Cardiovascular risk prediction model and stratification in patients with type 2 diabetes enrolled in a Medicare Advantage plan.

BACKGROUND: Cardiovascular (CV) risk tools have been developed both nationally and internationally to identify patients at risk for developing CV disease or experiencing a CV event. However, these tools vary widely in the definitions of endpoints, the time at which the endpoints are measured, patient populations, and their validity. The primary limitation of some of the most commonly utilized tools is the lack of specificity for a type 2 diabetes (T2D) population and/or among older patients. OBJECTIVE: To develop a predictive model within an older population of patients with T2D to identify patients at risk for CV events. METHODS: This retrospective cohort study used claims, laboratory, and enrollment data during the 2011-2018 study period. Patients with T2D were identified based on diagnoses and/or medications from 2012-2013. The patient cohort was split into 3 different datasets. The holdout dataset included only those patients residing in the northeastern United States. The rest of the sample was then randomly split: 70% for the training dataset, which were used to fit the predictive model, and 30% for the test dataset to assess internal validity. The primary outcome was the first composite CV event defined as at least 1 of the following: inpatient hospitalization for myocardial infarction, ischemic stroke, unstable angina, or heart failure; or any evidence of revascularization. A survival model for the composite outcome was fitted with baseline demographic and clinical characteristics prognostic for the dependent variable utilizing augmented backwards elimination. For assessing model performance, accuracy, sensitivity, specificity, and the c-statistic were used. Patients were ranked as having a low, moderate, or high probability of a future CV event. RESULTS: A total of 362,791 patients were identified. The holdout dataset included only those patients residing in the northeastern United States (n = 8,303). There were 248,142 patients included in the training dataset and 106,346 patients in the test dataset. The proportion with at least 1 observed composite CV event was 20.9%. The final model included 42 variables. The c-statistic was 0.68, and the accuracy, sensitivity, and specificity were approximately 63%. Results were consistent across the training, test, and holdout samples. The optimal cut points minimizing the difference in sensitivity and specificity for low-, moderate-, and high-risk future CV events were determined to be less than 0.18, 0.18-0.63, and greater than 0.63, respectively, in the training dataset at 5 years. The 5-year observed event risk was 11%, 27%, and 51% for patients classified as low, moderate, and high risk of a future CV event, respectively. CONCLUSIONS: A model predicting CV events among older patients with T2D using administrative claims to identify those at risk may be used for focusing interventions to prevent future events. DISCLOSURES: This study was funded by Boehringer Ingelheim (BI) and conducted as part of the BI-Humana Research Collaboration. Caplan is employed by Humana Healthcare Research, Inc., a wholly owned subsidiary of Humana Inc., which received fees to conduct the study from the sponsor BI. At the time of the study, Hayden and Harvey were employees of Humana Healthcare Research, Inc. Additionally, Prewitt, who owns stock in Humana Inc, and Chiguluri are employees of Humana Inc. Kattan, associated with the Cleveland Clinic in Ohio, served as a consultant to BI, and Pimple and Goss are employees of BI. Luthra was employed by BI for the duration of the study. Portions of this work were accepted as an abstract and presented as a poster at the American Diabetes Association 2020 virtual meeting, June 12-16, 2020.

Real-world treatment, clinical outcomes and healthcare resource utilization among persons with hemophilia A by age.

Aim: Examine real-world characteristics, treatment patterns, and outcomes among treated persons with hemophilia A (PwHA) stratified by age. Patients & methods: This study utilized US claims data from 1 January 2007-31 July 2018 from the Humana Research Database. Unadjusted comparisons were conducted across PwHA (<18, 18-55, 56-89 years) enrolled in commercial or Medicare Advantage Prescription Drug plans. Results: A total of 294 PwHA were identified; 21.1% experienced ≥1 bleeding event, and 41.2 and 53.1% had evidence of arthropathy or related disorders, and pain, respectively. Along with all-cause and hemophilia-related healthcare resource utilization (HCRU), these were highest among PwHA aged 56-89 years. Conclusion: Insights into treatment, outcomes and HCRU may identify opportunities for enhanced disease management, particularly in older PwHA.

Novel Approach Using Administrative Claims to Evaluate Trends in Oncology Multigene Panel Testing for Patients Enrolled in Medicare Advantage Health Plans.

PURPOSE: To develop an approach to identify and evaluate recent use of multigene panel testing over time. METHODS: We conducted a retrospective database analysis using medical and pharmacy claims data. Medicare Advantage Prescription Drug Plan members diagnosed with select malignant solid tumors were identified. The pattern of somatic genetic testing for each patient was evaluated from January 2016 through December 2018. Tests were classified by the number of genes tested in the panel: < 50 (small or medium) and ≥ 50 (large). RESULTS: An initial feasibility study using our novel approach for identifying panel tests resulted in 2.4 and 1.2 times more large and medium panels, respectively, identified compared with using procedure codes alone. A total of 121,675 eligible patients were identified, with 131,915 unique cancer cases. Overall, 5,457 (4.5%) patients received any panel test from 2016 to 2018. We found the number of tests performed each quarter increased from 238 in Q1 of 2016 to 755 in Q4 of 2018. The highest number of cases were genitourinary cancers; however, the highest proportion of cancer-related genetic testing was among patients with respiratory cancer. Across all tumor types, the proportion of large-panel tests performed as a function of all multigene panel tests increased from 20.7% of tests in Q1 of 2016 to 46.4% of tests in Q4 of 2018. The three cancer categories with the highest count of cancer-related panel tests, respiratory cancer, GI cancer, and female reproductive cancer, had a consistently greater proportion receiving a panel test at any point postindex. CONCLUSION: Across a variety of cancers, use of somatic, large-panel cancer-related genetic testing, as a proportion of all somatic cancer-related genetic testing, increased from 2016 to 2018, although testing overall was low.

Glomerular filtration rate change and outcomes in type 2 diabetes.

OBJECTIVES: To assess the relationship between relative estimated glomerular filtration rate (eGFR) change and outcomes in patients with type 2 diabetes (T2D). STUDY DESIGN: This retrospective cohort study utilized administrative claims (Humana Research Database) for patients with T2D aged 65 to 89 years, enrolled in a Medicare Advantage plan, with an initial eGFR of 25 to 89 mL/min/1.73m2 in 2008 to 2017, and a second eGFR measurement within 3 to 24 months after the identification date. METHODS: The primary exposure was relative decline in eGFR of 40% or more in a 2-year period. Outcomes included end-stage kidney disease (ESKD) or kidney failure, a composite cardiovascular (CV) outcome, and all-cause mortality assessed with multivariable adjusted survival models. Days out of the home and all-cause total costs were assessed using multivariable adjusted generalized linear models. RESULTS: A total of 288,170 patients were included. The adjusted HR for ESKD or kidney failure was 4.38 (95% CI, 3.99-4.81) in patients with 40% or greater decline versus those with a decline of less than 40%. The adjusted HR was 1.67 (95% CI, 1.53-1.82) for the composite CV outcome and 1.98 (95% CI, 1.87-2.10) for all-cause mortality. Patients with a 40% or greater relative decline had 2.23 times higher all-cause total per patient per month costs ($1910 difference) and 1.82 times higher odds of 7 or more days out of the home versus those with less than 40% relative eGFR decline. CONCLUSIONS: Our results indicate that a relative eGFR decline of 40% or greater is associated with an increased risk of ESKD or kidney failure, CV outcomes and all-cause mortality, and increased health care resource utilization and costs.

An Evaluation of Longitudinal Measures of Anticholinergic Exposure for Application in Retrospective Administrative Data Analyses.

INTRODUCTION: As continuous exposure to anticholinergics has been associated with adverse outcomes, accurately measuring exposure is important. However, no gold standard measure is available, and the performance of existing measures has not been compared. Our objective was to compare the properties of the Cumulative Anticholinergic Burden (CAB) measure against two existing measures of anticholinergic exposure and to assess their compatibility for use in observational studies based on claims data. METHODS: The average daily dose, cumulative dose and CAB measures were evaluated on: the applicability for use with anticholinergic burden scales, the ability to consider duration and/or accumulation of exposure, and consideration of anticholinergic dose, potency, and residual effect. To calculate each measure empirically, Truven MarketScan claims data from 2012 to 2015 were analyzed. Cumulative anticholinergic exposure over 1-year post-enrollment was calculated for each measure using Anticholinergic Cognitive Burden scale scores. Median [interquartile range (IQR)] and ranges of measure scores, and Spearman's correlation coefficients between measures, were estimated. Due to the differing methods of calculation, the absolute values of each score cannot be compared. RESULTS: The properties of the different measures varied, with only the CAB considering both dose and theoretical potency. The cohort included 99,742 individuals (mean age = 73.1 years; 54.9% female). Among individuals prescribed anticholinergics (n = 55,969), 1-year median (IQR) scores based on average daily dose, cumulative dose and CAB measures were 0.9 (0.3-1.5), 16.9 (7.3-33.9) and 203 (68-500), respectively. Measures were highly inter-correlated (r2 = 0.74-0.83). CONCLUSIONS: Considering both potency and dose, the CAB may prove a more comprehensive measure of anticholinergic burden; however, additional research is necessary to demonstrate whether it has any association with relevant health-related outcomes. FUNDING: Astellas Pharma Global Development, Inc.

The Relationship Between Anticholinergic Exposure and Falls, Fractures, and Mortality in Patients with Overactive Bladder.

BACKGROUND: Understanding risk factors associated with falls is important for optimizing care and quality of life for older patients. OBJECTIVE: Our objective was to determine the relationship between anticholinergic exposure and falls, fractures, and all-cause mortality. METHODS: An observational retrospective cohort study was conducted using administrative claims data from 1 January 2007 to 30 September 2015. Individuals aged 65-89 years newly diagnosed or treated for overactive bladder (OAB) were identified. Index date was the first OAB diagnosis or OAB medication prescription claim. Follow-up began on the index date and continued until death, disenrollment, or end of study period. The Anticholinergic Cognitive Burden (ACB) scale was used to define and quantify daily anticholinergic exposure and intensity. The primary study outcome was a combined endpoint of falls or fractures. All-cause mortality was a secondary endpoint. RESULTS: There were 113,311 patients with mean age of 74.8 ± standard deviation (SD) 6.2 years included. Current anticholinergic exposure was associated with a 1.28-fold increased hazard of a fall/fracture (95% confidence interval [CI] 1.23-1.32) compared with unexposed person-time, and past exposure was associated with a 1.14-fold increased hazard of a fall/fracture (95% CI 1.12-1.17). Compared with unexposed person-time, low-, moderate-, and high-intensity anticholinergic exposure was associated with a 1.04-fold (95% CI 1.00-1.07), 1.13-fold (95% CI 1.09-1.17), and 1.31-fold (95% CI 1.26-1.36) increased hazard of falls/fractures, respectively. A similar pattern was observed for all-cause mortality. CONCLUSIONS: Anticholinergic exposure is associated with an increased risk of falls or fractures in older patients and is an important consideration when evaluating treatment options for such patients with OAB.

Impact of Coexisting Overactive Bladder in Medicare Patients With Dementia on Clinical and Economic Outcomes.

BACKGROUND: Patients with dementia commonly suffer from symptoms of overactive bladder (OAB); however, limited research exists on the clinical impact of coexisting OAB among patients with dementia. As such, the objective of this study was to examine the impact of OAB on clinical outcomes, health-care resource use, and associated costs among patients with dementia. METHODS: We conducted a retrospective cohort analysis of patients with dementia using 3861 matched pairs of patients with and without OAB. Analyses were based on administrative claims data from January 1, 2007, to September 30, 2015, and compared clinical outcomes, health services use, and associated costs. RESULTS: Patients with dementia and OAB were more likely than those without OAB to have least one fall (incidence rate ratio [IRR]: 1.43, 95% confidence interval [CI], 1.22-1.68, P < .001), fracture (IRR: 1.23, 95% CI, 1.05-1.44, P = .008), combined fall/fracture (IRR: 1.25, 95% CI, 1.11-1.42, P < .001), or urinary tract infection (IRR: 2.75, 95% CI, 2.55-2.96, P < .001). Patients with dementia and OAB demonstrated greater utilization of all-cause encounter types compared to similar patients without coexisting OAB (P < .01). All-cause and dementia-related total health-care costs were approximately 23% (95% CI, 0.19-0.28, P < .001) and 13% (95% CI, 0.05-0.20, P = .001), respectively, greater than similar patients without coexisting OAB. CONCLUSION: Coexisting OAB was associated with impacts on clinical outcomes, health-care resource utilization, and costs in patients with dementia.

The Effect of an Educational Intervention on Adherence to Intraocular Pressure-Lowering Medications in a Large Cohort of Older Adults with Glaucoma.

BACKGROUND: Glaucoma is a progressive, irreversible disease that can lead to vision loss and lower quality of life if treatment is not optimized. Effective glaucoma therapies are available to lower intraocular pressure (IOP) and minimize or delay disease progression. Nonetheless, adherence to treatment remains suboptimal for many patients. OBJECTIVE: To identify potentially nonadherent patients and evaluate the effect of patient- and physician-centric educational interventions on adherence by using a validated predictive model of nonadherence to glaucoma medication. METHODS: This prospective, randomized, controlled, and interventional study included Humana Medicare Advantage Prescription Drug plan patients with a glaucoma diagnosis between May and October 2014, ≥ 1 pharmacy claim for glaucoma medication, and ≥ 50% likelihood of nonadherence. Patients and physicians were randomized to cohorts A (no interventions), B (physician intervention), or C (patient and physician interventions). Physicians in cohorts B and C received information on the model, adherence, and patient profiles at baseline and months 3, 6, and 9. Patients in cohort C received educational materials on glaucoma and adherence (same schedule). The primary outcome was the proportion of days covered (PDC) with medication over 12 months. Adherence was defined as PDC ≥ 0.80. RESULTS: Overall, 23,306 patients and 2,955 physicians were eligible. After excluding physicians with < 3 nonadherent patients, each cohort included 200 physicians and 600 patients. Mean PDC was 0.54-0.56 across cohorts. At 12 months, ≥ 90.5% of physicians and ≥ 75.5% of patients remained in the study; mean PDC was 0.53-0.54 across cohorts. No statistically significant between-cohort differences in PDC and adherence were observed. CONCLUSIONS: Intensive educational mailings to patients and their physicians did not improve PDC or adherence in this large population of potentially nonadherent patients with glaucoma. Findings highlight the difficulty of improving adherence in a disease that requires lifelong therapy despite being largely asymptomatic and can inform development of future interventions aimed at improving adherence to glaucoma therapy. DISCLOSURES: This study was sponsored by Allergan plc (Dublin, Ireland). Fiscella and Chandwani are employees of Allergan plc. Caplan, Kamble, Bunniran, and Uribe are employees of Comprehensive Health Insights, a Humana company. The authors did not receive honoraria or other payments for authorship.

Positive predictive value between medical-chart body-mass-index category and obesity versus codes in a claims-data warehouse.

OBJECTIVE: To evaluate the positive predictive value of claims-based V85 codes for identifying individuals with varying degrees of BMI relative to their measured BMI obtained from medical record abstraction. METHODS: This was a retrospective validation study utilizing administrative claims and medical chart data from 1 January 2009 to 31 August 2015. Randomly selected samples of patients enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan and with a V85 claim were identified. The claims-based BMI category (underweight, normal weight, overweight, obese class I-III) was determined via corresponding V85 codes and compared to the BMI category derived from chart abstracted height, weight and/or BMI. The positive predictive values (PPVs) of the claims-based BMI categories were calculated with the corresponding 95% confidence intervals (CIs). RESULTS: The overall PPVs (95% CIs) in the MAPD and commercial samples were 90.3% (86.3%-94.4%) and 91.1% (87.3%-94.9%), respectively. In each BMI category, the PPVs (95% CIs) for the MAPD and commercial samples, respectively, were: underweight, 71.0% (55.0%-87.0%) and 75.9% (60.3%-91.4%); normal, 93.8% (85.4%-100%) and 87.8% (77.8%-97.8%); overweight, 97.4% (92.5%-100%) and 93.5% (84.9%-100%); obese class I, 96.9 (90.9%-100%) and 97.2% (91.9%-100%); obese class II, 97.0% (91.1%-100%) and 93.0% (85.4%-100%); and obese class III, 85.0% (73.3%-96.1%) and 97.1% (91.4%-100%). CONCLUSIONS: BMI categories derived from administrative claims, when available, can be used successfully particularly in the context of obesity research.

Impact of coexisting overactive bladder in Medicare patients with osteoporosis.

BACKGROUND: Osteoporosis and overactive bladder (OAB) are prevalent conditions in older adults and are independent risk factors for falls and fractures. A paucity of evidence exists examining the impact of coexisting OAB in patients with osteoporosis. OBJECTIVE: To examine the impact of OAB on healthcare resource utilization (HRU), clinical outcomes, and healthcare costs among older adult patients with osteoporosis. METHODS: This retrospective analysis compared patients with osteoporosis with and without OAB. Patients with an osteoporosis diagnosis, enrolled in a Medicare Advantage plan, and aged 65-89 inclusive were eligible. Incident OAB among patients with prevalent osteoporosis was identified. A comparison group of patients with osteoporosis but no evidence of OAB was propensity score matched on baseline characteristics. Fall and/or fracture outcomes, HRU and healthcare costs were evaluated during 12 months of follow-up. Bivariate comparisons of outcomes were conducted. Ordinary least squared regression was used to examine the relationship between OAB and total healthcare costs. RESULTS: After matching, 5,526 patients in each group were included. Patients with osteoporosis and OAB demonstrated greater all-cause HRU across all encounter types compared to patients without OAB (all P values<0.001). Patients with osteoporosis and OAB had a greater frequency of any fall/fracture (17.7% vs. 14.9%, P<0.001). Patients with osteoporosis and OAB had 35% greater all-cause total healthcare costs than patients without OAB (P<0.001). CONCLUSIONS: Patients with OAB and osteoporosis had significantly greater all-cause HRU and costs. Falls and fractures were significantly more common in patients with osteoporosis and OAB compared to patients with osteoporosis without OAB.

Impact of Overactive Bladder Step Therapy Policies on Medication Utilization and Expenditures Among Treated Medicare Members.

BACKGROUND: The impact of formulary management strategies on utilization and expenditures in overactive bladder (OAB) treatment has not been extensively investigated. In 2013, step therapy (ST) policies for 2 branded OAB treatments, mirabegron and fesoterodine, were removed from Humana Medicare Advantage Prescription Drug (MAPD) plans and Medicare prescription drug plans (PDP), allowing for an examination of the effect of ST policies on OAB medication use patterns and costs. OBJECTIVE: To assess the impact of removal of formulary restriction policies for mirabegron and fesoterodine on medication utilization patterns and costs associated with OAB treatment in Medicare patients. METHODS: A retrospective cross-sectional study design was utilized. Subjects included individuals enrolled in Humana MAPD plans or PDPs, aged ≥ 65 years, with ≥ 1 prescription for an OAB medication in 2013. Patient demographic characteristics, OAB medication utilization, and pharmacy cost trends in 2013 were described. OAB medication use was calculated as the number of 30-day-supply equivalent medication claims and reported as a percentage of the total number of 30-day-supply equivalent claims across all OAB products. OAB medication expenditures were calculated as a percentage of the sum of pharmacy costs for OAB medications and reported separately for each month and drug during 2013. Temporal trends of OAB medication utilization and expenditures in 2013 were calculated using ordinary least squares regression. RESULTS: Of 194,511 patients, trends in utilization of OAB medications indicated that on average, there was a statistically significant monthly increase in utilization of mirabegron (regression coefficient [B] = 274; P < 0.001; 95% CI: 218, 330), fesoterodine (B = 167; P < 0.001; 95% CI = 129, 205), oxybutynin extended release (ER; B = 357; P = 0.011; 95% CI = 99, 614), and trospium ER (B = 33; P = 0.001; 95% CI = 17, 50) and statistically significant decreases in utilization of solifenacin (B = -202; P = 0.048; 95% CI = -402, -2), tolterodine ER (B = -287; P = 0.002; 95% CI = -437, -137), darifenacin (B = -94; P < 0.001; 95% CI = -128, -61), and trospium immediate release (IR; B = -22; P = 0.001; 95% CI = -32, -12). Total OAB medication expenditures significantly increased an average of 0.12% for each month during the course of 2013 (B = 0.12; P = 0.026; 95% CI = 0.017, -0.223). While monthly oxybutynin IR utilization did not change significantly throughout 2013 (B = 228; P = 0.169; 95% CI = -114, -570), it demonstrated the largest average monthly expenditure increase (B = 0.082; P < 0.001; 95% CI = 0.056, 0.108). When removing oxybutynin IR costs from the total OAB medication costs, the trend in total OAB medication average monthly expenditures was not significant (B = 0.038; P = 0.365; 95% CI = -0.051, -0.126). An over 4-fold per-unit-cost increase for oxybutynin IR was noted. CONCLUSIONS: Utilization of 2 branded OAB products increased in the months after ST removal with minimal cost impact. One of the possible reasons total OAB expenditures increased may have been due to the increased cost of the largest-volume generic product, oxybutynin IR. DISCLOSURES: This research was funded by Astellas Pharma Global Development and was conducted as part of the Astellas-Humana Research Collaboration. Ng, Kristy, Schermer, and Bradt are employees of Astellas. Astellas manufactures mirabegron (Myrbetriq) and solifenacin (VESIcare). Abbass, Caplan, Collins, and Suehs are employees of Comprehensive Health Insights, a subsidiary of Humana, which received funding from Astellas for this study. Suehs owns stock in Humana. Chan is an employee of Humana Pharmacy Solutions. Portions of this study were presented as a poster at Academy of Managed Care Pharmacy Nexus 2015; October 26-29, 2015; Orlando, Florida. Study concept and design were contributed by Ng, Chan, Suehs, and Abbass, along with Collins. Abbass took the lead in data collection, along with Collins and with assistance from Caplan, Chan, and Suehs. Data interpretation was provided by Kristy and Bradt, along with Abbass, Caplan, Ng, Suehs, Collins, and Chan. The manuscript was written primarily by Caplan, along with Schermer, Suehs, and Abbass, and revised by Caplan, Schermer, and Ng, along with the other authors.