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.

Activation, physical activity, and outcomes among individuals with T2D.

OBJECTIVES: To explore the associations among activation, physical activity, hemoglobin A1c (HbA1c), and healthy days in older adults with type 2 diabetes (T2D) who participated in wellness programs. STUDY DESIGN: Observational, longitudinal cohort study utilizing survey, claims, and wellness program data. METHODS: From January to May 2018, individuals enrolled in a commercial or Medicare Advantage and prescription drug plan with T2D (aged 55-89 years) and SilverSneakers or step count data were eligible. Three waves of surveys were mailed (n = 5000) to collect information on activation (Consumer Health Activation Index; Influence, Motivation, and Patient Activation for Diabetes) and health-related quality of life (Healthy Days). Generalized linear models and predictive models evaluated the associations of unhealthy days and HbA1c with physical activity and activation factors. Additional models tested the relationship between physical activity and future acute care visits, accounting for potential confounders via inverse probability of treatment weighting. RESULTS: Respondents to all 3 waves (n = 1147) had higher comorbidity indices but lower HbA1c than individuals with T2D without physical activity data (P < .0001). Individuals with moderate and high activation levels had 67.4% to 74.0% and 71.6% to 85.6% fewer unhealthy days, respectively, than those with lower activation (P < .01). Individuals with high (> 8000/day) step counts at baseline were predicted to have 2.04 fewer unhealthy days/month at follow-up (P < .05) and 0.19% (P < .02) lower HbA1c units, respectively, compared with those with less than 4000 steps per day. High SilverSneakers activity (> 2 activities per week) reduced subsequent acute care visits by 49%. CONCLUSIONS: Increasing patient activation levels encourages physical activity, which can help improve glycemic control and health-related quality of life, especially among older adults.

Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes.

Objective: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes. Methods: This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores. Results: Participants (n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%-48.1%, P = 0.004; 4.49%-2.93%, P < 0.001; mean 8.8%-8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%-49.0%, P < 0.001). MBD/day was negatively associated with TIR (P = 0.016) and positively associated with TAR (P = 0.015) for T1D and positively associated with TBR (P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D. Conclusions: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.

Trends in U.S. Insulin Use and Glucose Monitoring for People with Diabetes: 2009-2018.

BACKGROUND: The delivery and administration of insulin has undergone many changes over the years. This research examines U.S. trends in insulin use among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009 to 2018. METHODS: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends in insulin use over 10 years. The study included people with T1D or T2D who filled a prescription for insulin in any calendar year from 2009 to 2018. The analyses examined insulin regimen and delivery and the use of glucose monitoring systems. Generalized estimating equations were used to test whether trends were statistically significant. RESULTS: Individuals with T1D were most commonly prescribed a basal and bolus insulin regimen or short/rapid insulin only, while for people with T2D the use of basal-only insulin increased significantly over the study period. In both groups there was a significant decline in the use of premix insulin from 2009 to 2018. Insulin pump use increased for individuals with T1D, while disposable pen use increased for people in both cohorts. In both cohorts, there was a statistically significant increase in the use of continuous glucose monitoring, although this increase was more pronounced and occurred earlier among individuals with T1D. CONCLUSIONS: Results indicate significant changes in insulin regimens and delivery and glucose monitoring from 2009 to 2018. These findings suggest that insulin prescribing continues to change in response to the development of new therapeutics, advances in insulin delivery technology, and glucose monitoring systems.

Evaluating the relationship between clinical and demographic characteristics of insulin-using people with diabetes and their health outcomes: a cluster analysis application.

BACKGROUND: The aim of this study was to determine how clusters or subgroups of insulin-treated people with diabetes, based upon healthcare resource utilization, select social demographic and clinical characteristics, and diabetes management parameters, are related to health outcomes including acute care visits and hospital admissions. METHODS: This was a non-experimental, retrospective cluster analysis. We utilized Aetna administrative claims data to identify insulin-using people with diabetes with service dates from 01 January 2015 to 30 June 2018. The study included adults over the age of 18 years who had a diagnosis of type 1 (T1DM) or type 2 diabetes mellitus (T2DM) on insulin therapy and had Aetna medical and pharmacy coverage for at least 18 months (6 months prior and 12 months after their index date, defined as either their first insulin prescription fill date or their earliest date allowing for 6 months' prior coverage). We used K-means clustering methods to identify relevant subgroups of people with diabetes based on 13 primary outcome variables. RESULTS: A total of 100,650 insulin-using people with diabetes were identified in the Aetna administrative claims database and met study criteria, including 11,826 (11.7%) with T1DM and 88,824 (88.3%) with T2DM. Of these 79,053 (78.5%) people were existing insulin users. Seven distinct clusters were identified with different characteristics and potential risks of diabetes complications. Overall, clusters were significantly associated with differences in healthcare utilization (emergency room visits, inpatient admissions, and total inpatient days) after multivariable adjustment. CONCLUSIONS: This analysis of healthcare claims data using clustering methodologies identified meaningful subgroups of patients with diabetes using insulin. The subgroups differed in comorbidity burden, healthcare utilization, and demographic factors which could be used to identify higher risk patients and/or guide the management and treatment of diabetes.

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.

Observation versus treatment among men with favorable risk prostate cancer in a community-based integrated health care system: a retrospective cohort study.

BACKGROUND: The objective of this study was to describe overall survival and the management of men with favorable risk prostate cancer (PCa) within a large community-based health care system in the United States. METHODS: A retrospective cohort study was conducted using linked electronic health records from men aged ≥40 years with favorable risk PCa (T1 or 2, PSA ≤15, Gleason ≤7 [3 + 4]) diagnosed between January 2005 and October 2013. Cohorts were defined as receiving any treatment (IMT) or no treatment (OBS) within 6 months after index PCa diagnosis. Cohorts' characteristics were compared between OBS and IMT; monitoring patterns were reported for OBS within the first 18 and 24 months. Cox Proportional Hazards models were used for multivariate analysis of overall survival. RESULTS: A total of 1425 men met the inclusion criteria (OBS 362; IMT 1063). The proportion of men managed with OBS increased from 20% (2005) to 35% (2013). The OBS group was older (65.6 vs 62.8 years, p < 0.01), had higher Charlson comorbidity index scores (CCI ≥2, 21.5% vs 12.2%, p < 0.01), and had a higher proportion of low-risk PCa (65.2% vs 55.0%, p < 0.01). For the OBS cohort, 181 of the men (50%) eventually received treatment. Among those remaining on OBS for ≥24 months (N = 166), 88.6% had ≥1 follow-up PSA test and 26.5% received ≥1 follow-up biopsy within the 24 months. The unadjusted mortality rate was higher for OBS compared with IMT (2.7 vs 1.3/100 person-years [py]; p < 0.001). After multivariate adjustment, there was no significant difference in all-cause mortality between OBS and IMT groups (HR 0.73, p = 0.138). CONCLUSIONS: Use of OBS management increased over the 10-year study period. Men in the OBS cohort had a higher proportion of low-risk PCa. No differences were observed in overall survival between the two groups after adjustment of covariates. These data provide insights into how favorable risk PCa was managed in a community setting.

Healthcare costs among men with favorable risk prostate cancer managed with observation strategies versus immediate treatment in an integrated healthcare system.

OBJECTIVE: This study explored short-term healthcare costs of men managed with observation strategies (OBS) vs immediate treatment (IMT) for favorable risk prostate cancer (PCa) from the Geisinger Health System, a single integrated health system in Pennsylvania, as evidence from the community setting is limited. METHODS: A retrospective cohort study was conducted using electronic health records from men aged ≥40 years diagnosed with favorable risk PCa (T1 or 2, PSA ≤15 ng/mL, Gleason ≤7 [3 + 4]) between January 2005 and October 2013. Prostate-specific healthcare costs were compared between the OBS and IMT cohorts in men with ≥3 years of follow-up and available linked claims data. Sub-group analyses focused on those men with low-risk PCa (T1-2a, PSA ≤10 ng/mL, Gleason ≤6). Sensitivity analysis stratified the study sample in three cohorts: OBS, switched from OBS to definitive treatment (OBS switch), and IMT. RESULTS: A total of 352 patients were included (OBS = 70 and IMT = 282). Compared with IMT, OBS resulted in significantly lower cumulative PCa-related healthcare costs for the first 3 years ($15,785 vs $23,177; p-value <.001). The main cost drivers were outpatient procedures. The OBS cohort had the lowest incremental PCa-related healthcare costs in the first 3 years (OBS: $5,011 vs OBS switch: $26,040, net cost savings = $21,029, p < .001; OBS: $5,011 vs IMT: $24,064, net cost savings = $19,053, p < .001). CONCLUSIONS: In favorable risk PCa, half of the patients who initially chose OBS eventually underwent treatment after their PCa diagnosis. As expected, OBS was associated with reduced disease management costs compared with IMT.

A phase 1/2a follistatin gene therapy trial for becker muscular dystrophy.

Becker muscular dystrophy (BMD) is a variant of dystrophin deficiency resulting from DMD gene mutations. Phenotype is variable with loss of ambulation in late teenage or late mid-life years. There is currently no treatment for this condition. In this BMD proof-of-principle clinical trial, a potent myostatin antagonist, follistatin (FS), was used to inhibit the myostatin pathway. Extensive preclinical studies, using adeno-associated virus (AAV) to deliver follistatin, demonstrated an increase in strength. For this trial, we used the alternatively spliced FS344 to avoid potential binding to off target sites. AAV1.CMV.FS344 was delivered to six BMD patients by direct bilateral intramuscular quadriceps injections. Cohort 1 included three subjects receiving 3 × 10(11) vg/kg/leg. The distance walked on the 6MWT was the primary outcome measure. Patients 01 and 02 improved 58 meters (m) and 125 m, respectively. Patient 03 showed no change. In Cohort 2, Patients 05 and 06 received 6 × 10(11) vg/kg/leg with improved 6MWT by 108 m and 29 m, whereas, Patient 04 showed no improvement. No adverse effects were encountered. Histological changes corroborated benefit showing reduced endomysial fibrosis, reduced central nucleation, more normal fiber size distribution with muscle hypertrophy, especially at high dose. The results are encouraging for treatment of dystrophin-deficient muscle diseases.

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.