An Evaluation of the Effect of the OxyContin Reformulation on Unintentional Fatal and Nonfatal Overdose.

OBJECTIVES: OxyContin was reformulated with a polyethylene oxide matrix in August 2010 to reduce the potential for intravenous abuse and for abuse by insufflation. The objective of this study was to evaluate the impact of OxyContin's reformulation on overdose (OD) risk for individuals dispensed OxyContin in comparison to those dispensed other opioids under regular care. MATERIALS AND METHODS: Three national insurance databases with National Death Index linkage identified OD in individuals with any dispensing of OxyContin or a primary comparator opioid (extended release morphine, transdermal fentanyl, or methadone) between July 2008 through September 2015. A difference-in-differences design was used to compare the pre-post reformulation changes in OD rates for OxyContin versus comparators. RESULTS: A total of 297,836 individuals were dispensed OxyContin and 659,673 individuals were dispensed a primary comparator across the 3 databases. Overall, there was little or no difference in the temporal change in OD incidence in comparators versus OxyContin (Medicaid: adjusted ratio-of-rate-ratios (aRoRs) ranging from 0.90 to 1.05; MarketScan/HIRD: aRoR ranging from 1.10 to 1.22). However, restriction to person-time without concomitant opioid use revealed a modestly greater reduction in OD incidence over time during OxyContin use, as the aRoRs comparing the primary comparators to OxyContin ranged from 1.06 to 1.30 in Medicaid and from 1.64 to 1.85 in MarketScan/HIRD. DISCUSSION: This study did not detect an overall effect of the OxyContin reformulation on OD in insured patients under regular medical care. There is a suggestion of a modestly reduced OxyContin-associated OD risk following the reformulation but only in commercially insured individuals receiving single-opioid regimens.

Real-World Outcomes and Costs Following 6 Months of Treatment with the Long-Acting Injectable (LAI) Aripiprazole Lauroxil for the Treatment of Schizophrenia.

BACKGROUND: Continuous antipsychotic therapy is recommended as part of long-term maintenance treatment of schizophrenia, and gaps in antipsychotic treatment have been associated with increased risks of relapse and rehospitalization. Because the use of long-acting injectable (LAI) antipsychotics may reduce the likelihood of undetected medication gaps, initiating an LAI medication may affect resource utilization and costs. The LAI aripiprazole lauroxil (AL) was approved in the United States (US) in 2015 for the treatment of schizophrenia in adults. OBJECTIVE: The objective of this retrospective observational cohort study was to examine treatment patterns, resource utilization, and costs following initiation of AL for the treatment of schizophrenia in adults. METHODS: A retrospective analysis of Medicaid claims data identified a cohort of patients (N = 485) starting AL shortly after Food and Drug Administration approval in October 2015. Treatment patterns, resource utilization, and costs were compared 6 months before and after treatment initiation. Subgroup analyses were conducted based on the type of antipsychotic (LAI, oral, or none) received before initiation of AL. RESULTS: Over 6 months of follow-up, patients received an average of 4.6 injections out of a maximum of six (77%). After initiating AL, all-cause inpatient admissions decreased by 22.4%; other significant reductions were observed in mental health-related admissions and emergency room (ER) visits. All-cause inpatient costs decreased by an average of US$2836 per patient (p < 0.05) in the 6-month post-AL period, whereas outpatient pharmacy costs increased by US$4121 (p < 0.05), resulting in no significant difference in overall costs between the pre- and post-AL periods. The subgroup of patients who had been prescribed an oral antipsychotic before starting AL had significant reductions in proportion of patients with inpatient and ER visits and costs, but also reported a significant increase in pharmacy costs. CONCLUSIONS: AL was associated with a significant reduction in inpatient costs and an increase in outpatient pharmacy costs, resulting in no changes in total healthcare costs over 6 months. The adherence rate and reductions in inpatient use may indicate the potential for greater clinical stability among patients initiated on AL compared with their previous treatment.

Impact of pharmacy channel on adherence to oral oncolytics.

BACKGROUND: Oral chemotherapy is increasingly prescribed to treat cancer. Despite its benefits, concerns have been raised regarding adherence to therapy. The study objective was to compare and measure adherence, persistence, and abandonment in patients filling prescriptions in traditional retail (TR) versus specialty pharmacy (SP) channels. METHODS: Using a retrospective cohort design, we selected newly treated patients aged ≥18 years with a prescription for erlotinib, capecitabine, or imatinib during 2007-2011 from a Medco population of both United States commercial and Medicare health plans. Patients were classified according to pharmacy channel providing the medication. Abandonment was defined as a reversal following initial approval of the index prescription claim with no additional paid claims for agent within 90 days of reversal. Patients were considered adherent if the proportion of days covered between the date of the first and last oral prescription was ≥80%. RESULTS: In our retrospective cohort, 11,972 filled their prescriptions within the SP channel, and 30,394 filled their prescriptions within the TR channels, respectively. The SP channel had the highest proportion of adherent patients compared with TR (71.6% vs. 56.4%, P < .001). Abandonment of the initial prescription was low with overall rates of only 1.7%. In multivariate models controlling for demographic characteristics, index oncolytic, days of supply, and copay, SP channel (relative to TR) was significantly associated with lower rates of abandonment and increased adherence. CONCLUSIONS: Pharmacy channel may be influential on abandonment and adherence. Lower rates of abandonment and higher rates of adherence were observed among SP patients versus TR.

Changes in Patterns of Utilization and Cost of Health Care Services Associated With Initiation of Asenapine for the Treatment of Schizophrenia in Adults.

PURPOSE: To examine changes in patterns of utilization and cost of health care services associated with initiation of asenapine for the treatment of schizophrenia in adults. DESIGN: Retrospective cohort study using 2 large US health care claims databases. METHODOLOGY: All adults who initiated therapy with asenapine between Aug. 1, 2009, and Dec. 31, 2012, were identified; the date of the earliest claim for asenapine during this period was deemed the index date. Patients without ≥1 claims with a schizophrenia diagnosis within 12 months prior to the index date were excluded. We compared patterns of utilization and cost of health care services between 6-month periods immediately before and after index date ("preindex"and "postindex" respectively). RESULTS: 366 patients were identified who initiated asenapine and who met all other selection criteria; mean (SD) age was 40.5 (16.3) years and 57.1% were women. Relative to preindex, patients were less likely during postindex to be hospitalized (41.8% vs 26.2%, P<.001) or to visit the emergency room (24.9% vs 18.9%, P=.03). Mean (SD) total health care costs decreased by $4776 in the postindex period ($16,811 [$26,176] vs $12,035 [$17,037] during preindex), primarily due to a decrease in inpatient costs ($10,616 [$24,977] vs $5286 [$15,846]); mean pharmacy costs increased by $828 ($3656 [$3309] vs $4482 [$3,073]) (all P<.001). CONCLUSION: Use of asenapine for the treatment of schizophrenia was associated with reduced levels of health care utilization and cost during the 6-month period immediately following therapy initiation, primarily due to reduced levels of inpatient care.

Impact of initiation of asenapine on patterns of utilization and cost of healthcare resources associated with the treatment of bipolar I disorder.

OBJECTIVE: To assess the impact of initiation of asenapine on "real-world" levels of utilization and cost of healthcare services for the treatment of bipolar I disorder (BPD) in the US. METHODS: Using two large US healthcare claims databases that collectively included commercially insured patients aged < 65 years and Medicare enrollees, this study identified all adults (≥ 18 years) with evidence of BPD who began therapy with asenapine between 2009-2012. The date of the earliest claim for asenapine during this period was deemed the 'index date', and patients without continuous enrollment for the 6-month periods before and after this date were excluded ('pre-index' and 'post-index', respectively). Healthcare claims with a BPD diagnosis, plus psychiatric medications and the costs thereof (2012 dollars) were deemed 'BPD-related'. Differences in BPD-related utilization and cost of healthcare services were compared between the pre- and post-index periods. RESULTS: A total of 1403 patients met all selection criteria; the mean age was 42.8 years and 70.6% were women. Relative to pre-index, significant decreases were noted in post-index use of BPD-related healthcare services, most notably admissions (from 24.0% to 12.3% during the post-index period) and emergency department visits (from 4.6% to 2.6%) (both p < 0.05). While pharmacy costs increased, mean total post-index BPD-related healthcare costs were $979 lower than pre-index ($5002 vs $5981; p < 0.05), primarily due to the decrease in BPD-related admissions. CONCLUSIONS: Relative to the 6-month period beforehand, levels of utilization of BPD-related healthcare services and costs decreased during the 6-month period immediately following initiation of asenapine therapy.

Outcomes associated with comorbid atrial fibrillation and heart failure in Medicare beneficiaries with acute coronary syndrome.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) are both common comorbid conditions of elderly patients with acute coronary syndrome (ACS), but published data on their associated clinical and economic outcomes are limited. METHODS: Our study included patients from the Medicare Current Beneficiary Survey with an incident hospitalization for ACS between 03/01/2002 and 12/31/2006. Applying population weights, we identified 795 incident ACS patients, representing more than 2.5 million Medicare beneficiaries. Of this population, 13.1% had comorbid AF, and 22.9% had HF, which were identified from Medicare claims during the 6 months prior to the first ACS event (index date) Subsequent cardiovascular (CV) hospitalizations and mortality were compared using Kaplan-Meier curves. Cox proportional hazards regressions were used to estimate the relative risk of AF and HF on CV events and mortality. Healthcare costs were summarized for the calendar year in which the incident ACS event occurred. RESULTS: HF was associated with a 41% higher risk of mortality (HR = 1.41; 95% confidence interval [CI] 1.05-1.89). Both AF (HR = 1.46; 95% CI 1.14-1.87) and HF (HR = 1.61; 95% CI 1.26-2.06) were associated with higher risks of subsequent CV events. During the year of the incident ACS event, ACS patients with comorbid AF or HF had approximately $18,000 higher total healthcare costs than those without these comorbidities. CONCLUSION: Using a nationally representative sample of Medicare beneficiaries, we observed a significantly higher clinical and economic burden of patients hospitalized for ACS with comorbid AF and HF compared with those without these conditions.

Antimuscarinic use among individuals with urinary incontinence who reside in long-term care facilities.

PURPOSE: To assess appropriateness of antimuscarinic use in long-term care facilities (LTCFs) among treated and untreated urinary incontinence (UI) residents from 2007 to 2009. METHODS: We conducted a retrospective analysis using the AnalytiCare(SM) database consisting of minimum data sets (MDS) assessments and prescription records of 90,660 residents from 2007 to 2009. UI (MDS H1b ≥ 1) residents with ≥ 14-day LTCF stay were identified and categorized as treated if they had ≥ 1 antimuscarinic prescription and untreated if they had no antimuscarinics. A random sample of untreated residents was matched based on treated residents' type of MDS assessment. We defined appropriate antimuscarinic use if residents had adequate cognitive function [≤ 4 on the cognitive performance scale (0 = intact to 6 = very severe impairment)] and mobility [scoring <4 on mobility for toileting scale (MDS item G1iA 0 = independent to 4 = total dependent)]. Chi-square tests were used to detect statistical difference between cohorts. RESULTS: A total of 5,327 residents (2,840 treated; 2,487 untreated) were selected [mean age (standard deviation) 80 (8), 81 (8) years; female (76, 65 %), respectively]. On study-defined MDS assessment, 63 % of treated and 69 % of untreated residents had UI (P < 0.01). Approximately 84 % of treated and 74 % of untreated residents may have had cognitive function and mobility sufficient for appropriate antimuscarinic use (P < 0.01). CONCLUSIONS: Our study identified a high percentage of LTCF residents with UI who may have been candidates for antimuscarinics. However, due to the MDS limitation, we were unable to identify overactive bladder patients among these untreated residents with UI. It is possible that untreated control residents had UI due to other factors not amenable to treatment with antimuscarinic agents. Therefore, choice of treatment for each resident needs to be individualized and carefully monitored for efficacy and adverse effects. This retrospective analysis requires prospective confirmation. Proper patient selection for antimuscarinic treatment requires careful assessment of underlying physical status including cognitive function, mobility, and comorbidities.

Moving branded statins to lowest copay tier improves patient adherence.

BACKGROUND: Statins are efficacious in reducing the risk of major cardiovascular events for both primary and secondary prevention, yet long-term adherence is poor. Their effectiveness could be compromised in actual practice when patients are not adherent to the treatments. Higher copayments have been shown to be associated with lower adherence to statins. OBJECTIVE: To assess the effect on patient adherence of moving branded atorvastatin and rosuvastatin from the second to the first tier by a Medicare Part D plan sponsor. METHODS: Pharmacy claims and eligibility records between July 1, 2009, and July 31, 2011, of Medicare Part D members not receiving the low-income subsidy were analyzed. New atorvastatin and rosuvastatin users in January 2010 (2010 cohort) were compared with those in January 2011 (2011 cohort) after this formulary tier change (tier-reduction group). Adherence was defined by the proportion of days covered (PDC) over 6 months. The impact of tier reduction on adherence was evaluated via logistic regression for binary outcome (PDC≥0.8) and generalized linear regression for continuous PDC by comparing the 2011 cohort with the 2010 cohort, adjusting for demographic and clinical characteristics. Other statin users (97% on generic statins) were also analyzed, serving as a nontier-reduction comparator group. RESULTS: We identified 12,437 members in the tier-reduction group. Between the 2010 and 2011 cohorts, mean PDC increased from 0.77 to 0.83, and the proportion of members with high adherence increased from 62.0% to 72.9% (both P < 0.001). After regression adjustment, members in the 2011 cohort were more likely to be adherent (OR=1.68; 95% CI=1.55-1.82) and had a 5.9% increase in PDC (P < 0.05). There was no significant increase in adherence observed in the comparator nontier-reduction group. CONCLUSION: Findings from this study suggest that financial incentives may improve medication adherence. Future studies should evaluate whether such formulary strategies improve long-term adherence and patient outcomes.

Compliance to fingolimod and other disease modifying treatments in multiple sclerosis patients, a retrospective cohort study.

BACKGROUND: Adherence to disease-modifying therapies (DMTs) results in the reduction of the number and severity of relapses and delays the progression of multiple sclerosis (MS). Patients with lower adherence rates experience more inpatient visits and higher MS-related medical costs. Fingolimod, the first oral DMT approved by the US Food and Drug Administration, may improve the access and compliance to MS treatment when compared to injectable DMTs. METHODS: This retrospective cohort study used pharmacy claims from Medco Health Solutions, Inc., of patients who initiated DMTs between October 2010 and February 2011. Initiation was defined as no prescription fills for the same DMT in the prior 12 months. Patients without a DMT prescription fill 12 months before the index date were considered naïve users. Compliance was measured via proportion of days covered (PDC) and medication possession ratio (MPR) for 12 months post-index. Discontinuation was defined as a ≥60-day gap of index DMT supply. Cox proportional hazard models compared time to discontinuation between cohorts. RESULTS: Of 1,891 MS patients (mean age: 45.7; female: 76.4%), 13.1% initiated fingolimod, 10.7% interferon beta-1b, 20.0% intramuscular interferon beta-1a, 18.8% subcutaneous interferon beta-1a, and 37.4% glatiramer acetate. Patients initiating fingolimod had highest average PDC and MPR in both experienced (fingolimod: mean PDC=0.83, 73.7% with PDC≥0.8; mean MPR=0.92, 90.5% with MPR≥0.8) and naïve DMT users (fingolimod: mean PDC=0.80, 66.7% with PDC≥0.8; mean MPR=0.90, 87.4% with MPR≥0.8). The proportion of patients discontinuing index DMT within 12 months was significantly lower for the fingolimod cohort (naïve: 31.3%; experienced: 25.7%). Adjusted results found that patients receiving self-injected DMTs discontinued significantly sooner than fingolimod users. This association was generally stronger in experienced DMT users. CONCLUSIONS: Fingolimod initiators were more compliant, less likely to discontinue treatment, and discontinued later than patients who initiated self-injected DMT.

Estimated medical cost reductions associated with apixaban in real-world patients with non-valvular atrial fibrillation.

OBJECTIVE: The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial demonstrated that apixaban was effective in reducing the risk of stroke and major bleeding in non-valvular atrial fibrillation (NVAF) patients. Medical cost avoidance studies for oral anticoagulants have used warfarin event rates from clinical trials, which may not reflect the real-world (RW) setting. This study aimed to estimate the difference in medical costs associated with apixaban instead of warfarin in RW NVAF patients. METHODS: This study selected patients with NVAF diagnosis during 2007-2010 from a Medco population of US commercial and Medicare health plans. Stroke and major bleeding excluding intracranial hemorrhage (MBEIH) were identified using diagnosis codes. Pharmacy claims were used to define warfarin exposure periods. Rates of stroke and MBEIH were calculated during warfarin exposure. To estimate the absolute risk reduction (ARR) between warfarin and apixaban in RW, the relative risk reductions (RRR) from ARISTOTLE were multiplied by the event rates observed in RW during warfarin exposure. Medical cost reductions associated with apixaban were calculated by applying the ARR to the 1-year incremental cost for each event. Stroke and MBEIH costs were obtained from the literature and adjusted to 2011 levels. RESULTS: During a patient year, the use of apixaban instead of warfarin resulted in medical cost reductions of $493 for stroke and $752 for MBEIH and $1245 for the combined outcome of both events. The medical costs avoided were greater as baseline stroke risk increased. CONCLUSION: If RRRs demonstrated in ARISTOTLE persist in RW, the use of apixaban will be associated with lower medical costs vs warfarin. Main limitations of this study were: identification of clinical events using administrative codes rather than confirmatory clinical data, inability to evaluate the level of international normalized ratio (INR) control, and not including INR monitoring and drug costs.

Application of randomized clinical trial data to actual practice: apixaban therapy for reduction of stroke risk in non-valvular atrial fibrillation patients.

BACKGROUND: Clinical event rates may differ among patients treated in the real world (RW) compared to randomized controlled trials (RCTs). When translating the efficacy of new treatments to RW, the relative risk reductions (RRRs) from RCTs may produce different absolute risk reductions in RW. OBJECTIVE: To estimate the absolute effect of apixaban on stroke and major bleeding (MB) rates in a RW non-valvular atrial fibrillation (NVAF) population. METHODS: NVAF patients were selected during 2007-2010 from a population of U.S. commercial and Medicare health plans using the Medco claims database. Pharmacy claims were used to define warfarin exposure periods. Stroke and MB were identified using diagnosis codes. RW event rates were calculated during periods of warfarin exposure. The numbers of stroke and MB events estimated to be avoided in RW with apixaban versus warfarin were calculated by applying RRRs from the ARISTOTLE trial to RW rates from the Medco database. The Medco data did not contain information for patients receiving apixaban as it was not on the market at the time of analysis. RESULTS: Stroke and MB rates among RW NVAF patients during warfarin exposure were higher compared with event rates in patients treated with warfarin in ARISTOTLE (stroke: 5.29 vs. 1.51 per 100 person years (PYs); MB: 10.78 vs. 3.09 per 100 PYs). If RRRs from trials persist in RW, apixaban vs. warfarin would result in greater absolute risk reductions (ARRs) and a lower number needed to treat (NNT) in RW vs. ARISTOTLE (stroke: 91 vs. 313; MB: 30 vs. 105). CONCLUSION: The impact of apixaban, as an alternative to warfarin in RW may be greater than in RCTs. The NNT with apixaban versus warfarin in RW may be lower versus ARISTOTLE if RRRs from the trial persists in RW and if baseline stroke and MB rates among RW patients are higher compared to trial participants.

One-year adherence to warfarin treatment for venous thromboembolism in high-risk patients and its association with long-term risk of recurrent events.

BACKGROUNDS: Warfarin is the predominant oral anticoagulant used for the prevention of recurrent venous thromboembolism (VTE) events. However, its long-term use is complicated by the need to manage the drug within a narrow therapeutic range and by possible food and drug interactions. OBJECTIVE: To examine the association between 1-year adherence, measured through compliance with and persistence on warfarin treatment for VTE, and long-term risk of recurrent events among patients at high risk. METHODS: Medical and pharmacy claims for patients with commercial or Medicare supplemental insurance in the Thomson Reuters MarketScan database were analyzed. Adult patients with medical claims with an associated VTE diagnosis between January 1, 2006, and March 31, 2008, were identified. The index date was defined as the date of the first observed VTE claim or the date of discharge if the index event was a hospital stay. High-risk patients (patients with cancer, or noncancer patients who did not have reversible risk factors during the 3-month period prior to the index date) who filled a warfarin prescription within 2 weeks of the index date were included. Persistence was evaluated in terms of discontinuation, defined as a 90-day gap in warfarin supply during a 1-year assessment period following the index date. Compliance was measured by the proportion of days covered (PDC) over the 1-year assessment period, with PDC less than 0.8 defined as noncompliance. Recurrent VTE events were identified as hospitalizations where VTE was the primary diagnosis after the 1-year assessment period and until patients were lost to follow-up. The association between adherence to warfarin therapy and VTE recurrence was evaluated descriptively via Kaplan-Meier curves and a Cox proportional hazards model, adjusted for patient demographic and clinical characteristics. A similar analysis using the medication possession ratio (MPR) as a measure of compliance was also performed in a subset of patients who had filled at least 2 warfarin prescriptions. RESULTS: The study included 8,040 VTE patients identified as being at high risk of recurrence (mean age 61 years, 59.4% male), of whom 76.9% were not compliant with warfarin therapy based on PDC, and 51.5% discontinued therapy. Among those with at least 2 warfarin prescriptions (n = 7612), 34.1% of high-risk patients were not compliant with warfarin therapy between the first and last refills based on MPR. Kaplan-Meier curves showed that patients who were compliant or continued warfarin therapy were less likely to experience a VTE event (all P less than 0.05). Noncompliant patients had a 3 times greater risk of VTE recurrence than compliant patients, based on PDC (hazard ratio [HR] = 3.01, 95% confidence interval [CI]: 1.28-4.97). Among the subpopulation who filled at least 2 warfarin prescriptions, noncompliant patients (based on MPR) were also found to be more likely to have recurrent VTE events, compared with compliant patients (HR = 1.60, 95% CI: 1.18-2.16). Patients who discontinued warfarin were more likely to have recurrent VTE events compared with patients who did not discontinue on warfarin treatment (HR = 1.48, 95% CI: 1.09-2.01). CONCLUSION: Adherence to a year of therapy was low in patients at high risk of recurrent VTE, even though long-term therapy should be considered in this population. Noncompliance and discontinuation of warfarin treatment over a 1-year period was associated with a higher risk of recurrent VTE. Future research should investigate and differentiate between patient and provider discontinuation to develop strategies to improve compliance and persistence with appropriate anticoagulation therapy that may potentially reduce recurrent VTE.

Clinical and economic outcomes among hospitalized patients with acute coronary syndrome: an analysis of a national representative Medicare population.

OBJECTIVE: To evaluate the clinical and economic burden of acute coronary syndrome (ACS), a common cardiovascular illness, in the Medicare population. METHODS: Data from the Medicare Current Beneficiary Survey were analyzed. Patients with incident hospitalization for ACS without similar events during the 6 months prior were included. Outcomes evaluated included inpatient mortality, 30-day mortality and readmission, subsequent hospitalization events, and total direct health care costs. Sample population weights were applied, accounting for multistage sampling design to obtain nationally representative estimates for the US Medicare population. RESULTS: Between March 1, 2002 and December 31, 2006, we identified 795 incident ACS patients (mean age 76 years; 49% male) representing 2,542,211 Medicare beneficiaries. The inpatient mortality rate was 9.71% and the 30-day mortality ranged from 10.96% to 13.93%. The 30-day readmission rate for surviving patients was 18.56% for all causes and 17.90% for cardiovascular disease (CVD)-related diagnoses. The incidence of death since admission was 309 cases per 1000 person-years. Among patients discharged alive, the incidence was 197 for death, 847 for CVD-related admission, and 906 for all-cause admission. During the year when the ACS event occurred, mean annual total direct health care costs per person were US$50,458, with more than half attributable to inpatient hospitalization ($27,609). CONCLUSION: In this national representative Medicare population, we found a substantial clinical and economic burden for ACS. These findings suggest a continuing unmet medical need for more effective management of patients with ACS. The continuous burden underscores the importance of development of new interventions and/or strategies to improve long-term outcomes.

Impact of care management processes and integration of care on blood pressure control in diabetes.

BACKGROUND: Fragmentation within health care systems may negatively impact the quality of chronic disease patient care. We sought to evaluate the relationship between care management processes (CMP), integration of services, and blood pressure (BP) control among diabetic patients. METHODS: Retrospective chart reviews were performed for a random sample of adult diabetic hypertensive patients (n = 2,162) from 28 physician organizations in the United States (US). A modified version of the Physician Practice Connection Readiness Survey (PPC-RS) was completed by the chief medical officer at each site. The PPC-RS measured health system organization, delivery system redesign, decision support, clinical information systems, and self-management support, and an integration scale measured structure, functions, and financial risk. Correlations between PPC and integration scores and BP outcomes were assessed using Spearman correlation coefficients. RESULTS: Approximately 39.9% of diabetic patients had controlled BP. Mean total PPC score across sites was 55, with highest mean scores for health system organization (81), followed by design support (60), clinical information systems (57), self-management support (39), and delivery system redesign (39). Mean integration score was 46 (SD 27, range 4-93), and means of subscores were 64 for structure, 33 for financial risk, and 42 for function. Clinical information systems subscore was correlated with uncontrolled BP (r = -0.38, p < 0.05), while association with total PPC score was strong but not significant at p < 0.05 (r = -0.32). Total integration score and the structure subscore were significantly correlated with BP control (r = 0.38, p < 0.05, and r = 0.49, p < 0.01). CONCLUSIONS: This study suggests that CMP and service integration may be associated with better outcomes in diabetes, though results were mixed and limited by a small number of participating sites. Primary care implementation of integrated electronic medical records may have a beneficial effect on patient outcomes for diabetes and other chronic diseases.

Myocardial perfusion imaging laboratory efficiency with the use of regadenoson compared to adenosine and dipyridamole.

OBJECTIVE: Adenosine, dipyridamole, and regadenoson are pharmacologic stress agents used in myocardial perfusion imaging (MPI), to diagnose and monitor coronary artery disease. Clinical studies suggest that regadenoson has pharmacologic properties that simplify the MPI procedure through availability to a wider range of patients and easier administrative requirements. This study assesses the operational advantages and laboratory efficiency associated with the use of regadenoson compared to adenosine and dipyridamole. METHODS: A web-based survey of 141 nuclear medicine technologists working in US-based cardiovascular imaging laboratories from June-July 2009. MAIN OUTCOME MEASURES: Descriptive statistics measured the adenosine, dipyridamole, and regadenoson cohorts. Bivariate analyses compared the overall and staff-specific time to conduct an MPI test. The site-specific sub-groups were defined by hospital vs non-hospital setting, hours of operation, number of SPECT cameras, and number of full-time equivalent staff, including nurses, nuclear technologists, physicians, and nurse practitioners/physician assistants. RESULTS: The total time to conduct an MPI test was shortest with regadenoson 156 (46) min compared to adenosine and dipyridamole 182 (63) and 191 (61) min, respectively. Time from regadenoson administration to the start of the imaging session, including dose calculation and infusion time, was 14.2 min less than adenosine, and 12.0 min less than dipyridamole. The time to manage adverse events was shortest if it occurred with regadenoson compared to adenosine and dipyridamole, with minor exceptions. Due to the nature of survey implementation, possible recall bias may limit the results. Some differences in procedures times may be attributable to differences in laboratories' protocols. CONCLUSIONS: Overall time savings and time savings stratified by operational ability (number of staff, number of SPECT cameras, hours of operation) translate to a more efficient utilization of laboratory resources when using regadenoson compared to adenosine and dipyridamole. Regadenoson is the most efficient pharmacologic stress agent compared to adenosine and dipyridamole.

Antiepileptic drug treatment patterns and economic burden of commercially-insured patients with refractory epilepsy with partial onset seizures in the United States.

OBJECTIVE: To assess the economic burden in direct healthcare utilization and costs for refractory epileptic patients with partial onset seizures (POS) and assess the antiepileptic drug (AED) treatment patterns among these patients. METHODS: This retrospective database study analyzed administrative claims of commercially-insured patients with POS from 2004-2008. Healthcare costs and utilization were compared between refractory (defined as ≥3 AEDs) and non-refractory patients by calendar year and AED treatment patterns were described for refractory patients. RESULTS: Of the 79,149 patients identified (mean age 33 years; 54.8% female), 8714 (11%) were classified as refractory. In 2008, average annual healthcare costs for refractory patients were significantly higher than non-refractory patients ($33,613 vs $19,085), also by settings for inpatient ($11,780 vs $6076), outpatient ($13,431 vs $8637), and pharmacy costs ($8402 vs $4372) (all p < 0.001). Among refractory patients, close to one-third of total costs were for POS-related services. Similar trends were observed when assessing POS-related utilization and costs. The differences were consistent across all calendar years examined. Among refractory patients, 80.5% were on monotherapy at the beginning of the follow-up period. Levetiracetam is the common AED in mono/combination therapy as well as add-on/switch-to. LIMITATIONS: The onset of seizure cannot be identified, and the indication of each AED could not be confirmed from the pharmacy claims. Only direct medical costs were assessed. CONCLUSIONS: Pattern of use was very dynamic, suggesting seizures are not well-controlled. Improving seizure control and reducing economic burden of refractory epilepsy remain important unmet medical needs in this population.

Factors associated with adherence to phosphodiesterase type 5 inhibitors for the treatment of pulmonary arterial hypertension.

OBJECTIVES: To assess factors associated with adherence to phosphodiesterase type 5 inhibitors (PDE5Is) in the management of pulmonary arterial hypertension (PAH). METHODS: This study analyzed pharmacy benefit claims of naïve Adcirca and Revatio users between January 1, 2008 and December 31, 2010. Patients were considered adherent if their proportion of days covered (PDC) was ≥ 80% over a 6-month period. Logistic regressions were estimated to assess the factors associated with adherence. Analyses were stratified by use of a specialty pharmacy or retail pharmacy. A sensitivity analysis was performed by excluding individuals with 90-day supply. RESULTS: Of the total of 2143 patients included, 46.8% were adherent. Adherence was higher among 930 specialty pharmacy users (65.6%) than 1213 retail pharmacy users (32.3%, p < 0.001). Adherence was higher among Adcirca users (60.7%; approved dose 40 mg once-daily) than Revatio users (44.3%, p < 0.001; approved dose 20 mg thrice-daily). Among retail pharmacy users, adherence was higher in patients using Adcirca (OR = 2.59; 95% CI = 1.60-4.22) and patients with an index prescription given by pulmonologists (OR = 1.70; 95% CI = 1.15-2.50), while lower in patients with higher copayment ($51-$250: OR = 0.61, 95% CI = 0.42-0.90; $251+: OR = 0.57, 95% CI = 0.39-0.83). Among specialty pharmacy users, only high copayment ($251+: OR = 0.56, 95% CI = 0.35-0.90) was found to be a significant factor for non-adherence. After excluding individuals with 90-day supply, adherence rate was 29.6% in retail pharmacy and 57.9% in specialty pharmacy (p < 0.001), and regression results were similar. LIMITATIONS: Diagnosis of PAH was not confirmed without access to medical claims. Pharmacy refill records might not reflect actual consumption. Adherence evaluated for 6 months might not be generalizable to longer periods. CONCLUSION: Adherence to PDE5Is for PAH is sub-optimal. The findings suggest that adherence to PDE5Is in patients with PAH is associated with the use of specialty pharmacy, simpler dosing frequency, a lower financial barrier, and a prescription given by pulmonologists.

Use of select medications prior to duloxetine initiation among commercially-insured patients.

BACKGROUND: The purpose of this study was to assess select medication utilization prior to duloxetine initiation among patients with major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and musculoskeletal pain associated with osteoarthritis or low back pain. METHODS: Commercially insured duloxetine initiators between January 1, 2007 and March 31, 2010 were identified from a large US administrative claims database. Disease subgroups were constructed based on diagnosis from medical claims during the 12 months prior to duloxetine initiation. Prior use of antidepressants, anticonvulsants, opioids, nonsteroidal anti-inflammatory drugs, and muscle relaxants was assessed during the 12-month preinitiation period. RESULTS: This study identified 56,845 (2007), 44,838 (2008), and 65,840 (January 2009 to March 2010) duloxetine initiators. Among the 2009 initiators, utilization patterns were similar for patients with major depressive disorder and generalized anxiety disorder, with antidepressants being the most used (84% and 80%, respectively), followed by opioids (58% and 55%, respectively). Patients across pain-related conditions also had similar utilization patterns, with opioid use being the highest (76%-82%), followed by antidepressants (65%-72%). Use of other medication classes was common (29%-63%) but less frequent, and over 50% of the patients used any antidepressants, 70% used any antidepressants or anticonvulsants, and 90% used any antidepressants, anticonvulsants, or opioids. Trends in the use of these select medications were similar between 2007 and 2009. CONCLUSION: Patients used several types of medications over the 12 months prior to initiating duloxetine across disease states, with antidepressants and opioids being the most frequently used medications. Trends of select medication use were similar over time.

Assessing achievement and maintenance of glycemic control by patients initiating basal insulin.

OBJECTIVE: Describe characteristics of diabetic patients who initiated basal insulin and assess their glycemic control. RESEARCH DESIGN AND METHODS: Physician encounters in the General Electric EMR Database (2005-2010) were assessed for patients with type II diabetes (T2DM) who initiated basal insulin between February 2006 and August 2009, with initiation defined as no prescription record of insulin in prior 15 months. Patients were followed for an average 2.5 years after insulin initiation. The proportion and time to achieving HbA1c ≤ 7% ('goal') were assessed. Among patients who reached goal, the proportion and time to HbA1c increasing above 7% were analyzed. Cox proportional hazard models were estimated to identify predictors of HbA1c goal achievement and goal sustainability. RESULTS: Basal insulin initiators with T2DM (n = 13,373) were on average 60 years old, 50.5% were females, and 59.5% had HbA1c > 8%; 5840 (44%) patients reached goal within one year and 7699 (58%) reached goal during the ∼2.5-year follow-up. Being older, white or male, lower baseline HbA1c values, and no OAD use before insulin initiation were associated with significantly higher rates of reaching goal. Among patients who reached goal, 57.6% could not sustain the goal. Being Hispanic, higher baseline HbA1c values, and baseline OAD use were associated with significantly lower rates of goal sustainment. CONCLUSION: A high proportion of T2DM patients did not have adequate glycemic control after initiating basal insulin. Various factors existing prior to insulin initiation were related to successful treatment of T2DM. Further research on how to improve glycemic control is encouraged.

Caregiver assistance among Medicare beneficiaries with atrial fibrillation and factors associated with anticoagulant treatment.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and disproportionately affects the elderly. OBJECTIVE: This study describes patient characteristics and caregiver assistance among Medicare beneficiaries with AF and examines factors associated with receiving anticoagulant treatment. METHODS: Patients with AF and age/gender-matched controls were identified from Medicare Current Beneficiary Survey data from 2001 to 2006. A logistic regression model was used to assess factors associated with receiving anticoagulants in a subgroup of patients with AF whose treatment pattern was established for 2 consecutive years. Sample weights were applied to obtain nationally representative estimates. RESULTS: A total of 2990 patients with AF and 5980 control patients were included in the burden of disease analysis, and 1481 patients with AF were included in the anticoagulant predictor analysis. Patients with AF had a higher level of comorbidity (Charlson Comorbidity Index: 3.3 vs 1.5; P < 0.05), worse self-perceived health status (P < 0.001), and greater level of disability (P < 0.001) than their matched counterparts. A greater proportion of patients with AF required caregiver assistance (62.8% vs 51.5%; P < 0.001). Logistic regression found that higher Charlson Comorbidity Index scores, difficulty in obtaining necessary health care, older age, being widowed, a history of psychiatric disorders, and being underweight decreased the likelihood of receiving anticoagulant therapy. CONCLUSIONS: In a Medicare population, a greater need for caregiver assistance was observed in patients with AF. Subgroups characterized by frailty or inability for self-care were identified as being less likely to receive anticoagulant therapy. The need for caregiver assistance among patients with AF, as well as the patient subgroups identified as less likely to receive anticoagulant therapy, should be considered when making treatment decisions.