Insights into insurance coverage for digital therapeutics: A qualitative study of US payer perspectives.

BACKGROUND: In the last decade there has been an increase in the development and marketing of digital therapeutic (DTx) products aiming to prevent, manage, or treat a medical disorder or disease. Health insurance coverage for these products is not well established, and payers are facing increasing pressure to include these products as a covered benefit. OBJECTIVE: To examine factors and characteristics that could drive health insurance coverage of DTx products from US payers' and coverage decision-makers' perspectives. METHODS: This was a qualitative noninterventional, cross-sectional study conducted from August 2022 to October 2022. Virtual focus group meetings with pharmacy benefit managers/directors or medical directors representing a range of health insurance organizations were held following a semistructured interview guide. Convenience and snowball sampling techniques were used to identify participants. Transcripts were coded and analyzed with Atlas.ti software to identify common themes and subthemes. RESULTS: Five focus group meetings and 1 individual interview were held from August to October 2022. Participants (n = 22) were mostly pharmacists (n = 18, 85%) with more than 15 years of experience (n = 18, 85%). Some participants indicated that DTx products for diabetes (n = 6, 29%), mental/behavioral health (n = 3, 14%), and substance abuse disorders (n = 3, 14%) were already covered by their organizations. The topics generating the most comments grouped by code were issues around the evidence for DTx (67 unique comments) and barriers for coverage (60 unique comments). Participants indicated they want to have evidence of effectiveness that is similar to traditional pharmaceutical products. Barriers for coverage included a need to revise benefit policies, exclusion of nonprescription products, and mechanisms for billing. DTx products with an indication for mental/behavioral health were viewed as most likely to be reimbursed. Coverage of DTx products may occur under either the pharmacy or medical benefit. CONCLUSIONS: Health care payers stated that evidence of effectiveness was a necessary condition for health insurance coverage of DTx products. Given these are relatively new in health care, payers had more questions than answers regarding how these products will be integrated into health benefits.

Understanding Patients' Experiences with Borderline Personality Disorder: Qualitative Interviews.

Background: Patient perspectives of living with borderline personality disorder (BPD) are not traditionally captured in the literature. To overcome this gap, we explored participants' experiences with BPD to gain a better understanding of symptoms and impacts related to the condition. Methods: Two experienced researchers conducted semistructured interviews with a subset of participants from a randomized controlled trial evaluating a BPD treatment. The interview study was independent from the trial. Interviews focused on participants' experiences with BPD prior to the trial, including the symptoms and impacts of BPD. Interview transcripts were analyzed to identify dominant trends and generate patterns in the way participants described their experiences with BPD. Results: A total of 50 adults with BPD participated in the interview study. The mean age of the participants was 28.5 years (range, 18-53 years) and 72.0% were female. All participants described having difficulties with extreme emotional responses and interpersonal relationships, and most participants reported experiencing issues with self-image, impulsivity, suspiciousness/distrust, feelings of emptiness, and anger. The symptoms that were most bothersome to participants were extreme moods or emotional responses and a pattern of unstable personal relationships. All participants remarked that their BPD-related symptoms negatively impacted their interpersonal relationships, and nearly two-thirds of the sample reported that the impact of BPD on their relationships was the most bothersome. Additionally, more than half of the participants discussed impacts on work or school, memory or thinking, self-care, and financial and legal issues. Conclusion: Participants reported that the most bothersome symptoms of BPD were those related to extreme moods or emotional responses and interpersonal relationships. Participants similarly described the impact of BPD on their interpersonal relationships as the most bothersome. Overall, participant perspectives from this study indicate that the burden of BPD is significant and new treatments tailored to patients' real-world needs are warranted.

Beyond clinical outcomes: Case control study of the role of race in disruptive life events for people with serious mental illness.

OBJECTIVE: To understand how race and serious mental illness (SMI) interact for disruptive life events defined as financial (bankruptcy and judgement filings), and non-financial (arrests). METHODS: Patients were adults with schizophrenia (SCZ; N = 16,159) or bipolar I disorder (BPI; N = 30,008) matched 1:1 to patients without SMI (non-SMI) from health systems in Michigan and Southern California during 1/1/2007 through 12/31/2018. The main exposure was self-reported race, and the outcome was disruptive life events aggregated by Transunion. We hypothesized that Black patients with SCZ or BPI would be the most likely to experience a disruptive life event when compared to Black patients without SMI, and all White or Asian patients regardless of mental illness. RESULTS: Black patients with SCZ had the least likelihood (37% lower) and Asian patients with BPI had the greatest likelihood (2.25 times higher) of experiencing a financial disruptive life event among all patients in the study. There was no interaction of race with either SCZ or BPI for experiencing an arrest. The findings did not support our hypotheses for patients with SCZ and partially supported them for patients with BPI. CONCLUSIONS: Clinical initiatives to assess social determinants of health should consider a focus on Asian patients with BPI.

Assessment of Disruptive Life Events for Individuals Diagnosed With Schizophrenia or Bipolar I Disorder Using Data From a Consumer Credit Reporting Agency.

Importance: There is a dearth of population-level data on major disruptive life events (defined here as arrests by a legal authority, address changes, bankruptcy, lien, and judgment filings) for patients with bipolar I disorder (BPI) or schizophrenia, which has limited studies on mental health and treatment outcomes. Objective: To conduct a population-level study on disruptive life events by using publicly available data on disruptive life events, aggregated by a consumer credit reporting agency in conjunction with electronic health record (EHR) data. Design, Setting, and Participants: This study used EHR data from 2 large, integrated health care systems, Kaiser Permanente Southern California and Henry Ford Health. Cohorts of patients diagnosed from 2007 to 2019 with BPI or schizophrenia were matched 1:1 by age at analysis, age at diagnosis (if applicable), sex, race and ethnicity, and Medicaid status to (1) an active comparison group with diagnoses of major depressive disorder (MDD) and (2) a general health (GH) cohort without diagnoses of BPI, schizophrenia, or MDD. Patients with diagnoses of BPI or schizophrenia and their respective comparison cohorts were matched to public records data aggregated by a consumer credit reporting agency (98% match rate). Analysis took place between November 2020 and December 2022. Main Outcomes and Measures: The differences in the occurrence of disruptive life events among patients with BPI or schizophrenia and their comparison groups. Results: Of 46 167 patients, 30 008 (65%) had BPI (mean [SD] age, 42.6 [14.2] years) and 16 159 (35%) had schizophrenia (mean [SD], 41.4 [15.1] years). The majoriy of patients were White (30 167 [65%]). In addition, 18 500 patients with BPI (62%) and 6552 patients with schizophrenia (41%) were female. Patients with BPI were more likely to change addresses than patients in either comparison cohort (with the incidence ratio being as high as 1.25 [95% CI, 1.23-1.28]) when compared with GH cohort. Patients with BPI were also more likely to experience any of the financial disruptive life events with odds ratio ranging from 1.15 [95% CI, 1.07-1.24] to 1.50 [95% CI, 1.42-1.58]). The largest differences in disruptive life events were seen in arrests of patients with either BPI or schizophrenia compared with GH peers (3.27 [95% CI, 2.84-3.78] and 3.04 [95% CI, 2.57-3.59], respectively). Patients with schizophrenia had fewer address changes and were less likely to experience a financial event than their matched comparison cohorts. Conclusions and Relevance: This study demonstrated that data aggregated by a consumer credit reporting agency can support population-level studies on disruptive life events among patients with BPI or schizophrenia.

Life Engagement Improvement Following Initiation of Brexpiprazole Treatment in Patients with MDD: A Naturalistic, Retrospective Real-World Study.

Purpose: Life engagement encompasses concepts such as life fulfillment, well-being, and participation in meaningful activities, encompassing cognitive, physical, social, and emotional dimensions. Patients with MDD experience impaired functioning across multiple domains of life engagement and have ranked concepts related to life engagement and fulfillment as important predictors of treatment success. Post-hoc analyses of three clinical trials of patients with MDD treated adjunctively with brexpiprazole have reported a significantly greater improvement in life engagement. This study investigated improvements in life engagement among patients with MDD following initiation of brexpiprazole treatment using a real-world dataset. Patients and Methods: Information was extracted from semi-structured clinical notes of the Mental Status Examination (MSE) of patients in a real-world setting to develop an outcome measure for quantifying life engagement of psychiatric patients. Measures of life engagement and its four sub-domains (emotional, physical, social, and cognitive) were calculated at each clinical visit for 624 adult patients with MDD during the 6 months following brexpiprazole initiation. Paired t-tests assessed differences between the index event and time periods within 6 months of the index event. Kaplan-Meier survival analyses were used to quantify the improvement in life engagement scores following brexpiprazole initiation. Results: The study identified 54 clinical features associated with life engagement. Statistically significant improvements were observed from as early as 1 month following brexpiprazole initiation, with 20.6%, 37.9%, and 53.9% of the patients demonstrating improved life engagement scores within 1, 3, and 6 months, respectively. The improvements were particularly apparent for the emotional and social sub-domains. Conclusion: The results of this study provide evidence of improved life engagement following brexpiprazole initiation in a real-world dataset.

The effects of early initiation of aripiprazole once-monthly on healthcare resource utilization and healthcare costs in individuals with schizophrenia: real-world evidence from US claims data.

AIM: To evaluate the impact of timing of aripiprazole once-monthly (AOM) initiation on healthcare resource utilization (HCRU), risk of hospitalization, and healthcare costs in patients with schizophrenia. METHODS: A retrospective cohort study was conducted using data from the Merative MarketScan database (01/01/2013-12/31/2019). Adults aged ≥18 years with a new episode of care for schizophrenia and an AOM claim were included. Patients were classified into two cohorts based on the time between the first schizophrenia diagnosis and the first AOM claim (early cohort: ≤1 year; late cohort: >1 year). All-cause and psychiatric-specific HCRU, risk of hospitalization, and healthcare costs were evaluated over 1-year post-AOM initiation. The relationship between the timing of AOM initiation and HCRU was evaluated using negative binomial regression, and healthcare costs using generalized linear models (log-link with gamma distribution). Logistic regression was used to estimate the likelihood of hospitalization during the follow up period for both all-cause and psychiatric-specific hospitalization. RESULTS: A total of 945 patients were included (early cohort: n = 525; late cohort: n = 420). At baseline, the early cohort had lower mean age, a greater proportion of males, and a lower mean Charlson Comorbidity Index score than the late cohort (all p < .05). After adjusting for baseline demographic and clinical characteristics, all-cause and psychiatric-specific hospitalization during the 1-year follow-up period were statistically significantly higher for the late cohort versus the early cohort (all-cause: incident rate ratio [IRR] = 1.63, 95% confidence interval [CI]: 1.28-2.07, p < .01; psychiatric-specific: IRR = 1.93, 95% CI: 1.46-2.55, p < .01). The early cohort had statistically significantly lower adjusted all-cause ($21,686 versus $29,033; p = .0002) and psychiatric-specific ($24,414 versus $32,461; p = .0002) healthcare costs versus the late cohort. LIMITATIONS: This study utilized claims data, which are intended for administrative purposes rather than for research. CONCLUSIONS: This analysis extends previous evidence for the benefits of AOM in patients with new episodes of schizophrenia, by demonstrating lower HCRU, risk of hospitalization, and healthcare costs with early AOM initiation compared with later initiation.

Schizophrenia is a costly disease that impacts patients, caregivers, and the healthcare system. Antipsychotic medications are an important component of schizophrenia treatment. These medications reduce symptom severity, improve functioning and reduce costs. Aripiprazole once-monthly (AOM) is a long-acting injectable antipsychotic used to treat schizophrenia. This study evaluates whether starting AOM early in the disease course improves outcomes for people with schizophrenia. Outcomes include healthcare resource utilization, risk of hospitalization, and healthcare costs. The study team found that hospitalization and costs were lower for people who started AOM early in the disease course as opposed to later. This study points to the importance of early treatment to improve outcomes for people with schizophrenia.

Treatment patterns and clinical outcomes among Medicare beneficiaries using antipsychotic medications for FDA-approved indications before and after transitioning from the community to a nursing home.

OBJECTIVES: This study examines the relationships between changes in antipsychotic medication (AP) use and acute clinical events (identified with administrative claims data) for patients with FDA-approved indications for APs following transition from the community (e.g. home) to a nursing home (NH) in a Medicare population. METHODS: A retrospective analysis was conducted using 100% Medicare fee-for-service (FFS) research identifiable files (RIF) claims data (2016-2018). Medicare beneficiaries with a condition for which APs are approved by the FDA were examined using logistic regression models to determine whether changes in AP use following transition from community to NHs were correlated with the likelihood of experiencing acute clinical events. RESULTS: We identified 38,448 Medicare FFS beneficiaries meeting our study criteria. A change in AP use after transition to a NH did not have a statistically significant association with acute skeletal events, coronary artery events, or cerebrovascular events (p = .55, p = .69, and p = .59, respectively). CONCLUSIONS: Between 2016 and 2018, Medicare FFS patients with approved-use indications for APs had lower average AP use following transition to a NH. Changes in the use of other medications of interest largely followed a similar pattern, indicating that these medications did not tend to be used as substitutions for APs. No clear relationship exists between increases or decreases in AP use and adverse events among NH residents who used APs and had FDA-approved conditions in the community setting.

Psychiatric healthcare resource utilization following initiation of aripiprazole once-monthly: a retrospective real-world study.

OBJECTIVES: This observational retrospective real-world study examined changes in healthcare resource utilization (HCRU) pre- and post-initiation of aripiprazole once-monthly (AOM 400) in patients with schizophrenia or bipolar I disorder. METHODS: Electronic health record-derived, de-identified data from the NeuroBlu Database (2013-2020) were used to identify patients ≥18 years with schizophrenia (n = 222) or bipolar I disorder (n = 129) who were prescribed AOM 400, and had visit data within 3, 6, 9, or 12 months pre- and post-initial AOM 400 prescription. Rates of inpatient hospitalization, emergency department visits, inpatient readmissions, and average length of stay were examined and compared over 3, 6, 9, and 12 months pre-/post-AOM 400 using a McNemar test. RESULTS: Statistically significant differences were seen in both schizophrenia and bipolar I disorder patient cohorts pre- and post-AOM 400 in inpatient hospitalization rates (p < .001 all time points, both cohorts) and 30-day readmission per patient rates (p < .001 all time points, both cohorts). Statistically significant improvement in mean length of stay was observed in both cohorts at all time points, except for at six months in patients with schizophrenia. Emergency department visit rates were significantly lower after AOM 400 initiation for both cohorts at all time points (p < .001). CONCLUSIONS: A reduction in the rate of hospitalizations, emergency department visits, 30-day readmissions, and average length-of-stay was observed for patients diagnosed with either schizophrenia or bipolar I disorder, which suggests a positive effect of AOM 400 treatment on HCRU outcomes and is supportive of earlier analyses from different data sources.

Readmissions, costs, and duration to subsequent outpatient visit after hospital discharge among Medicaid beneficiaries utilizing oral versus long-acting injectable antipsychotics in bipolar disorder or schizophrenia.

BACKGROUND: Long-acting injectable antipsychotics (LAIs) may reduce hospitalizations versus oral formulations (OAP) in bipolar disorder (BP) and schizophrenia/schizoaffective disorder (SCZ), but the impact on time to outpatient follow-up is less understood. OBJECTIVES: To assess hospital readmissions and medical costs among Medicaid beneficiaries with BP or SCZ utilizing OAP or LAI SGAs. METHODS: Cross-sectional and longitudinal analyses utilized comprehensive administrative claims of Oklahoma Medicaid beneficiaries (≥18 years) with BP or SCZ between 1 January 2013 and 31 December 2017. Readmissions, total direct medical costs, and psychiatry-related outpatient visits were assessed via generalized linear models and generalized estimating equations, controlling for demographic and clinical covariates. RESULTS: Among 2523 included members, LAI utilization was associated with 1.50 and 1.73 times higher odds of any hospitalization and any readmission, respectively (p < .05). Cases involving both BP and SCZ were associated with a 2.40 times higher odds of any readmission, 2.26 times higher number of readmissions, and 24.5% higher costs (p < .001). Of the 468 members with a subsequent psychiatry-related outpatient visit, LAIs were associated with a 23.9% shorter duration to outpatient visit and 16.4% lower costs (p < .05). CONCLUSION: In contrast to prior studies, this real-world investigation noted higher hospitalizations and readmissions among LAIs relative to OAP medications, but among members with a hospitalization or ED visit, LAIs were associated with shorter durations to outpatient visits and lower costs. Those with diagnoses of both BP with SCZ had higher odds of any readmission, number of readmissions, and costs relative to those with bipolar disorder alone and may be a key target for interventions.

This study compared long-acting antipsychotics that were administered by injection (LAIs) to antipsychotic agents taken orally (OAPs) among Medicaid members with bipolar disorder and/or schizophrenia. Readmission to the emergency department (ED) or hospital (within 30 days of a previous visit) and costs were observed to be similar with LAIs relative to OAPs. Among members who went to the hospital, a shorter time to psychiatric follow-up outpatient visit and lower costs were observed among those taking LAIs relative to OAPs.

Mental Illness Disclosure in the Workplace: An Opportunity for Improvement.

Background: The Americans with Disabilities Act (ADA) prohibits discrimination based on physical or mental disabilities and requires that employers provide reasonable accommodations to workers with disabilities who can perform their essential job functions. However, the ADA also states that an employer is not required to hire or keep an individual with a psychiatric disability if it poses a direct threat to his or her safety or the safety of others. Objectives: To identify employers' disclosure requirements for mental illness diagnosis or treatment during the job application process and/or as a condition of ongoing employment, to determine disclosure requirements of state and federal licensing bodies, and to evaluate the legality of disclosure of mental health status. Methods: We conducted an Internet-based search to identify public and private employers' disclosure requirements based on 4 keyword combinations, including "employment/mental health," "employment/mental illness," "license application/mental illness," and "license application/mental health." Other employers were included based on known federal and/or state certification requirements or a governing body policy for employee suitability and fitness. A panel of 3 investigators reviewed the data and analyzed the key findings, industry trends, and workplace implications. Results: Of the 23 industries (eg, construction, government, military, transportation) investigated, 5 were public and 18 were private. Public employees and government-regulated companies often required disclosure of mental health conditions because of the nature of the work. Private companies showed more variability than public in whether applications contained disclosure requirements, some of which were not compliant with the ADA regulations. Conclusion: Across the United States, job applicants and workers are often asked to disclose mental health status as a condition of employment. Consequently, applicants and workers may hide mental health issues, resulting in the underuse of mental health resources by those in need.

Health Care Cost in Patients With Schizophrenia Treated With Brexpiprazole Versus Other Oral Atypical Antipsychotic Therapy.

PURPOSE: Brexpiprazole is an oral atypical antipsychotic (OAA) for the treatment of schizophrenia (SCZ). This study compared all-cause and psychiatric inpatient hospitalization and medical costs in adult patients with SCZ newly treated with brexpiprazole versus other US Food and Drug Administration-approved OAAs in a real-world setting. METHODS: This retrospective cohort study analyzed data from: (1) the IBM MarketScan Commercial and Medicare Supplemental databases, and the MarketScan Multi-State Medicaid database; and (2) the de-identified Optum Clinformatics Datamart. Adult patients were identified if they had SCZ and initiated either brexpiprazole or another OAA during the study identification period (July 1, 2015, to September 30, 2016, for MarketScan Commercial and Medicare Supplemental and for Optum; July 1, 2015, to June 30, 2016, for MarketScan Multi-State Medicaid) and had ≥12 months of continuous enrollment before (baseline) and after (follow-up) the first treatment date. Linear regression analyses were performed to test associations between treatment groups (brexpiprazole vs another OAA) and costs (total and medical); negative binomial regression models were used to estimate number of hospitalizations per year, adjusting for baseline characteristics and medication adherence to index treatment during the 12-month follow-up. FINDINGS: The final study sample consisted of 6254 patients with SCZ: 176 initiated brexpiprazole; 391, ziprasidone; 453, paliperidone; 523, lurasidone; 786, aripiprazole; 1234, quetiapine; 1264, olanzapine; and 1427, risperidone. Controlling for baseline characteristics and medication adherence, the adjusted number of hospitalizations (both all-cause and psychiatric), all-cause total costs, and all-cause medical costs did not differ across groups. Brexpiprazole users had the lowest mean psychiatric costs among all OAA users ($12,013; 95% bootstrap CI, 7488-16,538). Compared with brexpiprazole users, paliperidone (incidence rate ratio [95% CI], 1.52 [1.05-2.19]; P = 0.027) and quetiapine (incidence rate ratio [95% CI], 1.47 [1.04-2.07]; P = 0.029) users had more psychiatric hospitalizations per year. Paliperidone had higher psychiatric costs than brexpiprazole (total, $32,066 [95% bootstrap CI, 28,779-35,353] vs $23,851 [18,907-28,795]; medical, $19,343 [16,294-22,392] vs $12,013 [7488-16,538]). Psychiatric medical costs were also $6744 higher in olanzapine users (95% bootstrap CI, 1694-11,795; P = 0.009) than in brexpiprazole users. IMPLICATIONS: Patients with SCZ treated with brexpiprazole had fewer psychiatric hospitalizations and lower psychiatric costs than those treated with paliperidone. Differences in the number of all-cause hospitalizations and medical costs among treatments were not statistically significant. Although treatment decisions are driven by a number of factors (eg, clinical circumstances and drug costs), choice of OAA may affect health care costs.

A claims-based algorithm to reduce relapse and cost in schizophrenia.

OBJECTIVES: To refine a payer algorithm identifying patients with schizophrenia at high risk of relapse within a managed Medicaid population and evaluate its effectiveness in a case management (CM) program. STUDY DESIGN: Cross-sectional and longitudinal study design. METHODS: The algorithm used a single payer's Medicaid medical and pharmacy claims (August 1, 2009, to July 31, 2014) for patients with schizophrenia (N = 12,353) to predict those at high risk for hospitalization. The final algorithm was used in a CM program (outbound communication to providers) at 3 payer service centers in 3 states. Based on the algorithm, 60 patients (20 from each site) with the highest risk scores were targeted for CM (CM group) and 60 (those patients ranked 21st-40th most at-risk at each site) comprised the control group. Chi-square tests compared groups on frequency measures (hospitalizations, emergency department [ED] visits). Pre- to postimplementation differences were tested using McNemar's test. A pre-post analysis of variance assessed mean numbers of inpatient admissions, inpatient days, and ED visits for both groups. RESULTS: The algorithm had good positive predictive power (64.0%), negative predictive power (94.7%), sensitivity (40.2%), and specificity (97.9%). Following CM, the proportion of patients with at least 1 inpatient admission in the CM group decreased (23.3% to 13.3%), as did the rate of ED visits per month (by approximately 15%), whereas increases were observed in the control group. CONCLUSIONS: Although not all of these differences were statistically significant, they suggest that the algorithm may be an effective case-finding tool for plans attempting to mitigate hospitalizations among high-risk patients with schizophrenia.

Evaluating the Impact of Integrated Care on Service Utilization in Serious Mental Illness.

Serious mental illness (SMI) affects 5% of the United States population and is associated with increased morbidity and mortality, and use of high-cost healthcare services including hospitalizations and emergency department visits. Integrating behavioral and physical healthcare may improve care for consumers with SMI, but prior research findings have been mixed. This quantitative retrospective cohort study assessed whether there was a predictive relationship between integrated healthcare clinic enrollment and inpatient and emergency department utilization for consumers with SMI when controlling for demographic characteristics and disease severity. While findings indicated no statistically significant impact of integrated care clinic enrollment on utilization, the sample had lower levels of utilization than would have been expected. Since policy and payment structures continue to support integrated care models, further research on different programs are encouraged, as each setting and practice pattern is unique.

Claims-based proxies of patient instability among commercially insured adults with schizophrenia.

OBJECTIVE: Schizophrenia (Sz) patients are among the highest utilizers of hospital-based services. Prevention of relapse is in part a treatment goal in order to reduce hospital admissions. However, predicting relapse is a challenge, particularly for payers and disease management firms with only access to claims data. Understandably, such organizations have had little success predicting relapse. A tool that allows payers to identify patients at elevated risk of relapse could facilitate targeted interventions prior to relapse and avoid rehospitalization. In this study, a series of proxy measures of patient instability, calculated from claims data were examined for their utility in identifying Sz patients at elevated risk of relapse. METHODS: Aetna claims were used to assess the relationship between instability of Sz patients and valence and magnitude of antipsychotic (AP) medication change during a 2-year period. Six proxies of instability including hospital admissions, emergency department visits, medication utilization patterns, and use of outpatient services were identified. Results were replicated using claims data from Truven MarketScan®. RESULTS: Patients who switched AP ingredient had the highest overall instability at the point of switch and the second steepest decline in instability following switch. Those who changed to a long-acting injectable AP showed the second highest level of instability and the steepest decrease in instability following the change. Patients augmented with a second AP showed the smallest increase in instability, up to the switch. Results were directionally consistent between the two data sets. CONCLUSION: Using claims-based proxy measures to estimate instability may provide a viable method to better understand Sz patient markers of change in disease severity. Also, such proxies could be used to identify those individuals with the greatest need for treatment modification preventing relapse, improving patient outcomes, and reducing the burden of illness.

Relapse Risk Assessment for Schizophrenia Patients (RASP): A New Self-Report Screening Tool.

OBJECTIVES: The Relapse Assessment for Schizophrenia Patients (RASP) was developed as a six-question self-report screener that measures indicators of Increased Anxiety and Social Isolation to assess patient stability and predict imminent relapse. This paper describes the development and psychometric characteristics of the RASP. METHODS: The RASP and Positive and Negative Syndrome Scale (PANSS) were administered to patients with schizophrenia (n=166) three separate times. Chart data were collected on a subsample of patients (n=81). Psychometric analyses of RASP included tests of reliability, construct validity, and concurrent validity of items. Factors from RASP were correlated with subscales from PANSS (sensitivity to change and criterion validity [agreement between RASP and evidence of relapse]). RESULTS: Test-retest reliability returned modest to strong agreement at the item level and strong agreement at the questionnaire level. RASP showed good item response curves and internal consistency for the total instrument and within each of the two subscales (Increased Anxiety and Social Isolation). RASP Total Score and subscales showed good concurrent validity when correlated with PANSS Total Score, Positive, Excitement, and Anxiety subscales. RASP correctly predicted relapse in 67% of cases, with good specificity and negative predictive power and acceptable positive predictive power and sensitivity. CONCLUSIONS: The reliability and validity data presented support the use of RASP in settings where addition of a brief self-report assessment of relapse risk among patients with schizophrenia may be of benefit. Ease of use and scoring, and the ability to administer without clinical supervision allows for routine administration and assessment of relapse risk.

Managing to low-density lipoprotein particles compared with low-density lipoprotein cholesterol: a cost-effectiveness analysis.

BACKGROUND: Meta-analyses of clinical trials have shown that using statins to lower low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular events, and more intensive lowering of LDL-C further decreases the risk of occlusive vascular events. Lipoprotein studies suggest treating patients more aggressively when low-density lipoprotein particle (LDL-P) number is discordantly high in the presence of normal LDL-C levels. Failure to manage LDL-P numbers may lead to additional direct and indirect costs. OBJECTIVE: This analysis modeled direct and indirect costs associated with cardiovascular events due to suboptimal treatment resulting from discordance between LDL-C and LDL-P levels. METHODS: The analysis was conducted from the payer perspective and the employer perspective, respectively, over a 3-year time period. Clinical data were obtained from the Multi-Ethnic Study of Atherosclerosis, a community-based population study. The employer perspective included indirect costs and quality-adjusted life years in addition to the direct costs and cardiovascular disease events considered in the payer analysis. All costs are reported in 2011 dollars. RESULTS: From the payer perspective, managing LDL-C and LDL-P in comparison with LDL-C alone reduced costs ($21,212) and cardiovascular events (9 events). Similar patterns were observed for managing LDL-P alone in comparison with LDL-C. From the employer perspective, managing both LDL-P alone or in combination with LDL-C also resulted in lower costs, fewer cardiovascular disease events, and increased quality-adjusted life years in comparison with LDL-C. CONCLUSION: This analysis indicates that the benefits of additional testing to optimally manage LDL-P levels outweigh the costs of more aggressive treatment. These favorable results depended on the cost of drug therapy.

Economic measurement of medical errors using a hospital claims database.

OBJECTIVE: The primary objective of this study was to estimate the occurrence and costs of medical errors from the hospital perspective. METHODS: Methods from a recent actuarial study of medical errors were used to identify medical injuries. A visit qualified as an injury visit if at least 1 of 97 injury groupings occurred at that visit, and the percentage of injuries caused by medical error was estimated. Visits with more than four injuries were removed from the population to avoid overestimation of cost. Population estimates were extrapolated from the Premier hospital database to all US acute care hospitals. RESULTS: There were an estimated 161,655 medical errors in 2008 and 170,201 medical errors in 2009. Extrapolated to the entire US population, there were more than 4 million unique injury visits containing more than 1 million unique medical errors each year. This analysis estimated that the total annual cost of measurable medical errors in the United States was $985 million in 2008 and just over $1 billion in 2009. The median cost per error to hospitals was $892 for 2008 and rose to $939 in 2009. Nearly one third of all medical injuries were due to error in each year. CONCLUSIONS: Medical errors directly impact patient outcomes and hospitals' profitability, especially since 2008 when Medicare stopped reimbursing hospitals for care related to certain preventable medical errors. Hospitals must rigorously analyze causes of medical errors and implement comprehensive preventative programs to reduce their occurrence as the financial burden of medical errors shifts to hospitals.

Effect of a continuous measure of adherence with infliximab maintenance treatment on inpatient outcomes in Crohn's disease.

BACKGROUND: To assess the impact of a continuous measure of adherence with infliximab maintenance treatment in Crohn's disease (CD) during the first year of treatment on CD-related health care utilization, CD-related hospitalizations, inpatient costs, and length of hospital stay. PATIENTS AND METHODS: A retrospective claims analysis using the IMS LifeLink Health Plan Claims Database (September 1, 2004, to June 30, 2009) was conducted. Continuous enrollment for 12 months before and 12 months after the index date was required. Patients were required to have at least two claims with an International Classification of Diseases, 9th Revision, Clinical Modification diagnosis code for CD (555.xx) pre-index and be aged ≥ 18 years at index. Patients with three infusions during the first 56 days post-index and at least one infusion following day 56 post-index were considered to have maintenance therapy. Adherence and nonadherence were defined as a medication possession ratio of ≥ 80% and < 80%, respectively. RESULTS: Four hundred forty-eight patients were included in the analysis (mean age, 42.6 years; 56% female; mean ± standard deviation [SD] and median number of infliximab infusions, 7.35 ± 1.60 and 8). The number of patients who met the definition of adherence was 344 (77%). CD-related health care utilization was not significantly impacted by adherence except for ancillary services and radiology. Fewer adherent patients were hospitalized compared with nonadherent patients (9% versus 16%; P = 0.03). Adherent patients had fewer mean ± SD and median days in the hospital (5.5 ± 3.4 and 5 days) compared with nonadherent patients (13.1 ± 14.2 and 8 days; P = 0.01). Mean ± SD and median hospital costs were significantly greater for nonadherent patients ($40,822 ± $49,238 and $28,864) compared with adherent patients ($13,704 ± $10,816 and $9938; P = 0.002). CONCLUSION: Adherence with maintenance infliximab over 12 months was associated with lower rates of CD-related hospitalizations and inpatient costs and a shorter length of hospital stay.

Resource utilization before and during infliximab therapy in patients with inflammatory bowel disease.

OBJECTIVE: Although Remicade (infliximab) is costly relative to non-biologic therapy, its impact on healthcare resource utilization and mucosal healing may make it a cost-effective option. This study aimed to compare gastrointestinal (GI)-related healthcare resource utilization and severity of mucosal damage before and during infliximab therapy in Crohn's disease (CD) or ulcerative colitis (UC) patients. METHODS: A retrospective chart review was conducted at 14 gastroenterology practices from across the country, which varied in practice sizes and types. Patients were aged ≥18 years, diagnosed with CD or UC, and had an infliximab index date between January 1, 2005 and September 30, 2007. GI-related utilization 12 months before and 12 months after the index date was compared. Endoscopic disease severity was categorized based on blinded review of abstracted reports. RESULTS: Results from 268 patients indicated significantly lower rates of surgery (29.7% to 9.9%, p < 0.0001, CD; 24.4% to 12.8%, p = 0.042, UC) and colonoscopy (54.4% to 17.6%, p < 0.0001, CD; 50.0% to 22.1%, p = 0.0007, UC) during infliximab therapy. The rates of hospitalizations in UC (15.1% to 3.5%, p = 0.0124) and radiology assessments in CD (23.1% to 10.4%, p = 0.006) also decreased. Based on severity data from 183 procedures, greater proportions of patients had normal or mild ratings during infliximab treatment compared with pre-treatment. LIMITATIONS: This retrospective descriptive study is limited by the type and quantity of information available in patient charts from 14 gastroenterology clinics during the first year of infliximab treatment. In addition, the number of patients with pre-treatment and post-treatment disease severity information was too small to make comparisons among disease severity groups. Further information about the severity of disease and the extent of mucosal healing could be helpful in determining the effect of therapy on resource utilization in future research. CONCLUSIONS: GI-related resource utilization was significantly lower and attenuation of mucosal damage severity was observed during infliximab treatment compared with the pre-treatment period.

Impact of infliximab adherence on Crohn's disease-related healthcare utilization and inpatient costs.

INTRODUCTION: Few published reports have described the impact of adherence with biologic agents on hospitalizations and inpatient costs in Crohn's disease (CD). METHODS: A retrospective claims analysis using the IMS LifeLink Health Plan Claims Database between September 1, 2004 and June 30, 2009 was conducted. Continuous enrollment for 12 months before and 12 months after the index date was required. Patients were required to have ≥2 claims with an International Classification of Diseases, 9th Edition, Clinical Modification diagnosis code for CD (555.xx) preindex, be ≥18 years of age at index, and have ≥4 infliximab infusions with a gap no greater than 12 weeks between each infusion. Patients with 7-9 infliximab infusions (12 months postindex) were considered adherent; patients with 4-6 infliximab infusions were considered nonadherent. RESULTS: In total, 638 patients were included in the analyses (mean age, 43 years; 58% female in the adherent group and 53% in the nonadherent group). The number of patients who met the definition of adherence was 466 (73%). A smaller proportion of adherent patients had a CD-related emergency room visit, compared with nonadherent patients (11% vs. 17%, P=0.029). A smaller proportion of adherent patients required CD-related hospitalization, compared with nonadherent patients (8% vs. 12%, P=0.117). Among those hospitalized, adherent patients had fewer mean [median] days in the hospital (5.9 [5] days), compared with nonadherent patients (12.8 [8] days, P=0.015). Mean [median] hospital costs were significantly lower for adherent patients ($13,427 [$9,352]), compared with nonadherent patients ($37,783 [$28,864], P=0.001). Multivariate analyses confirmed lower inpatient (P<0.001) costs for adherent versus nonadherent patients. CONCLUSION: Adherence with infliximab therapy during the first year of treatment in patients with CD was associated with a shorter hospital length of stay and lower inpatient costs compared with nonadherent patients. Strategies for increasing adherence rates to infliximab maintenance therapy may be valuable in reducing hospitalizations and inpatient costs in patients with CD.