Clinical characteristics and health care resource use of patients at risk for wild-type transthyretin amyloid cardiomyopathy identified by machine learning model.

BACKGROUND: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, life-threatening systemic disorder that is an underrecognized cause of heart failure (HF). When the diagnosis of wild-type ATTR-CM (ATTRwt-CM) is delayed, patients often undergo additional assessments, deferring appropriate management as symptoms potentially worsen. Prompt recognition of patients at risk for ATTRwt-CM is essential to facilitate earlier diagnosis and disease-modifying treatment. A previously developed machine learning model performed well in identifying ATTRwt-CM in patients with HF vs controls with nonamyloid HF using medical claims/electronic health records, providing a systematic framework to raise disease suspicion. OBJECTIVE: To further evaluate this model's performance in identifying ATTRwt-CM using a large claims database of older adults with HF and confirmed ATTRwt-CM or nonamyloid HF; and to explore the characteristics and health care resource utilization (HCRU) of patients with confirmed and suspected ATTRwt-CM. METHODS: In this retrospective study, the prior model was applied using Humana administrative claims for patients diagnosed with ATTRwt-CM (cases) and nonamyloid HF (controls [1:1]). Patients were aged 65-89 years, had at least 2 claims for HF diagnosis (2015-2020), and were continuously enrolled in a Medicare Advantage prescription drug plan for at least 12 months before and at least 6 months after HF diagnosis. For the assessment of characteristics and HCRU, the suspected risk level was categorized based on the predicted probability (PP) from model output (high, moderate, and low risk: PP≥0.70; ≥0.50 and < 0.70; and < 0.50, respectively). RESULTS: Of 267,025 eligible patients, 119 (0.04%) had confirmed ATTRwt-CM; of 266,906 patients with nonamyloid HF, 10,997 (4.1%), 68,174 (25.5%), and 187,735 (70.3%) were categorized as high, moderate, and low risk for ATTRwt-CM, respectively. The model demonstrated sensitivity/specificity/accuracy/receiver operating characteristic area under the concentration-time curve of 88%/65%/77%/0.89, respectively, in differentiating ATTRwt-CM from nonamyloid HF. In patients with confirmed ATTRwt-CM, the mean (SD) time between HF and ATTRwt-CM diagnoses was 751 (528) days; 65% and 48% were hospitalized before and after ATTRwt-CM diagnosis, respectively. Atrial fibrillation was more common in patients with confirmed ATTRwt-CM and high risk (39% and 55%) vs low risk (27%). Hospitalization and emergency department visits after HF diagnosis were reported in 57% and 46% of patients with high ATTRwt-CM risk, respectively. CONCLUSIONS: The ATTRwt-CM predictive model performed well in identifying disease risk in the Humana Research Database. Patients at high risk for ATTRwt-CM had high HCRU and may benefit from the earlier suspicion of ATTRwt-CM. The model may be used as a tool to identify patients with a suspected high risk for the disease to facilitate earlier detection and treatment. DISCLOSURES: This study was sponsored by Pfizer. Medical writing support was provided by Donna McGuire of Engage Scientific Solutions and funded by Pfizer. Drs Bruno and Schepart and Mr Casey are currently employees of Pfizer and equity holders in this publicly traded company. Dr Reed was an employee of Pfizer at the time that this analysis was planned and conducted. Mr Sheer and Dr Simmons are currently employees of Humana, which received research funding from Pfizer. Dr Nair was an employee of Humana at the time that this analysis was planned and conducted.

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.

Predictive Risk Models to Identify Patients at High-Risk for Severe Clinical Outcomes With Chronic Kidney Disease and Type 2 Diabetes.

INTRODUCTION/OBJECTIVE: Predictive risk models identifying patients at high risk for specific outcomes may provide valuable insights to providers and payers regarding points of intervention and modifiable factors. The goal of our study was to build predictive risk models to identify patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at high risk for progression to end stage kidney disease (ESKD), mortality, and hospitalization for cardiovascular disease (CVD), cerebrovascular disease (CeVD), and heart failure (HF). METHODS: This was a retrospective observational cohort study utilizing administrative claims data in patients with CKD (stage 3-4) and T2D aged 65 to 89 years enrolled in a Medicare Advantage Drug Prescription plan offered by Humana Inc. between 1/1/2012 and 12/31/2017. Patients were enrolled ≥1 year pre-index and followed for outcomes, including hospitalization for CVD, CeVD and HF, ESKD, and mortality, 2 years post-index. Pre-index characteristics comprising demographic, comorbidities, laboratory values, and treatment (T2D and cardiovascular) were evaluated and included in the models. LASSO technique was used to identify predictors to be retained in the final models followed by logistic regression to generate parameter estimates and model performance statistics. Inverse probability censoring weighting was used to account for varying follow-up time. RESULTS: We identified 169 876 patients for inclusion. Declining estimated glomerular filtration rate (eGFR) increased the risk of hospitalization for CVD (38.6%-61.8%) and HF (2-3 times) for patients with eGFR 15 to 29 mL/min/1.73 m2 compared to patients with eGFR 50 to 59 mL/min/1.73 m2. Patients with urine albumin-to-creatinine ratio (UACR) ≥300 mg/g had greater chance for hospitalization for CVD (2.0 times) and HF (4.9 times), progression to ESKD (2.9 times) and all-cause mortality (2.4 times) than patients with UACR <30 mg/g. Elevated hemoglobin A1c (≥8%) increased the chances for hospitalization for CVD (21.3%), CeVD (45.4%), and death (20.6%). Among comorbidities, history of HF increased the risk for ESKD, mortality, and hospitalization for CVD, CeVD, and HF. CONCLUSIONS: The predictive models developed in this study could potentially be used as decision support tools for physicians and payers, and the risk scores from these models can be applied to future outcomes studies focused on patients with T2D and CKD.

Medicare Advantage-pharmacy partnership improves influenza and pneumococcal vaccination rates.

OBJECTIVES: To evaluate the impact of a collaborative effort of a Medicare Advantage and prescription drug (MAPD) plan and community pharmacies to improve vaccination rates for pneumonia and influenza. STUDY DESIGN: This quasiexperimental, cluster-randomized intervention study used MAPD data to assess the impact of community pharmacists on vaccination rates. Pharmacies in specific regions (districts) were randomly assigned to intervention or control groups. Intervention pharmacies received reports of patients with a gap in influenza (aged 19-89 years) and/or pneumococcal (aged 65-89 years) vaccinations based on medical and pharmacy claims history. Vaccine-naïve patients were offered vaccinations. METHODS: The vaccination rates for the previously vaccine-naïve patients utilizing intervention and control pharmacies were compared 6 months post randomization. Inverse probability weighted hierarchical generalized linear models determined the odds of receiving pneumonia and influenza vaccinations for intervention and control groups, controlling for baseline clinical and demographic characteristics. RESULTS: Intervention and control groups had similar ages in the pneumococcal older-adult cohort (mean age, 73.0 vs 73.4 years, respectively; P = .1255). The intervention group was older than the control group in the influenza cohort (mean age, 67.7 vs 66.4 years, respectively; P = .0006). Slightly more than half of each cohort were women, and the proportion of women was not significantly different between the intervention and control groups in each cohort. In multivariable analyses, intervention pharmacies were associated with higher odds of delivering pneumococcal (odds ratio [OR], 1.91; 95% CI, 1.26-2.87) and influenza (OR, 2.18; 95% CI, 1.37-3.46) vaccinations than control pharmacies. CONCLUSIONS: A health plan-enabled, pharmacist-led intervention was effective in increasing the number of older adults receiving pneumococcal vaccination and individuals receiving influenza vaccination.

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.

Evaluation of an Osteoporosis Outreach Program for Men With a Fragility Fracture and Their Physicians.

BACKGROUND: Many health plans have outreach programs aimed at appropriately screening, evaluating, and treating women experiencing fragility fractures; however, few programs exist for men. OBJECTIVE: The objective of this study was to develop, implement, and evaluate an osteoporosis outreach program for men with a recent fragility fracture and their physicians. RESEARCH DESIGN AND SUBJECTS: A total of 10,934 male patients enrolled in a Medicare Advantage with Prescription Drug Plan with a recent fragility fracture were randomized to a program or control group. Patients and their physicians received letters followed by phone calls on osteoporosis and the importance of screening and treatment. The evaluation compared bone mineral density (BMD) test utilization and osteoporosis medication treatment (OPT) among patients who received the outreach versus no outreach at 12 months. The effect of the program was estimated through univariate and multivariable logistic regressions. RESULTS: The program had a significant impact on BMD evaluation and OPT initiation. At 12 months, 10.7% of participants and 4.9% of nonparticipants received a BMD evaluation. The odds ratio (OR) (95% confidence interval) was 2.31 (1.94, 2.76), and the number needed to outreach to receive a BMD test was 18. OPT was initiated in 4.0% of participants and 2.5% of nonparticipants. The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69. Adjusted ORs were similar in magnitude and significance. CONCLUSION: The program was highly effective by more than doubling the rate of BMD evaluation; however, more intensive interventions may yield an even higher screening rate.

Real-World Analysis of Guideline-Based Therapy After Hospitalization for Heart Failure.

Background Patients hospitalized with heart failure (HF) with reduced ejection fraction have high risk of rehospitalization or death. Despite guideline recommendations based on high-quality evidence, a substantial proportion of patients with HF with reduced ejection fraction receive suboptimal care and/or do not comply with optimal care following hospitalization. Methods and Results This retrospective observational study identified 17 106 patients with HF with reduced ejection fraction with an incident HF-related hospitalization using the Humana Medicare Advantage database (2008-2016). HF medication classes (beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin receptor neprilysin inhibitors, or mineralocorticoid receptor antagonists) received in the year after hospitalization were recorded, and categorized by treatment intensity (ie, number of concomitant medication classes received: none [23% of patients; n=3987], monotherapy [22%; n=3777], dual therapy [41%; n=7056], or triple therapy [13%; n=2286]). Compared with no medication, risk of primary outcome (composite of death or rehospitalization) was significantly reduced (hazard ratio [95% CI]) with monotherapy (0.68 [0.64-0.71]), dual therapy (0.56 [0.53-0.59]), and triple therapy (0.45 [0.41-0.50]). Nearly half (46%) of patients who received post-discharge medication had no dose escalation. Overall, 59% of patients had follow-up with a primary care physician within 14 days of discharge, and 23% had follow-up with a cardiologist. Conclusions In real-world clinical practice, increasing treatment intensity reduced risk of death and rehospitalization among patients hospitalized for HF, though the use of guideline-recommended dual and triple HF therapy remained low. There are opportunities to improve post-discharge medical management for patients with HF with reduced ejection fraction such as optimizing dose titration and improving post-discharge follow-up with providers.

Validated prediction of imminent risk of fracture for older adults.

OBJECTIVES: To develop and validate predictive models for imminent fracture risk in a Medicare population. STUDY DESIGN: This retrospective administrative claims (Humana Research Database) study assessed imminent risk in Humana's Medicare Advantage and Prescription Drug plan members. METHODS: Individuals (aged 67-87 years on January 1, 2015 [index]) with 1 year or more of history were followed for 3 months to up to 2 years, with censoring at death/disenrollment. The cohort was split into training and validation samples (1:1). Cox regression models assessed demographics, fracture history, medically significant falls, osteoporosis-related factors, frailty markers, and selected medications and comorbidities for independent predictors (P <.001) of incident nontraumatic clinical fractures in 12 and 24 months. A 6-variable model of 12-month risk used a published method for the risk-scoring point system. RESULTS: Of 1,287,354 individuals (mean age, 74.3 years; 56% female; 84% white), 3.8% had at least 1 fragility fracture at 12-month follow-up; 6.6% experienced fracture at 24 months (women vs men: 12 months, 4.8% vs 2.5%; 24 months, 8.3% vs 4.4%; both P <.01). At 12 months, recent fracture conferred approximately 3-fold-higher fracture risk (vs no recent fracture). Older age, white race, female sex, osteoporosis-related screening/diagnosis/medication, antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications, history of falls, fracture history, and respiratory conditions also increased risk (all P <.0001). The simplified model (recent fracture, age, sex, race, falls, antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications) performed well (C statistic = 0.71). CONCLUSIONS: Recent fracture, older age, female sex, white race, falls, and antidepressant/antipsychotic/sedative hypnotic/muscle relaxant medications predict imminent fracture risk in an older-adult Medicare Advantage population. Imminent fracture risk can be assessed using 6 easily quantified factors.

Factors Related to the Use of Topical vs. Oral NSAIDs for Sprains, Strains, and Contusions in a Senior Population: A Retrospective Analysis of Administrative Claims Data.

BACKGROUND: Research to date on sprains, strains, and contusions has focused mainly on the analysis of sports-related injuries, occupational injuries, injuries resulting from automobile accidents, and severe injuries that result in inpatient hospital stays. Little is known about real-world acute sprains, strains, and contusions in an aging population. Patients may be treated with over-the-counter, oral, non-steroidal anti-inflammatory drugs (NSAIDs) for acute sprains, strains, and contusions or may require the use of prescription NSAIDs. For sprains, strains, and contusions treated with prescription NSAIDs, the choice of topical administration or oral administration likely depends on a number of factors such as age and comorbid conditions. OBJECTIVES: The objective of the study was to identify factors associated with the use of a prescription topical NSAID or a prescription oral NSAID for the treatment of sprains, strains, and contusions among patients aged 65-89 years enrolled in the Medicare Advantage with Prescription Drug plan. METHODS: The study sample was selected from the Humana Research Database (Louisville, KY, USA). Study subjects were identified as patients enrolled in Medicare Advantage with Prescription Drug plans, aged 65-89 years, having a medical claim with an International Classification of Diseases, Ninth Revision, Clinical Modification indicative of an acute sprain, strain, and contusion between 1 January, 2010 and 31 March, 2014 (identification period). The date of the first claim was considered the index date, and subjects were required to have 12 months of continuous enrollment before the index date and a minimum of 3 months continuous enrollment after the index date. Prescription NSAID use during the 3 months after the index sprain, strain, and contusion diagnosis was required for study inclusion and was identified based on a pharmacy claim for a topical or an oral NSAID. Patients with prescription NSAID use leading up to the sprains, strains, and contusions were excluded. Potential factors related to the use of a topical vs. oral NSAID were identified using stepwise logistic regression with backward elimination. RESULTS: After applying the inclusion and exclusion criteria, 42,283 patients were prescribed an oral or topical NSAID (39,294 oral; 2989 topical) within 3 months of the index sprain, strain, and contusion diagnosis. After applying stepwise logistic regression, and retaining variables with statistically significant parameter estimates (p < 0.05), use of topical NSAIDs was higher among female individuals [odds ratio and 95% confidence interval = 1.34 (1.24-1.45)], and appeared to increase with age [odds ratio = 1.04 (1.04-1.05)]. Topical NSAID use was lower in the Midwest region [odds ratio = 0.85 (0.77-0.94)] in comparison to the Southern region. Clinical factors associated with topical NSAID use included Elixhauser Comorbidity Index score [odds ratio = 1.06 (1.04-1.09)], medication burden [odds ratio = 1.06 (1.04-1.08), pill burden [odds ratio = 1.02 (1.01-1.03), specific comorbid conditions, including site-specific osteoarthritis of the upper arm [odds ratio = 2.34 (1.19-4.60)], ankle/foot [odds ratio = 1.46 (1.14-1.87)], or lower leg [odds ratio = 1.21 (1.07-1.36)], myofascial pain [odds ratio = 1.31 (1.21-1.42)], gastrointestinal/hepatic disorders [odds ratio = 1.15 (1.05-1.25)], systemic/central pain [odds ratio = 1.12 (1.01-1.23)], and cataracts [odds ratio = 1.10 (1.02-1.20)]. Conversely, a diagnosis of diabetes mellitus was related to use of an oral NSAID rather than a topical NSAID [odds ratio = 0.86 (0.78-0.94)]. Diagnosis of the index sprain, strain, and contusion in an emergency department instead of a physician's office was also associated with oral NSAID use [odds ratio = 0.42 (0.37-0.47)]. CONCLUSIONS: Topical NSAIDs were used less often than oral NSAIDs following a sprain, strain, or contusion. Age, medication burden, pill burden, evidence of gastrointestinal disorder, and evidence of certain pain-related conditions were significant factors associated with topical NSAID as opposed to oral NSAID use. In comparison to oral NSAIDs, topical NSAIDs were more likely to be prescribed in a physician's office than an emergency department, possibly because a patient's physician has a better understanding of the patient's concomitant medications and comorbidities. Although topical NSAIDs were more likely to be used than oral NSAIDs in patients with gastrointestinal disorders, the use of oral NSAIDs among patients with gastrointestinal bleeding was substantial.

Educational intervention for physicians to address the risk of opioid abuse.

OBJECTIVE: To evaluate the impact of a pilot intervention for physicians to support their treatment of patients at risk for opioid abuse. SETTING, DESIGN AND PATIENTS, PARTICIPANTS: Patients at risk for opioid abuse enrolled in Medicare plans were identified from July 1, 2012 to April 30, 2014 (N = 2,391), based on a published predictive model, and linked to 4,353 opioid-prescribing physicians. Patient-physician clusters were randomly assigned to one of four interventions using factorial design. INTERVENTIONS: Physicians received one of the following: Arm 1, patient information; Arm 2, links to educational materials for diagnosis and management of pain; Arm 3, both patient information and links to educational materials; or Arm 4, no communication. MAIN OUTCOME MEASURES: Difference-in-difference analyses compared opioid and pain prescriptions, chronic high-dose opioid use, uncoordinated opioid use, and opioid-related emergency department (ED) visits. Logistic regression compared diagnosis of opioid abuse between cases and controls postindex. RESULTS: Mailings had no significant impact on numbers of opioid or pain medications filled, chronic high-dose opioid use, uncoordinated opioid use, ED visits, or rate of diagnosed opioid abuse. Relative to Arm 4, odds ratios (95% CI) for diagnosed opioid abuse were Arm 1, 0.95(0.63-1.42); Arm 2, 0.83(0.55-1.27); Arm 3, 0.72(0.46-1.13). While 84.7 percent had ≥1 psychiatric diagnoses during preindex (p = 0.89 between arms), only 9.5 percent had ≥1 visit with mental health specialists (p = 0.53 between arms). CONCLUSIONS: Although this intervention did not affect pain-related outcomes, future interventions involving care coordination across primary care and mental health may impact opioid abuse and improve quality of life of patients with pain.

Predictors of reaching a serum uric acid goal in patients with gout and treated with febuxostat.

PURPOSE: Clinical guidelines recommend febuxostat as first-line pharmacologic urate-lowering therapy for patients with gout to achieve a goal serum uric acid (sUA) <6 mg/dL; however, little is known about other contributing factors. This study identified clinical characteristics of patients treated with febuxostat to develop and validate a predictive model for achieving a goal sUA. PATIENTS AND METHODS: Patients with Humana Medicare or commercial insurance, diagnosed with gout and newly initiated on febuxostat (index date February 1, 2009 - December 31, 2013), were identified for a retrospective cohort study. Patients were followed for 365 days and the first valid sUA test result ≥120 days after index was retained. A stepwise logistic regression with backward elimination was estimated to model sUA goal attainment, and a linear model was estimated to model the impact of predictor variables on sUA level. RESULTS: The study sample (n=678) was divided into a development (training) dataset (n=453) and a validation (holdout) dataset (n=225). In the training sample, patients in the sUA <6 mg/dL group were on febuxostat for a longer time, were more adherent, and had a lower average base-line sUA level (all p<0.0001) vs patients in the sUA ≥6 mg/dL group. In the logistic model, febuxostat adherence (odds ratio [OR]=1.03, p<0.0001) and baseline sUA level (OR=0.84, p<0.0001) increased the odds of attaining sUA <6 mg/dL. In the linear regression model, increase in febuxostat adherence (p<0.0001), baseline sUA level (p<0.0001), advanced age (p=0.0021), and not having congestive heart failure (p<0.05) were associated with a reduction of sUA level. Pre-index allopurinol use was a marginally significant predictor of sUA level reduction (p=0.06). CONCLUSIONS: Among febuxostat users diagnosed with gout in a real-world setting, adherence to febuxostat and lower baseline sUA level were the strongest predictors of attaining sUA goal. These findings may help clinicians to identify appropriate patients most likely to benefit from febuxostat treatment, and underscore the importance of medication adherence in this challenging patient population.

Healthcare utilization and costs for patients initiating Dabigatran or Warfarin.

BACKGROUND: Novel oral anticoagulants (NOAC) such as dabigatran, when compared to warfarin, have been shown to potentially reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) together with lower healthcare resource utilization (HCRU) and similar total costs. This study expands on previous work by comparing HCRU and costs for patients newly diagnosed with NVAF and newly initiated on dabigatran or warfarin, and is the first study specifically in a Medicare population. METHODS: A retrospective matched-cohort study was conducted using data from administrative health care claims during the study period 01/01/2010-12/31/2012. Cox regression analyses were used to compare all-cause risk of first hospitalizations and emergency room (ER) visits. Medical, pharmacy, and total costs per-patient-per-month (PPPM) were compared between dabigatran and warfarin users. RESULTS: A total of 1110 patients initiated on dabigatran were propensity score-matched with corresponding patients initiated on warfarin. The mean number of hospitalizations (0.92 vs. 1.13, P = 0.012), ER visits (1.32 vs. 1.56, P < 0.01), office visits (21.43 vs. 29.41; P < 0.01), and outpatient visits (10.86 vs. 22.02; P < 0.01) were lower among dabigatran compared to warfarin users. Patients initiated on dabigatran had significantly lower risk of first all-cause ER visits [hazard ratio (HR): 0.84, 95% confidence interval (CI): 0.73-0.98] compared to those initiated on warfarin. Adjusted mean pharmacy costs PPPM were significantly greater for dabigatran users ($510 vs. $250, P < 0.001); however, mean medical costs PPPM ($1912 vs. $1956, P = 0.55) and mean total costs PPPM ($2381 vs. $2183, P = 0.10) were not significantly different compared to warfarin users. CONCLUSIONS: Dabigatran users had significantly lower HCRU compared to warfarin users. In addition, dabigatran users had lower risk of all-cause ER visits. Despite higher pharmacy costs, the two cohorts did not differ significantly in medical or total all-cause costs.

Predictors of Nonadherence to Topical Intraocular Pressure Reduction Medications Among Medicare Members: A Claims-Based Retrospective Cohort Study.

BACKGROUND: Reported adherence rates with ocular hypotensive medications typically range from 51% to 56% over the first year of therapy. As intraocular pressure (IOP) reduction slows the progression of vision loss from glaucoma, early identification of nonadherent members is crucial to effective disease management. OBJECTIVES: To (a) identify member characteristics and other factors related to nonadherence with topical IOP-lowering medications available in administrative claims data and (b) create a predictive model incorporating these variables. METHODS: This retrospective cohort study analyzed data from Humana's administrative claims database. The study cohort included members aged 65-89 years enrolled in a Medicare Advantage Prescription Drug plan (MAPD; medical and pharmacy benefits), with > 1 topical IOP-lowering medication claims between January 2011 and September 2012 and a minimum of 24 months of continuous enrollment-12 months before and 12 months after the initial (index) prescription claim for a topical IOP-lowering medication. Adherence was defined as the proportion of days covered (PDC) with drug supply (calculated from the number of drops per bottle and dose) over the first year after the index prescription. Members with PDC > 0.80 were considered adherent, while members with PDC < 0.80 were considered nonadherent. Multivariable stepwise logistic regression with backward elimination was used to construct a predictive model for the likelihood of nonadherence (PDC < 0.80). The model was developed using 28 input variables*#x2013;10 variables were retained in the final model. RESULTS: 73,256 MAPD members were included in this study; most (69%) of these members were continuing topical IOP-lowering medication users. The proportion of patients adherent (PDC > 0.80) to IOP-lowering medications was 51%. The study sample was split, using a 2:1 ratio, into a development sample (n = 48,840 members) and a validation sample (n=24,416 members). The model performed equally well in the development sample and the validation sample (area under the curve = 0.71 for development and validation sets), making it appear robust in this Medicare population. In the final predictive model, characteristics increasing the likelihood (P < 0.01) of nonadherence to IOP-lowering medication within the MAPD population included index IOP prescription filled through mail order, higher medical costs during the pre-index period, being a new IOP-lowering medication user, and being male. Characteristics that lowered the likelihood of nonadherence included advanced age, higher pharmacy costs during the pre-index period, receiving a low-income subsidy, residing in the South, and a previous diagnosis of open-angle glaucoma or history of glaucoma surgery. CONCLUSIONS: Nonadherence to topical IOP-lowering medication can be predicted with 10 commonly available demographic, clinical, and treatment-related variables generally available in administrative claims data for an MAPD population. Given that this predictive model was constructed using these generally available data, it could potentially be replicated by other health plans for use in predicting nonadherence to topical IOP-lowering medications among MAPD plan members. This predictive model can be used to identify members that are likely to be nonadherent in order to target interventions intended to improve ocular hypotensive medication adherence. DISCLOSURES: Funding for this study was contributed by Allergan. Comprehensive Health Insights was contracted by Allergan to conduct this study. Sheer, Bunniran, and Uribe are employed by Comprehensive Health Insights/Humana and own stock in Humana. Fiscella, Chandwani, and Patel are employed by Allergan. Study concept and design were contributed by Sheer, Fiscella, and Patel, along with Bunniran and Uribe. Sheer and Bunniran took the lead in data collection, and data interpretation was performed by Bunniran and Uribe, along with the other authors. The manuscript was written and revised by Sheer, Bunniran, Chandwani, and Uribe, with assistance from Fiscella and Patel.

Fragility fracture-related direct medical costs in the first year following a nonvertebral fracture in a managed care setting.

The objective of this study was to estimate the fracture-related direct medical costs during the first year following a fragility nonvertebral fracture in a managed care setting. This was a retrospective cohort study conducted among patients (aged 45+ years) with a primary diagnosis for a fragility nonvertebral fracture between July 1, 2000, and December 31, 2000, using MarketScan, an integrated administrative, medical, and pharmacy claims database. All patients had 6 months of observation prior to their fracture and 12 months following a nonvertebral fracture. Fracture-related direct medical costs were evaluated in the 12-month period following fracture diagnosis using 2003 Medicare fee schedule payments. The costs per fracture per year (PFPY) for specific nonvertebral fracture sites were determined, as well as costs by type of care (i.e., outpatient, inpatient, and other). A total of 4,477 women and men fulfilled the inclusion criteria. The sample was comprised of 73% women and the mean age was 70 years. The most prevalent nonvertebral fracture sites were wrist/forearm (37%), hip (25%), and humerus (15%). Mean total costs per patient per year were highest for fractures of the hip ($26,856), femur ($14,805), tibia ($10,224), and pelvis ($10,198). On average, 84% of the annual fracture-related costs were inpatient; 3% were outpatient, and 13% were long-term care and other costs. In a patient population aged 45+ years, the first month following a nonvertebral fracture has a major impact on medical care costs. The most costly nonvertebral fracture sites were hip, femur, and tibia fractures.

Comparison of risedronate to alendronate and calcitonin for early reduction of nonvertebral fracture risk: results from a managed care administrative claims database.

OBJECTIVE: Recent randomized clinical trials have shown that risedronate reduces the risk of nonvertebral fractures and clinical vertebral fractures within 6 months of initiating treatment. The objective of the current study was to determine whether this early antifracture effect could be demonstrated in nonvertebral fractures for risedronate and other osteoporosis therapies in an observational administrative claims database. METHODS: A proprietary administrative claims database was used to identify managed care members who received a new prescription for risedronate, alendronate, or nasal calcitonin from July 1, 2000, to December 31, 2001. Patient records were analyzed for the incidence of nonvertebral fractures (clavicle, humerus, wrist, pelvis, hip, and leg) in the first 6 and 12 months following initiation of treatment. A Cox proportional hazards regression model was used to estimate relative risk (RR) of fracture at 6 and 12 months. RESULTS: In the 6-month analysis, 774 patients (11%) received calcitonin, 5,307 (75%) received alendronate, and 1,000 (14%) received risedronate. Twelve-month data were available for a subset (71%) of patients (656 calcitonin [13%], 3,716 alendronate [74%], and 652 risedronate [13%]). Most were women (93%); mean age was similar for alendronate and risedronate, and nasal calcitonin patients were about 3 years older, on average. Risedronate and alendronate patients were more likely to have used estrogen, while nasal calcitonin patients were more likely to have been hospitalized and had higher use of concomitant medications and more physician visits. Relative risks were adjusted for these differences. Risedronate and alendronate patients were similar with respect to these indicators of general health status. In the 6-month analysis, nonvertebral fractures were observed in 2.2% of patients receiving nasal calcitonin, 1.4% of patients receiving alendronate, and 0.6% of patients receiving risedronate. The adjusted RR reduction was 69% for risedronate versus calcitonin (RR = 0.31; 95% CI, 0.12 to 0.81; P = 0.02), 54% for risedronate versus alendronate (RR = 0.46; 95% CI, 0.20 to 1.06; P = 0.07), and 26% for alendronate versus calcitonin (RR = 0.74; 95% CI, 0.43 to 1.27; P = 0.28). In the 12-month analysis, nonvertebral fracture rates were 2.9% for nasal calcitonin, 2.4% for alendronate, and 0.9% for risedronate patients. The adjusted RR reduction was 75% for risedronate versus calcitonin (RR = 0.25; 95% CI, 0.10 to 0.64; P<0.01), 59% for risedronate versus alendronate (RR = 0.41; 95% CI, 0.18 to 0.94; P = 0.04), and 25% for alendronate versus calcitonin (RR = 0.75; 95% CI, 0.45 to 1.25; P = 0.27). CONCLUSIONS: This analysis of medical and pharmacy claims contained in an administrative database confirms the early fracture reduction with risedronate that was shown in randomized clinical trials. Risedronate was more effective than calcitonin in reducing the risk of nonvertebral fractures within the first 6 months of treatment. Risedronate was more effective than either calcitonin or alendronate in reducing the risk of nonvertebral fractures within 12 months of treatment.