Virologic Response to Dolutegravir Plus Lamivudine in People With Suppressed Human Immunodeficiency Virus Type 1 and Historical M184V/I: A Systematic Literature Review and Meta-analysis.

Background: To investigate the impact of the M184V/I mutation on virologic response to dolutegravir plus lamivudine (DTG + 3TC) in suppressed-switch populations, a meta-analysis was performed using virologic outcomes from people with human immunodeficiency virus type 1 (PWH) with and without M184V/I before DTG + 3TC switch in real-world studies identified via systematic literature review. Sensitivity analyses were performed using data from PWH with M184V/I in interventional studies identified via targeted literature review. Methods: Single-arm meta-analyses using common- and random-effects models were used to estimate proportions of PWH with virologic failure (VF) among real-world populations with and without M184V/I and interventional study participants with M184V/I at 24, 48, and 96 weeks. Results: Literature reviews identified 5 real-world studies from 3907 publications and 51 abstracts meeting inclusion criteria and 5 interventional studies from 1789 publications and 3 abstracts. All time points had low VF incidence in PWH with M184V/I (real-world: 1.43%-3.81%; interventional: 0.00%) and without (real-world: 0.73%-2.37%). Meta-analysis-estimated proportions (95% confidence interval) with VF were low at weeks 24, 48, and 96, respectively, for PWH with M184V/I (real-world: 0.01 [.00-.04], 0.03 [.01-.06], and 0.04 [.01-.07]; interventional: 0.00 [.00-.02], 0.00 [.00-.01], and 0.00 [.00-.03]) and without (real-world: 0.00 [.00-.02], 0.02 [.01-.04], and 0.02 [.00-.05]). One real-world study (n = 712) reported treatment-emergent M184V at VF in 1 of 652 (0.15%) PWH without prior M184V/I. Conclusions: Results suggest that prior M184V/I has minimal impact on virologic suppression after switching to DTG + 3TC and provide reassurance when considering switching regimens in virologically suppressed PWH with incomplete treatment history or limited treatment options.

Comparing Real-World Healthcare Costs Associated with Single-Tablet Regimens for HIV-1: The 2-Drug Regimen Dolutegravir/Lamivudine vs. Standard 3- or 4-Drug Regimens.

INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) is a 2-drug regimen for HIV-1 treatment with long-term efficacy and good tolerability comparable to 3- or 4-drug regimens. This study evaluated DTG/3TC cost versus other standard single-tablet regimens during its first year of approval. METHODS: This retrospective study analyzed US claims data from adults with HIV-1. Eligibility criteria included ≥ 1 dispensing of DTG/3TC, DTG/abacavir (ABC)/3TC, bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF, and darunavir (DRV)/COBI/FTC/TAF (index date was first dispensing) and ≥ 6 months of continuous eligibility before index date (baseline period). All-cause and HIV-related healthcare costs were evaluated during the observation period (index date until earliest of end of continuous eligibility or data availability). Adjusted cost differences and adjusted cost ratios were estimated using multivariable regression models controlling for differences in baseline characteristics between cohorts. RESULTS: Overall, 22,061 individuals with HIV-1 and dispensed treatment with DTG/3TC (n = 590), DTG/ABC/3TC (n = 4355), BIC/FTC/TAF (n = 9068), EVG/COBI/FTC/TAF (n = 7081), or DRV/COBI/FTC/TAF (n = 967) were included. Most claims data were from men (mean age ~ 46 years). Mean unadjusted all-cause total healthcare costs per patient per month were significantly lower for DTG/3TC versus BIC/FTC/TAF and DRV/COBI/FTC/TAF, and mean unadjusted HIV-related healthcare costs per patient per month were significantly lower for DTG/3TC versus DRV/COBI/FTC/TAF. Cost differences were primarily driven by significantly lower pharmacy costs for DTG/3TC versus other regimens (P < 0.001), while medical costs were similar across cohorts. Results were similar among treatment-naive and treatment-experienced individuals. After adjusting for baseline covariates, significant adjusted cost differences were generally consistent with unadjusted findings. Adjusted cost ratios generally favored DTG/3TC for all-cause healthcare and HIV-related costs, with all pharmacy cost ratios favoring DTG/3TC (P < 0.001). CONCLUSION: Dolutegravir/lamivudine had the lowest healthcare costs of BIC/FTC/TAF, EVG/COBI/FTC/TAF, and DRV/COBI/FTC/TAF, and the lowest pharmacy costs of all regimens, in unadjusted and adjusted analyses and by treatment experience, supporting the economic benefits of DTG/3TC as an initial or switch regimen for HIV-1.

Characterization of Heavily Treatment-Experienced People With HIV and Impact on Health Care Resource Utilization in US Commercial and Medicare Advantage Health Plans.

BACKGROUND: This retrospective administrative claims study aimed to describe clinical characteristics, health care resource utilization (HCRU), and costs of people with HIV (PWH) in US commercial and Medicare Advantage health plans by antiretroviral treatment (ART) experience and CD4+ cell count. METHODS: Data from the national Optum Research Database between January 1, 2014, and March 31, 2018, for adult PWH continuously enrolled 6 months before and ≥12 months after the first ART identified (follow-up) were summarized by treatment (heavily treatment-experienced [HTE] with limited remaining ART options, treatment-experienced but not HTE [non-HTE], or treatment-naive starting a first antiretroviral regimen) and index CD4+ cell count (<200, 200-500, or >500 cells/mm3). RESULTS: Compared with non-HTE (n=7604) and treatment-naive PWH (n=4357), HTE PWH (n=2297) were older (53.5 vs 48.8 and 42.3 years), were more likely to have HIV-related emergency department visits (22.3% vs 12.4% and 18.6%) and inpatient stays (15.8% vs 7.1% and 10.3%), and had a higher mean (SD) daily pill burden (9.7 [7.7] vs 5.1 [5.9] and 3.6 [5.3] pills/d) and a higher mortality rate (5.9% vs 2.9% and 2.3%) during follow-up (all P<.001). More HTE (21.8%) and treatment-naive PWH (27.0%) had <200 CD4+ cells/mm3 vs non-HTE PWH (8.0%; P<.001). All-cause and HIV-related costs were higher among HTE PWH in all CD4+ cell count strata and treatment-naive PWH with CD4+ cell counts <200 cells/mm3 vs non-HTE PWH in all CD4+ cell count strata. CONCLUSIONS: Improved support and clinical monitoring of HTE PWH are needed to prevent worsening outcomes and increased costs.

Retrospective analysis of adherence to HIV treatment and healthcare utilization in a commercially insured population.

AIMS: Single-tablet regimens (STRs) can improve antiretroviral therapy (ART) adherence; however, the relationship between long-term adherence and patient healthcare resource utilization (HRU) is unclear. The objective of this study was to assess long-term ART adherence among people living with HIV (PLHIV) using STRs and multi-tablet regimens (MTRs) and compare HRU over time by adherence. MATERIALS AND METHODS: This retrospective study analyzed medical and pharmacy claims (Optum Clinformatics Data Mart Database). Included PLHIV were aged ≥18 years, had ≥1 medical claim with an HIV diagnosis, and had pharmacy claims for a complete STR or MTR. Adherence was analyzed as the proportion of days covered (PDC), stratified as ≥95%, very high; 90-95%, high; 80-90%, moderate; <80%, low. Cumulative all-cause and HIV-related HRU were calculated across 4 years. Among PLHIV with ≥4-year follow-up, HRU was assessed by adherence. RESULTS: Among 15,153 PLHIV included, 63% achieved PDC ≥90% during Year 1. Among the subgroup of PLHIV with ≥4-year follow-up (N = 3,818), the proportion maintaining PDC ≥90% fell from 67% in Year 1 to 54% by Year 4. The difference from Years 1 to 4 in the proportion of PLHIV with PDC ≥90% was 13% and 17% in the STR and MTR groups, respectively. Cumulative HRU across the 4-year follow-up was higher in PLHIV with low vs high adherence (27% with low adherence had ≥1 emergency room visit vs 17% for very high, p < .0001; 15% with low adherence had ≥1 inpatient stay vs 7% for very high, p < .0001). CONCLUSIONS: ART adherence showed room for improvement, particularly over the long term. PLHIV receiving STRs exhibited higher adherence vs those receiving MTRs; this difference increased over time. The proportion of PLHIV with higher HRU was significantly higher among those with lower adherence and became greater over time. Interventions and alternative therapies to improve adherence among PLHIV should be explored.

Virologic Outcomes Among People Living With Human Immunodeficiency Virus With High Pretherapy Viral Load Burden Initiating on Common Core Agents.

BACKGROUND: People living with human immunodeficiency virus (PLWH) initiating antiretroviral therapy (ART) with viral loads (VLs) ≥100 000 copies/mL are less likely to achieve virologic success, but few studies have characterized real-world treatment outcomes. METHODS: ART-naive PLWH with VLs ≥100 000 copies/mL initiating dolutegravir (DTG), elvitegravir (EVG), raltegravir (RAL), or darunavir (DRV) between 12 August 2013 and 31 July 2017 were identified from the OPERA database. Virologic failure was defined as (i) 2 consecutive VLs ≥200 copies/mL after 36 weeks of ART; (ii) 1 VL ≥200 copies/mL with core agent discontinuation after 36 weeks; (iii) 2 consecutive VLs ≥200 copies/mL after suppression (≤50 copies/mL) before 36 weeks; or (iv) 1 VL ≥200 copies/mL with discontinuation after suppression before 36 weeks. Cox modeling estimated the association between regimen and virologic failure. RESULTS: There were 2038 ART-naive patients with high VL who initiated DTG (36%), EVG (46%), DRV (16%), or RAL (2%). Median follow-up was 18.1 (interquartile range, 12.4-28.9) months. EVG and DTG initiators were similar at baseline, but RAL initiators were older and more likely to be female with low CD4 cell counts while DRV initiators differed notably on factors associated with treatment failure. Virologic failure was experienced by 9.2% DTG, 13.2% EVG, 18.4% RAL, and 18.8% DRV initiators. Compared to DTG, the adjusted hazard ratio (95% confidence interval) was 1.46 (1.05-2.03) for EVG, 2.24 (1.50-3.34) for DRV, and 4.13 (1.85-9.24) for RAL. CONCLUSIONS: ART-naive PLWH with high VLs initiating on DTG were significantly less likely to experience virologic failure compared to EVG, RAL, and DRV initiators.Antiretroviral therapy-naïve people living with HIV (PLWH) initiating therapy with viral loads ≥100,000 copies/mL varied markedly at baseline. In adjusted models, PLWH initiating dolutegravir-based regimens were less likely to experience virologic failure as compared to elvitegravir, raltegravir and darunavir initiators.

Real-world treatment patterns, healthcare resource utilisation and costs in patients with systemic lupus erythematosus treated with belimumab: a retrospective analysis of claims data in the USA.

Objective: To examine the effects of belimumab initiation on healthcare resource utilisation (HCRU) and costs in SLE. Methods: This retrospective observational cohort study used healthcare administrative claims data from the IBM MarketScan Commercial Claims and Encounters Database to identify patients with SLE billing codes who received ≥1 intravenous belimumab infusion between March 2011 and December 2015. The first belimumab administration was the 'index date'. During the 6-month postindex period, nine belimumab infusions were recommended: three during the initiation period and six during the maintenance period. HCRU and cost data for inpatient admissions, emergency department visits, physician office visits, hospital-based outpatient visits, laboratory services, other outpatient services and outpatient pharmacy prescriptions were compared in the 6-month pre/postindex periods. Results: Of the 1879 patients with SLE included, 43% received ≥3 intravenous initiation administrations. An average of 5.3 (SD: 2.4) of the nine recommended belimumab administrations were received within 6 months. In the 6-month preindex versus postindex periods, significant reductions were noted for inpatient hospitalisations (18% vs 9%, p<0.001; mean visits: 0.3 vs 0.14, p<0.001) and emergency department visits (40% vs 24%, p<0.001; mean visits; 3.53 vs 1.96, p<0.001). Mean total costs were higher in the 6-month postindex versus preindex period ($41 426 vs $29 270; p<0.001). Conclusions: In this study of real-world intravenous belimumab for SLE, adherence to recommended infusion schedules was low. Outpatient healthcare and associated costs were higher in the 6 months after belimumab was initiated, although inpatient costs were lower. Reasons for non-adherence with belimumab and implications should be investigated.

Retrospective analysis of comorbidities and treatment burden among patients with HIV infection in a US Medicaid population.

Objective: Comorbidities and comedications are important factors influencing optimal therapy because people are living longer with HIV infection. This study describes the long-term comorbidity profile and treatment burden among people with HIV-1 infection.Methods: This retrospective study included Medicaid claims data from patients with ≥1 antiretroviral (ARV) claim between 2016 and 2017 (most recent claim defined the index date), ≥1 HIV diagnosis within 1 year before index, age ≥18 years at first HIV diagnosis and <65 years at index, ≥12 months of continuous eligibility before index, and no history of HIV-2 infection. Comorbidities, concomitant medication use, and pill burden were assessed in the 4 years before index. Analyses were stratified by patient age and treatment experience.Results: Among 3456 patients, the mean (standard deviation [SD]) age was 47.1 (10.4) years; the majority were black (55%) and men (63%). In general, the prevalence of comorbidities increased from the fourth year to the first year before index and included cardiovascular disease (28-40%), hypertension (24-37%), hyperlipidemia (12-17%), and asthma/chronic obstructive pulmonary disease (13-19%). Concomitant medication use corresponding to these comorbidities slightly increased over time. In the year before index, mean (SD) daily pill burden was 2.1 (1.4) for ARVs and 5.9 (5.9) for non-ARVs. Older age and prior treatment experience were associated with higher rates of comorbidities and greater pill burden.Conclusions: In people with HIV infection, comorbidities and concomitant medication use increased with age, supporting considerations for streamlined ARV regimens highlighted in treatment guidelines.

Benchmarking HIV Quality Measures Across US Payer Types.

Despite advances in antiretroviral therapy (ART), human immunodeficiency virus (HIV) remains a significant issue in the United States. Early diagnosis, continuous treatment access/adherence, and long-term care engagement help patients benefit fully from ART; however, a shortfall in care engagement remains, potentially leading to poorer health outcomes. This analysis benchmarks rates of health care quality and process measures to identify areas for improvement. This retrospective, claims-based, real-world cohort study assessed the percentage of prevalent (existing) and incident (newly diagnosed) patients with HIV with commercial or public health insurance meeting 4 National Quality Forum (NQF)-endorsed, 1 Pharmacy Quality Alliance (PQA), and 3 Centers for Disease Control and Prevention (CDC) measures over a 4-year period. Most prevalent patients consistently met the NQF-endorsed prescribed ART and gaps in visits measures. Longer-term visit frequency measure rates were well below the 90% Joint United Nations Programme on HIV/AIDS target. Proportion of prevalent patients meeting each NQF-endorsed measure was maintained/increased with increasing age in 2015-2016. Substantially fewer incident patients than prevalent patients met NQF-endorsed measures across all measurement periods, particularly for visit frequency (32%-51%). PQA ART adherence was low (36%-73%). CDC receipt of care rates were high (83%-92%), whereas retention in care rates were low (67%-72%) among prevalent patients. For incident patients, linkage to care rates were consistently low (21%-44%). This study benchmarks current US HIV care engagement and highlights the need for improvement in early care engagement, ART adherence and long-term retention of care among patients with HIV.

Clinical characteristics and treatment patterns among US patients with HIV.

OBJECTIVES: Describe the clinical characteristics and treatment patterns of patients with HIV-1 who have commercial or Medicare health insurance in the United States. STUDY DESIGN: Retrospective cohort study. METHODS: Administrative claims for adult commercial and Medicare health plan enrollees with evidence of HIV-1 and antiretroviral therapy (ART) between January 1, 2007, and March 31, 2017, were assessed. Current and previous complete ART regimens were identified using a claims-based algorithm. Results were stratified by treatment status and insurance type. RESULTS: Of 18,699 eligible patients, 5027 (27%) had no previous ART regimens; 15,275 (82%) had commercial insurance. Mean age was 47.5 years. Common comorbidities included hyperlipidemia, cardiovascular disease, hypertension, depression, and anxiety. The mean number of ART regimens was 1.43, with 31% of patients having 2 or more regimens. Mean (SD) daily pill burden was higher in patients with more than 1 ART regimen over time (5.7 [6.0] pills) or with Medicare insurance (9.2 [8.0] pills) than in patients with no previous ART (1.9 [4.4] pills) or with commercial insurance (3.7 [4.7] pills). Overall, 60% of patients achieved 90% or greater adherence to their ART regimen and 16% had a prescription filled for any contraindicated medication to an ART during their regimen. CONCLUSIONS: This descriptive study demonstrated that people living with HIV enrolled in Medicare have a significant amount of comorbidities and total pill burden. Although advancements in ART have significantly improved life expectancy and quality of life for people living with HIV, it is important to take into account individual complexities such as comorbidities and pill burden when selecting ART regimens.

Benchmarking HIV Quality Measures in the US OPERA HIV Cohort.

BACKGROUND: Quality measures are effective tools to improve patient outreach, retention in care, adherence, and outcomes. This study benchmarks National Quality Forum-endorsed HIV quality measures in a US clinical cohort. METHODS: This observational study utilized prospectively captured data from the Observational Pharmaco-Epidemiology Research and Analysis (OPERA) database over 2014-2016 to assess quality measure achievement among patients with HIV in terms of medical visit frequency (#2079), medical visit gaps (#2080), viral suppression (#2082), and antiretroviral therapy (ART) prescriptions (#2083). The proportion of patients meeting each measure was calculated. Generalized estimating equations assessed trends in measure achievement. RESULTS: The OPERA sample included 23 059-42 285 patients with similar demographics and characteristics across measurement periods. Overall, 62%-66% of patients met the visit frequency measure (#2079), 81%-85% had no gaps between visits (#2080), 71%-73% achieved viral suppression (#2082), and 92%-94% were prescribed ART (#2083). The adjusted odds of achieving viral suppression and being prescribed ART increased over time by 3% and 19%, respectively, despite a significant decline in patient engagement (16% for #2079, 25% for #2080). Patients <30 years of age were significantly less likely to meet all measures than older patients (P < .0001), with particularly low levels of engagement. Measure achievement also varied by gender, ethnicity, region, and select clinical characteristics. CONCLUSIONS: Despite gains in the rate of ART prescription and viral suppression, there remains room for improvement in the care of patients with HIV. Strategies for quality improvement may be more effective if tailored by age group.

Physician-patient interactions in African American patients with systemic lupus erythematosus: Demographic characteristics and relationship with disease activity and depression.

OBJECTIVE: African American patients with systemic lupus erythematosus (SLE) are at high risk for poor outcomes. Both patient characteristics and the severity of the disease may influence physician-patient interactions, which in turn can impact disease outcomes. We aimed to examine whether patient perceptions of interpersonal processes of care (i.e. physician-patient interactions) varied by demographic characteristics, disease activity, and/or depression in African American patients with SLE. METHODS: The Georgians Organized Against Lupus (GOAL) is a cohort drawn from a population-based registry of people with SLE. We conducted a cross-sectional analysis of patient-reported data collected in 2016-17 among 698 African American participants (out of 863 GOAL participants). We assessed physician-patient interactions (communication, patient-centered decision making, and physician interpersonal style) through the Interpersonal Processes of Care survey (IPC-29), disease activity through the Systemic Lupus Activity Questionnaire, and depression through the Patient Health Questionnaire-9. Mean scores of the IPC-29 scales were compared by gender, age and educational attainment with Wilcoxon rank-sum 2-sample test or Kruskal Wallis test. We conducted linear trend test to examine demographic-adjusted scores of IPC across severity of disease activity and depression, and multivariate logistic regression analyses to examine the association of disease activity and depression with suboptimal IPC scores. RESULTS: Overall, the lowest mean scores were observed for the patient-centered decision making domain, and specifically about how often doctors assessed patients' problems to follow recommendations and treatment among females compared with males (mean scores 3.13 ±â€¯1.42 and 3.64 ±â€¯1.38, respectively; p = 0.015). Mean scores for the assumed socioeconomic level subdomain (how often doctors make assumptions about a patient's socioeconomic level) were worse in individuals aged 18-34 (mean score 1.59 ±â€¯0.94), compared to those aged 35-55 (mean score 1.47 ±â€¯0.94; p = 0.033). Patients with some college or higher educational attainment reported poorer mean scores for most communication and interpersonal style scales than those who reported high-school or less. We found significant linear trends of poorer scores for all communication scales across more severe disease activity and depression symptoms, and poorer scores for all interpersonal style scales across more severe disease activity. Multivariate models revealed that while depression was associated with suboptimal quality of both communication (OR 1.20; 95% CI 1.04-1.39) and interpersonal style (OR 1.12; 95% CI 1.01-1.25), disease activity only increased the odds of suboptimal interpersonal style (OR 1.13; 95% CI 1.03-1.25). CONCLUSION: In the African American population with SLE, suboptimal interactions with providers may be explained in part by the mental and physical symptoms of the patient, regardless of age, gender and education. In addition to standard of care treatment, SLE patients with more severe disease activity and depression might need provider-based interventions focused on communication and interpersonal style.

Prompt initiation of maintenance treatment following a COPD exacerbation: outcomes in a large insured population.

BACKGROUND: The aim of this study was to extend previous findings and determine the value of prompt initiation of maintenance treatment (MT) following COPD exacerbations requiring hospitalization or an emergency department (ED) visit. PATIENTS AND METHODS: Administrative claims data (collected between January 1, 2009 and June 30, 2012) from an employer-sponsored commercially insured population were retrospectively used to identify patients with a COPD exacerbation resulting in hospitalization or an ED visit. Patients initiating approved MT for COPD within 30 days of discharge/diagnosis (prompt) were compared with those initiating MT within 31-180 days (delayed). COPD-related total, medical, and prescription drug costs during a 1-year follow-up period were evaluated using semilog ordinary least square regressions, controlling for baseline characteristics plus COPD-related costs from the previous year. The odds and number of subsequent COPD-related exacerbations during the follow-up were compared between the prompt and delayed cohorts using logistic regression and zero-inflated negative binomial models, respectively. RESULTS: A total of 6,521 patients with a COPD-related hospitalization or an ED visit were included, of whom 4,555 received prompt MT and 1,966 received delayed MT. Adjusted COPD-related total and medical costs were significantly lower for the prompt MT than the delayed MT cohorts (US$3,931 vs US$4,857 and US$2,327 vs US$3,087, respectively; both P<0.010), as were COPD-related prescription costs (US$1,526 vs US$1,683, P<0.010) during the 1-year follow-up period. Patients receiving delayed MT were 68% more likely to have a subsequent exacerbation requiring hospitalization and 80% more likely to have an exacerbation requiring an ED visit. CONCLUSION: Prompt initiation of MT following a COPD-related hospitalization or an ED visit was associated with a significant reduction in COPD-related costs and odds of exacerbation in the following year compared with delayed initiation.

Burden of vaccine-preventable disease in adult Medicaid and commercially insured populations: analysis of claims-based databases, 2006­2010.

Vaccination rates among United States (US) adults are suboptimal, resulting in morbidity, mortality, and financial burden attributable to potentially vaccine-preventable diseases (VPDs). Unadjusted annual incidence proportions of VPDs were estimated for Medicaid and commercially insured adults aged 19-64 years using 2006-2010 claims, along with age/gender-adjusted incidence proportions for 2010. In 2010, 1.6 million Medicaid adults (mean age 34 ± 12 years; 73.4% female) and 33 million commercially insured (mean age 42 ± 13 years; 52.2% female) were included. Age/gender-adjusted incidence proportions (per 100 000) in 2010 among Medicaid vs commercially insured adults for meningococcal disease were 26.2 (95% CI 22.9-29.8) vs 2.0 (1.9-2.2) (P < 0.001); hepatitis B 88.9 (82.6-95.6) vs 17.5 (17.0-17.9) (P < 0.001); pneumococcal disease 98.2 (91.7-105.1) vs 21.1 (20.7-21.6) (P < 0.001); hepatitis A 19.8 (16.9-23.1) vs 4.5 (4.3-4.7) (P < 0.001); mumps 2.1 (1.3-3.3) vs 1.4 (1.3-1.6) (P = 0.14); measles 0.3 (0.1-1.0) vs 0.3 (0.2-0.3) (P = 0.38); herpes zoster (60- to 64-year-olds only) 459 (408-515) vs 473 (466-481) (P = 0.35); varicella (19- to 39-year-olds only) 6.5 (4.8-8.5) vs 8.0 (7.5-8.5) (P = 0.12); influenza 586 (573-598) vs 633 (631-636) (P < 0.001); and pertussis 1.8 (1.1-2.8) vs 3.2 (3.0-3.4) (P < 0.001). Research is needed to fully understand the causes of the disparity of the coded incidence of some VPDs in adult Medicaid population than commercially insured adults in the US.

Quality of care, health care costs, and utilization among Medicare Part D enrollees with and without low-income subsidy.

The objective of this cross-sectional, retrospective, claims-based analysis was to evaluate disease-specific quality measures, use of acceptable therapies, and health care cost and utilization among Medicare Advantage Part D (MAPD) enrollees overall and by income/subsidy eligibility status. Individuals aged ≥65 years with evidence of ≥1 of 8 common conditions and continuously enrolled in a MAPD plan throughout 2007 were assigned to low-income/dually eligible (LI/DE) or non-LI/DE cohorts. Quality of care metrics were calculated for asthma, chronic obstructive pulmonary disease (COPD), diabetes, and new episode depression. Persistence (proportion with percentage of days covered ≥80%), compliance (proportion with medication possession ratio ≥80%), health care costs, and utilization metrics were assessed by condition. All measures were evaluated for calendar year 2007. Bivariate comparisons were made between all LI/DE and non-LI/DE subgroups. A total of 183,213 patients were included. Metrics showed deficiencies in quality of care overall but generally favored non-LI/DE patients. The proportion of patients filling acceptable medication was suboptimal for most conditions, ranging from 40% to 96% across conditions and cohorts, with COPD the lowest and heart failure (HF) the highest. LI/DE patients were significantly more likely than non-LI/DE patients to fill acceptable therapy in each disease group (P<0.001) except HF. Percentages persistent and compliant with acceptable therapies were lowest for asthma and COPD, and highest for HF; percentages were generally higher among LI/DE patients. Mean disease-specific health care costs ranged from $345 (hyperlipidemia) to $2086 (HF) and were significantly higher for LI/DE than for non-LI/DE enrollees (P<0.001) for all diseases except coronary artery disease and HF. Overall, quality indicators, use of acceptable medications, and persistence/compliance metrics were suboptimal. Quality metrics favored non-LI/DE patients but medication metrics favored LI/DE patients. With an aging population and increasing health care costs, the deficits identified highlight the need for comprehensive strategies to improve clinical and economic outcomes across diseases.

Quality of care for veterans with chronic diseases: performance on quality indicators, medication use and adherence, and health care utilization.

This study was conducted to assess and benchmark the quality of care, in terms of adherence to nationally recognized treatment guidelines, for veterans with common chronic diseases (ie, asthma, chronic obstructive pulmonary disease [COPD], coronary artery disease [CAD], diabetes, heart failure, hyperlipidemia [HL]) in a Veterans Health Administration (VHA) system. Patients with at least 1 of the target diagnoses in the period between January 2002 and mid-year 2006 were identified using electronic medical records of patients seen at the James A. Haley Veterans' Hospital in Tampa, Florida. The most common diseases identified were HL (34%), CAD (21%), and diabetes (19%). The percentage of patients filling a prescription for any guidelines-sanctioned pharmacotherapy ranged from 28% (heart failure) to 91% (asthma). Persistence to medication ranged from 21% (HL) to 63% (asthma), while compliance ranged from 49% (COPD) to 85% (CAD). Most patients with diabetes (88%) had at least 1 A1c test in a year, but only 47% of patients had A1c values <7%. This study found that quality of care was generally good for conditions such as cardiovascular disease and diabetes, but quality care for conditions that have not been a primary focus of previous VHA quality improvement efforts, such as asthma and COPD, has room for improvement.

Quality of care associated with common chronic diseases in a 9-state Medicaid population utilizing claims data: an evaluation of medication and health care use and costs.

The objective of this cross-sectional, retrospective study was to utilize claims data to establish a quality-of-care benchmark in a large multistate Medicaid population overall and by race. Quality of care and medication adherence (persistence and compliance) per national treatment guidelines, and health care costs/utilization were assessed across common chronic conditions in a large, 9-state Medicaid population. Overall, quality of care was suboptimal across conditions. Over 15% of asthma patients had ≥ 1 asthma-related emergency room/hospital event and 12% of chronic obstructive pulmonary disease patients had a Level II or III exacerbation. Only 36% of depression patients filled any antidepressant medication within 90 days of new episode. Only 45% of diabetes patients received ≥ 2 A1c tests. Patients who filled a prescription for any acceptable pharmacotherapy ranged from 35% (depression) to 83% (heart failure [HF]). Persistence for those filling any acceptable medication ranged from 16% (asthma) to 68% (HF). Compliance for patients filling ≥ 2 prescriptions ranged from 27% (asthma) to 75% (HF). Blacks had the lowest medication compliance and persistence for all conditions except hyperlipidemia. The results highlight the need to assess and improve quality across the spectrum of care, both overall and by race.

Adherence to treatment guidelines and therapeutic regimens: a US claims-based benchmark of a commercial population.

The objective of this cross-sectional, retrospective study assessing commercially insured patients was to provide a useful benchmark to US health care payers and decision makers to assess quality of care, medication use and adherence, and health care resource utilization/costs associated with common chronic diseases. Measures of quality of care were suboptimal and substantial numbers of patients were not using any pharmacotherapy considered acceptable according to treatment guidelines. The widespread nature of undertreatment, poor medication adherence, and substantial health care costs highlights deficits and points to the need for comprehensive, multifaceted strategies to improve clinical and economic outcomes for chronic diseases.

Nonadherence to clinical practice guidelines and medications for multiple chronic conditions in a California Medicaid population.

OBJECTIVES: To assess and profile quality of care in California Medicaid beneficiaries with chronic conditions. DESIGN: Retrospective cohort study. SETTING: California from 2002 to 2004. PATIENTS: 1,123,577 beneficiaries. INTERVENTION: Eligibility and claims data (2002-2004) were used to identify beneficiaries with dyslipidemia, hypertension, coronary artery disease (CAD), heart failure, or diabetes. MAIN OUTCOME MEASURES: Quality of care was based on nonadherence with clinical practice guidelines including recommended medications. Chi-square was used to evaluate nonadherence and patient characteristics. RESULTS: The proportion of patients without a prescription fill for recommended medications varied by disease (43% hypertension, 40% dyslipidemia and CAD, and 25% diabetes and heart failure). For Medicaid-only beneficiaries with diabetes, 78% lacked glycosylated hemoglobin tests, 62% lacked low-density lipoprotein cholesterol tests, and 50% lacked eye exams. Medication nonadherence was high (69% hypertension, 64% CAD, 57% heart failure, 48% dyslipidemia, 41% diabetes). Overall, younger age, Medicaid-only status, and black/other race were associated with poorer rates. CONCLUSION: Quality of care was suboptimal, with nonadherence varying by condition. Programs targeting both patients and providers and addressing patient-related characteristics (e.g., age, race) and policy reform addressing alterable factors (e.g., insurance eligibility) should be developed to improve guideline adherence.

The effects of health plan copayments on adherence to oral diabetes medication and health resource utilization.

OBJECTIVE: To assess the effects of copayments on oral diabetes medication adherence, health resource utilization, and expenditure. METHODS: Retrospective, observational analysis of medical and pharmacy claims data from PPG Industries employees, retirees, and dependents (2003-2005). Average monthly copayments were stratified low (US$0-9), medium (US$10-19), or high (US$20+). RESULTS: In 2052 individuals, adherence to oral diabetes medication was highest for the low copayment group for both age groups >or=65 years; 84% low, 77% medium, 64% high (P < 0.0001) and <65 years; 74% low, 71% medium, 55% high (P < 0.0001). For patients <65 years, total health care expenditure was 22% lower in the low versus high copayment group (P = 0.024), resulting in average savings of US $3116 per patient per year. Risk of hospitalization was significantly lower in the low versus the high copayment group for patients >or=65 years of age. CONCLUSIONS: High copayments were associated with lower adherence to oral diabetes medications for all patients and higher total health care costs for patients less than 65.

Knowledge of hereditary prostate cancer among high-risk African American men.

PURPOSE/OBJECTIVES: To measure knowledge of hereditary prostate cancer in a group of high-risk African American men. DESIGN: Cross-sectional, correlational pilot study. SETTING: Four geographic sites: Detroit, MI; Houston, TX; Chicago, IL; and Columbia, SC. SAMPLE: 79 men enrolled in the African American Hereditary Prostate Cancer Study. METHODS: Telephone interviews. MAIN RESEARCH VARIABLES: Knowledge of hereditary prostate cancer. FINDINGS: Knowledge of hereditary prostate cancer was low. CONCLUSIONS: The high percentage of incorrect responses on questions that measure genetic testing, prevention, and risk based on a positive family history highlights educational needs. IMPLICATIONS FOR NURSING: A critical need exists for nurses to educate high-risk African American men about hereditary prostate cancer.