A pooled analysis of exenatide use and risk of acute pancreatitis.

OBJECTIVE: To estimate the association between exenatide BID use and acute pancreatitis across two claims-based studies. RESEARCH DESIGN AND METHODS: We pooled two cohort studies within separate commercial health insurance databases. We included initiators of exenatide BID and all other antihyperglycemic drugs without prior pancreatitis from 2005-2008. Poisson regression models provided rate ratios (RRs) and 95% confidence intervals (CIs) of the association of exenatide BID with acute pancreatitis adjusted for quintiles of propensity scores. MAIN OUTCOME MEASURES: Primary inpatient diagnoses of acute pancreatitis with correction for misclassification via a validation sub-study. RESULTS: There were 49,956 initiators of exenatide BID and 692,333 initiators of other antihyperglycemic drugs. Patients in the two studies were similar on many demographic and clinical characteristics. Exenatide BID initiators had a higher prevalence of diagnoses consistent with diabetes complications (e.g. peripheral neuropathy) and cardiovascular risk factors (e.g. hypertension). In both studies, current exenatide BID use was not associated with uncorrected outcomes of acute pancreatitis (pooled RR 1.0; CI 0.8-1.3). PPV correction resulted in a slightly higher point estimate for current use (pooled RR 1.3; CI 1.0-1.7) and past use (pooled RR 1.6; 95% CI 1.2-2.1). CONCLUSIONS: These data are consistent with little or no higher risk of acute pancreatitis associated with current exenatide BID use relative to nonuse. Although previous work identified non-causal mechanisms, an increased incidence of acute pancreatitis following cessation of treatment remains a possibility. Bias due to residual confounding or outcome misclassification may remain, and should be considered a potential explanation for these findings.

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

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Patient out-of-pocket payments for oral oncolytics: results from a 2009 US claims data analysis.

OBJECTIVES: 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. MATERIALS AND METHODS: Patients aged >18 years who received 1 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. RESULTS: A total of 6094 patients who received at least 1 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. CONCLUSIONS: 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.

Economic outcomes of exenatide vs liraglutide in type 2 diabetes patients in the United States: results from a retrospective claims database analysis.

OBJECTIVE: The safety and efficacy of the GLP-1 receptor agonists exenatide BID (exenatide) and liraglutide for treating type 2 diabetes mellitus (T2DM) have been established in clinical trials. Effective treatments may lower overall treatment costs. This study examined cost offsets and medication adherence for exenatide vs liraglutide in a large, managed care population in the US. METHODS: This was a retrospective cohort analysis comprising adult patients with T2DM who initiated exenatide or liraglutide between 1/1/2010 and 6/30/2010 and had 6 months pre-index and post-index continuous eligibility. Patients were propensity score-matched to controls for baseline differences. Medication adherence was measured by proportion of days covered (PDC). Paired t-test and McNemar's test were used to compare outcomes. RESULTS: Matched exenatide and liraglutide cohorts (n=1347 pairs) had similar average total 6-month follow-up costs ($6688 vs $7346). However, exenatide patients had significantly lower mean pharmacy costs ($2925 vs $3272, p<0.001). Among liraglutide patients, patients receiving the 1.8 mg dose had significantly higher average total costs compared to those receiving the 1.2 mg dose ($8031 vs $6536, p=0.026), with higher mean pharmacy costs in the 1.8 mg cohort ($3935 vs $3146, p<0.001). There were no significant differences in inpatient or outpatient costs or medication adherence between groups (mean PDC: exenatide 56% vs liraglutide 57%, p=0.088). LIMITATIONS: The study assumed that all information needed for case classification and matching of cohorts was present and not differential across cohorts. The study did not control for covariates that were unavailable, such as HbA1c and duration of diabetes. CONCLUSIONS: Patients initiating exenatide vs liraglutide for T2DM had similar medication adherence and total healthcare costs; however, exenatide patients had significantly lower total pharmacy costs. Patients prescribed 1.8 mg liraglutide had significantly higher costs compared to those on 1.2 mg.

Patterns of treatment with chemotherapy and monoclonal antibodies for metastatic colorectal cancer in Western Europe.

BACKGROUND AND OBJECTIVES: Treatment outcomes improved in metastatic colorectal cancer (mCRC) due to the introduction of new chemotherapies and monoclonal antibodies. This study describes current patterns of pharmacological treatment for mCRC in clinical practice in four European countries. METHODS: This cohort study used physician-survey data from the LifeLink Oncology Analyzer Database for mCRC patients in France, Germany, Italy and Spain. All patients aged ≥21 years at mCRC diagnosis and with data collected during 2009 were included. Treatment patterns were examined descriptively by lines of therapy. RESULTS: The study sample included 2682 mCRC patients. In first-line, more patients received FOLFOX (infusional 5-fluorouracil/leucovorin and oxaliplatin)- than FOLFIRI (infusional 5-fluorouracil/leucovorin and irinotecan)-, containing regimens in Germany (42 vs. 30%) and Spain (25 vs. 16%), while in Italy and France the reverse was true (Italy: 34% FOLFIRI vs.29% FOLFOX; France: 26 vs. 19%). In second-line, FOLFIRI-containing regimens were more commonly used than FOLFOX-containing regimens in Germany (36 vs. 18%), Italy (29 vs. 14%), and Spain (34 vs. 6%), while similar proportions of FOLFOX and FOLFIRI were used in France (18 vs. 15%). As part of first-line treatment, bevacizumab use ranged from 44% of patients in Italy to 30% in Spain, with slightly lower rates in second-line. Cetuximab first-line use ranged from 14% of patients in Spain to 7% in Italy, increasing in second-line to 30% in Spain, 26% in Italy, 20% in Germany, and 17% in France. LIMITATIONS: This analysis focused on description of treatment patterns, however, the actual clinical benefits of these treatment regimens on survival or quality of life were not addressed due to lack of relevant information in the data source. Some country differences in treatment patterns were observed. These differences might be partly explained by differences in local treatment guidelines, physician prescribing behaviours, reimbursement policies, and response to various regimens due to genetic differences. CONCLUSIONS: In clinical practice in four European countries, FOLFOX- and FOLFIRI-based regimens are common standard of care chemotherapies for mCRC (FOLFOX and bevacizumab + FOLFIRI are the most common regimens), and monoclonal antibodies are often combined with these chemotherapies.

Major surgery in patients with metastatic colorectal cancer in Western europe.

PURPOSE: Given the potential interference between treatment for metastatic colorectal cancer (mCRC) and surgical procedures, we sought to determine the prevalence of major surgery following mCRC diagnosis in clinical practice. METHODS: This cohort study used physician-surveyed data from the LifeLink™ Oncology Analyzer database for mCRC patients in five European countries (France, Germany, Italy, Spain, and the United Kingdom [UK]). All patients aged ≥21 years at mCRC diagnosis and with data collected during 2009 were included. Major surgical procedures were examined descriptively by the purpose and location of surgery. RESULTS: The study sample included 3,249 mCRC patients; 515, 862, 656, 649, and 567 were from France, Germany, Italy, Spain, and the UK, respectively. Following mCRC diagnosis, at least one major surgical procedure for any purpose was seen in 30.5% (UK), 35.2% (Germany), 35.6% (Spain), 36.3% (France), and 38.4% (Italy) of patients, with a mean of 1.3 (UK) to 1.6 (France) procedures. The rate of major surgery for curative purposes was the highest in Italy (13.4%), followed by France (12.8%), Spain (10.3%), and Germany (9.2%); the lowest was in the UK (7.2%). Major surgery performed on the primary tumor (12.4-27.1% of patients, depending on the country) and metastasis (6.4-14.6%) made up the majority of all surgical procedures. CONCLUSIONS: Major surgery is highly prevalent following mCRC diagnosis, suggesting an important role in meeting the goals of mCRC treatment. The role of pharmacological treatment options and their potential to interfere with both surgery use and surgical outcomes should be considered when evaluating mCRC treatment strategies.

Risk of cardiovascular disease events in patients with type 2 diabetes prescribed the glucagon-like peptide 1 (GLP-1) receptor agonist exenatide twice daily or other glucose-lowering therapies: a retrospective analysis of the LifeLink database.

OBJECTIVE: To test the hypothesis that exenatide twice daily reduces the relative incidence of cardiovascular disease (CVD) events among patients with type 2 diabetes compared with other glucose-lowering agent(s). RESEARCH DESIGN AND METHODS: A retrospective database analysis was performed of the LifeLink database of medical and pharmaceutical insurance claims for June 2005 through March 2009. Patients with no history in the preceding 9 months of myocardial infarction, ischemic stroke, or coronary revascularization procedure were assigned to the exenatide-initiated or non-exenatide-initiated cohorts based on the first new prescription filled and reassigned if exenatide was prescribed or discontinued. Incident CVD events (myocardial infarction, ischemic stroke, or coronary revascularization procedure) were identified by ICD-9-CM diagnosis codes. Patient outcomes were adjusted for differences in clinical and demographic characteristics and compared using propensity score-weighted discrete time survival analysis with time-varying exposure to exenatide. RESULTS: A total of 39,275 patients with type 2 diabetes were treated with exenatide twice daily, and 381,218 patients were treated with other glucose-lowering therapies. Patients who initiated exenatide were more likely to have prior ischemic heart disease, obesity, hyperlipidemia, hypertension, and/or other comorbidities at baseline. Exenatide-treated patients were less likely to have a CVD event than non-exenatide-treated patients (hazard ratio 0.81; 95% CI 0.68-0.95; P = 0.01) and lower rates of CVD-related hospitalization (0.88; 0.79-0.98; P = 0.02) and all-cause hospitalization (0.94; 0.91-0.97; P < 0.001). CONCLUSIONS: Exenatide twice-daily treatment was associated with a lower risk of CVD events and hospitalizations than treatment with other glucose-lowering therapies.

Can adherence to antihypertensive therapy be used to promote adherence to statin therapy?

OBJECTIVE: To compare adherence with statin therapy in patients switching to single-pill amlodipine besylate/atorvastatin calcium with patients adding a separate statin to their amlodipine regimen. METHODS: We identified hypertensive patients prescribed amlodipine who switched to amlodipine/atorvastatin (switch) or added a statin to their amlodipine regimen (add-on) from July 2004 to June 2007. Propensity score matching (1 switch:3 add-on) was applied based on 'nearest neighbor' approach. The primary adherence measure was patients with proportion of days covered (PDC) >/=0.80 at 180 days; secondary measures included mean PDC and persistence. A sensitivity analysis was performed, accounting for total statin/amlodipine exposure. RESULTS: Among 4556 matched patients (n = 1139 switch; n = 3417 add-on), mean age was 53.9 years and 52.1% were male. After 180 days, adherence with statin therapy was higher for the switch vs add-on cohort (50.8% vs 44.3%; P < 0.001). After adjusting for pre-index amlodipine adherence, the switch cohort was more likely to be adherent than the add-on cohort (odds ratio: 1.64 [95% confidence interval: 1.42 to 1.89]). Persistence was higher in the switch than the add-on cohort (127.6 vs 117 days; P < 0.001). CONCLUSION: Hypertensive patients taking amlodipine who initiated statin therapy via single-pill amlodipine/atorvastatin were more likely to remain adherent to their statin than patients adding a separate statin to their antihypertensive regimen.

Economic outcomes associated with microvascular complications of type 2 diabetes mellitus: results from a US claims data analysis.

BACKGROUND: Patients with diabetes mellitus have been shown to be at high risk for both macrovascular and microvascular complications (MVC). Recent studies have focused on MVC and their effect on the healthcare system, but limited published data exist on long-term costs associated with MVC in patients with type 2 diabetes mellitus (T2DM). OBJECTIVE: The objective of this study was to compare resource utilization and medical costs over a 12-month period among patients diagnosed with T2DM with versus without MVC in a managed-care population. METHODS: Patients aged >/=18 years, diagnosed with T2DM between 1 January 2003 and 31 December 2004 were identified in an administrative claims database of approximately 55 million beneficiaries in private and public health plans. The date of the first T2DM diagnosis during this period was the 'index date' for each patient. All patients had to have a minimum of 12 months of continuous enrolment both prior to and following the index date. MVC was identified during the 12 months prior to the first T2DM diagnosis and these patients were matched (1 : 2) by age, sex and ten co-morbid conditions to those with no evidence of MVC during the entire study period. RESULTS: Among the 15 326 MVC patients included in the study, 61% had a history of peripheral neuropathy, 28% diabetic retinopathy and 19% nephropathy. Compared with 30 652 patients without MVC, the MVC patients were more likely to use oral antidiabetics and insulin and had a higher co-morbidity score. Over 12 months, patients with MVC had more (mean 0.3 vs 0.2; p < 0.001) and longer (mean length of stay 1.79 days vs 0.85 days; p < 0.001) hospital stays; physician office visits (19.7 vs 13.7; p < 0.001); and prescriptions for oral antidiabetic (6.3 vs 5.6 scripts; p < 0.001) and insulin (0.7 vs 0.2 scripts; p < 0.001) use. Average total costs per patient over 12 months were $US14 414 with MVC versus $US8669 without MVC (p < 0.001). CONCLUSIONS: This study indicates that in patients with T2DM, MVC is associated with significant consumption of healthcare resources. Mean total costs with MVC were almost double those of patients without MVC over a 12-month period.

Pharmacotherapy adherence and costs versus nonpharmacologic management in overactive bladder.

OBJECTIVE: To evaluate adherence with overactive bladder (OAB) pharmacotherapy and compare costs between patients receiving pharmacotherapy versus nonpharmacologic management. STUDY DESIGN: Retrospective cohort study using anonymous, patient-level data from administrative claims from the PharMetrics database. METHODS: Patients 18 years of age or older who received an OAB diagnosis or OAB medication prescription from January 1, 2005, through December 31, 2006, were identified. Eligible patients had continuous health plan enrollment from 6 months before to 12 months after the index date (date of first OAB prescription or first OAB diagnosis); exclusion criteria included prior OAB therapy use. Study cohorts were stratified as OAB therapy or nonpharmacologically managed based on evidence of treatment and matched using propensity score methodology. Outcomes included adherence rates with OAB therapy (defined as proportion of days covered [PDC]) and comparative costs of OAB pharmacotherapy versus nonpharmacologic management from a healthcare payer perspective. RESULTS: Adherence among OAB therapy patients was low, with 14% of patients achieving PDC of 80% or higher and an average PDC of 32%. Unadjusted total costs were approximately 3% higher for OAB therapy versus nonpharmacologically managed patients due to higher pharmacy costs. Conversely, outpatient service and inpatient hospitalization costs were higher for nonpharmacologically managed patients. Results did not change after adjusting for patient characteristics. CONCLUSION: Results confirm low adherence to OAB pharmacotherapy, with few patients achieving PDC of 80% or higher. Total costs were higher among OAB therapy patients due to higher pharmacy costs, but outpatient and inpatient costs were higher among nonpharmacologically managed patients. Additional research into optimizing pharmacotherapeutic regimens may provide insight into improving treatment adherence.

Economic outcomes in patients diagnosed with systemic lupus erythematosus with versus without nephritis: results from an analysis of data from a US claims database.

BACKGROUND: Based on a literature search, there are limited data on the economic burden of systemic lupus erythematosus (SLE), particularly in patients with lupus nephritis. OBJECTIVE: The objective of this study was to compare health care resource utilization and direct medical care costs over a period of 12 months in patients with a history of SLE with or without nephritis. METHODS: Patients aged >or=18 years with >or=1 claim for an immunosuppressive/disease-modifying antirheumatic drug, antimalarial agent, NSAID/cyclooxygenase-2 inhibitor, or other SLE-related treatment (eg, opioid and combination analgesic, antianxiety agent, antihyperlipidemic agent, antihypertensive agent, bisphosphonate, vitamin D) dated between January 1, 2007, and December 31, 2007, were identified using a nationally representative, US commercial insurance claims database. The date of the first dispensation of the treatment represented the index date. Patients were required to have >or=2 claims containing a diagnosis of SLE during a 6-month preindex period through 3 months postindex and to have continuous health plan enrollment for 6 months before and 12 months after the index date. Patients with >or=1 claim containing a diagnosis of nephritis during the preindex period were identified. Health care resource utilization and direct medical care cost data were assessed over a period of 12 months; paid amounts were used as a proxy for costs and were expressed in year-2008 US dollars. RESULTS: A total of 15,590 patients with SLE were identified (13,828 women, 1762 men; mean age, 48 years); 1068 (6.9%) had a history of nephritis. The mean age of patients with SLE without nephritis was significantly greater compared with the group with nephritis (47.9 vs 46.5 years, respectively; P < 0.001), and a greater proportion of this group were women (89.0% vs 84.7%; P < 0.001). Over a period of 12 months, 30.3% of patients with nephritis were hospitalized compared with 13.6% of those without nephritis (P < 0.001); the mean lengths of hospital stays were 16.52 and 9.69 days (P < 0.001) in patients with and without nephritis, respectively. Patients with nephritis also underwent more outpatient laboratory tests (mean, 64.42 vs 30.96; P < 0.001) and had a significantly higher mean number of intravenous infusions (mean, 1.7 vs 1.1; P < 0.001), and total 12-month follow-up costs were significantly greater in patients with nephritis compared with those without nephritis (mean, $30,652 vs $12,029; P < 0.001). Costs associated with inpatient and outpatient care were 252% and 146% higher in patients with SLE with nephritis, respectively. Outpatient costs were associated with approximately half of the total costs in patients with or without nephritis; pharmacy costs accounted for 20% of the total costs in patients with SLE and nephritis and 27% of total costs among those without nephritis. Significantly higher costs also were found in patients with nephritis when only SLE-related costs were assessed and after differences in patient characteristics and comorbidities were adjusted through multivariate analyses (all, P < 0.05). CONCLUSIONS: The present data analysis found that patients with SLE with nephritis consumed significantly more health care resources, with >2.5-fold the costs, compared with those without nephritis. The majority (84%) of added costs were attributable to inpatient hospitalizations and outpatient services, and 16% were attributable to pharmacy services.

Oseltamivir and influenza-related complications, hospitalization and healthcare expenditure in healthy adults and children.

OBJECTIVE: To assess influenza-related secondary complications and healthcare use and costs in patients prescribed oseltamivir for influenza. RESEARCH DESIGN AND METHODS: This study examined health insurance claims data for patients diagnosed with influenza during five influenza seasons. Patients prescribed oseltamivir were propensity matched with patients not prescribed antiviral therapy. MAIN OUTCOME MEASURES: Clinical outcomes were diagnosis with pneumonia, otitis media and hospitalizations, along with in-patient, out-patient and pharmacy use and costs. RESULTS: Each group included 45,751 patients. Patients prescribed oseltamivir had significant reductions in the risks of pneumonia (odds ratio [OR]: 0.89, 95% CI: 0.80, 1.00), otitis media (OR: 0.84, 95% CI: 0.77, 0.91) and hospitalization (OR: 0.71, 95% CI: 0.62, 0.83). The risks of pneumonia and otitis media were also lower in children and adolescents (< or = 17 years) prescribed oseltamivir (OR: 0.74, 95% CI: 0.60, 0.91 and OR: 0.77, 95% CI: 0.69, 0.85, respectively). Total healthcare costs were lower for patients prescribed oseltamivir versus no antiviral therapy (mean US$500 versus 510; p < 0.0001). Patients prescribed oseltamivir had fewer claims per patient for antibiotics (0.37 versus 0.45; p < 0.0001), fewer physician visits (1.72 versus 1.78; p < 0.0001), emergency room visits (0.11 versus 0.12; p < 0.0001), and spent fewer days in hospital (0.04 versus 0.05; p < 0.0001). CONCLUSION: The risks of influenza-related complications and hospitalization, as well as healthcare use and costs, were lower for patients prescribed oseltamivir than for those with no antiviral prescription.

Direct medical costs for type 2 diabetes mellitus complications in the US commercial payer setting: a resource for economic research.

BACKGROUND: Medical complications are the key drivers of the direct medical costs of treating patients with type 2 diabetes mellitus. However, the published literature shows great variability across studies in the number and type of sources from which these costs for diabetes are obtained. OBJECTIVE: To provide to researchers a set of costs for type 2 diabetes complications, originally developed for input into an established diabetes model, that are empirically based, clearly and consistently defined and applicable to a large segment of managed care patients in the US. METHODS: Patients with 1 of 24 diabetes-related complications between 1 January 2003 and 31 December 2004 and with evidence of type 2 diabetes were identified using a nationally representative US commercial insurance claims database. Therapy utilization and complication cost data were extracted for all patients for the 12 months following the first identified complication; data for months 13-24 were obtained for a subset of patients with at least 24 months of follow-up enrollment. Medical costs included both the amounts charged by medical providers and the health plan contracted allowed amounts. Costs were expressed as $US, year 2007 values. RESULTS: A total of 44 021 patients with a minimum of 12 months of continuous follow-up enrollment were identified, with a mean age of 56 years; a subset of 32 991 patients with at least 24 months of continuous health-plan enrollment was also identified. Among the aggregate sample, 74% of patients were receiving oral antidiabetics, 26% were receiving insulin, 43% were receiving ACE inhibitors and 50% were receiving antihyperlipidaemics/HMG-CoA reductase inhibitors (statins) during the first 12 months following the index complication. The majority of patients had at least one physician office visit (99.8%), laboratory diagnostic test (96.2%) and other outpatient visit (97.5%). Six complications (angina pectoris, heart failure, peripheral vascular disease, renal disease, nonproliferative retinopathy and neuropathy) had a prevalence of at least 10%. Allowed amounts for most complications were 30-45% of charges. Myocardial infarction, heart failure and renal disease had the greatest fiscal impact because of the total number of patients experiencing them (7.2%, 14.0% and 11.0%, respectively) and their associated costs; 12-month mean allowed amounts were $US 14,853, $US 11,257 and $US 13,876, respectively, and 12-month mean charged amounts were $US 41,695, $US 30, 066 and $US 34,987, respectively. Similarly, in the subset of 32 991 patients, these three complications had higher allowed and charged amounts over months 13-24 compared with the majority of other complications of interest. CONCLUSION: These costing results provide an important resource for economic modelling and other types of costing research related to treating diabetes-related complications within the US managed care system.

Epidemiology and economic burden of brain metastases among patients with primary breast cancer: results from a US claims data analysis.

OBJECTIVE: To estimate the incidence, prevalence, and economic burden of secondary breast cancer brain metastases (BCBM) among a US-based population of patients with primary breast cancer. METHODS: Female patients diagnosed with secondary BCBM between 1/2002 and 12/2004 and with a brain or head diagnostic test within 30 days of the BCBM diagnosis were identified in a US commercial insurance claims database. A 12-month look-back period was used to identify patients with a breast cancer diagnosis and those with and without a history of BCBM. Patients were required to be continuously enrolled in their health plan for the duration of the study. Incident BCBM patients were matched to a control group of breast cancer patients with no evidence of BCBM. Patient characteristics at baseline, incidence and prevalence rates, and resource utilization and health care costs were determined. RESULTS: From 2002 to 2004, 779 incident and 995 prevalent BCBM patients and 8,518 primary breast cancer patients were identified. The incidence of BCBM during this time period was 9.1% (95% CI=8.5%, 9.8%); the prevalence of BCBM was 11.7% (95% CI=11.0%, 12.4%), with rates increasing from 2002 to 2004. About 22% of incident patients died (based on a proxy measure) during the follow-up period, an average of 158 days (95% CI=131.1, 183.9) from the index BCBM diagnosis. A 1:1 match of incident BCBM patients to controls resulted in 775 patients in each group. At 6 months follow-up (N=398), incident BCBM patients had significantly more hospital stays (mean 1.1 vs. 0.5, P<0.001) and remained hospitalized for a longer period (mean 8.0 days vs. 2.5 days, P<0.001) compared to controls. Incident BCBM patients also averaged more physician office visits (32.8 vs. 24.3, P<0.001) as well as pharmacy claims (56.0 vs. 39.1, P<0.001). Similar differences were found at 12 months (N=230). Average total costs for incident BCBM patients at 6 months were $60,045 compared to $28,193 for controls (P<0.001); this difference was driven by higher mean inpatient ($17,462 vs. $5,362, P<0.001) and outpatient ($26,209 vs. $11,652, P<0.001) costs among incident BCBM patients. At 12 months, higher mean total costs persisted in incident BCBM patients ($99,899 vs. $47,719, P<0.001). After adjusting for key variables, mean costs for these patients were 123% higher than those for control group patients. CONCLUSIONS: Secondary BCBM is a common occurrence among breast cancer patients, with rates increasing over time. Breast cancer patients with secondary BCBM incurred significantly more health care resources following diagnosis compared to those with breast cancer but no BCBM. Mean total costs for BCBM patients were more than double those of patients without BCBM at 6 and 12 months. The increasing prevalence and economic burden associated with BCBM suggests an unmet need that could be filled with newer treatments that improve breast cancer outcomes, including the prevention or delay of BCBM.

Payer costs in patients undergoing uterine artery embolization, hysterectomy, or myomectomy for treatment of uterine fibroids.

PURPOSE: To compare health resource use and medical costs in patients with uterine leiomyomas treated with hysterectomy, myomectomy, or uterine artery embolization (UAE). MATERIALS AND METHODS: Patients who underwent hysterectomy, myomectomy, or UAE for leiomyomas were identified from a nationally representative private payer claims database based on their diagnosis and procedure codes. The study included patients with no prior hysterectomy, myomectomy, or UAE and no previous diagnosis of gynecologic cancer. Health resource use and medical costs were evaluated over a period of 12 months. RESULTS: The study included 2,836 hysterectomy, 704 myomectomy, and 125 UAE patients. Average patient ages were 46 years for hysterectomy, 38 years for myomectomy, and 45 years for UAE (P < .001). Median UAE procedure costs were $5,968, compared with $7,299 for myomectomy (P = .031) and $7,707 for hysterectomy (P < .001). Median total 12-month payer costs were not significantly different among the three procedures ($10,519 for UAE vs $9,652 for myomectomy [P = .372] and $10,044 for hysterectomy [P = .813]). There were no differences in overall hospital admissions or emergency room visits after the procedures. Patients who underwent UAE had greater fibroid-related hospital and physician office use beyond 30 days after treatment (P < .001). During this period, 65.6% of patients treated with UAE had at least one imaging study, versus 37.1% of those treated with myomectomy (P < .001) and 14.1% of those treated with hysterectomy (P < .001). CONCLUSIONS: Procedure costs were significantly lower for UAE versus myomectomy and hysterectomy, but there was no difference in total 12-month payer costs. Postprocedural imaging appears to be a factor in total UAE costs. Further research is needed to better understand the role of imaging studies after UAE.

Clinical and economic effects of coronary restenosis after percutaneous coronary intervention in a managed care population.

PURPOSE: The epidemiology of coronary restenosis after percutaneous coronary intervention (PCI) has been documented extensively in clinical trials, but no data exist on the clinical and economic burden of restenosis in a managed care population. DESIGN: Retrospective cohort with a nationally representative managed care claims database (IHCIS, Waltham, Mass.) representing 2.8 million members. METHODOLOGY: Patients undergoing initial PCI between 1/1/00 and 12/31/00 (N=3,258) were identified and followed to 1 year. Clinical events, resource use, and costs between 1 month and 1 year after the initial PCI were identified. The clinical restenosis rate was estimated by multiplying the observed repeat revascularization rate by 0.85, based on previously published studies. All costs are reported from a managed care perspective in Year 2000 dollars. PRINCIPAL FINDINGS: Overall, 14.7 percent of patients required 1 or more repeat revascularization procedures between 1 month and 1 year after initial PCI, which implies an estimated clinical restenosis rate of 12.5 percent. Mean 1-year costs were nearly 6-fold higher among patients with and without repeat revascularization (dollars 31,954 +/- dollars 31,857 vs. dollars 5,474 +/- dollars 12,006, P<.001). After adjusting for baseline imbalances, the independent incremental cost for each patient with repeat revascularization was dollars 24,955 (95 percent confidence interval, dollars 23,401-dollars 26,510). Annual follow-up costs attributable to restenosis were dollars 3,118 per initial PCI recipient (i.e., dollars 24,955 x 12.5 percent). CONCLUSION: Clinical restenosis occurred in approximately 12.5 percent of real-world managed care PCI patients and increased health care costs by an average of dollars 3,118 per patient. These findings have important implications for the cost-effectiveness of new treatments that substantially reduce restenosis.

Clinical and economic outcomes of percutaneous coronary interventions in the elderly: an analysis of medicare claims data.

BACKGROUND: Outcomes after percutaneous coronary intervention (PCI) have been documented extensively in clinical trials and single-center series, but few data exist on the clinical and economic outcomes after PCI in an unselected population. METHODS AND RESULTS: We used the Medicare Standard Analytic File to identify all initial PCI procedures performed in 1998 among a random sample of 5% of all Medicare beneficiaries > or =65 years of age. These patients (n=9868) were followed up for 1 year after PCI to identify clinical outcomes, medical resource use, and costs. Between 1 month and 1 year after PCI, 16.9% of patients required > or =1 repeat revascularization procedures. Mean 1-year medical care costs increased 5-fold among patients with repeat revascularization compared with those without (26,186 dollars versus 5344 dollars; P<0.001). After adjustment for baseline differences, the independent cost of repeat revascularization was 19,074 dollars (95% CI, 18,440 to 19,707). Assuming from previous studies that 85% of repeat revascularization procedures over the first year of follow-up are attributable to restenosis, the estimated clinical restenosis rate was 14.4%, and the 1-year economic burden of restenosis to the healthcare system was 2747 dollars per initial PCI procedure. CONCLUSIONS: Among unselected elderly patients undergoing PCI, repeat revascularization occurs in approximately 14% and increases 1-year healthcare costs by >19,000 dollars per occurrence. These findings have important implications for the cost-effectiveness of new treatments that substantially reduce restenosis.

Impact of respiratory symptoms on health-related quality of life and medical resource utilization of patients treated by allergy specialists and primary care providers.

BACKGROUND: Respiratory symptoms associated with allergy and asthma cause substantial health care burden. OBJECTIVE: This observational pilot study compared internal medicine/family practice (IM/FP) and pediatric primary care providers with allergists in the diagnosis, treatment, and health-related quality of life (HRQL) outcomes of adults and children with respiratory symptoms. METHODS: Two allergists, 2 IM/FP, and 2 pediatricians enrolled 242 patients with respiratory symptoms ages 5 to 16 years old (n = 123) and 17 to 70 years old (n = 119). HRQL questionnaires were completed at enrollment and quarterly for 1 year. The adult questionnaire included SF-36, respiratory symptom role productivity, ITG Asthma Short Form, and allergy symptom index (ASI) scales. The child questionnaire included CHQ-PF28, respiratory symptom family impact, ITG Child Asthma Short Form, and ASI scales. HRQL changes were evaluated over the study period. RESULTS: Adults treated by allergists reported significantly greater improvement in HRQL on 5 of 8 SF-36 scales, the respiratory symptom role productivity scale, 3 of 5 ITG Asthma Short Form scales, and 2 of 4 ASI scales compared with adults treated by an IM/FP (P < 0.05). Pediatric patients treated by allergists had significantly greater improvement on 3 of 15 CHQ-PF28 scales, the respiratory symptom family impact scale, and one ASI scale compared with patients treated by pediatricians (P < 0.05). CONCLUSIONS: Compared with patients treated by primary care physicians, patients treated by allergists reported greater improvement in HRQL in a number of scales. Additional research is required to further evaluate the impact of provider specialty and patterns of care on outcomes of respiratory symptoms patients.