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.

Comparison of real-world outcomes in patients with nonvalvular atrial fibrillation treated with direct oral anticoagulant agents or warfarin.

PURPOSE: To compare patients with atrial fibrillation (AF) initiating direct oral anticoagulants (DOACs) versus warfarin on clinical outcomes including stroke, systemic embolism (SE), bleeding events, and cost of care. METHODS: This retrospective observational study used Medicare Advantage Prescription Drug and fully insured commercial claims from the Humana Research Database. Patients with AF who initiated a DOAC or warfarin from January 1, 2012, through September 30, 2015, were included. Date of the first prescription of DOAC or warfarin was the index date. Patients in the DOAC and warfarin groups were matched on propensity scores. Patients were censored at end of enrollment or study period, discontinuation, or switch of index medication. Clinical outcomes were compared in the matched groups using Cox proportional hazards models. Annualized costs and costs adjusted for censoring using Lin's interval method were also compared between the two cohorts. RESULTS: Patients on DOACs had a significantly lower risk of ischemic stroke (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.79-0.98), hemorrhagic stroke (HR, 0.65; CI, 0.46-0.92), SE (HR, 0.53; 95% CI, 0.43-0.65), and composite outcome of stroke or SE (HR, 0.78; 95% CI, 0.71-0.86) compared with patients on warfarin. Bleeding risk was not statistically significant (HR, 0.85; 95% CI, 0.71-1.01). While annualized pharmacy costs were higher, annualized medical and total costs were lower in the DOAC group compared with the warfarin group. CONCLUSION: The results of the study indicated that patients on DOACs had lower rates of ischemic stroke, hemorrhagic stroke, SE, and composite outcome of stroke or SE compared with patients on warfarin. No significant differences in bleeding rates between the DOAC and warfarin groups were observed, while total cost of care was lower in the DOAC group.

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.

Patient Preferences Associated with Therapies for Psoriatic Arthritis: A Conjoint Analysis.

BACKGROUND: As psoriatic arthritis (PsA) treatment choices continue to expand, it is important to consider patient preferences for treatment modalities for PsA. Involving patients in treatment decisions can influence adherence to treatment and outcomes of therapy. OBJECTIVE: To determine patient preferences for medication attributes prescribed for patients with PsA. METHODS: A choice-based conjoint survey was mailed to 2800 randomly selected patients with PsA who were enrolled in Humana Medicare and commercial plans. Patients had been diagnosed with PsA between January 1, 2012, and September 30, 2016. The medication attributes included in the survey were the medication route of administration, frequency of administration, ability to reduce daily joint pain and swelling, likelihood of serious infections, improvement in the patient's ability to perform daily activities, achieving clear or almost clear skin, and cost. Hierarchical Bayesian models were used to score patient preferences after adjusting for demographic and clinical characteristics. The mean attribute importance scores were used to rank patient preferences. RESULTS: A total of 468 patients (258 with a Medicare plan and 210 with a commercial plan) completed the survey. The top 3 medication attributes for patients in Medicare plans were route of administration, cost, and improvement in the ability to perform daily activities. For patients in commercial plans, the top 3 medication attributes were cost, route of administration, and frequency of administration. Within the top 2 attributes for patients in both plans, the oral route of administration and lower cost were most preferred. CONCLUSION: Medication route of administration and cost were the 2 most important considerations for patients diagnosed with PsA who were enrolled in Medicare or commercial plans with Humana. As PsA treatment choices continue to expand, considering patient preferences may improve patient adherence and treatment outcomes and should be considered when making treatment decisions for this patient population.

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.

Ulcerative Colitis Treatment Patterns and Cost of Care.

OBJECTIVES: To examine treatment patterns, dosing, health care resource utilization, and cost of tumor necrosis factor inhibitors (TNFi), adalimumab (ADA) and infliximab (IFX), among patients enrolled in US Humana insurance plans who have been diagnosed with ulcerative colitis (UC). METHODS: This retrospective cohort study identified the first pharmacy or medical claim for ADA or IFX (from January 1, 2007, to December 31, 2014) in patients with continuous enrollment for 6 months or more preindex and 12 months or more postindex, with one or more UC diagnosis claim 6 months pre- or postindex. TNFi discontinuation was defined as a therapy gap of 56 days or more for ADA and 112 days or more for IFX. TNFi switch was defined as nonindex TNFi initiation. Health care resource utilization and costs were characterized quarterly according to treatment patterns. RESULTS: The study population comprised 295 patients: mean age 50.9 years, 50.5% females, and 61.7% in southern United States. At the index date, 17% of patients received ADA and 83% received IFX. Treatment discontinuation was observed in 52% of ADA and 45% of IFX users through 12 months postindex (mean time 19 and 22 weeks, respectively). Among discontinuers, 46% of ADA and 68% of IFX users did not restart/switch TNFi. ADA and IFX showed mean times to switch of 18 and 30 weeks, respectively. TNFi discontinuers had the lowest mean quarterly total health care cost ($3,935) versus patients who initiated/switched TNFi ($15,004). Nevertheless, discontinuers had higher UC-related hospitalization versus patients receiving therapy. CONCLUSIONS: Approximately half of ADA and IFX users discontinued, with approximately half of discontinuers not restarting/switching therapies. Further investigation of treatment patterns and outcomes after TNFi discontinuation is required.

Patient Preferences Regarding Rheumatoid Arthritis Therapies: A Conjoint Analysis.

BACKGROUND: Tofacitinib, an oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA), provides patients with an alternative to subcutaneously or intravenously administered biologic disease-modifying antirheumatic drugs (DMARDs). Little is known about patient preference for novel RA treatments. OBJECTIVE: To investigate patient preferences for attributes associated with RA treatments. METHODS: A choice-based conjoint survey was mailed to 1400 randomly selected commercially insured patients (aged 21-80 years) diagnosed with RA, who were continuously enrolled from May 1, 2012, through April 30, 2013, and had ≥2 medical claims for International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 714.0 and no previous biologic DMARD use. Treatment attributes included route of administration; monthly out-of-pocket cost; frequency of administration; ability to reduce daily joint pain and swelling; likelihood of serious adverse events; improvement in the ability to perform daily tasks; and medication burden. Mean attribute importance scores were calculated after adjusting for patient demographics (eg, age, sex, years since diagnosis) using a hierarchical Bayes model. Patient preferences for each treatment attribute were ranked by the importance score. Part-worth utilities (ie, preference scores) were used to perform a conjoint market simulation. RESULTS: A total of 380 patients (response rate, 27.1%) returned the survey. Their mean age (± standard deviation) was 54.9 (± 9.3) years. Nonrespondents were 2 years younger (mean, 52.9 years; P = .002) but did not differ significantly from respondents in known clinical characteristics. After adjustment for demographic characteristics, mean patients' ranking of treatment attribute importance, in decreasing order, was route of administration, 34.1 (± 15.5); frequency of administration, 16.4 (± 6.8); serious adverse events, 12.0 (± 9.3); cost, 10.1 (± 6.2); medication burden, 9.8 (± 8.2); joint pain reduction, 8.9 (± 3.8); and daily tasks improvement, 8.8 (± 4.7). For the route of administration attribute, the part-worth utility was highest for the oral route. Conjoint simulation results showed that 56.4% of respondents would prefer an oral route of administration. CONCLUSION: Based on this survey completed by 380 patients with RA, commercially insured patients with RA consider the route of administration to be the most important attribute of their RA treatment. In this study, the majority (56.4%) of patients preferred the oral route of administration over other routes. Understanding patient preferences may help to inform provider and payer decisions in treatment selection that may enhance patient adherence to therapy.

Impact of Out-of-Pocket Costs on Prescription Fills Among New Initiators of Biologic Therapies for Rheumatoid Arthritis.

BACKGROUND: Biologic disease-modifying antirheumatic drug (DMARD) therapies are a mainstay of treatment for rheumatoid arthritis (RA), yet high member out-of-pocket (OOP) costs for such therapies may limit patient access to these therapies. OBJECTIVE: To understand whether there is a relationship between OOP costs and the initial fill and subsequent refills of biologic DMARD treatments for RA members. METHODS: Members of a national Medicare Advantage and Prescription Drug (MAPD) plan with an adjudicated (paid or reversed) claim for a biologic DMARD indicated for RA were identified from July 1, 2007, to December 31, 2012, and followed retrospectively. The first adjudicated claim date was the index date. Members were required to have 180 days of continuous enrollment pre- and post-index and ≥ 1 diagnosis for RA (ICD-9-CM: 714.0 or 714.2) during pre-index or ≤ 30 days post-index. Low-income subsidy and Medicaid-Medicare dual-eligible patients were excluded. The analysis used multivariate regression models to examine associations between initial prescription (Rx) abandonment rates and OOP costs and factors influencing the refill of a biologic DMARD therapy based on pharmacy claims. RESULTS: The final sample size included 864 MAPD members with an adjudicated claim for a biologic DMARD. The majority were female (77.4%) and mean age was 63.5 years (SD = 10.9). Most (78%) had conventional nonbiologic DMARD utilization during pre-index. The overall initial abandonment rate was 18.2% for biologic DMARDs, ranging from 1.3% for the lowest OOP cost group ($0-$250) to 32.7% for the highest OOP cost group (> $550; P < 0.0001 for Cochran-Armitage trend test). ORs for abandonment rose from 18.4 to 32.7 to 41.2 for OOP costs of $250.01-$400.00, $400.01-$550.00, and > $550.00 respectively, relative to OOP costs of ≤ $250.00 (all P < 0.0001). Meeting the catastrophic coverage limit and utilization of a specialty pharmacy for the index claim were both associated with a decreased likelihood of abandoning therapy (OR = 0.29 and OR = 0.14, respectively; both P < 0.05). Among the subset of 533 members with a paid claim, 82.4% had at least 1 refill post-index. The negative association between OOP cost and likelihood of refilling an Rx was highly significant (P < 0.0001). CONCLUSIONS: This study suggests that the higher the member OOP cost, the less likely an MAPD member is to initiate or refill a biologic DMARD therapy for RA. Further research is needed to understand reasons for initial Rx abandonment and lack of refills, including benefit design and adverse events.

COPD exacerbations associated with the modified Medical Research Council scale and COPD assessment test among Humana Medicare members.

BACKGROUND: The Global initiative for chronic Obstructive Lung Disease guidelines recommend assessment of COPD severity, which includes symptomatology using the modified Medical Research Council (mMRC) or COPD assessment test (CAT) score in addition to the degree of airflow obstruction and exacerbation history. While there is great interest in incorporating symptomatology, little is known about how patient reported symptoms are associated with future exacerbations and exacerbation-related costs. METHODS: The mMRC and CAT were mailed to a randomly selected sample of 4,000 Medicare members aged >40 years, diagnosed with COPD (≥2 encounters with International Classification of Dis eases-9th Edition Clinical Modification: 491.xx, 492.xx, 496.xx, ≥30 days apart). The exacerbations and exacerbation-related costs were collected from claims data during 365-day post-survey after exclusion of members lost to follow-up or with cancer, organ transplant, or pregnancy. A logistic regression model estimated the predictive value of exacerbation history and symptomatology on exacerbations during follow-up, and a generalized linear model with log link and gamma distribution estimated the predictive value of exacerbation history and symptomatology on exacerbation-related costs. RESULTS: Among a total of 1,159 members who returned the survey, a 66% (765) completion rate was observed. Mean (standard deviation) age among survey completers was 72.0 (8.3), 53.7% female and 91.2% white. Odds ratios for having post-index exacerbations were 3.06, 4.55, and 16.28 times for members with 1, 2, and ≥3 pre-index exacerbations, respectively, relative to members with 0 pre-index exacerbations (P<0.001 for all). The odds ratio for high vs low symptoms using CAT was 2.51 (P<0.001). Similarly, exacerbation-related costs were 73% higher with each incremental pre-index exacerbation, and over four fold higher for high-vs low-symptom patients using CAT (each P<0.001). The symptoms using mMRC were not statistically significant in either model (P>0.10). CONCLUSION: The patient-reported symptoms contribute important information related to future COPD exacerbations and exacerbation-related costs beyond that explained by exacerbation history.

Healthcare Utilization and Costs of Knee or Hip Replacements versus Pain-Relief Injections.

BACKGROUND: Given the dramatic increase in total knee and hip replacement procedures among the US population aged 45 years and older, there is a need to compare the downstream healthcare utilization and costs between patients who undergo joint replacement and those who receive intraarticular injections as a low-cost alternative. OBJECTIVE: To compare changes in osteoarthritis (OA)-related healthcare utilization and costs for Medicare members with OA who underwent knee or hip replacement versus those receiving steroid or viscosupplementation injections. METHODS: Medicare members aged ≥45 years diagnosed with OA were identified for this retrospective longitudinal study. Data were compared for patients who underwent primary knee or hip replacement surgery between July 1, 2007, and June 30, 2012, and those receiving injection of pain-relief medication during the same period. The date of joint replacement surgery was considered the index date. For the comparison cohort, the index date was 180 days postinjection of the first intraarticular injection. Medical and pharmacy claims were examined longitudinally in 90-day increments, from 180 days preindex until 360 days postindex. Difference-in-difference analyses were conducted to compare the change in OA-related healthcare costs, postindex versus preindex, between the study cohorts. Time-to-event analyses were used to measure rates of readmissions and venous thromboembolism (VTE). RESULTS: The mean age was 70.7 years for patients with knee replacement, 71.7 years for those with hip replacement, and 71.1 years for those receiving pain-relief injection (P <.0001). The RxRisk-V comorbidity index scores were 4.7, 4.4, and 4.8, respectively (P <.0001). Difference-in-difference analyses indicated that decreases in OA-related costs were greater for the joint replacement cohorts (coefficient for knee replacement*time: -0.603; hip replacement*time: -0.438; P <.001 for both) than for the comparison cohort. The VTE rates were 5.6% (knee) and 5.1% (hip) postsurgery versus 1.4% (knee) and 1.3% (hip) presurgery. CONCLUSION: The overall difference-in-difference results showed a greater decrease in healthcare utilization and costs for the members with joint replacement than for those receiving injection.

A Comparative Assessment of Observational Medical Outcomes Partnership and Mini-Sentinel Common Data Models and Analytics: Implications for Active Drug Safety Surveillance.

INTRODUCTION: An often key component to coordinating surveillance activities across distributed networks is the design and implementation of a common data model (CDM). The purpose of this study was to evaluate two drug safety surveillance CDMs from an ecosystem perspective to better understand how differences in CDMs and analytic tools affect usability and interpretation of results. METHODS: Humana claims data from 2007 to 2012 were mapped to Observational Medical Outcomes Partnership (OMOP) and Mini-Sentinel CDMs. Data were described and compared at the patient level by source code and mapped concepts. Study cohort construction and effect estimates were also compared using two different analytical methods--one based on a new user design implementing a high-dimensional propensity score (HDPS) algorithm and the other based on univariate self-controlled case series (SCCS) design--across six established positive drug-outcome pairs to learn how differences in CDMs and analytics influence steps in the database analytic process and results. RESULTS: Claims data for approximately 7.7 million Humana health plan members were transformed into the two CDMs. Three health outcome cohorts and two drug cohorts showed differences in cohort size and constituency between Mini-Sentinel and OMOP CDMs, which was a result of multiple factors. Overall, the implementation of the HDPS procedure on Mini-Sentinel CDM detected more known positive associations than that on OMOP CDM. The SCCS method results were comparable on both CDMs. Differences in the implementation of the HDPS procedure between the two CDMs were identified; analytic model and risk period specification had a significant impact on the performance of the HDPS procedure on OMOP CDM. CONCLUSIONS: Differences were observed between OMOP and Mini-Sentinel CDMs. The analysis of both CDMs at the data model level indicated that such conceptual differences had only a slight but not significant impact on identifying known safety associations. Our results show that differences at the ecosystem level of analyses across the CDMs can lead to strikingly different risk estimations, but this can be primarily attributed to the choices of analytic approach and their implementation in the community-developed analytic tools. The opportunities of using CDMs are clear, but our study shows the need for judicious comparison of analyses across the CDMs. Our work emphasizes the need for ongoing efforts to ensure sustainable transparent platforms to maintain and develop CDMs and associated tools for effective safety surveillance.

Pain conditions ranked by healthcare costs for members of a national health plan.

Healthcare resource utilization (HCRU) and associated costs specific to pain are a growing concern, as increasing dollar amounts are spent on pain-related conditions. Understanding which pain conditions drive the highest utilization and cost burden to the healthcare system would enable providers and payers to better target conditions to manage pain adequately and efficiently. The current study focused on 36 noncancer chronic and 14 noncancer acute pain conditions and measured the HCRU and costs per member over 365 days. These conditions were ranked by per-member costs and total adjusted healthcare costs to determine the most expensive conditions to a national health plan. The top 5 conditions for the commercial line of business were back pain, osteoarthritis (OA), childbirth, injuries, and non-hip, non-spine fractures (adjusted annual total costs for the commercial members were $119 million, $98 million, $69 million, $61 million, and $48 million, respectively). The top 5 conditions for Medicare members were OA, back pain, hip fractures, injuries, and non-hip, non-spine fractures (adjusted annual costs for the Medicare members were $327 million, $218 million, $117 million, $82 million, and $67 million, respectively). The conditions ranked highest for both per-member and total healthcare costs were hip fractures, childbirth, and non-hip, non-spine fractures. Among these, hip fractures in the Medicare member population had the highest mean cost per member (adjusted per-member cost was $21,058). Further examination specific to how pain is managed in these high-cost conditions will enable providers and payers to develop strategies to improve patient outcomes through appropriate pain management.