Evaluation of a Natural Language Processing Model to Identify and Characterize Patients in the United States With High-Risk Non-Muscle-Invasive Bladder Cancer.

PURPOSE: Treatment of non-muscle-invasive bladder cancer (NMIBC) is guided by risk stratification using clinical and pathologic criteria. This study aimed to develop a natural language processing (NLP) model for identifying patients with high-risk NMIBC retrospectively from unstructured electronic medical records (EMRs) and to apply the model to describe patient and tumor characteristics. METHODS: We used three independent EMR-derived data sets including adult patients with a bladder cancer diagnosis in 2011-2020 for NLP model development and training (n = 140), validation (n = 697), and application for the retrospective cohort analysis (n = 4,402). Deep learning methods were used to train NLP recognition of medical chart terminology to identify seven high-risk NMIBC criteria; model performance was assessed using the F1 score, weighted across features. An algorithm was then used to classify each patient as high-risk NMIBC (yes/no). Manually reviewed records served as the gold standard. RESULTS: The F1 scores after model training were >0.7 for all but one uncommon feature (prostatic urethral involvement). The highest area under the receiver operating curves (AUC) was observed for Ta (0.897) and T1 (0.897); the lowest AUC was for carcinoma in situ (CIS; 0.617). For high-risk NMIBC classification, positive predictive value was 79.4%, negative predictive value was 93.2%, and false-positive rate was 8.9%. Sensitivity and specificity were 83.7% and 91.1%, respectively. Of 748 patients manually confirmed as having high-risk NMIBC, 196 (26%) had CIS (of whom 19% also had T1 and 23% also had Ta disease); 552 tumors (74%) had no associated CIS. CONCLUSION: The NLP model, combined with a rule-based algorithm, identified high-risk NMIBC with good performance and will enable future work to study real-world treatment patterns and clinical outcomes for high-risk NMIBC.

Costs and Outcomes Comparison of Diabetes Technology Usage Among People With Type 1 or 2 Diabetes Using Rapid-Acting Insulin.

BACKGROUND: Does initiation of a continuous glucose monitor (CGM) or insulin pump lower health care utilization and/or costs? METHODS: Distinct cohorts of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using a blood glucose monitor (BGM), CGM, pump, or CGM with pump were identified from a large claims database. Patients ≥40 years old with 12 months of continuous enrollment before and after the device start date qualified for the study. Outcomes included one-year medical utilization and costs (minus device) for events such as hospitalizations and office visits. Generalized linear models were fitted, controlling for numerous baseline covariates. The Holm method corrected for the multiplicity of hypotheses tested. RESULTS: Of the 8235 total patients, the BGM control group was the largest, had the lowest percentage of patients with T1D, and was significantly different from the device groups in most baseline categories. Formally, only two comparisons were statistically significant: Compared with BGM, the pump cohort had greater adjusted first-year total medical and office visit costs. Other secondary outcomes such as days hospitalized, emergency department visits and labs, favored pump. Most endpoints were favorable for CGM. Results for CGM with pump generally were intermediate between CGM and pump alone. CONCLUSIONS: During a one-year follow-up, unadjusted medical costs of both CGM and pump appear lower than BGM, but multivariable modeling yielded adjusted savings only for CGM use. Economic benefits might be observable sooner for CGMs than for pumps. Generalized linear models fitted to health care utilization event rates produced favorable results for both CGM and pump.

Predicting Response to Bolus Insulin Therapy in Patients With Type 2 Diabetes.

BACKGROUND: The aim of this study was to develop a predictive model to classify people with type 2 diabetes (T2D) into expected levels of success upon bolus insulin initiation. METHODS: Machine learning methods were applied to a large nationally representative insurance claims database from the United States (dNHI database; data from 2007 to 2017). We trained boosted decision tree ensembles (XGBoost) to assign people into Class 0 (never meeting HbA1c goal), Class 1 (meeting but not maintaining HbA1c goal), or Class 2 (meeting and maintaining HbA1c goal) based on the demographic and clinical data available prior to initiating bolus insulin. The primary objective of the study was to develop a model capable of determining at an individual level, whether people with T2D are likely to achieve and maintain HbA1c goals. HbA1c goal was defined at <8.0% or reduction of baseline HbA1c by >1.0%. RESULTS: Of 15 331 people with T2D (mean age, 53.0 years; SD, 8.7), 7800 (50.9%) people met HbA1c goal but failed to maintain that goal (Class 1), 4510 (29.4%) never attained this goal (Class 0), and 3021 (19.7%) people met and maintained this goal (Class 2). Overall, the model's receiver operating characteristic (ROC) was 0.79 with greater performance on predicting those in Class 2 (ROC = 0.92) than those in Classes 0 and 1 (ROC = 0.71 and 0.62, respectively). The model achieved high area under the precision-recall curves for the individual classes (Class 0, 0.46; Class 1, 0.58; Class 2, 0.71). CONCLUSIONS: Predictive modeling using routine health care data reasonably accurately classified patients initiating bolus insulin who would achieve and maintain HbA1c goals, but less so for differentiation between patients who never met and who did not maintain goals. Prior HbA1c was a major contributing parameter for the predictions.

Temporal and Geographic Variation in the Incidence of Alzheimer's Disease Diagnosis in the US between 2007 and 2014.

OBJECTIVES: Our aim was to describe the incidence of Alzheimer's disease (AD) in the United States, overall and by geographic region. DESIGN: We conducted retrospective analyses of administrative claims data for a 5% random sample of US Medicare beneficiaries aged 65 years or older. AD incidence, defined as a diagnosis for AD (International Classification of Disease, Ninth Revision, Clinical Modification code 331.0×) in a given year, with no AD diagnosis in the beneficiary's entire medical history, was estimated for each calendar year between 2007 and 2014. Beneficiaries were required to be enrolled in Medicare for the calendar year of evaluation as well as the preceding 12 months. In addition, a cross-sectional assessment of geographic variation in AD incidence was conducted for 2014. For each population area (specifically, core-based statistical area, as defined by the US Census Bureau), AD incidence was estimated overall, as well as adjusted for differences in underlying patient demographics and metrics of access to care and quality of care. Changes in AD incidence from 2007 were also estimated. SETTING: US fee-for-service Medicare. PARTICIPANTS: US Medicare beneficiaries aged 65 years or older with no history of AD. RESULTS: Overall, the diagnosed incidence of AD decreased over time, from 1.53% in 2007 to 1.09% in 2014; trends were similar for most population areas. In 2014, the rates of AD incidence ranged from 0% to more than 3% across population areas, with the highest observed incidence rates in areas of the Midwest and the South. Statistical models explain little of the geographic variation, although following adjustment, the incidence rates increased the most (in relative terms) in rural areas of western states. CONCLUSION: Our findings are consistent with previously reported estimates of incidence of AD in the United States and its recent declining trend. Additionally, the study highlights the considerable geographic variation in the incidence of AD in the United States and suggests that further research is needed to better understand the determinants of this geographic variation. J Am Geriatr Soc 68:346-353, 2020.

Reduced medical spending associated with increased use of a remote diabetes management program and lower mean blood glucose values.

Aims: Many new mobile technologies are available to assist people in managing chronic conditions, but data on the association between the use of these technologies and medical spending remains limited. As the available digital technology offerings to aid in diabetes management increase, it is important to understand their impact on medical spending. The aim of this study was to investigate the financial impact of a remote digital diabetes management program using medical claims and real-time blood glucose data. Materials and methods: A retrospective analysis of multivariate difference-in-difference and instrumental variables regression modeling was performed using data collected from a remote digital diabetes management program. All employees with diabetes were invited, in a phased introduction, to join the program. Data included blood glucose (BG) values captured remotely from members via connected BG meters and medical spending claims. Participants included members (those who accepted the invitation, n = 2,261) and non-members (n = 8,741) who received health insurance benefits from three self-insured employers. Medical spending was compared between people with well-controlled (BG ≤ 154 mg/dL) and poorly controlled (BG > 154 mg/dL) diabetes. Results: Program access was associated with a 21.9% (p < 0.01) decrease in medical spending, which translates into a $88 saving per member per month at 1 year. Compared to non-members, members experienced a 10.7% (p < 0.01) reduction in diabetes-related medical spending and a 24.6% (p < 0.01) reduction in spending on office-based services. Well-controlled BG values were associated with 21.4% (p = 0.03) lower medical spending. Limitations and conclusions: Remote digital diabetes management is associated with decreased medical spending at 1 year. Reductions in spending increased with active utilization. It will be beneficial for future studies to analyze the long-term effects of the remote diabetes management program and assess impacts on patient health and well-being.

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

BACKGROUND: While 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. METHODS: This 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. RESULTS: Of 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. CONCLUSIONS: For 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.

Factors associated with treatment of women with osteoporosis or osteopenia from a national survey.

BACKGROUND: Health outcomes could be improved if women at high risk for osteoporotic fracture were matched to effective treatment. This study determined the extent to which treatment for osteoporosis/osteopenia corresponded to the presence of specific risk factors for osteoporotic fracture. METHODS: This retrospective analysis of the United States 2007 National Health and Wellness Survey included women age ≥ 40 years who reported having a diagnosis of osteoporosis (69% of 3276) or osteopenia (31% of 3276). Patients were stratified by whether they were or were not taking prescription treatment for osteoporosis/osteopenia. Using 34 patient characteristics as covariates, logistic regression was used to determine factors associated with treatment. RESULTS: Current prescription treatment was reported by 1800 of 3276 (54.9%) women with osteoporosis/osteopenia. The following factors were associated with receiving prescription treatment: patient-reported diagnosis of osteoporosis (versus osteopenia); previous bone mineral density test; ≥ 2 fractures since age 50; older age; lower body mass index; better physical functioning; postmenopausal status; family history of osteoporosis; fewer comorbidities; prescription insurance coverage; higher total prescription count; higher ratio of prescription costs to monthly income; higher income; single status; previous visit to a rheumatologist or gynecologist; and 1 or 2 outpatient visits to healthcare provider (vs. none) in the prior 6 months. Glucocorticoid, tobacco, and daily alcohol use were risk factors for fracture that were not associated with treatment. CONCLUSIONS: There is a mismatch between those women who could benefit from treatment for osteoporosis and those who are actually treated. For example, self-reported use of glucocorticoids, tobacco, and alcohol were not associated with prescription treatment of osteoporosis. Other clinical and socioeconomic factors were associated with treatment (e.g. prescription drug coverage and higher income) or not (e.g. comorbid osteoarthritis and anxiety) and could be opportunities to improve care.

Cost-effectiveness of prasugrel in a US managed care population.

OBJECTIVE: Decision-makers in the US may be interested in the applicability to their populations of cost-effectiveness results generated from clinical trial populations. METHODS: An economic model estimating the cost-effectiveness of prasugrel plus aspirin relative to clopidogrel plus aspirin for patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) was developed from a managed care organization (MCO) perspective. The model estimated 15-month cardiovascular events or bleeding-related outcomes, life expectancy, and costs for patients who received thienopyridine treatment during and after a PCI following a diagnosis of ACS. Post-ACS event rates for patients treated with clopidogrel were from an MCO. The relative risks of these events with prasugrel compared with clopidogrel were from a head-to-head clinical trial. RESULTS: The results of the base-case analysis indicated that, in an MCO population, use of prasugrel-based therapy rather than clopidogrel-based therapy at current prices resulted in cost-savings and fewer clinical events over the 15 months after an ACS diagnosis followed by PCI. At possible lower prices for generic clopidogrel-based therapy, the cost-effectiveness ratio for prasugrel-based therapy compared with clopidogrel-based therapy was between $6643 and $13,906 per life-year gained. The results were most sensitive to the relative costs of the two treatments and the cost for hospital stays. LIMITATIONS: Limitations of the study included lack of follow-up of patients disenrolling from the MCO before the end of the 15-month observation period, the assumption of equal relative risks of events in an MCO as in the clinical trial, and the lack of information on the ratio of cost to charges in the MCO database. CONCLUSIONS: Use of prasugrel-based therapy compared with clopidogrel-based therapy in ACS patients having a PCI resulted in cost-savings at current prices and favorable cost-effective ratios at likely generic prices for clopidogrel-based therapy because of offsetting savings in the costs of rehospitalization.

Persistence with biologic therapies in the Medicare coverage gap.

OBJECTIVES: To describe persistence with teriparatide and other biologic therapies in Medicare Part D plans with and without a coverage gap. STUDY DESIGN: Retrospective (2006) cohort study of Medicare Part D prescription drug plan beneficiaries from a large benefits company. Two plans with a coverage gap (defined as "basic") were combined and compared with a single plan with coverage for generic and branded medications (defined as "complete"). METHODS: Patients taking alendronate (nonbiologic comparator), teriparatide, etanercept, adalimumab, interferon ß-1a, or glatiramer acetate were selected for the study. For patients with complete coverage, equivalent financial thresholds were used to define the "gap."The definition of discontinuation was failure to fill the index prescription after reaching the gap. RESULTS: For alendronate, 27% of 133,260 patients had enrolled in the complete plan. Patients taking biologic therapies had more commonly enrolled in complete plans: teriparatide (66% of 6221), etanercept (58% of 1469), adalimumab (52% of 824), interferon ß-1a (60% of 438), and glatiramer acetate (53% of 393). For patients taking either alendronate or teriparatide, discontinuation rates were higher in the basic, versus complete, plan (adjusted odds ratios, 2.02 and 3.56, respectively). Discontinuation did not significantly vary by plan type for etanercept, adalimumab, interferon ß-1a, or glatiramer acetate. CONCLUSIONS: For patients who reached the coverage gap, discontinuation was more likely for patients taking osteoporosis (OP) medication. Not having a coverage gap was associated with improved persistence with OP treatment.

Factors Associated with Persistence with Teriparatide Therapy: Results from the DANCE Observational Study.

Purpose. Determine patient-reported reasons for discontinuation with teriparatide. Methods. Patients taking teriparatide in a multicenter, prospective, and observational study were given three questionnaires: baseline, follow-up questionnaire 1 (QF1, 2 to 6 months), and follow-up questionnaire 2 (QF2, 12 months). Discontinuation reported at QF1 and QF2 was defined as "early" and "late," respectively, and remaining patients were considered persistent. Cochran-Armitage trend test was used to identify factors associated with discontinuation. Results. Side effects, concern about improper use, injection difficulties, and several patient-perceived physician issues were associated with early discontinuation. Low patient-perceived importance of continuing treatment, side effects, difficulty paying, and low patient-perceived physician knowledge were associated with late discontinuation. The most common specific reasons selected for discontinuing treatment were "concerns about treatment outweighing the benefits" (n = 53) and "difficulty paying" (n = 47). Conclusions. Persistence with teriparatide is dependent on managing side effects, addressing financial challenges, proper training, and obtaining support from the healthcare provider.

Out-of-pocket drug costs and drug utilization patterns of postmenopausal Medicare beneficiaries with osteoporosis.

BACKGROUND: The Medicare Part D coverage gap has been associated with lower adherence and drug utilization and higher discontinuation. Because osteoporosis has a relatively high prevalence among Medicare-eligible postmenopausal women, we examined changes in utilization of osteoporosis medications during this coverage gap. OBJECTIVES: The purpose of this study was to investigate changes in out-of-pocket (OOP) drug costs and utilization associated with the Medicare Part D coverage gap among postmenopausal beneficiaries with osteoporosis. METHODS: This retrospective analysis of 2007 pharmacy claims focuses on postmenopausal female Medicare beneficiaries enrolled in full-, partial-, or no-gap exposure standard or Medicare Advantage prescription drug plans (PDPs), retiree drug subsidy (RDS) plans, or the low-income subsidy program. We compared beneficiaries with osteoporosis who were taking teriparatide (Eli Lilly and Company, Indianapolis, Indiana) (n = 5657) with matched samples of beneficiaries who were taking nonteriparatide osteoporosis medications (NTO; n = 16,971) or who had other chronic conditions (OCC; n = 16,971). We measured average monthly prescription drug fills and OOP costs, medication discontinuation, and skipping. RESULTS: More than half the sample reached the coverage gap; OOP costs then rose for teriparatide users enrolled in partial- or full-gap exposure plans (increase of 121% and 186%; $300 and $349) but fell for those in no-gap exposure PDPs or RDS plans (decrease of 49% and 30%; $131 and $40). OOP costs for beneficiaries in partial- or full-gap exposure PDPs increased >120% (increase of $144 and $176) in the NTO group and nearly doubled for the OCC group (increase of $124 and $151); these OOP costs were substantially lower than those for teriparatide users. Both teriparatide users and NTO group members discontinued or skipped medications more often than persons in the OCC group, regardless of plan or benefit design. CONCLUSION: Medication discontinuation and OOP costs among beneficiaries with osteoporosis were highest for those enrolled in Part D plans with a coverage gap. Providers should be aware of potential cost-related nonadherence among Medicare beneficiaries taking osteoporosis medications.

Compliance with mammography and bone mineral density screening in women at least 50 years old.

OBJECTIVE: The aim of this study was to examine the utilization of mammography and bone mineral density (BMD) screenings and factors associated with compliance according to the recommended clinical practice guidelines. METHODS: Mammography and BMD were assessed using employer's administrative claims data for eligible women identified between January 2004 and December 2006. Women were categorized into five cohorts based on mammography- and BMD-recommended screening guidelines. Logistic regression modeling was used to examine the covariates associated with compliance. RESULTS: Mammography and BMD screening utilization were low in relation to recommendations, with 21%, 27%, and 16% of women complying with mammography, age-motivated BMD, and fracture-motivated BMD screening guidelines, respectively. BMD screening use (odds ratio [OR], 7.19; 95% CI, 7.08-7.31) was associated with compliance in the mammogram cohort. Mammogram use was associated with compliance in both the age-motivated BMD cohort (OR, 6.01; 95% CI, 5.28-6.85) and the fracture-motivated BMD cohort (OR, 2.20; 95% CI, 2.07-2.33). Having a Papanicolaou test was strongly associated with compliance in the combined mammogram plus age-motivated BMD cohort (OR, 16.83; 95% CI, 14.01-20.22) and the combined mammogram plus fracture-motivated BMD cohort (OR, 10.46; 95% CI 9.26-11.81). CONCLUSIONS: Postmenopausal women with employer-sponsored health insurance had low utilization of mammography and BMD screening relative to clinical guidelines. Use of other health screening services was associated with compliance with guidelines. Methods to improve adherence to mammography and BMD screening guidelines should be explored, which could possibly leverage the increased likelihood that women who receive one screening service will receive another.

Illness-associated productivity costs among women with employer-sponsored insurance and newly diagnosed breast cancer.

OBJECTIVE: Determine lost work time and job attrition for incident breast cancer (BC). METHODS: The cases were employed women, aged 18 to 64, with BC identified by a validated algorithm between 1999 and 2005, from claims (MarketScan) and attendance databases. Controls without cancer were matched 3:1 on age, comorbidity, and index year. RESULTS: First-year mean disability days were 60 (cases, N = 880) versus 5 (controls, N = 2640) (P < 0.001). The first-year disability costs were $4900 for cases versus $385 for controls (P < 0.001). In years 2 through 4, the disability days and associated costs were similar for the cases versus controls. After 4 years, 56.4% of cases were still enrolled in the employer-sponsored insurance programs compared to 6.5% of controls (P < 0.001). CONCLUSIONS: The lost work associated with BC is substantial in the first year after diagnosis. Employee retention is much higher for BC cases versus controls.

Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates.

BACKGROUND: Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis. METHODS: This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate. RESULTS: Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model. CONCLUSION: In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.

Actual versus predicted first-year utilization patterns of teriparatide in patients with employer-sponsored health insurance.

OBJECTIVE: To characterize first-year utilization patterns of teriparatide derived from a claims database analysis versus predictions from an economic model. RESEARCH DESIGN AND METHODS: Claims data for actual teriparatide utilization were obtained from an integrated administrative database of approximately 3.4 million beneficiaries. A control group included patients with osteoporosis but without the use of teriparatide. An economic model, which relied on first-year market share projections, predicted the utilization of teriparatide from the demographic characteristics of the plan. Predictions were compared to actual utilization for eight health plans within the database. MAIN OUTCOME MEASURES: Demographic and clinical characteristics, number of teriparatide patients, and days of teriparatide therapy. RESULTS: Less than 1% of patients diagnosed with osteoporosis received teriparatide. Teriparatide-treated patients, compared to other patients with osteoporosis, were older and more likely to have experienced a previous fracture or to have received previous osteoporosis pharmacotherapy. For the combined 505 300 lives in the eight plans used for the comparative analysis, there were 134 teriparatide patients; the model predicted 131. For individual plans, the predictions varied in their accuracy. The greatest under-prediction for one plan was 17 patients (40 predicted vs. 57 actual), while the greatest over-prediction was 18 patients (34 predicted vs. 16 actual). For the other 6 plans, the predictions were within four patients of the actual number of teriparatide users. A similar pattern of differences was observed by comparing actual versus predicted days of teriparatide therapy across the eight plans. LIMITATIONS: Some clinical details of the actual patient cohorts, such as bone mineral density results, were not available in the database. The comparisons made between the teriparatide model predictions and actual utilization were based on analyses of a single model and do not speak to the broader issue of the accuracy of predictive economic models in general. CONCLUSIONS: Overall, first-year teriparatide utilization was relatively limited, consistent with model predictions. Predictions for individual plans varied in their accuracy.

Assessment of the clinical management of fragility fractures and implications for the new HEDIS osteoporosis measure.

BACKGROUND: Rates of screening for and treatment of osteoporosis have been low, even among those with fractures who are at greatest risk for new fractures. OBJECTIVE: The objective of this study was to examine trends in the clinical management of patients with fragility fractures to provide baseline data for future assessments of the impact of the new Health Plan Employer Data and Information Set (HEDIS) measure. RESEARCH DESIGN: The MarketScan Medicare Supplemental and Coordination of Benefits (COB) database was used to examine adherence to the 2004 HEDIS guidelines by measuring the percent of women age 67 and older who were screened and/or treated after a fracture from 2000 through 2005. Clinical, demographic, and provider characteristics were assessed to determine the correlates of being screened and treated. RESULTS: The overall unadjusted percent of women screened and treated remains low, with just 10.2% screened and 12.9% treated in 2005. Multivariate analyses, which controlled for fracture location, patient characteristics, physician specialty, and region indicated small, albeit statistically significant, increases in treatment and screening over time. Women fracturing in 2005 were 27% more likely to be screened and 15% more likely to receive treatment relative to those fracturing in the year 2000. CONCLUSIONS: Although our study found some improvements in the screening for and treatment of osteoporosis among Medicare beneficiaries with a fragility fracture from 2000 through 2005, the overall percent of women screened and/or treated remained low. These data provide a baseline for assessing the impact of the new HEDIS measure in the coming years.

Cost-effectiveness of preventative therapies for postmenopausal women with osteopenia.

BACKGROUND: Limited data are available regarding the cost-effectiveness of preventative therapies for postmenopausal women with osteopenia. The objective of the present study was to evaluate the cost-effectiveness of raloxifene, alendronate and conservative care in this population. METHODS: We developed a microsimulation model to assess the incremental cost and effectiveness of raloxifene and alendronate relative to conservative care. We assumed a societal perspective and a lifetime time horizon. We examined clinical scenarios involving postmenopausal women from 55 to 75 years of age with bone mineral density T-scores ranging from -1.0 to -2.4. Modeled health events included vertebral and nonvertebral fractures, invasive breast cancer, and venous thromboembolism (VTE). Raloxifene and alendronate were assumed to reduce the incidence of vertebral but not nonvertebral fractures; raloxifene was assumed to decrease the incidence of breast cancer and increase the incidence of VTEs. Cost-effectiveness is reported in $/QALYs gained. RESULTS: For women 55 to 60 years of age with a T-score of -1.8, raloxifene cost approximately $50,000/QALY gained relative to conservative care. Raloxifene was less cost-effective for women 65 and older. At all ages, alendronate was both more expensive and less effective than raloxifene. In most clinical scenarios, raloxifene conferred a greater benefit (in QALYs) from prevention of invasive breast cancer than from fracture prevention. Results were most sensitive to the population's underlying risk of fracture and breast cancer, assumed efficacy and costs of treatment, and the discount rate. CONCLUSION: For 55 and 60 year old women with osteopenia, treatment with raloxifene compares favorably to interventions accepted as cost-effective.

Economic burden of osteoporosis-related fractures in Medicaid.

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

Duloxetine in the treatment of women with stress urinary incontinence: results from DESIRE (Duloxetine Efficacy and Safety for Incontinence in Racial and Ethnic populations).

OBJECTIVE: To evaluate the effectiveness and safety of duloxetine for the treatment of African-American and Hispanic women with stress urinary incontinence. RESEARCH DESIGN AND METHODS: The 10-week (a 2-week lead in period followed by 8 weeks of active treatment), open-label, multicenter study of duloxetine 40 mg twice daily included women with stress urinary incontinence or stress predominant mixed incontinence. Efficacy was measured by the median percent change from baseline to endpoint of weekly incontinence episode frequency. The primary objective assessed the treatment response in a pre-specified group of women (n = 2960; 2321 Caucasian, 271 African-American, and 368 Hispanic) with similar baseline incontinence and comorbidity characteristics as the subjects enrolled in the placebo-controlled trials of duloxetine for the treatment of stress urinary incontinence. The efficacy in African-American and Hispanic women was compared with Caucasians using a predefined non-inferiority subpopulation analysis. Safety measures included adverse events, laboratory test results, and vital signs. RESULTS: All three subgroups reported significant (all p < 0.001) median percent decreases in weekly incontinence episode frequency: -65.7% (African-American), -73.0% (Hispanic), and -75.0% (Caucasian). Non-inferior efficacy was demonstrated for African-American and Hispanic women compared to the Caucasian women. Common adverse events included nausea (21.8%, 28.0%, 25.3%), dry mouth (7.7%, 11.4%, 11.9%), and fatigue (9.2%, 5.7%, 11.6%) for the African-American, Hispanic, and Caucasian groups, respectively. CONCLUSION: Duloxetine was efficacious and well tolerated for the treatment of African-American, Hispanic, and Caucasian women with stress urinary incontinence. The trial design was successful in enrolling a diverse population of patients. The most important limitations include the lack of placebo control, the short study duration, and the exclusion of patients with less than seven incontinence episodes per week.