Jonathan R. Korn

Medication Adherence and Hospitalization Among Patients With Schizophrenia Treated With Antipsychotics

OBJECTIVE This analysis assessed rates of medication adherence and predictors of nonadherence and hospitalization among patients treated with long-acting injectable and oral antipsychotic therapies. METHODS Data were from a retrospective analysis of Florida Medicaid recipients with schizophrenic disorder (ICD-9-CM code 295.XX) who received a prescription for an antipsychotic between July 1, 2004, and June 30, 2005. Patients were required to have filled one additional antipsychotic prescription during follow-up. Adherence measures included medication possession ratio (MPR), medication persistence, medication consistency, and maximum gap in treatment. Multivariate logistic regression models identified predictors of nonadherence and hospitalization. RESULTS Patients were considered adherent if they had an MPR ≥ .8. A total of 12,032 patients met selection criteria. The mean ± SD MPR was .79 ± .23, medication persistence was 94.1% ± 16.4%, medication consistency was 83.3% ± 16.4%, and the maximum gap in treatment was 29.7 ± 41.4 days. Thirty-seven percent of patients were hospitalized for any cause, and 32% had a psychiatric hospitalization. Predictors of nonadherence included newly starting treatment; younger age; a substance abuse diagnosis; use of a mood stabilizer, antidepressant, anxiolytic, or anticholinergic; and receipt of long-acting first-generation antipsychotics. Receipt of long-acting second-generation therapy or receipt of both first- and second-generation medications was associated with lower likelihood of nonadherence. Predictors of hospitalization risk included a diagnosis of other psychoses or substance abuse, anticholinergic use, and nonadherence to therapy. CONCLUSIONS Results document rates of antipsychotic adherence and predictors of nonadherence and hospitalization. Findings may be useful to health plan administrators, formulary decision makers, and physicians.

Relapse rates in patients with multiple sclerosis switching from interferon to fingolimod or glatiramer acetate: a US claims database study.

Background Approximately one-third of patients with multiple sclerosis (MS) are unresponsive to, or intolerant of, interferon (IFN) therapy, prompting a switch to other disease-modifying therapies. Clinical outcomes of switching therapy are unknown. This retrospective study assessed differences in relapse rates among patients with MS switching from IFN to fingolimod or glatiramer acetate (GA) in a real-world setting. Methods US administrative claims data from the PharMetrics Plus™ database were used to identify patients with MS who switched from IFN to fingolimod or GA between October 1, 2010 and March 31, 2012. Patients were matched 1∶1 using propensity scores within strata (number of pre-index relapses) on demographic (e.g. age and gender) and disease (e.g. timing of pre-index relapse, comorbidities and symptoms) characteristics. A claims-based algorithm was used to identify relapses while patients were persistent with therapy over 360 days post-switch. Differences in both the probability of experiencing a relapse and the annualized relapse rate (ARR) while persistent with therapy were assessed. Results The matched sample population contained 264 patients (n = 132 in each cohort). Before switching, 33.3% of patients in both cohorts had experienced at least one relapse. During the post-index persistence period, the proportion of patients with at least one relapse was lower in the fingolimod cohort (12.9%) than in the GA cohort (25.0%), and ARRs were lower with fingolimod (0.19) than with GA (0.51). Patients treated with fingolimod had a 59% lower probability of relapse (odds ratio, 0.41; 95% confidence interval [CI], 0.21–0.80; p = 0.0091) and 62% fewer relapses per year (rate ratio, 0.38; 95% CI, 0.21–0.68; p = 0.0013) compared with those treated with GA. Conclusions In a real-world setting, patients with MS who switched from IFNs to fingolimod were significantly less likely to experience relapses than those who switched to GA.

Persistence with and adherence to fingolimod compared with other disease-modifying therapies for the treatment of multiple sclerosis: a retrospective US claims database analysis

Abstract Objective: Achieving therapeutic goals in multiple sclerosis (MS) requires strict adherence to treatment schedules. This retrospective study analyzed persistence with, and adherence to, fingolimod compared with injectable/infusible disease-modifying therapies (DMTs) in patients with MS. Methods: Patients in the PharMetrics Plus™ US administrative claims database with at least one prescription for, or administration of, fingolimod, glatiramer acetate (GA), interferon (IFN), or natalizumab (index DMT) between October 1, 2010 and September 30, 2011 were included. Patients were naïve to index DMT (no claim in the previous 360 days) and had an MS diagnosis code within 360 days of the first index DMT prescription. Outcomes were persistence, risk of discontinuing index DMT (evaluated by a Cox proportional hazards model), adherence (measured using the medication possession ratio [MPR] and proportion of days covered [PDC] in patients with at least two index DMT prescriptions), and the risk of being non-adherent (MPR <80% and PDC <80%, assessed using a logistic regression model). Results: The study included 3750 patients (fingolimod, n = 889; GA, n = 1233; any IFN, n = 1341; natalizumab, n = 287). Discontinuation rates (fingolimod, 27.9%; GA, 39.5%; IFN, 43.7%; natalizumab, 39.5%; all p < 0.001) and risk of discontinuation were significantly higher (hazard ratios vs fingolimod [95% confidence interval]: GA, 1.75 [1.49–2.07]; IFN, 2.01 [1.71–2.37]; natalizumab, 1.53 [1.22–1.91]) for patients receiving other DMTs compared with fingolimod. The risk of being non-adherent was also lower for patients in the fingolimod cohort than the other treatment cohorts, irrespective of whether non-adherence was defined as MPR <80% (p < 0.05 for all) or PDC <80% (p < 0.05 for GA and IFN). Limitations: As with all studies assessing real-world treatment patterns it is unclear if medications were used as prescribed. Conclusions: In a real-world setting, persistence with, and adherence to, oral fingolimod was higher than for injectable and infusible DMTs.

The economic costs to United States hospitals of invasive fungal infections in transplant patients

BACKGROUND Patients with a solid organ transplant (SOTs) and hematopoietic stem cell or bone marrow transplants (HSC/BMTs) are at risk of contracting invasive fungal infections (IFIs). Data on the economic burden of IFIs in the United States are sparse. METHODS We conducted a retrospective matched cohort study using the 2004-2005 Healthcare Cost and Utilization Project Nationwide Inpatient Sample. The IFI cohort included patients with ICD-9-CM codes indicating a transplant procedure and an IFI. Matched controls (transplant recipients without an IFI) were chosen based on age (10 year categories), sex, region, hospital type, year, and transplant type. Mortality, length of stay, and costs were reported overall, by transplant type, and by type of mycosis. RESULTS Nine thousand eight hundred ninety-six patients underwent SOT, and 4661 underwent HSC/BMT. Of these, 80 (0.8%) SOT and 111 (2.4%) HSC/BMT patients had an IFI. Mean age was 41.8 years (SOT) and 37.8 years (HSC/BMT). Aspergillosis was the most common infection. Patients with an IFI had a 5-fold increase in mortality, an additional 19.2 hospital days, and

Predicted coronary risk for adults with coronary heart disease and low HDL-C: an analysis from the US National Health and Nutrition Examination Survey

55,400 in excess costs compared with patients without an IFI. Excess mortality, length of stay, and costs varied by type of transplant and mycosis. CONCLUSION The clinical and economic burden of IFIs in transplant recipients may be high.

Comparative effectiveness of fingolimod versus interferons or glatiramer acetate for relapse rates in multiple sclerosis: a retrospective US claims database analysis

ABSTRACT Purpose: To assess the national prevalence of low levels of high-density lipoprotein cholesterol (HDL-C) among adults with coronary heart disease (CHD) and the relationship between low HDL-C and predicted rates of recurrent CHD events. Methods: This study used data from the 1999–2004 National Health and Nutrition Examination Survey (NHANES) to examine the prevalence of risk factors for recurrent CHD events among survey respondents with existing CHD. The predicted probability of recurrent CHD events in the next 10 years was estimated using published Framingham Heart Study equations for secondary CHD prevention. All data analyses were weighted to produce national estimates using the NHANES sampling weights. Results: This study included 1291 survey participants aged ≥ 40 years who self-reported having coronary heart disease, angina, or heart attack. Of the study subjects with available HDL-C data, the percentage of respondents who had low HDL-C (< 40 mg/dL), intermediate HDL-C (40 to < 60 mg/dL), and high HDL-C (≥ 60 mg/dL) was 29%, 50%, and 21%, respectively, based on the national weighted population estimate. For respondents with low HDL-C, the prevalence of diabetes in men and the prevalence of smoking in women were significantly higher than those with high HDL-C ( p < 0.05). The predicted 10-year coronary risk for subjects with low HDL-C was considerably higher than for subjects with intermediate and high HDL-C. Although subjects with low HDL-C comprised only 29% of the population, they contributed approximately 38% of the subjects with predicted CHD events. Limitations: The assessment of certain CHD risk factors and the existence of CHD in the NHANES surveys relied on self-reports, which are subject to recall bias. Conclusions: Study results showed that US adults with CHD and low HDL-C will likely contribute a disproportionately high percentage to total CHD events in the next 10 years, suggesting the need for greater awareness of the consequences of low HDL-C.

Predictors of medication nonadherence and hospitalization in Medicaid patients with bipolar I disorder given long-acting or oral antipsychotics

Abstract Objective: Disease-modifying therapies, such as fingolimod, interferon (IFN) and glatiramer acetate (GA), have differing effects on relapse rates in patients with multiple sclerosis (MS), but little is known about the real-world differences in relapse rates with these treatments. This retrospective study assessed relapse rates in patients with active MS initiating fingolimod, IFN or GA therapy in a real-world setting. Methods: Using administrative claims data from the US PharMetrics Plus database, we identified previously treated and untreated patients with MS who initiated fingolimod, IFN or GA treatment between 1 October 2010 and 31 March 2011 and had experienced a relapse in the previous year. A claims-based algorithm was used to identify relapses over the persistence period in patients with 540 days of post-index continuous enrolment. A logistic regression model assessed the probability of having at least one relapse and a generalized linear model estimated differences in annualized relapse rates (ARRs). Results: The study enrolled 525 patients (fingolimod, n = 128; combined IFN/GA cohort, n = 397) of the 31,041 initially identified. Similar findings for fingolimod and IFN/GA were observed for the unadjusted proportion of patients experiencing relapses (31.3% vs. 34.0%, respectively; p = 0.5653) and ARRs (0.50 vs. 0.55, respectively) while persistent to treatment. After adjusting for baseline differences, fingolimod was associated with a 52% reduction in the probability of having a relapse (odds ratio, 0.48; 95% confidence interval [CI], 0.28–0.84; p = 0.0097) and a 50% reduction in ARR (rate ratio, 0.50; 95% CI, 0.34–0.75; p = 0.0006) compared with IFN/GA. Limitations: Identification of relapses is based on the claims in the database rather than on a clinical assessment. Conclusions: In a real-world setting, fingolimod was shown to be associated with significantly lower relapse rates than IFN/GA in patients with MS who had a history of relapses.

Use of a validated algorithm to estimate the annual cost of effective biologic treatment for rheumatoid arthritis

Abstract Purpose: To assess rates and predictors of medication nonadherence and hospitalization among patients with bipolar I disorder. Methods: This was a retrospective cohort analysis of Medicaid patients who were aged ≥18 years, had ≥1 inpatient or ≥2 outpatient medical claims indicating bipolar I disorder (ICD-9-CM codes 296.0x–296.1x, 296.4x–296.7x), and filled ≥1 prescription for antipsychotic medication between January 1, 2004, and December 31, 2006. Patients were followed for 1 year from the date of first (index) antipsychotic prescription. Patients were required to be continuously eligible for Medicaid without dual Medicare eligibility from 1 year before (baseline) through 1 year after (follow-up) index, and were required to receive ≥1 additional antipsychotic during follow-up. Descriptive statistics and predictors of medication nonadherence (medication possession ratio <0.8) and hospitalization were generated. Results: A total of 9410 patients met study eligibility criteria with a mean age of 38 years; 74% were female and 75% were white. Approximately 31% and 57% had baseline diagnoses of substance abuse and other psychiatric conditions, respectively. During follow-up, roughly 60% of patients were nonadherent and 40% of patients were hospitalized for any reason (37% psychiatric-related). Multivariate analysis showed that new antipsychotic starts, younger patients, those with a baseline concomitant substance abuse diagnosis, those taking a baseline antidepressant, and those with a baseline psychiatric hospitalization had significantly higher risk of nonadherence. Baseline psychiatric hospitalization, baseline substance abuse or other psychosis diagnosis, baseline use of an anxiolytic, anticholinergic, or anticonvulsant, and nonadherence to therapy in the follow-up period were significant predictors of increased risk of hospitalization. Limitations: This analysis did not attempt to evaluate the complex relationships among treatment type, adherence, hospitalization, and other variables. Conclusions: Study results showed that the risk of nonadherence is relatively high and confirmed that nonadherence is associated with a greater risk of hospitalization.

Healthcare resource use and relapses with fingolimod versus natalizumab for treating multiple sclerosis: a retrospective US claims database analysis

Abstract Objectives: To estimate biologic cost per effectively treated patient with rheumatoid arthritis (RA) using a claims-based algorithm for effectiveness. Methods: Patients with RA aged 18–63 years in the IMS PharMetrics Plus database were categorized as effectively treated if they met all six criteria: (1) a medication possession ratio ≥80% (subcutaneous) or at least as many infusions as specified in US labeling (intravenous); (2) no biologic dose increase; (3) no biologic switch; (4) no new non-biologic disease-modifying anti-rheumatic drug; (5) no new or increased oral glucocorticoid; and (6) ≤1 glucocorticoid injection. Biologic cost per effectively treated patient was defined as total cost of the index biologic (drug plus intravenous administration) divided by the number of patients categorized by the algorithm as effectively treated. Similar methods were used for the index biologic in the second year and for a second biologic after a switch. Results: Rates that the index biologic was categorized as effective in the first year were 31.0% etanercept (2243/7247), 28.6% adalimumab (1426/4991), 28.6% abatacept (332/1160), 27.2% golimumab (71/261), and 20.2% infliximab (474/2352). Mean biologic cost per effectively treated patient, per the algorithm, was

Estimating Effectiveness and Cost of Biologics for Rheumatoid Arthritis: Application of a Validated Algorithm to Commercial Insurance Claims

50,141 etanercept,