US Managed Care Organization Research Articles

HPR116 Do US Managed Care Organizations Restrict Coverage More Than the Food and Drug Administration Label?

HPR116 Do US Managed Care Organizations Restrict Coverage More Than the Food and Drug Administration Label?

HTA184 Investigating How Orphan Drug Manufacturers Can Optimize Clinical Trial Design so Patients across Geographies Can Access Life-Saving Innovations

Orphan drugs offer significant clinical benefit, however their cost leads to potentially unsustainable budget impact. US Managed Care Organizations (MCOs) and Pharmacy Benefit Managers (PBMs) often provide coverage, regardless of price and limitations of data at launch, while European payers review data more critically before providing coverage. This poses a challenge to manufacturers of how to design clinical trials that ensure their product will be reimbursed across geographies.

Economic modelling of costs associated with outcomes reported for type 2 diabetes mellitus (T2DM) patients in the CANVAS and EMPA-REG cardiovascular outcomes trials

Aims: To model direct medical costs associated with reductions in cardiovascular disease (CVD) events in T2DM patients reported in the CANVAS and EMPA-REG trials, which assessed the cardiovascular safety of canagliflozin and empagliflozin, respectively.Materials and methods: Costs were modeled from a US managed care organization (MCO) perspective for the CVD outcomes included in both trials: three-point major adverse cardiovascular event (MACE) and its components (cardiovascular-related death, nonfatal myocardial infarction, nonfatal stroke), as well as heart failure requiring hospitalization. The rate of CVD events averted (difference between study drug and placebo) was projected to the portion of an MCO T2DM population matching the respective trial’s inclusion criteria. A targeted literature search for paid amounts directly associated with each CVD event provided the unit costs, which were applied to the projected number of events averted, to calculate costs avoided per member per year (PMPY). One-way sensitivity analyses were performed on events averted, unit costs, and percentages of trial-applicable patients.Results: Based on three-point MACE events averted, costs avoided PMPY of $6.17 (range: $1.27–$10.94) for CANVAS and $2.75 ($0.19–$4.83) for EMPA-REG were estimated. Costs avoided for individual components of MACE ranged from $0.77 to $3.84 PMPY for CANVAS and from -$0.97 (additional costs) to $1.54 for EMPA-REG. PMPY costs avoided for heart failure were $2.72 for CANVAS and $1.32 for EMPA-REG.Limitations and conclusions: Models assumed independent, non-recurrent outcomes and were restricted to medical costs directly associated with the trial-reported events. The reductions in CVD events in T2DM patients reported for both CANVAS and EMPA-REG project to a positive cost avoidance for these events in an MCO population. The analysis did not include an assessment of the impact on total cost, as the costs associated with adverse events, drug utilization or other clinical outcomes were not examined.

Health Care Resource Utilization, Costs, and Persistence in Patients Newly Diagnosed as Having Nonvalvular Atrial Fibrillation and Newly Treated With Dabigatran versus Warfarin in the United States

PurposeThis study compared health care resource utilization (HCRU), costs, and persistence among patients newly diagnosed as having nonvalvular atrial fibrillation (NVAF) and newly treated with dabigatran versus warfarin. MethodsThis retrospective claims-based study used data from a large US managed care organization. The earliest claim for dabigatran or warfarin during October 1, 2010 through October 31, 2011 was the index date, with cohort assignment based on index medication. Evidence of newly diagnosed NVAF within 30 days before the index date and no claims for oral anticoagulants during the 12-month preindex period were required. Cohorts were matched using propensity scores. Per-patient-per-month HCRU, costs, and persistence were calculated during the variable follow-up period of up to 12 months after the index date. Descriptive and multivariable analyses were used to examine differences in outcomes. FindingsAfter matching, 869 patients per cohort were identified (mean age, 67.8 years; 40.4% female). Compared with warfarin, dabigatran had fewer per-patient-per-month emergency department (0.10 vs 0.13, P = 0.010), office (1.98 vs 2.96, P < 0.001), and outpatient (1.05 vs 1.48, P < 0.001) visits. Despite higher mean pharmacy costs for dabigatran (P < 0.001), mean total health care (P = 0.309) and medical costs (P = 0.568) were similar to warfarin. Persistence was higher with dabigatran versus warfarin (median, 204 vs 161 days; mean, 213.7 vs 195.5 days, P = 0.001). ImplicationsAmong patients newly diagnosed as having NVAF, those newly treated with dabigatran had lower HCRU, higher persistence, and similar total health care costs compared with those treated with warfarin.

SAT0044 The Role of C-Reactive Protein or Erythrocyte Sedimentation Rate in Predicting Cardiovascular Outcomes in Rheumatoid Arthritis: Analysis of Data from US Managed Care Organization

BackgroundPatients with RA are at a 2- to 3-fold higher risk for cardiovascular (CV) events. Disease activity in RA is often assessed by C-reactive protein (CRP) or erythrocyte sedimentation rate...

Further Evidence for Bias in Observational Studies of Influenza Vaccine Effectiveness: The 2009 Influenza A(H1N1) Pandemic

Preinfluenza periods have been used to test for uncontrolled confounding in studies of influenza vaccine effectiveness, but some authors have claimed that confounding differs in preinfluenza and influenza periods. We tested this claim by comparing estimates of the vaccine-mortality association during the 2009/2010 influenza year, when there was essentially no circulation of seasonal influenza in the United States, and 2007/2008, a typical influenza year. We pooled data on seniors (adults aged ≥65 years) from 7 US managed care organizations that participated in the Vaccine Safety Datalink Project. We defined influenza vaccination, all-cause mortality, and potential confounders from administrative databases. We quantified the vaccine-mortality association using Cox regression. During 2007/2008, the adjusted hazard ratio was 0.44 prior to influenza season, 0.62 during influenza season, and 0.71 after influenza season. A similar pattern was observed during 2009/2010, when any effect of seasonal influenza vaccine observed during all time periods must have resulted from confounding: 0.65 during the autumn, 0.80 during the winter, and 0.84 during the summer. In a year with minimal seasonal influenza, we found no evidence that confounding in autumn preinfluenza periods is qualitatively different from confounding in winter. This supports the use of preinfluenza periods as control time periods in studies of influenza vaccine effectiveness.

Budget impact of rosuvastatin initiation in high-risk hyperlipidemic patients from a US managed care perspective

Introduction:Statins reduce low-density lipoprotein cholesterol (LDL-C) levels, which, when elevated, represent a significant risk factor for cardiovascular (CV) disease. Hyperlipidemic patients at risk of CV events initiated on simvastatin or atorvastatin may be less likely to meet LDL-C goals (defined in National Cholesterol Education Program guidelines) and more likely to experience CV events than patients initiated on rosuvastatin. A 3-year budget impact model was developed to estimate the clinical impact and cost to a US managed care organization (MCO) with 1 million members of initiating high-risk hyperlipidemic patients on rosuvastatin rather than simvastatin or atorvastatin.Methods:A total of 1000 adult patients were assumed to initiate statins. The average baseline LDL-C level was 189 mg/dL. In scenario 1, all patients were initiated on simvastatin or atorvastatin and titrated to a higher dose, or switched to atorvastatin (if initiated on simvastatin) or rosuvastatin; in scenario 2, 50% of the 520 high-risk patients were initiated on rosuvastatin. Drug acquisition and administration costs were considered. Product labeling, clinical trial results, national prescription claims data, and published literature were used to populate the model.Results:Over 3 years, 75 additional patients reached their LDL-C goal in scenario 2, compared with scenario 1 (633 vs 558, respectively), at an increased cost of $240,628 ($1,415,516 vs $1,174,888, respectively). The additional per member per month (PMPM) cost of scenario 2 was $0.007.Limitations:This analysis assumed that statin efficacy is the same in real life as in trials, and used titration and switching patterns not based on patients’ goal attainment. However, sensitivity and scenario analyses showed that the model was less sensitive to these parameters than to cost-related parameters.Conclusions:Initiating high-risk hyperlipidemic patients on rosuvastatin may increase the number of patients reaching LDL-C goal at a relatively modest increase in PMPM cost to an MCO.

Safety of Zostavax™—A cohort study in a managed care organization

BackgroundZostavax™ is a live, attenuated varicella-zoster virus vaccine indicated for the prevention of herpes zoster (shingles). An observational post-licensure (Phase IV) study was conducted at Kaiser Permanente Northern California (KPNC), a US managed care organization, to assess the safety of zoster vaccine in people 60 years of age or older, vaccinated in routine medical care. MethodsWe performed a cohort study, comparing rates of clinical events resulting in hospitalizations or emergency department visits in a 42-day risk time period immediately following vaccination with rates in the same cohort in a subsequent comparison time period. The study data were reviewed and interpreted by an external safety review committee of 3 independent experts. ResultsApproximately 29,000 people≥60 years of age were vaccinated with zoster vaccine from July 2006 to November 2007. Of the 386 comparisons performed for the main analysis, 4 had an increased relative risk with a nominal p-value≤0.05. After medical records review, the timing of these conditions and procedures was found to be often prior to vaccination, and no clear increase in health events was observed in the risk period following vaccination compared to later. Persons receiving zoster vaccine appeared to be in their optimal health at the time of vaccination, which led to an apparent protective effect of the vaccine for some health outcomes, due to the study design. ConclusionsThere was no evidence of a safety concern for zoster vaccine.

Epidemiology of Systemic Sclerosis in a Large US Managed Care Population

To estimate the incidence and prevalence of systemic sclerosis (SSc) in a large US managed care organization (MCO) database. Subjects with claims-based evidence of SSc (ICD-9-CM code 710.1x) were identified from a health plan database. Incidence and prevalence for the period 2003-2008 were calculated. The overall age- and sex-adjusted incidence rate (2003-2008) for SSc was 5.6 cases per 100,000 person-years. The annual prevalence of SSc ranged from 13.5 in 2003 to 18.4 (per 100,000) in 2008. This analysis suggests a higher incidence and lower prevalence of SSc in this MCO than those previously reported for the United States.

Safety of Trivalent Inactivated Influenza Vaccine in Children Aged 24 to 59 Months in the Vaccine Safety Datalink

To evaluate the safety of trivalent inactivated influenza vaccine (TIV) in children aged 24 to 59 months and to evaluate the risk of medically attended events (MAEs) in a subcohort of children who had multiple annual doses of TIV over their lifetimes. Self-controlled screening study. Seven US managed care organizations from October 1, 2002, to March 31, 2006. Children aged 24 to 59 months who received at least 1 TIV dose (66 283 children and 91 692 TIV doses). Vaccination with TIV. Medically attended events in inpatient and emergency department settings in one of the following risk windows: 0 to 2, 1 to 14, or 1 to 42 days after vaccination. All MAEs that met the screening criteria of incidence rate ratios (IRRs) exceeding 1.0 and P ≤ .05 or IRRs exceeding 2.0 and P < .20 underwent medical record review. A secondary analysis examined the risk of MAEs in children who had multiple annual lifetime TIV doses. Nine diagnoses met the screening criteria. After medical record review, gastrointestinal tract symptoms (IRR, 1.18; 95% confidence interval [CI], 1.10-1.25), gastrointestinal tract disorders (7.70; 1.11-53.52), and fever (1.71; 1.64-1.80) remained significantly associated with vaccination. None of the events seemed to be serious, and none had complications. In the secondary analysis, there was an apparent dose response for vaccine and allergic reactions in the 1- to 3-day risk window. There was no evidence of serious MAEs following vaccination with TIV among children aged 24 to 59 months. Further studies are warranted to evaluate the risk of MAEs in children with multiple lifetime TIV doses.

IN3 COSTS ASSOCIATED WITH HCV AND RELATED COMPLICATIONS IN THE UNITED STATES FROM A MANAGED CARE PAYER'S PERSPECTIVE

COSTS ASSOCIATED WITH HCV AND RELATED COMPLICATIONS IN THE UNITED STATES FROM A MANAGED CARE PAYER’S PERSPECTIVE McAdam Marx C1, Hane CA2, Biskupiak J1, Deniz B3, McGarry L4, Brixner D1 1University of Utah, Salt Lake City, UT, USA, 2Ingenix, Eden Prairie, MN, USA, 3Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA, 4i3 Innovus, Medford, MA, USA OBJECTIVES: Estimate current healthcare costs for HCV and its consequences in a large, US managed care organization (MCO). METHODS: Patients with ICD-9 diagnosis codes for Hepatitis C viral (HCV) infection (1st diagnosis index date), age 18 years with 6 months of continuous enrollment were identified in a large, MCO claims database from 1/1/2002 to 3/31/2010. HCV patients were matched 1: 10 to patients without an HCV diagnosis or advanced liver disease (ALD), based on gender, age, index year (where synthetic index date enrollment median post-enrollment days to case index date), hospital referral region (HRR) state, pre-index healthcare costs, alcoholism, HIV/AIDS, and modified Charlson Comorbidity Index. Cases were stratified by disease state: chronic HCV without liver involvement (CHCV), compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), or liver transplant. Mean per-member per-year (PMPY) costs were estimated post-index (total post-index cost of all patients /[sum of all postindex days/365]). Incremental PMPY costs for HCV patients vs. matched controls were estimated overall and by each disease state. RESULTS: 34,597 HCV patients were matched to 330,435 controls. Mean age of cases was 49.9 ( 8.5) years; 62% were female; 78% had C-HCV, 4% CC, 12% DC, 3% HCC, and 3% transplant. Incremental costs vs. controls overall were $9,681 PMPY. Incremental PMPY costs for patients with ALD were DC: $27,845, HCC: $43,671, and transplant: $93,609. For patients without ALD, incremental PMPYs were C-HCV: $5,870, and CC: $5,330. Incremental drug costs for HCV treatment were $2,739 overall, ranging from $1,893$8,736 for different states. C-HCV and CC drug costs were $2,659 and $3,102, respectively. CONCLUSIONS: Current estimates of HCV cost burden to MCOs were higher than previously reported and increased substantially with progression to ALD. The higher estimated costs of managing chronic HCV were likely due to high non-liver related costs among HCV patients or imprecise coding of CC.

Coverage of insulin delivery devices and basal insulin analogs by US managed care organizations

Objective:The perception in the US is that insulin formulations prescribed for type 1 and type 2 diabetes and delivered via insulin pens are more costly to patients than the same or similar products provided in vials, and that basal insulin analogs offered either in pens or vials are likewise more costly to patients than human insulin formulations. This study compares levels of coverage and copays by private and Medicare Part D plans for insulin pens and vials containing basal insulin analogs and for NPH formulations in vials.Methods:A commercially available formulary database (Access Point, Pinsonault Associates; updated quarterly) was analyzed as of January 2010 for private insurance plans and as of March 2010 for Medicare Part D plans. Analyses were performed for Tier-level coverage and copays per prescription for basal insulin analogs in pens and vials, and NPH in vials.Results:Basal insulin analogs in pens were covered by >91% of private and Part D plans. NPH coverage was reported by >92% of private plans and 69–95% of Part D plans, depending on brand. Irrespective of delivery mode, copays in the majority of private plans for basal insulin analogs and NPH were in the >$10–35 range. Copays were higher in Part D plans, with the majority of plans and subscribers in a >$35–50 range. Prior authorization was required by <10% of insurance plans for insulin analog pen prescriptions, and <3% of plans for insulin analog or NPH prescriptions in vials.Limitations:This analysis was descriptive, copay stratification was not based on a statistical model but on copay ranges typically used by the plans, and there were no direct correlations performed on the numbers of subscribers per plan vs copay or Tier level.Conclusion:These results counter the widely held perception that insurance coverage is less extensive for insulin pens vs vials. Medicare Part D plans often had higher copay requirements than private plans for the same product at the same copay Tier.

Association between glycemic control and short-term healthcare costs among commercially insured diabetes patients in the United States

Objectives:Glycemic control, measured by HbA1c, is well known to be a risk marker for long-term costly diabetes-related complications. The relationship between HbA1c and short-term costs is unclear. This study investigates how HbA1c is correlated to short-term diabetes-related medical expenses.Methods:Patients with diabetes with an HbA1c reading ≥6% between April and September 2007 were identified from a large US managed-care organization. Healthcare utilization data was obtained during the subsequent 12-month period. Multivariate analyses were performed to estimate the correlation between HbA1c and diabetes-related healthcare costs.Results:In all, 34,469 and 1,837 patients with type 2 and type 1 diabetes, respectively, were identified with an HbA1c reading ≥6% (mean HbA1c: 7.4% and 7.9%). The majority of patients with type 1 diabetes were treated with insulin, while most patients with type 2 diabetes were treated with metformin. The multivariate analysis showed that several characteristics, including HbA1c, significantly correlate with diabetes-related medical costs for both patients with type 1 and type 2 diabetes. A 1-percentage-point increase in HbA1c will, on average, lead to a 6.0% and 4.4% increase in diabetes-related medical costs for type 1 and type 2 diabetes, respectively. This corresponds to an annual cost increase of $445 and $250 for patients with type 1 and type 2 diabetes, respectively.Limitations:Retrospective data analyses inherently associated with selection bias which can only partly be adjusted by statistical techniques. Furthermore, the study population is not necessarily representative of the general population and there can be isolated coding or data errors in the dataset.Conclusions:These results suggest that tighter glycemic control is associated with short-term cost benefits for patients with diabetes. This supplements conventional wisdom that HbA1c affects risk of long-term complications and long-term costs.

An Economic Evaluation of Colesevelam when Added to Metformin-, Insulin- or Sulfonylurea-Based Therapies in Patients with Uncontrolled Type 2 Diabetes Mellitus

Several early studies demonstrated that bile acid sequestrants were useful for lowering lipid levels in patients with hypercholesterolaemia and may also be useful for lowering glucose levels in patients with type 2 diabetes mellitus (T2DM) uncontrolled on existing treatment (metformin-, insulin- or sulfonylurea-based therapies). This study modelled efficacy and safety data from the three clinical trials to evaluate the cost effectiveness to US Managed Care Organizations of add-on treatment with colesevelam for reducing diabetes-related complications. Three randomized controlled trials in patients with T2DM and one in hyperlipidaemia established that colesevelam lowered both glycaemic and lipid parameters in adult patients participating in the studies. The validated 'diabetic risk equation' (DRE) and the 'LIPID cardiovascular risk equation' (LCRE) were used to translate the observed clinical benefits (surrogate markers related to T2DM [glycosylated haemoglobin {HbA(1c)} and fasting plasma glucose] and cardiovascular disease [low-density lipoprotein cholesterol {LDL-C}]). Performing an appropriate economic evaluation required the use of both the DRE and the LCRE. These equations parameterize the clinical efficacy measures as continuous, facilitating their application to clinical trial results as well as the replication of other well established epidemiological data. Tobit regressions were applied to a large commercially available managed care administrative claims database (2000-6), Integrated Health Care Services (IHCS), to evaluate the incremental costs associated with each type of diabetic complication. Costs were inflated to 2010 values using the Healthcare Consumer Price Index, while second- and third-year cost savings were discounted at 5% to the current year. Bootstrap sampling with 5000 samples of 100 patients per cohort was conducted, varying the number of events avoided as well as their associated cost. With established metformin-, insulin- or sulfonylurea-based therapies, the addition of colesevelam significantly reduced HbA(1c) by approximately 0.5% (p < 0.001) in all three studies. In addition, colesevelam reduced placebo-adjusted LDL-C by 12.8-16.7% (p < 0.001). Using the DRE and LCRE equations, the total savings from reductions in diabetes-related and cardiovascular events were $US3543, $US4074 and $US3855 for colesevelam added to metformin-, insulin- and sulfonylurea-based regimens in patients with normal lipid levels. After subtracting the cost of colesevelam, first-year savings were $US1326, $US1852 and $US1629 in the metformin, insulin and sulfonylurea studies, respectively, for patients with raised lipid levels. In adult patients with T2DM, the addition of colesevelam to metformin-, insulin- or sulfonylurea-based therapies significantly improves glycaemic control while also reducing LDL-C, and these improvements could translate into substantial cost reductions due to reductions in the rates of diabetes-related and cardiovascular complications.

Budget impact model of tobramycin inhalation solution for treatment of Pseudomonas aeruginosa in cystic fibrosis patients

Background:Pseudomonas aeruginosa (PA) is the most common airway pathogen in cystic fibrosis (CF) patients. The objective of this analysis was to determine the costs of managing PA infection in CF patients with a chronic regimen of tobramycin inhalation solution (TIS).Methods:A budget impact model of CF patients was developed to evaluate the costs of TIS from a US managed-care organization (MCO) perspective. The Microsoft Excel model compared TIS treatment plus standard care with standard care alone over a 4-year time horizon and included the cost of drugs, medical care, and annual probabilities of hospitalization and IV anti-pseudomonal (anti-PA) antibiotics administration.Results:For an MCO with 5,000,000 members, 389 members 6 years of age or older were estimated to have CF, and 218 (56%) had PA infection. Assuming that use of TIS increased from 20% to 25%, the 1-year budget increased $231,251 or from $0.049 to $0.053 per member per month (PMPM). The net drug budget increase was $243,919, while medical costs associated with exacerbation management decreased $12,669 over the first year. Increasing utilization of TIS, from 20% to 40% over 4 years resulted in an incremental overall budget increase of $925,002, a 3% decrease in hospitalizations, and a 4% decrease in administrations of IV anti-PA antibiotics. These reductions translated to a medical care cost saving of $50,676 over 4 years. Limitations of this study include that the clinical data for the model are from clinical trials conducted in 1996 and the estimation of TIS use for CF patients with chronic PA infections can be impacted by TIS adherence.Conclusion:Model results suggest that increasing the use of TIS decreases medical care costs due to decreased hospital admissions and the use of IV anti-PA antibiotics at the expense of higher drug costs.

Healthcare utilization changes in relation to treatment intensification with insulin aspart in patients with type 2 diabetes. Data from a large US managed-care organization

ABSTRACTObjective: Most patients with type 2 diabetes eventually require exogenous insulin therapy to achieve good glycemic control due to the progressive nature of the disease. Insulin aspart is a rapid-acting insulin analog developed for prandial use. This study aimed to illustrate the implications on healthcare costs of adding insulin aspart to basal therapy in a real-world setting.Methods: Patients with type 2 diabetes who intensified previous basal therapy with insulin aspart were identified from a large commercial US healthcare data source between April 2007 and September 2008. Patients were required to have received basal insulin treatment with or without concomitant oral antidiabetic (OAD) therapy for at least 90 days pre- and post-initiation of insulin aspart. Wilcoxon signed-rank test and McNemar's test were used for continuous and categorical variables, respectively, to analyze the difference of self-comparison between pre- and post insulin aspart add-on.Results: In total, 1,739 patients with an average age of 56 years were identified, of whom 55% were male. After initiation of insulin aspart, a significant improvement in glycemic control was observed (change in HbA1c: –0.5%, p=0.0013). Similarly, a reduction of 0.4% in HbA1c was observed for the subpopulation of 151 patients, who had both pre-and post-index HbA1c data (p=0.0085). Also, significantly fewer patients used OADs after insulin aspart initiation (56 vs. 64%, p< 0.0001). Overall and diabetes-related healthcare costs also significantly decreased by $2,283 and $2,028, respectively (p≤0.0001). Diabetes-related inpatient visits appear to be the main contributor to total cost (46%); however, after initiation of insulin aspart the number of inpatient visits decreased by 0.50 visits/patient/year (p< 0.05). This decrease was reflected in a large reduction in cost related to inpatient visits ($3,019/patient).Limitations: A regression to the mean effect may be associated with this pre-post comparison. The ability to make conclusions regarding cause and effect may be limited due to the retrospective design of this study.Conclusions: Patients with type 2 diabetes achieved better glycemic control and needed less OAD treatment after adding insulin aspart to previous basal therapy. Furthermore, patients experienced on average reduced healthcare utilization after initiation of insulin aspart, which resulted in significant cost savings.

Cost of atrial fibrillation in United States managed care organizations

Atrial fibrillation (AF) has been shown to be associated with high healthcare costs; however, limited data are available from large-scale studies quantifying the overall cost burden of AF in the USA. We therefore aimed to provide an up to date estimate of the overall per-patient costs of AF in managed care organizations across the USA. This retrospective cohort study used claims data from the Integrated Healthcare Information Systems National Managed Care Benchmark Database from January 2005 to December 2006. Patients included in the analysis were aged > or =20 years and had at least two outpatient AF-related claims without hospitalization, or a hospitalization with a primary or secondary discharge diagnosis of AF in 2005. AF-related inpatient and outpatient costs over 12 months from the initial outpatient claim or first hospitalization were examined. For secondary AF hospitalizations, incremental costs associated with AF were measured by comparing costs for patients with AF with a group of matched controls hospitalized without AF. In total, 35,255 patients diagnosed as having AF (5008 with a primary AF diagnosis, 10,776 with a secondary AF diagnosis, 19,471 with outpatient-managed AF), and 20,571 controls without AF, were included in the analysis. Over 12 months, for primary AF hospitalization patients, inpatient costs were $11,306.53 and outpatient costs were $2826.78 (total $14,133.30) per patient. For hospitalized patients with secondary AF, incremental AF-related inpatient costs were $5181.19 and outpatient costs were $1376.33 (total $6557.52). For AF patients with outpatient management in 2005, 12-month AF-related costs were $2177.30 ($175.47 for AF hospitalizations in 2006 and $2001.85 for outpatient costs). Overall costs of AF in the US managed care organizations are high. Costs are primarily due to inpatient expenses. Improved disease management strategies to reduce AF-related hospitalizations and decrease the overall cost burden of AF are needed.

A comparison of insulin use, glycemic control, and health care costs with insulin detemir and insulin glargine in insulin-naive patients with type 2 diabetes

Objectives: The goal of this study was to compare daily insulin use, glycemic control, and health care costs in insulin-naive patients with type 2 diabetes who initiated treatment with either insulin detemir or insulin glargine. Methods: This was a retrospective cohort analysis of health care claims data and laboratory results for adult, insulin-naive patients with type 2 diabetes who were enrolled in a large US managed care organization and initiated basal therapy with insulin detemir or insulin glargine between May 1, 2006, and December 31, 2006. The daily average consumption (DACON) of insulin was calculated as the total number of units dispensed (excluding the last fill) divided by the number of days between the index date and the date of the last fill of the index insulin. Glycemic control was evaluated by comparing mean glycosylated hemoglobin (HbA 1c) values in the preindex period (the 180 days before the index date) and the follow-up period (the 180 days after the index date). Mean all-cause and diabetes-related health care costs in the preindex and follow-up periods were calculated and compared. Results: The analysis included 48 patients initiating therapy with insulin detemir and 258 initiating therapy with insulin glargine. The mean age of the 2 cohorts was ~54 years, and most patients in each cohort were male (52.1% and 59.7%, respectively). Few patients in either cohort had a baseline HbA 1c value <7% (13% and 10%), suggesting poor glycemic control at the time of insulin initiation. After adjustment for confounders (eg, preindex diabetes medication), the DACON of insulin was comparable between cohorts (29.3 and 29.6 U/d; P = NS), as were follow-up HbA 1c values (8.2% and 7.9%). Insulin detemir and insulin glargine also were associated with comparable mean adjusted all-cause pharmacy costs ($3074 and $2899), medical costs ($2319 and $3704), and total health care costs ($6014 and $7023). However, insulin glargine was associated with significantly higher mean adjusted diabetes-related medical costs compared with insulin detemir ($1510 vs $707, respectively; P = 0.03), as well as significantly higher mean adjusted total diabetes-related health care costs ($3408 vs $2261; P = 0.03). Conclusions: In this managed care population of insulin-naive patients who initiated therapy with insulin detemir or insulin glargine, the daily insulin dose and glycemic control did not differ significantly between the 2 insulins. However, patients receiving insulin detemir incurred lower diabetes-related medical and total health care costs.

Delay in filling the initial prescription for a statin: A potential early indicator of medication nonpersistence

Background: Identification of early predictors of medication nonpersistence may allow timely adherence-promoting interventions and potentially reduce the risk of negative health outcomes. Objective: This study was conducted to determine whether delay in filling an initial statin prescription predicts subsequent nonpersistence with medication. Methods: This observational study of a cohort of adult patients (>18 years) who newly initiated statin therapy between December 1997 and June 2000 employed data from the administrative claims database of a large US managed care organization. Patients initiating statin therapy had to have at least 18 months of continuous eligibility and no statin use in the 6-month period before the index prescription. A new measure, dispensation delay, was measured as the gap between the most recent physician or hospital visit and the fill date of the index prescription. Five categories of dispensation delay were created—no delay, 1 to 7 days, 8 to 30 days, 31 to 183 days, and >183 days. Nonpersistence was defined as a gap of ≥30 days in the statin prescription supply during the follow-up period. Cox proportional hazards regression was used to model the risk of the initial dispensation delay on the time to discontinuation, controlling for such variables as demographic characteristics, comorbidities, physician specialty, and previous health care utilization. Results: The final sample included 19,038 patients. Among all variables studied, the dispensation-delay variables were the most significant predictors of non-persistence, with a longer delay predicting a higher risk of early discontinuation. Patients with delays in filling the initial prescription of >30 days but <183 days were 30% more likely to discontinue therapy than those without delays (hazard ratio = 1.30; 95% CI = 1.20–1.40). Conclusions: The delay in filling the first statin prescription significantly predicted future non-persistence. Use of this measure may allow early identification of patients at high risk for early discontinuation.

37: Inpatient Use of Erythropoiesis Stimulating Agents (ESA) Among Commercially-Insured Dialysis Patients

INPATIENT USE OF ERYTHROPOIESIS STIMULATING AGENTS (ESA) AMONG COMMERCIALLY-INSURED DIALYSIS PATIENTS Donald Brophy, Carolyn Harley, Benjamin Chastek, Gregory Daniel, Brian McNeeley, Matthew Gitlin, Tracy J Mayne. Virginia Commonwealth Univ, Richmond, VA; i3 Innovus, Eden Prairie, MN; HealthCore, Inc, Wilmington, DE, Amgen Inc., Thousand Oaks, CA. There is evidence that dialysis patients return from hospitalizations with low hemoglobin levels (Yaqub, 2001; Turenne 2007). Dialysis patients receive outpatient ESAs and one possible factor may be that patients do not receive ESA therapy during hospitalization. This study descriptively evaluates inpatient ESA use from 2004 2005 among privately insured dialysis patients. This was a cross-sectional retrospective analysis of claims from two large US managed care organizations (MCO) covering a combined 20 million lives over two years. ESRD patients were identified by ≥1 ESRDspecific claim in the inpatient setting, or ≥3 dialysis-related claims on separate days during each 12-month period. We examined patient demographics and hospitalization characteristics, including the percent of patients receiving ESAs during hospitalization by length of stay (LOS). Patient demographics were similar across years and MCOs. The mean (+SD) number of hospitalizations over both years were ~1.1 (+1.3) for MCO#1 and ~1.6 (+ 1.7) for MCO#2. Table 1:% of hospitalizations with ESA use by LOS