiotropium In Asthma In The USA.

BackgroundTiotropium bromide (TIO) is a long-acting muscarinic antagonist recommended as an add-on therapy option for patients with uncontrolled asthma on inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA). However, real-world data on TIO use in asthma remains limited. To identify unmet needs, this study explored the use of TIO in US patients with asthma.MethodsThis retrospective cohort study used IQVIATM Health Plan Claims Data (October 1, 2014─December 31, 2016). Patients with asthma diagnoses initiating TIO 1.25 or 2.5 mcg after September 16, 2015 (first dispensing on index date) with ≥6 and ≥3 months continuous enrollment pre- and post-index, respectively, were identified. Patients with COPD diagnoses were excluded. Baseline characteristics, healthcare resource utilization and costs, and treatment patterns before and following TIO initiation were described for TIO cohorts and subgroups classified by concomitant medications received during the 30-day period after initiation.ResultsThe study included 766 TIO 1.25 mcg and 1055 TIO 2.5 mcg users. In the TIO 1.25 mcg cohort, 16% (126/766) used TIO monotherapy while 61% (465/766) used TIO+ICS/LABA± leukotriene receptor antagonists (triple therapy). In TIO 1.25 mcg monotherapy and triple therapy subgroups, 39% and 49% were treated by allergists/pulmonologists, 27% and 48% experienced a moderate/severe asthma exacerbation, and 50% and 68% used rescue oral corticosteroids during the baseline period, respectively. Following triple therapy initiation, 44% of patients discontinued ICS within 6 months. The TIO 2.5 mcg cohort demonstrated similar trends.ConclusionThis study provided insights into real-world US use of TIO in asthma. Overall, 16–19% of patients received TIO monotherapy and had high baseline exacerbation rates, suggesting that additional ICS-containing medication may be beneficial. Patients initiating triple therapy were among the most severe, with high baseline exacerbation rates and rescue medication use, and had high post-treatment ICS discontinuation rates, suggesting unmet needs in this population.

Treatment patterns and cost of care in commercially insured relapsed acute myeloid leukemia (AML) patients in the outpatient setting.

99 Background: Outpatient administration of cancer therapy has become more common in recent years. The objective of this study was to evaluate treatment patterns and cost of care for relapsed AML patients in the outpatient setting. Methods: A retrospective analysis was performed using the IQVIA Health Plan Claims Data–US database. Patients were eligible if they had at least one outpatient claim associated with relapsed AML diagnosis as identified by ICD-9 (205.02) and ICD-10 (C92.02, C92.42, C92.52, C92.62, C92.A2) codes between 1/1/2009 to 12/31/2017, had no inpatient claim for AML diagnosis within 30 days of index claim, and received treatment for relapsed AML as recommended by NCCN guidelines within 30 days of index outpatient claim. Utilization of high intensity chemotherapy (HIC), hypomethylating agent (HMA), low-dose cytarabine (LoDAC) and sorafenib, duration of treatment and the cost per 28-day treatment cycle were examined. Patients were censored at either treatment switching or end of follow-up. Results: Of the 6,242 patients with relapsed AML diagnosis in the IQVIA™ database, 709 did not have inpatient claim of which only 281 patients [26.0% &gt;65 years; 43.8% females] met inclusion criteria and received a total of 1,336 treatment cycles of NCCN recommended treatment as outpatient. About 75% of patients (n=209) received HMA, 6% (n=17) received HIC and 19.6% (n=55) received LoDAC. Patients &gt;65 years were more likely to receive HMA than HIC and LoDAC (p=0.003). Mean (SD) number of treatment cycles for HMA, high-intensity chemotherapy and LoDAC was 5.7 (5.2), 1.2 (0.4) and 2.2 (1.4), respectively. Sorafenib was used in 4.8%, 17.6% and 3.6% patients treated with HMA, HIC and LoDAC. Mean (SD) cost per cycle was $11,246 (8,895), $10,620 (16,722), $3,254 (2,948), and $10,799 (3,057) for HMA, HIC, LoDAC and sorafenib, respectively. Conclusions: Treatment for relapsed AML in the outpatient setting without hospitalization was uncommon during the study period. Low-intensity regimens remain the mainstay of therapy in the outpatient setting, suggesting that treatment toxicities and monitoring requirement are key determinants for treatment setting for relapsed AML.

The promise and perils of 'Big Data': focus on spondyloarthritis.

This review will describe the available large-scale data sources to study spondyloarthritis (SpA), enumerate approaches to identify SpA and its disease-related manifestations and outcomes, and will outline existing and future methods to collect novel data types [e.g. patient-reported outcomes (PRO), passive data from wearables and biosensors]. In addition to traditional clinic visit-based SpA registries, newer data sources, such as health plan claims data, single and multispecialty electronic health record (EHR) based registries, patient registries and linkages between data sources, have catalyzed the breadth and depth of SpA research. Health activity tracker devices and PRO collected via PROMIS instruments have been shown to have good validity when assessed in SpA patients as compared to legacy disease-specific instruments. In certain cases, machine learning outperforms traditional methods to identify SpA and its associated manifestations in EHR and claims data, and may predict disease flare. Although caution remains in the application of newer data sources and methods including the important need for replication, the availability of new data sources, health tracker devices and analytic methods holds great promise to catalyze SpA research.

Trend analysis in hepatitis C testing, OptumLabs® Data Warehouse, 2011–2017

ObjectiveUsing administrative claims for privately insured and Medicare Advantage enrollees from a large, private, U.S. health plan, we estimated the prevalence of hepatitis C testing among individuals who were recommended to be tested (i.e., baby boomer cohort born between 1945 and 1965) by the CDC and United States Preventive Services Task Force. This panel will discuss strengths and weaknesses for monitoring hepatitis C testing using alternative data sources including self-reported data, insurance claims data, and laboratory testing data.IntroductionHepatitis C virus (HCV) infection is the most common blood-borne disease in the US and the leading cause of liver-related morbidity and mortality. Approximately 3.5 million individuals in the US were estimated to be living with HCV in 2010 and approximately half of them were unaware that they were currently infected. Among HCV infected individuals, those born between 1945 and 1965 (usually referred to as the baby boomer cohort) represents approximately 75% of current cases. Because of the substantial burden of disease among this age group, CDC expanded its existing HCV risk-based testing recommendations to include a one-time HCV antibody test for all persons born between 1945-1965. The United States Preventive Services Task Force (USPSTF) subsequently made the same recommendation in June 2013.MethodsWe obtained health plan enrollment information and claims data from the 2011 - 2017 OptumLabs® Data Warehouse, and utilized data from patients enrolled in either commercially insured programs or Medicare Advantage. We examined trends in HCV testing for the birth cohort born between 1945 and 1965 and compared their trend in testing to individuals who were not in the birth cohort. We developed two different estimates for HCV testing incidence in order to make comparisons to other commercial claims datasets. The denominator for both estimates was the number of adults continuously enrolled in one or more health plan(s) in a given calendar year (allowing up to a 45-day gap in coverage). The numerator for the first estimate was the number of people receiving any HCV related test in the current calendar year who had not received any HCV related test including HCV antibody test, HCV RNA test or HCV genotype test in the previous calendar years. The numerator for the second estimate was the number of people who were given an HCV antibody test (CPT: 86803 and 80074) in a given calendar year, irrespective of previous testing history.ResultsDuring the study period 2011 - 2017, there were 20,332,848 unique adults who met the inclusion criteria in the OptumLabs® data. Approximately 7.1 million (35.0%) of these individuals were born between 1945 and 1965. On average, there were approximately 2.8 million birth cohort enrollees for any given calendar year. For the birth cohort, the annual incidence of HCV testing was about 2% per year during the time period between 2008 and 2011 (data not shown). In general, between 2011 and 2017, the trends in testing rates were consistent across both estimation methods. Specifically for the birth cohort, the HCV testing rate increased substantially between 2012 and 2017, peaking in 2017 at 8.56% [95% CI: 8.53-8.59%] and 10.24% [95% CI: 10.21-10.27%]. The greatest increase occurred between 2016 and 2017 when the testing rate almost doubled. In contrast, for the non-birth cohort, the HCV testing rate started in 2012 at a rate similar to the birth cohort but did not increase in a similar fashion and did not see a substantial increase in HCV testing in 2016 or 2017.ConclusionsSince CDC and USPSTF recommended universal testing for the birth cohort in 2012 and 2013, respectively, hepatitis C testing rates have been increasing across all age groups. The rate of increase for the birth cohort was substantially greater than that for the non-birth cohort. CDC and USPSTF recommendations are likely a strong contributing factor impacting hepatitis C testing rates in the US. Efforts to promote hepatitis C testing should continue.

Trends in pancreatic cancer chemotherapy treatment in the United States from 2008 through 2016.

e15734 Background: Pancreatic cancer is the third leading cause of cancer death in the United States. 55% of patients present with advanced disease at diagnosis and are treated with chemotherapy, with gemcitabine and 5FU-backbone based therapies both demonstrating efficacy. However, data on the adoption of these of therapies in academic and non-academic centers is scarce. The goal of this study is to examine the aggregate adoption of these therapeutic regimens in widespread clinical practice from 2008 through 2016 using health plan claims data. Methods: Privately insured and Medicare patients with advanced pancreatic cancer treated with chemotherapy from 2008 through 2016 were identified from the OptumLabs Data Warehouse. First-line treatment regimen and duration were correlated with age, sex, race, Charlson Comorbidiy Index (CCI) score, and opioid use measured by morphine milligram equivalents (MME) (as a proxy for pain) in the 6 months prior to starting chemotherapy. Disease status was classified as advanced, adjuvant or neo-adjuvant. Results: For 14,301 patients treated with chemotherapy primarily, the use of monotherapy has significantly decreased from 73% to 27% (p &lt; 0.001) between 2008 and 2016, while combination therapy using two antineoplastic agents (20% to 41%; p &lt; 0.001) and three or more agents (6% to 32%; p &lt; 0.001) increased. Since 2013, patients receiving combination therapy vs. monotherapy are significantly younger (mean 66 vs. 70; p &lt; 0.001), have higher CCI (6.3 vs. 6.1; p = 0.002), and have similar daily opioid dose prior to chemotherapy (5.2 vs. 3.8 MMEs; p = 0.086). Duration on first-line regimen was greater in patients receiving combined therapy, compared to those on gemcitabine monotherapy (median 130 vs. 119 days; p &lt; 0.001) after adjusting for CCI, disease status, and demographics. Conclusions: The use of combined therapy for the treatment of pancreatic cancer has increased over time, with patients on combined therapy appearing to be younger. [Table: see text]

Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health.

Health plan administrative claims data present a cost-effective complement to traditional trial-specific ascertainment of clinical events typically conducted through patient report or a single health system electronic health record. We aim to demonstrate the value of health plan claims data in improving the capture of endpoints in longitudinal pragmatic clinical trials. This retrospective cohort study paralleled the design of the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial designed to compare the effectiveness of two doses of aspirin. We applied the ADAPTABLE identification query in claims data from Anthem, an American health insurance company, and identified health plan members who met the ADAPTABLE trial criteria. Among the ADAPTABLE eligible members, we selected overlapping members with PCORnet Clinical Data Research Networks in the 2 years prior to the index date (1 April 2014). PCORnet Clinical Data Research Networks consist of network partners (or healthcare systems) that store their electronic health record data in the same format to support multi-institutional research. ADAPTABLE outcome events-cardiovascular hospitalizations including admissions for myocardial infarction, stroke, or cardiac procedures; hospitalizations for major bleeding; and in-hospital deaths-were evaluated for a 2-year follow-up period. Events were classified as within or outside PCORnet Clinical Data Research Networks using facility identifiers affiliated with each hospital stay. Patient characteristics were examined with descriptive statistics, and incidence rates were reported for available Clinical Data Research Networks and claims data. Among 884,311 ADAPTABLE eligible health plan members, 11,101 patients overlapped with PCORnet Clinical Data Research Networks. Average age was 70 years, 71% were male, and average follow-up was 20.7 months. Patients had 1521 cardiovascular hospitalizations (571 (37.5%) occurred outside PCORnet Clinical Data Research Networks), 710 for major bleeding (296 (41.7%) outside PCORnet Clinical Data Research Networks), and 196 in-hospital deaths (67 (34.2%) outside PCORnet Clinical Data Research Networks). Incidence rates (events per1000 patient-months) differed between available network partners and claims data: cardiovascular hospitalizations, 4.1 (95% confidence interval: 3.9, 4.4) versus 6.6 (95% confidence interval: 6.3, 7.0), major bleeding, 1.8 (95% confidence interval: 1.6, 2.0) versus 3.1 (95% confidence interval: 2.9, 3.3), and in-hospital death, 0.56 (95% confidence interval: 0.47, 0.67) versus 0.85 (95% confidence interval: 0.74, 0.98), respectively. This study demonstrated the value of supplementing longitudinal site-based clinical studies with administrative claims data. Our results suggest that claims data together with network partner electronic health record data constitute an effective vehicle to capture patient outcomes since >30% of patients have non-fatal and fatal events outside of enrolling sites.

Real-world impact of glycated hemoglobin reduction on treatment intensification and glycated hemoglobin goal attainment in type 2 diabetes mellitus patients initiated on a sodium glucose co-transporter 2 (SGLT2) inhibitor (SGLT2i)

Objective: To evaluate the impact of a 0.2% reduction in glycated hemoglobin (HbA1c) on treatment intensification, poor HbA1c control and HbA1c goal attainment in patients with type 2 diabetes mellitus (T2DM) initiated on a sodium glucose co-transporter 2 (SGLT2) inhibitor (SGLT2i).Methods: IQVIATM Health Plan Claims Data – US and IQVIATM Ambulatory EMR Data – US databases (29 October 2012–31 March 2016) were used to identify adults with T2DM initiated on an SGLT2i (index date) who had HbA1c measurements pre- and post-index, and ≥6 months of eligibility pre-index (baseline). HbA1c change was defined as the difference between the first post-index and the last pre-index measurements. Cox regression models were used to assess treatment intensification, poor HbA1c control (i.e. HbA1c > 9%, among patients <9% at baseline) and goal attainment (HbA1c < 7%, <8%; among patients with HbA1c above goal at baseline) adjusting for HbA1c change and baseline characteristics. Patients were observed up to one year after the first HbA1c measurement or end of eligibility. Hazard ratios (HRs) and 95% confidence intervals (CIs) were reported.Results: A total of 938 patients (mean age 54.9, 42.5% female, mean HbA1c 8.5%) were selected. Following SGLT2i initiation, each 0.2% reduction in HbA1c levels was associated with a decreased risk of treatment intensification (HR [95% CI] = 0.90 [0.86–0.92]), a decreased likelihood of reaching HbA1c > 9% (HR [95% CI] = 0.85 [0.79–0.88]) and higher likelihoods of achieving a treatment goal of HbA1c < 7% (HR [95% CI] = 1.17 [1.12–1.21]) and HbA1c < 8% (HR [95% CI] = 1.08 [1.04–1.10]).Conclusions: In T2DM patients, each HbA1c reduction of 0.2% following the initiation of an SGLT2i was associated with a significant positive impact on treatment intensification and HbA1c goal attainment.

Using a Budget Impact Model Framework to Evaluate Antidiabetic Formulary Changes and Utilization Management Tools.

Traditional budget impact models predict the financial consequences of a new drug entering the market. This study provides an example of applying the budget impact framework to a new research question of interest to managed care organizations-what is the budget impact of our formulary and utilization management (UM) policy changes? To predict the 3-year annual budgetary impact of TRICARE's antidiabetic formulary and UM policy changes using TRICARE claims data. A budget impact model was built in Microsoft Excel using health plan claims data for a 3-year time horizon. Model outcomes included spending on antidiabetic medications and medications used for side effect treatment. In sensitivity analyses, medical costs from inpatient, outpatient, and emergency room visits were also estimated. Model inputs included health plan antidiabetic medication utilization, as well as publicly available drug cost, rebate, dispensing fee, and patient cost-sharing estimates. Type of enrollee and pharmacy were also incorporated into the model. Sensitivity analyses varied estimates for utilization switch rates between preferred and nonpreferred agents, drug costs, rebates, and dispensing fees, as well as predicted impact from implementation delays. For the 623,827 affected by the formulary and UM policy changes, the model predicted annual savings that increased from $24 million in the first year to $43 million in the third year after the changes. The majority of savings came from drug acquisition costs, as opposed to rebates, copays, and dispensing fees. Sensitivity analyses found savings across all varied parameters and scenarios except an unlikely scenario when 0% of utilization switched from nonpreferred to preferred agents. The model also predicted that the formulary and UM policy changes would lead to $529,439 in savings from medical visit costs in Year 3. This budget impact model predicted cost savings from the payer's formulary and UM policy changes. This project was supported by grant number F32HS024857 from the Agency for Healthcare Research and Quality (AHRQ), which contracted with the University of Maryland School of Pharmacy to conduct this study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the AHRQ, which had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or design to submit the manuscript for publication. The findings discussed in this manuscript represent the views of the authors and do not necessarily reflect the views of the Department of Defense, the Defense Health Agency, nor the Departments of the Army, Navy, and Air Force. Hung reports a grant from the AHRQ, during the conduct of the study, and personal fees from CVS Health and BlueCross BlueShield Association, outside the submitted work. Mullins reports grants and personal fees from Bayer and Pfizer and personal fees from Boehringer-Ingelheim, Janssen/J&J, Regeneron, and Sanofi, outside the submitted work. Mullins, Slejko, and Shaya are employed by the University of Maryland School of Pharmacy. Haines and Lugo have nothing to disclose. Part of this content was previously presented as a poster at the 2017 AMCP Managed Care & Specialty Pharmacy Annual Meeting; March 27-30, 2017; Denver, CO, and as poster and oral presentations at the 2017 AMCP Nexus Meeting; October 16-19, 2017; Dallas, TX. Part of this content was published as Hung's PhD dissertation.

Evaluation of a Methodologic Approach to Define an Inception Cohort of Rheumatoid Arthritis Patients Using Administrative Data.

Identifying incident rheumatoid arthritis (RA) is desirable in order to create inception cohorts. We evaluated an approach to identify incident RA in health plan claims data. Both Medicare and commercial claims data were linked to Corrona, a US RA registry. We evaluated the accuracy of year of RA onset in the registry (gold standard) versus different claims algorithms, varying International Classification of Diseases, Ninth Revision codes for RA/arthritis, duration of health plan enrollment preceding diagnosis (minimum of 1 versus 2 years), and use of RA medications. Results were reported as positive predictive values (PPVs) of the claims-based algorithm for incident RA. Depending on the algorithm tested and whether patients were enrolled in Medicare or the commercial health plan, the PPVs for incident RA ranged from 68-81%. A 2-year clean period free of all RA-related diagnoses and medications was somewhat more optimal although, by comparison, a 1-year clean period yielded similar PPVs and retained approximately 90% more RA patients for analysis. Claims-based algorithms can accurately identify incident RA.

Trends in Visits to Acute Care Venues for Treatment of Low-Acuity Conditions in the United States From 2008 to 2015

Over the past 2 decades, a variety of new care options have emerged for acute care, including urgent care centers, retail clinics, and telemedicine. Trends in the utilization of these newer care venues and the emergency department (ED) have not been characterized. To describe trends in visits to different acute care venues, including urgent care centers, retail clinics, telemedicine, and EDs, with a focus on visits for treatment of low-acuity conditions. This cohort study used deidentified health plan claims data from Aetna, a large, national, commercial health plan, from January 1, 2008, to December 31, 2015, with approximately 20 million insured members per study year. Descriptive analysis was performed for health plan members younger than 65 years. Data analysis was performed from December 28, 2016, to February 20, 2018. Utilization, inflation-adjusted price, and spending associated with visits for treatment of low-acuity conditions. Low-acuity conditions were identified using diagnosis codes and included acute respiratory infections, urinary tract infections, rashes, and musculoskeletal strains. This study included 20.6 million acute care visits for treatment of low-acuity conditions over the 8-year period. Visits to the ED for the treatment of low-acuity conditions decreased by 36% (from 89 visits per 1000 members in 2008 to 57 visits per 1000 members in 2015), whereas use of non-ED venues increased by 140% (from 54 visits per 1000 members in 2008 to 131 visits per 1000 members in 2015). There was an increase in visits to all non-ED venues: urgent care centers (119% increase, from 47 visits per 1000 members in 2008 to 103 visits per 1000 members in 2015), retail clinics (214% increase, from 7 visits per 1000 members in 2008 to 22 visits per 1000 members in 2015), and telemedicine (from 0 visits in 2008 to 6 visits per 1000 members in 2015). Utilization and spending per person per year for low-acuity conditions had net increases of 31% (from 143 visits per 1000 members in 2008 to 188 visits per 1000 members in 2015) and 14% ($70 per member in 2008 to $80 per member in 2015), respectively. The increase in spending was primarily driven by a 79% increase in price per ED visit for treatment of low-acuity conditions (from $914 per visit in 2008 to $1637 per visit in 2015). From 2008 to 2015, total acute care utilization for the treatment of low-acuity conditions and associated spending per member increased, and utilization of non-ED acute care venues increased rapidly. These findings suggest that patients are more likely to visit urgent care centers than EDs for the treatment of low-acuity conditions.

Evidence that patient-centered medical homes are effective in reducing emergency department admissions for patients with depression

The patient-centered medical home (PCMH) has increasingly been touted as one means of integrating behavioral health and primary care and more holistically caring for patients with chronic disease. With its whole person orientation, the PCMH presents an opportunity to reduce emergency department visits for patients with depression by focusing on the patient and his/her health care needs, facilitating communication among providers and patients, and improving patients' access to care providers across settings. This study examines the relationship between PCMH capacity - defined as the ability to offer a service identified as a component part of the PCMH - and the number of emergency department visits for patients with depression. Health plan claims data, self-report data from physician practices on their PCMH characteristics, and the Area Resource File were analyzed. Results show that overall PCMH capacity is associated with fewer emergency department visits for patients with depression, and interpersonal aspects of the PCMH in particular, were associated with fewer emergency department visits while technical capabilities were not. Interpersonal activities that facilitate care coordination, patient engagement, and connect patients with community resources might be more effective in keeping patients out of the emergency department for unnecessary reasons as compared to technical activities focused on reporting and information management.

Abstract P4-12-03: Tailoring screening to individual risk decreases the cost and improves the value of screening

Abstract Introduction: Health care spending rose from 5% to 17.8% of GDP between 1960 and 2015. Clinicians and researchers must engage in increasing health care value – better outcomes at less cost. Personalized screening is one such opportunity. The Patient Centered Outcomes Research Institute recently funded WISDOM (Women Informed to Screen Depending On Measures of risk), a randomized trial to tests the safety and efficacy of basing starting age, stopping age, frequency and modality of breast cancer screening on individual risk (Clinical Trials Identifier NCT02620852). The personalized arm of WISDOM integrates genetic testing into the risk algorithm. Funding for the clinical services of WISDOM (genetic test, risk assessment, high-risk counseling) are expected to be covered ( health plans, insurers). Risk determines the frequency, time to initiate screening and drives cost of downstream screening services. The cost of genetic testing is now less than $250, comparable to a mammogram. The WISDOM study model brings payers, policy makers, provider, technology, and advocate partners together to generate evidence to see if risk based screening is as safe, less morbid, preferred by women, promotes prevention, and has greater health care value. Health plans need to know the value proposition, thus we evaluated financial implications of coverage for risk-based screening. Methods: A model was developed to compare costs and benefits of risk-based vs. current screening practices from the perspective of a health plan. Modeled cohorts resembled a screening population with risk determining screening interval for the risk-based model, and average time between mammograms determining the interval for the model of current screening practices. Model parameters were gathered from published literature, national databases, early findings from WISDOM and health plan claims data. Sensitivity analysis was performed on all parameters, including costs of clinical services, screening rates, and health plan turnover. The clinical services specific to WISDOM use a fixed-fee schedule, and not varied in the model. All other costs were conservative, based on Medicare rates and published literature. Results: We estimated that over five years, risk-based screening is at worst cost neutral with potential for savings of up to $215 per participant. Based on current trial enrollment, we estimated that 30 per 1,000 health plan enrollees would join, resulting in an upfront cost of $6,000 for WISDOM-specific services, primarily the genetic test, and $600 in ongoing costs after Year 1. However, the health plan would save on mammogram and work up costs as participants would receive an average of 2-3 fewer mammograms over five years. Savings are sensitive to the age of participants, cost of mammograms, and savings increase over time. Per participant, five-year savings of $300 and $35 for those aged 40-49 and 65-74 respectively, and increased costs of $30 for those aged 50-64. Overall, an upfront investment of $6,000 per 1,000 health plan enrollees (30 participants) yields $3,800 in five-year savings. Conclusion: Personalized screening could provide cost savings and has the potential to increase health care value. Enrollment in the Wisdom study is ongoing and results will be reported in 5 years. Citation Format: Wimmer K, Stover Fiscalini A, Eklund M, DiGiorgio K, Naeim A, Athena and Wisdom Investigators, Esserman L. Tailoring screening to individual risk decreases the cost and improves the value of screening [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P4-12-03.