US Managed Care Plan Research Articles

Care and Disease Management: Why Managed Care Organizations (MCOs) Need to have an Inclusive Approach to Patient Care

The health sector increasingly uses the terms "managed care" and "disease management," but few people understand them. Managed care refers to any health care system that pays for and provides treatment. Pressure to keep prices low has helped it flourish in the United States, and improved resource management is lowering costs. US managed care plans vary, but they share several traits. These include restricted doctor providers, secondary care access, selective contracting, financial incentives, quality monitoring, and utilization management. The NHS has all of these aspects, making it a united managed care system. Disease management coordinates resources across the health care system to treat patients throughout their illness. Business organizations have noticed that the NHS lacks a well-established system for disease management. Concerns regarding commercial engagement include the separation of basic medical services, the possibility of becoming a for-profit corporation, and the use of patient-based data. New guidelines may allow NHS disease control to increase.

Abstract 9: Alirocumab Prior Authorization Approval and Prescription Fill Rates Among Medicare Advantage Patients in a Large US Managed Care Plan

Introduction: Alirocumab is a proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitor approved as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol. Barriers to possession, including therapy cost and cost-sharing implications, may contribute to low utilization of this therapy. Objective: To explore differences in demographic and clinical characteristics between patients with prior authorization (PA) approvals or denials for alirocumab as evidenced through filled alirocumab prescription claims. Methods: A retrospective claims-based database analysis of patients with a Medicare Advantage Prescription Drug (MAPD) plan was conducted to identify patients with evidence of a PA approval for alirocumab. Among the group of patients with a PA for alirocumab, the pharmacy claims database was searched for evidence of a corresponding prescription claim within 30 days following the first PA request (index date). The analysis was stratified by evidence of Federal low income subsidy (LIS) support, a program that provides extra assistance with prescription drug costs for eligible individuals whose income and resources are limited, and/ or dual eligibility (DE) status, eligible for Medicare and Medicaid, (LIS/DE) at index. Results: A total of 2,098 MAPD patients meeting study inclusion/exclusion criteria and with a PA for alirocumab were identified between March 1, 2016 and February 28, 2017. Non-LIS/DE patients comprised approximately 82% of the eligible population (n=1,730). There were several notable differences in baseline demographics between the non-LIS/DE vs. the LIS/DE cohorts with an approved PA claim, including Deyo-Charlson Comorbidity Index (2.2 vs. 3.0), prevalence of diabetes mellitus (39.2% vs. 54.7%), and prevalence of HeFH (11.8% vs. 15.6%). While the percentage of patients with an approved PA was similar between the LIS/DE and non-LIS/DE cohorts, 88.9% and 91.2%, respectively, substantially more patients in the LIS/DE cohort had evidence of alirocumab possession based on a paid claim (60.6%) vs. those in the non-LIS/DE cohort (17.3%). Conclusion: Although a high percentage of MAPD patients had evidence of an approved PA, there were notable differences in clinical and demographic characteristics between those with and without LIS/ DE status. Further, the proportion of patients with an approved PA and a paid prescription claim differed markedly amongst MAPD patients with and without LIS/DE status, suggesting further research is needed to understand potential barriers to obtaining PCSK9i therapy.

Value analysis of digital breast tomosynthesis for breast cancer screening in a commercially-insured US population.

PurposeThe objective of this study was to conduct a value analysis of digital breast tomosynthesis (DBT) for breast cancer screening among women enrolled in US commercial health insurance plans to assess the potential budget impact associated with the clinical benefits of DBT.MethodsAn economic model was developed to estimate the system-wide financial impact of DBT as a breast cancer screening modality within a hypothetical US managed care plan with one million members. Two scenarios were considered for women in the health plan who undergo annual screening mammography, ie, full field digital mammography (FFDM) and combined FFDM + DBT. The model focused on two main drivers of DBT value, ie, the capacity for DBT to reduce the number of women recalled for additional follow-up imaging and diagnostic services and the capacity of DBT to facilitate earlier diagnosis of cancer at less invasive stages where treatment costs are lower. Model inputs were derived from published sources and from analyses of the Truven Health MarketScan® Research Databases (2010–2012). Comparative clinical and economic outcomes were simulated for one year following screening and compared on an incremental basis.ResultsBase-case analysis results show that 4,523 women in the hypothetical million member health plan who are screened using DBT avoid the use of follow-up services. The overall benefit of DBT was calculated at $78.53 per woman screened. Adjusting for a hypothetical $50 incremental cost of the DBT examination, this translates to $28.53 savings per woman screened, or $0.20 savings per member per month across the plan population and an overall cost savings to the plan of $2.4 million per year.ConclusionThe results of this study demonstrate clinical and economic favorability of DBT for breast cancer screening among commercially-insured US women. Wider adoption of DBT mammography presents an opportunity to deliver value-based care in the US health care system.

The potential association between postmenopausal hormone use and primary open-angle glaucoma.

Retinal ganglion cells are known to express estrogen receptors and prior studies have suggested an association between postmenopausal hormone (PMH) use and decreased intraocular pressure, suggesting that PMH use may decrease the risk for primary open-angle glaucoma (POAG). To determine whether the use of 3 different classes of PMH affects the risk for POAG. Retrospective longitudinal cohort analysis of claims data from women 50 years or older enrolled in a US managed-care plan for at least 4 years in which enrollees had at least 2 visits to an eye care provider during the period 2001 through 2009. Postmenopausal hormone medications containing estrogen only, estrogen + progesterone, and estrogen + androgen, as captured from outpatient pharmacy claims over a 4-year period. Hazard ratios (HRs) for developing incident POAG. Of 152,163 eligible enrollees, 2925 (1.9%) developed POAG. After adjustment for confounding factors, each additional month of use of PMH containing estrogen only was associated with a 0.4% reduced risk for POAG (HR, 0.996 [95% CI, 0.993-0.999]; P = .02). The risk for POAG did not differ with each additional month of use of estrogen + progesterone (HR, 0.994 [95% CI, 0.987-1.001]; P = .08) or estrogen + androgen (HR, 0.999 [95% CI, 0.988-1.011]; P = .89). Use of PMH preparations containing estrogen may help reduce the risk for POAG. If prospective studies confirm the findings of this analysis, novel treatments for this sight-threatening condition may follow.

Anti-diabetic drug utilization of pregnant diabetic women in us managed care

BackgroundWith the increasing prevalence of type 2 diabetes in young adulthood, treatment of diabetes in pregnancy faces new challenges. Anti-diabetic drug utilization patterns of pregnant women with pre-existing diabetes are poorly described. We aim to describe anti-diabetic (AD) agent utilization among diabetic pregnant women.MethodsWe utilized IMS LifeLink, including administrative claims data of patients in US managed care plans, to establish a retrospective cohort of women, age 18–46 years (N = 96,740) with billed procedures for a live birth, and a 12 month eligibility period before and 3 month after delivery. Diabetes mellitus was identified from ≥2 in- or outpatient claims with diagnoses (ICD-9-CM 250.XX) before pregnancy. We estimated the prevalence of AD drugs before, during and after pregnancy, and secular trends across the study period (1999–2009), using linear regression. A sensitivity analysis was conducted to identify the extent of misclassification of trimesters.ResultsAlmost six percent (n = 5,581) of the live birth cohort had diabetes mellitus. Throughout the study, 48% (1999) and 78% (2009) (p < 0.0001) of diabetic women received AD drugs during pregnancy. The most common AD drugs during pregnancy were insulin, metformin, sulfonylureas, thiazolidinediones (TZD), and combination AD. The annual prevalence of insulin use increased by only 1% from 39% (1999) to 40% (2009) (p = 0.589) during pregnancy, while use of sulfonylureas and metformin increased from 2.5% and 4.2% (1999) to 17.3% and 15.3% (2009) (p < 0.0001), respectively. Insulin and sulfonylurea use steadily increased in prevalence from the 1st to 3rd trimester (16.5% and 3.3% to 33.0% and 7.5%), while metformin and TZD use decreased (11.4% and 1.6% to 3.8% and 0.2%).ConclusionsAD use during pregnancy demonstrates the need for additional investigation regarding safety and efficacy of AD drugs on maternal outcomes.

AB0499 Post-discontinuation treatment patterns for tumor necrosis factor-blockers in rheumatoid arthritis patients in the US

BackgroundEtanercept (ETN), adalimumab (ADA), and infliximab (INF) are the 3 most frequently prescribed tumor necrosis factor (TNF)-blocker therapies that are approved by the US Food & Drug Administration for treatment...

Medical costs and healthcare resource use in patients with lupus nephritis and neuropsychiatric lupus in an insured population

Objective:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organ systems, including the kidneys (lupus nephritis) and the central nervous system (neuropsychiatric lupus, or NPSLE). The healthcare costs and resource utilization associated with treating lupus nephritis and NPSLE in a large US managed care plan were studied.Methods:SLE subjects ≥18 years of age and with claims-based evidence of nephritis or neuropsychiatric conditions were identified from a health plan database. An index date was set as a randomly drawn date from all qualifying claims during 2003–2008 for study subjects. Subjects were matched on the basis of demographic and clinical characteristics to unaffected controls. Costs and resource use were determined during a fixed 12-month post-index period.Results:Nine hundred and seven lupus nephritis subjects were matched to controls, and 1062 subjects with NPSLE were matched to controls. Mean overall post-index healthcare costs were significantly higher among subjects with lupus nephritis in comparison to matched controls ($33,472 vs $5347, p < 0.001). Similarly, mean overall post-index healthcare costs were significantly higher among subjects with NPSLE compared to controls ($30,341 vs $4646, p < 0.001). Subjects with lupus nephritis or NPSLE had higher mean post-index numbers of ambulatory visits, specialist visits, emergency department visits and inpatient hospital stays, compared to controls (all p < 0.001).Limitations:Additional research, such as medical chart review, could provide validation for the claims-based identification of lupus nephritis and NPSLE subjects. Also, indirect costs were not evaluated in this study.Conclusion:Subjects with lupus nephritis or NPSLE have high costs and resource use, compared to unaffected controls.

Off‐label antidepressant use in children and adolescents compared with young adults: extent and level of evidence

To estimate the degree of, and level of evidence supporting, off-label antidepressant (AD) prescribing for children and adolescents compared with young adults. Retrospective cohort study utilizing medical and pharmacy claims data from US-managed care plans, 1997-2009. Patients aged 5-24 years, with at least one (index) AD claim during a period of continuous enrollment. Drug-diagnosis pairs, on the basis of medical claims within 30 days pre-index or post-index AD, were grouped as (1) Food and Drug Administration (FDA)-approved or (2) off-label with one of three evidence categories based on Micromedex®2.0: favorable, inconclusive or limited-to-none (Thomson Micromedex, Greenwood Village, CO, USA). Over the study period, 290 816 subjects met eligibility criteria: 17% 5-12 years old, 40% 13-18 years old, and 43% 19-24 years old. Sertraline was the most commonly prescribed index AD (19-23%). Psychiatrists more often prescribed the AD for children (31%) and adolescents (35%) versus young adults (17%). Only 28% of all subjects had a diagnosis consistent with an FDA-approved indication within 30 days pre-index and post-index AD. Children less than 13 years old were less likely to have had an FDA-approved indication (5-10%). Most off-label prescribing had inconclusive to no evidence supporting efficacy. The lack of evidence was especially pronounced for younger children. Trends were consistent over the study period. Increasing the time period for potential indications pre-index and post-index AD did not result in significantly reduced off-label rates. Pediatric off-label AD prescribing occurs frequently without a strong evidence base, highlighting a need to generate additional evidence to ensure safe and effective use.

Rehospitalization following percutaneous coronary intervention for commercially insured patients with acute coronary syndrome: a retrospective analysis

BackgroundWhile prior research has provided important information about readmission rates following percutaneous coronary intervention, reports regarding charges and length of stay for readmission beyond 30 days post-discharge for patients in a large cohort are limited. The objective of this study was to characterize the rehospitalization of patients with acute coronary syndrome receiving percutaneous coronary intervention in a U.S. health benefit plan.MethodsThis study retrospectively analyzed administrative claims data from a large US managed care plan at index hospitalization, 30-days, and 31-days to 15-months rehospitalization. A valid Diagnosis Related Group code (version 24) associated with a PCI claim (codes 00.66, 36.0X, 929.73, 929.75, 929.78–929.82, 929.84, 929.95/6, and G0290/1) was required to be included in the study. Patients were also required to have an ACS diagnosis on the day of admission or within 30 days prior to the index PCI. ACS diagnoses were classified by the International Statistical Classification of Disease 9 (ICD-9-CM) codes 410.xx or 411.11. Patients with a history of transient ischemic attack or stroke were excluded from the study because of the focus only on ACS-PCI patients. A clopidogrel prescription claim was required within 60 days after hospitalization.ResultsOf the 6,687 ACS-PCI patients included in the study, 5,174 (77.4%) were male, 5,587 (83.6%) were <65 years old, 4,821 (72.1%) had hypertension, 5,176 (77.4%) had hyperlipidemia, and 1,777 (26.6%) had diabetes. At index hospitalization drug-eluting stents were the most frequently used: 5,534 (82.8%). Of the 4,384 patients who completed the 15-month follow-up, a total of 1,367 (31.2%) patients were rehospitalized for cardiovascular (CV)-related events, of which 811 (59.3%) were revascularization procedures: 13 (1.0%) for coronary artery bypass graft and 798 (58.4%) for PCI. In general, rehospitalizations associated with revascularization procedures cost more than other CV-related rehospitalizations. Patients rehospitalized for revascularization procedures had the shortest median time from post-index PCI to rehospitalization when compared to the patients who were rehospitalized for other CV-related events.ConclusionsFor ACS patients who underwent PCI, revascularization procedures represented a large portion of rehospitalizations. Revascularization procedures appear to be the most frequent, most costly, and earliest cause for rehospitalization after ACS-PCI.

Evaluation of the clinical benefit of long-term (beyond 2 years) treatment of skeletal-related events in advanced cancers with zoledronic acid

Background:Skeletal complications of malignant bone disease are common among patients with both solid tumors and multiple myeloma (MM). Zoledronic acid (ZOL; Zometa) is an intravenous bisphosphonate with proven efficacy in reducing the incidence of skeletal complications and delaying the time to a first skeletal complication. This study was designed to assess the continued benefit of ZOL treatment over a prolonged period.Methods:This was a retrospective claims analysis study using information gathered from two national US managed-care plan databases. Patients ≥18 years of age with a single type of solid tumor or MM who were diagnosed with bone lesions and experienced at least one skeletal complication (before or after receiving ZOL) were included.Results:Of the 28,385 patients, those with lung and breast cancer composed the largest group. Greater percentages of MM and breast cancer patients were treated with ZOL. On average, those with renal cell carcinoma and lung cancer had a longer time between bone metastasis diagnosis and start of therapy with ZOL. Compared with an untreated cohort, patients treated with ZOL had a 24% reduction in incidence of fracture, a 45% reduction in incidence of spinal cord compression, and a 56% reduction in risk of mortality. Patients with persistence with ZOL over 180 days had a reduced incidence of fracture before controlling for other factors.Conclusions:Patients treated with ZOL had reduced risks of fracture, spinal cord compression, and mortality compared with patients in the no-treatment cohort. Longer persistence with ZOL was associated with better outcomes. Greatest benefits were observed for patients treated on a regular basis with ZOL for a period beyond 18 months.

Patient Out-of-Pocket Payments for Oral Oncolytics: Results From a 2009 US Claims Data Analysis.

Oral oncolytics are an increasingly important treatment option for cancer. These agents often fall within the pharmacy benefit, with the potential for increased out-of-pocket (OOP) cost burden for patients. The purpose of this study was to evaluate patient OOP payments for oral oncolytic therapies in US managed care plans. Patients age ≥ 18 years who received one of 21 oral oncolytics were identified in 2009 US claims; the first oral therapy was the index therapy. OOP payments were calculated as the allowed amount (dollar amount a health plan allows for a therapy, including member liability) minus the paid amount (dollar amount paid by a health plan). Patient characteristics were provided, and per-claim OOP payments were evaluated for each of the 21 therapies in aggregate and stratified by payer type and index therapy. A total of 6,094 patients who received at least one oral oncolytic therapy were identified. Mean age was 53 years; 54% were women; 77% had a commercial payer; prevalent cancer diagnoses included breast, colorectal, glioblastoma, and lung. Mean OOP payments were highest for dasatinib ($527; median, $36) and lowest for cyclophosphamide ($15; median, $10). Medicare Risk patients had higher mean OOP payments for most therapies compared with commercial, Medicaid, and self-insured patients. Among 21 oral oncolytics, average OOP cost ranged from $15 to > $500. These results confirm previous findings showing OOP payments differing widely among oral oncolytic options. As cost for therapy becomes a greater part of treatment decisions, an understanding of patient OOP cost will be critical in informing choices.

Burden of Early-Stage Triple-Negative Breast Cancer in a US Managed Care Plan

ObjectiveTriple-negative breast cancer (TNBC) is a high-grade breast cancer with an aggressive clinical course. We examined the recurrence rate, health care utilization, and cost of early-stage TNBC in the US managed care setting. Study DesignA retrospective study using linked cancer registry, health care claims, and social administration databases. MethodsThis retrospective study used the Impact Intelligence Oncology Management cancer registry, linked to 1999-2009 administrative claims, from a national managed care health plan and also Social Security Administration mortality data. Patients with stage I-III TNBC and non-TNBC were followed from diagnosis to recurrence, disenrollment, or end of observation period. Risk-adjusted recurrence rate, health care utilization, and costs during the follow-up period were compared. ResultsA total of 1967 women (403 with TNBC) were included; 289 (14.7%) had local/distant recurrence during the follow-up period. Patients with TNBC were younger (53.68 vs. 56.16 years, P < .0001) and more likely to experience recurrence compared with non-TNBC (21.6% vs. 12.9%, P < .0001; adjusted hazard ratio=2.11, P < .0001). In terms of adjusted annual health care utilization and costs, patients with TNBC had significantly higher numbers of hospitalizations (1.20 vs. 0.90, P=.001); hospitalization days (8.80 vs. 4.97, P < .0001); and emergency department (ED) visits (1.45 vs. 0.95, P=.009). They also had significantly higher inpatient costs (all-cause: $9154 vs. $5501; cancer-related: $5632 vs. $2869; P < .0001 for both); and ED costs (all-cause: $303 vs. $182, P=.003; cancer-related: $240 vs. $138, P=.012). ConclusionsThis study demonstrates that, compared with non-TNBC, early-stage TNBC is associated with higher rate of recurrence, resulting in increased health care utilization and costs.

Retrospective evaluation of the clinical benefit of long-term continuous use of zoledronic acid in patients with lung cancer and bone metastases

Background:For patients with bone metastases, skeletal-related events including fracture are common, can cause considerable morbidity, and may reduce overall survival (OS). This retrospective analysis assessed the effect of Zometa (zoledronic acid, ZOL), an intravenous bisphosphonate (IV-BP), on fracture risk and OS in patients with bone metastases from lung cancer (LC). (Zometa is a registered trademark of Novartis Pharmaceuticals Corporation, USA.)Methods:A claims-based analysis using commercial and Medicare Advantage data from >45 US managed-care plans was used to evaluate the association between fracture risk and treatment persistency (31–90, 91–180, 181–365, and ≥366 days) and follow-up duration in LC patients diagnosed with bone metastases between 01/01/2001 and 12/31/2006 and treated with ZOL or without (no IV-BP). Persistency was defined as the absence of a >45-day gap between ZOL treatments. Analysis of variance tests were used to compare follow-up duration, a proxy for OS, between ZOL persistency groups. The effect of time to treatment with ZOL was also assessed.Results:In 9874 LC patients with bone metastases (n = 1090 ZOL; n = 8784 no IV-BP) the unadjusted relative fracture risk was reduced by 40% with ZOL vs no IV-BP; fracture risk decreased consistently with increasing duration of ZOL treatment. Even short-term (31–90 days) ZOL significantly reduced fracture risk (47%) vs no IV-BP (p = 0.005) with adjustment for differences in demographic and clinical characteristics. Delaying ZOL until after bone metastases were diagnosed significantly increased fracture risk (p = 0.0017). For a sub-set of patients included in a survival analysis (n = 550 ZOL; n = 4512 no IV-BP), mortality was significantly lower (mean, 38.6 vs 46.8 deaths/100 person-years; p = 0.038) in those treated with ZOL vs no IV-BP.Limitations:Interpretation of this claims-based analysis must be tempered by the inherent limitations of observational data, such as limited clinical information and the ability to control for prognostic factors.Conclusions:This retrospective analysis demonstrates that LC patients with bone metastases receiving ZOL had significantly reduced risk of fracture (p = 0.005) and death (p < 0.038) vs patients receiving no IV-BP. Longer ZOL persistency consistently yielded better outcomes, with ≥12 months’ treatment producing the greatest benefit.

Retrospective database analysis of the effect of zoledronic acid on skeletal-related events and mortality in women with breast cancer and bone metastasis in a managed care plan

Background:Bone metastases are common in patients with advanced breast cancer, and place patients at risk for skeletal-related events (SREs) including pathologic fracture, spinal cord compression, hypercalcemia of malignancy, and the need for radiotherapy and/or surgery to bone. These SREs are associated with reduced survival and quality-of-life. The nitrogen-containing bisphosphonates Zometa (zoledronic acid, ZOL) and Aredia (pamidronate disodium, PAM) reduce SRE risk in patients with bone metastases from breast cancer. This database analysis compared SRE and mortality rates in a real-life setting in women with breast cancer receiving ZOL and PAM, and assessed long-term ZOL benefit.Methods:A retrospective, claims-based analysis was conducted using commercial and Medicare Advantage data from >45 US managed-care plans. Eligible adult patients had diagnoses for breast cancer and bone metastasis between 01/01/01 and 12/31/06, continuous enrollment in the health plan, and no evidence of bone metastasis or intravenous bisphosphonate (IV-BP) use for 6 months before their first ZOL or PAM infusion. Patients were followed until disenrollment (including mortality) or end of the analysis period (12/31/07). Persistency was defined as absence of a >45-day gap between IV-BP treatments.Results:Of 8757 patients (mean age, 58.1 [SD 12.4] years), ∼ 30% were treated with ZOL, 15% with PAM, and 55% with no IV-BP. Patients treated with ZOL had a moderately lower incidence of SREs (mean, 36.2 vs 40.0 SREs/100 person-years; p = 0.0707) and significantly lower mortality (mean, 6.5 vs 11.2 deaths/100 person-years; p < 0.001) compared with PAM-treated patients. Longer persistency with ZOL was associated with lower risk of fracture and all SREs (trend-test p = 0.0076 and p = 0.0200, respectively).Limitations:Interpretation of this claims-based analysis must be tempered by the inherent limitations of observational data, such as imbalances in patient populations and the potential for bias in treatment selection.Conclusions:This analysis suggests that fewer than half of breast cancer patients with bone metastases receive IV-BPs. Longer persistence with ZOL was associated with lower SRE risk, and ZOL-treated patients had longer survival and a non-significant trend toward fewer SREs compared with PAM.

PIN32 Economic Burden of Non-CF Bronchiectasis Enrolled in a US Managed Care Plan

PIN32 Economic Burden of Non-CF Bronchiectasis Enrolled in a US Managed Care Plan

Improving automated case finding for ectopic pregnancy using a classification algorithm

Research and surveillance work addressing ectopic pregnancy often rely on diagnosis and procedure codes available from automated data sources. However, the use of these codes may result in misclassification of cases. Our aims were to evaluate the accuracy of standard ectopic pregnancy codes; and, through the use of additional automated data, to develop and validate a classification algorithm that could potentially improve the accuracy of ectopic pregnancy case identification. Using automated databases from two US managed-care plans, Group Health Cooperative (GH) and Kaiser Permanente Colorado (KPCO), we sampled women aged 15-44 with an ectopic pregnancy diagnosis or procedure code from 2001 to 2007 and verified their true case status through medical record review. We calculated positive predictive values (PPV) for code-selected cases compared with true cases at both sites. Using additional variables from the automated databases and classification and regression tree (CART) analysis, we developed a case-finding algorithm at GH (n = 280), which was validated at KPCO (n = 500). Compared with true cases, the PPV of code-selected cases was 68 and 81% at GH and KPCO, respectively. The case-finding algorithm identified three predictors: ≥ 2 visits with an ectopic pregnancy code within 180 days; International Classification of Diseases, 9th Revision, Clinical Modification codes for tubal pregnancy; and methotrexate treatment. Relative to true cases, performance measures for the development and validation sets, respectively, were: 93 and 95% sensitivity; 81 and 81% specificity; 91 and 96% PPV; 84 and 79% negative predictive value. Misclassification proportions were 32% in the development set and 19% in the validation set when using standard codes; they were 11 and 8%, respectively, when using the algorithm. The ectopic pregnancy algorithm improved case-finding accuracy over use of standard codes alone and generalized well to a second site. When using administrative data to select potential ectopic pregnancy cases, additional widely available automated health plan data offer the potential to improve case identification.

Thrombopoietin receptor agonist (TPO-RA) usage and treatment patterns among patients with chronic immune thrombocytopenic purpura (cITP) in a large U.S.-managed care plan.

e16586 Background: Little is known about real-world usage of TPO-RAs and treatment patterns for patients with cITP. Methods: Using medical/pharmacy claims and enrollment data of a large US managed care plan, adults being treated for cITP (ICD-9 287.31) were identified from Aug 2008 to Dec 2009. Patients were stratified into cohorts based on the treatments for cITP prescribed. Patients treated with chemotherapy were excluded, as were those with hepatitis, HIV or heparin-induced thrombocytopenia. Patients were followed from start of treatment until death, plan disenrollment, or March 2010. Sequence and rates of ITP treatments and splenectomy were assessed. Results: A total of 927 patients met study criteria. Corticosteroids were the most frequent first-line therapy (86.8%) while the most common second-line options were rituximab, IVIG, anti-D, or splenectomy, recorded for 24.7%, 18.3%, 14.6%, and 8.9%. Treatment with TPO-RA increased in later lines of therapy: second line (6.9%), third line (13.1%), fourth line (26.2%). About 21.4% received > 3 therapies; 2.3% of patients received > 5 therapies. The proportion of patients aged > 65 years was similar (≈ 25% in each group) among TPO-RA-treated patients and patients initiating other treatments, although the anti-D and splenectomy cohorts were slightly younger (8.3% and 17.0% respectively). Splenectomy was recorded in 12.7% of the total study population. Among TPO-RA-treated patients, 3.7% of eltrombopag- and 6.2% of romiplostim-treated patients had splenectomy prior to TPO-RA treatment; 11.5% of eligible eltrombopag- and 23.3% of eligible romiplostim- treated patients had post-TPO-RA splenectomies. Among TPO-RA users, 10.5% received both eltrombopag and romiplostim during their course of treatment. Conclusions: Wide practice variations, likely influenced by personal experience with different treatment options, were observed for management of cITP after initial treatment with corticosteroids. TPO-RAs were used mainly in later lines of therapy. Evidence-based treatment algorithms and guidelines for management of cITP may optimize treatment strategies, especially with introduction of new agents.

All-cause and disease-related health care costs in patients with painful diabetic peripheral neuropathy prescribed pregabalin versus duloxetine

The study objective was to compare changes in all-cause and painful diabetic peripheral neuropathy (pDPN)-related healthcare costs in patients initiating treatment with pregabalin (PGB) and duloxetine (DLX) in real-world settings. Patients (318 years) initiating PGB or DLX between 6/1/07-12/31/08 were identified from a large US managed care plan database. Those with 3 1 medical claim with: (1) primary or secondary ICD-9-CM code of 357.2; or (2) primary code of 249.xx or 250.xx plus 337.1, 354.4, 354.5, 354.8, 354.9, 355.7x, 355.8, 355.9 or 356.9 on the same claim were considered to have pDPN.

A Large Observational Study of Cardiovascular Outcomes Associated With Atorvastatin or Simvastatin Therapy in Hypertensive Patients Without Prior Cardiovascular Disease

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.6 mg/d) and 23,786 simvastatin users (mean dose 28.6 mg/d), and followed a median 1.5 years for the occurrence of a first CV event. The crude CV event rates were 2.81 and 3.92 per 100 person-years for atorvastatin and simvastatin, respectively [unadjusted hazard ratio (HR): 0.73; 95% confidence interval (CI): 0.68-0.78, P < 0.001]. After adjusting for clinical and demographic confounders, use of atorvastatin was associated with fewer CV events compared with simvastatin (HR: 0.91; 95% CI: 0.84-0.98, P = 0.009). However, the lipid-lowering efficacy of the 2 statins could not be assessed as patient lipid data were unavailable. In conclusion, hypertensive patients without cardiovascular disease who initiated atorvastatin (10 or 20 mg/d) had a significantly lower risk of subsequent CV events compared with those who initiated simvastatin at doses of similar potency (20 or 40 mg/d). As with all observational studies, the study is subject to certain limitations, and the findings should be regarded as hypothesis generating.

Physiciansʼ Decisions to Prescribe Antidepressant Therapy in Older Patients with Depression in a US Managed Care Plan

Published studies indicate that depression in older adults is severely under-recognized and under-treated. To characterize primary-care physicians' decisions to prescribe antidepressants to older patients with depression. Electronic medical record (EMR) notes from office visits of older patients (aged ≥65 years), treated in a central Massachusetts multi-specialty medical group practice, were screened every 2 weeks between August 2007 and July 2008 for mention of depression. Electronic surveys containing questions about depression severity and onset, and antidepressant treatment, were sent to physicians whose EMR notes indicated that they had treated an older patient with depression, until approximately 400 responses had been received. Physicians were asked about whether they prescribed antidepressants or made changes to antidepressant treatment and were asked about the extent to which they agreed with a set of pre-specified reasons for treatment recommendations. Physicians were also allowed to document any other reasons that influenced their decision. Patient characteristics and treatment were identified from administrative claims. Univariate analyses were used to describe patient characteristics and physician survey responses. Physicians responded to the survey and confirmed a depression diagnosis for 396 patients, for whom the average age was 77.1 years and 76.5% were female. Most patients had physician-reported depression onset after age 60 years (72.2%) and moderately severe depression (58.8%). Physicians reported that 62.9% of patients were already being treated with antidepressants prior to their visit, 28.5% were recommended antidepressant initiation and 8.6% were not prescribed antidepressants. Selective serotonin reuptake inhibitors were most frequently prescribed. Maintaining prior therapy was recommended for 81.1% of treated patients and treatment modification for 18.9%. Almost all physicians (>92%) agreed that experience in use of prescription drugs, safety/tolerability and patient improvement influenced their decision to maintain prior therapy or recommend new therapy. 85.8% of physicians agreed that availability of efficacy data in the elderly influenced their decision to prescribe new therapy. 38.9% of patients who were recommended new therapy initiation did not fill an antidepressant prescription. Despite previous reports of under-treatment of depression in the elderly, this study suggests that physicians are comfortable prescribing antidepressants to the elderly, and the majority of older patients with depression were prescribed antidepressants. Rather than a physician's prescribing decision, it may be patient factors, such as refusal to accept diagnosis/treatment and noncompliance, that may lead to under-treatment--approximately 40% of patients who were recommended new antidepressant therapy did not fill an antidepressant prescription.