Ann Hartry

Background: The Alzheimer’s Disease Patient and Caregiver Engagement™ Initiative‘s What Matters Most™ (WMM) Research Program includes seminal studies to identify and measure treatment‐related needs, preferences, and priorities of people living with Alzheimer’s disease (PLWAD) and their informal care partners (CPs). WMM research identified 42 concepts deemed to be of highest relevance and importance in treatment related needs across the AD spectrum (preclinical – severe AD). Now, the WMM Next Generation Studies (WMM NG) are generating data to contextualize findings through a conceptual model of disease, verify previously identified concepts, and learn of new emerging concepts from a more diverse and inclusive study sample. Results will be used to broaden the context of an online survey to inform additional studies, including health economic evaluations, across the Alzheimer’s research field.Method: A draft conceptual model of disease was developed building on an existing model (Hartry, 2018) after careful examination of previously collected WMM data (DiBenedetti, 2020; Hauber, 2023). A cross‐sectional, observational qualitative research study was conducted, comprised of a series of individual, in‐depth interviews of those with clinically confirmed PLWAD and their CPs. Analyses of these data include qualitative content analysis and thematic analysis methods (Hsiu‐Fang, 2005).Result: The 42 WMM concepts were categorized across thought processing (14), communication (3), mood/emotions (6), daily activities (12), social life/activities, (3) and independence (4) domains to form a draft conceptual model of disease. A total of 64 PLWAD and CPs of diverse ethnic and cultural backgrounds participated in in‐depth, web‐based interviews. Results reaffirmed the 42 WMM concepts, informed the model structure, and added missing concepts. Further, cognitive debriefing approaches elucidated participant perception of the terms “bother” and “interference” describing emotional connotation of these words, compared to the assessment of “impact”, to inform development of AD burden survey items.Conclusion: WMM concepts contextualized by domains offer a roadmap to support future clinical trials seeking to measure clinically meaningful outcomes and patient‐centric endpoints. WMM NG data collection will enhance robustness of the findings to evaluate the impact of disease symptoms and inform health economic evaluation. The conceptual model will be refined continuously over the WMM research.

Purpose: Major depressive disorder (MDD) is a chronic mental disorder with a substantial clinical and economic burden. Despite the efficacy of adjunctive atypical antipsychotics (AAP) for augmentation in patients with major depressive disorder (MDD) who failed first-line antidepressant therapy (ADT), little is known of the impact of AAP choices on healthcare resource use and costs in real-world practice. Therefore, this study compared real-world healthcare utilization and costs in patients with MDD treated with brexpiprazole or extended-release (XR) quetiapine as adjunctive treatment to ADT. Patients and methods: Adults with MDD starting adjunctive treatment with brexpiprazole (n=844) or extended-release (XR) quetiapine (n=688) were identified in the adjudicated health plan claims data (07/2014 – 09/2016). Resource use and healthcare costs in the 6 months following treatment initiation were compared between non-matched populations, and between propensity score-matched groups, and by multivariable regression analyses. Results: During follow-up, unadjusted all-cause hospitalization (6.6% vs 12.5%) and ED visits (17.0% vs 27.5%) were lower with brexpiprazole compared to quetiapine XR (both pConclusion: Significantly lower medical costs were observed in patients with MDD treated with brexpiprazole vs quetiapine XR.

Objective: Early initiation of antipsychotic treatment in schizophrenia is associated with improved outcomes. This study aimed to determine if initiation of long-acting injectable (LAI) antipsychotic treatment early in a new schizophrenia episode is associated with lower hospitalization rates and healthcare costs in a real-world setting. Methods: This retrospective (January 1, 2007–June 30, 2016) cohort analysis used claims from Truven Health Analytics MarketScan Commercial, Medicaid, and Medicare Supplemental databases. In adults ≥18 years with a new episode of schizophrenia, two mutually exclusive cohorts were identified based on time from first recorded schizophrenia diagnosis date to first date of LAI initiation (index date): ≤1 year (early initiators) and >1 year (late initiators). Logistic and general linear regression models were performed to estimate adjusted hospitalization rate and healthcare costs in a 1-year follow-up, controlling patient demographic and clinical characteristics, insurance type, baseline all-cause hospitalizations and ED visits, and baseline psychiatric medication use. Results: Of the subjects, 32% (n = 1388) initiated treatment early and 68% (n = 2978) initiated treatment later. In risk-adjusted models, all-cause hospitalization rates were 22.2% (95% CI = 19.9–24.6%) in early initiators and 26.9% (95% CI = 25.2–28.7%) in late initiators (p = .002). Of early initiators, 14.1% (95% CI = 12.3–16.1%) had a psychiatric hospitalization vs 19.2% (95% CI = 17.7–20.8%) of late initiators (p < .001). Adjusted psychiatric healthcare costs were significantly lower in early initiators compared with late initiators [mean (95% CI) = $21,545 (20,355–22,734) vs $24,132 (23,330–24,933)] (p < .001). Conclusions: LAI initiation within 1 year of a new schizophrenia episode led to lower hospitalization rates and healthcare costs compared with LAI initiation more than 1 year after a new episode.

Aims: This study explored the association between medication adherence to oral atypical antipsychotics (AAP) and both psychiatric hospitalization and associated costs in bipolar I disorder (BD-I) in a real-world setting. Materials and Methods: This retrospective study used the Truven Health MarketScan® Medicaid, Commercial, and Medicare Supplemental claims Databases. Adults were identified if they had BD-I and initiated an AAP treatment during the study identification period (7/1/15-6/30/16 for Medicaid, 7/1/15-3/31/16 for Commercial and Medicare Supplemental) and had ≥6-month continuous enrollment before (baseline) and after (follow-up) the first day of treatment. Medication adherence was measured by the proportion of days covered (PDC) and grouped as: fully-adherent (PDC ≥80%), partially-adherent (40%≤PDC Results: The final sample consisted of 5,892 (32.0%) fully-adherent, 4,246 (23.1%) partially-adherent, and 8,250 (44.9%) non-adherent patients. The adjusted rate of psychiatric hospitalization during the follow-up period was lower in the fully-adherent (6.0%) vs. partially-(8.3%) or non-adherent (8.8%) groups (p < 0.001). Using the fully-adherent cohort as the reference group, the odds of psychiatric hospitalization were significantly higher for the partially-adherent (1.42 (1.23-1.64)) and non-adherent (OR (95% CI): 1.51 (1.33-1.71)) cohorts. The mean adjusted psychiatric hospitalization cost over 6 months among hospitalized patients was lower for the fully-adherent cohort ($11,748), than the partially-adherent ($15,051 p = 0.002), or non-adherent cohorts ($13,170, not statistically significant). Limitations: The medication adherence measures relied on prescription claims data, not actual use. Conclusions: In the treatment of BD-I, better medication adherence to AAP was associated with fewer psychiatric hospitalizations. Among hospitalized patients, fully-adherent patients had statistically significantly lower psychiatric costs than partially-adherent ones. These findings suggest that improving adherence to AAP in BD-I may be a valuable goal from both clinical and economic perspectives.

Aims: The study compared all-cause and major depressive disorder (MDD)-related healthcare resource use (HRU) and costs in patients with MDD treated with atypical antipsychotic (AAP) adjunctive therapy early or later in treatment. Materials and methods: Adults with MDD and antidepressant treatment (ADT) who newly initiated adjunctive aripiprazole, brexpiprazole, lurasidone, or quetiapine between October 1, 2014 and September 30, 2015 were identified in the IQVIA Real-World Data Adjudicated Claims database; the index date was the date of the first AAP claim. Patients were stratified into three cohorts: AAP initiated in the first year (Y1); in the second year (Y2); and more than 2 years (Y3) of first ADT use. Within each cohort, HRU and costs were compared between the 12 months before and after the index date. Pre–post changes in HRU and costs were then compared between cohorts. Results: Five hundred and six (36.7%) patients were categorized as Y1; 252 (18.3%) as Y2; and 622 (45.1%) as Y3. AAP use was associated with significantly decreased rates of all-cause and MDD-related hospitalization and emergency department visits, and increased rates of pharmacy fills and physician office visits; and the magnitude of changes was largest in cohort Y1. Cohort Y1 had the largest reductions in mean (±SD) all-cause medical costs per patient (−$10,496 ± $85,022, p = .015) compared to Y2 (−$2,474 ± $85,022, p = .572) and Y3 (−$472 ± $31,334, p = .823), mainly due to the reduction in hospitalization. After adjusting for differences in baseline characteristics, the largest reductions in hospitalization and medical costs were observed in cohort Y1. Similar increases in all-cause pharmacy costs were seen in all cohorts. A similar trend in costs was observed in MDD-related healthcare services. Limitations and conclusions: AAP treatment was associated with reductions in all-cause and MDD-related medical costs, primarily in decreased hospitalization. The reductions were largest among patients who initiated treatment in the first year.

INTRODUCTION: Existing evidence on clinical and economic effectiveness of one long-acting injectable antipsychotic (LAI) versus another in successful management of schizophrenia is scarce. The study was conducted to compare all-cause inpatient healthcare utilization and associated costs among Medicaid patients with schizophrenia who initiated LAIs. METHODS: This retrospective cohort analysis used the Truven Health Analytics MarketScan® Medicaid claims database. Schizophrenia patients >18 years with at least one claim for one of the following LAI were identified between 1 January 2013 and 30 June 2014 (identification period): aripiprazole, fluphenazine, haloperidol, paliperidone palmitate, and risperidone. The first day of initiating an LAI was considered the index date. Patients were followed for 1 year from index date. Logistic and general linear regression models were used to estimate risk of inpatient hospitalization and associated costs during follow up. RESULTS: Of the identified Medicaid patients with schizophrenia, 1,672 (36.7 percent) initiated an LAI: 44.0 percent received paliperidone, 26.4 percent haloperidol, 13.8 percent risperidone, 9.2 percent aripiprazole, and 6.6 percent fluphenazine. With the aripiprazole cohort as the reference group, the odds of having any inpatient hospitalizations were significantly higher in haloperidol [Odds Ratio, OR (95 percent Confidence Interval, CI): 1.51 (1.05 - 2.16)] and risperidone [OR (95 percent CI): 1.58 (1.07 - 2.33)] cohorts. Fluphenazine and paliperidone palmitate cohorts also had higher risk of having any inpatient hospitalizations compared with aripiprazole, but the differences were not statistically significant (p>.05). Among LAI initiators with any inpatient hospitalizations, the adjusted mean inpatient costs were lowest in the aripiprazole cohort (USD25,616), followed by haloperidol (USD30,811), paliperidone (USD30,833), risperidone (USD31,584), and fluphenazine (USD37,338), although differences were not statistically significant. CONCLUSIONS: Our study findings highlight the value of aripiprazole in reducing inpatient hospitalizations and associated costs among patients with schizophrenia. However, our study is limited as our results are reflective of a multi-state Medicaid population. Future studies are warranted to confirm the results in non-Medicaid patient populations.

INTRODUCTION: Existing findings on effectiveness of long-acting injectable antipsychotics (LAIs) versus oral antipsychotics in preventing hospitalizations are inconclusive. This study was conducted to compare hospitalization costs between Medicaid patients diagnosed with schizophrenia who initiated a LAI and those who changed from one oral antipsychotic to another. METHODS: This retrospective cohort analysis used the Truven Health Analytics MarketScan® Medicaid claims database to study patients ≥18 years with schizophrenia. The two cohorts were: “LAI”, defined as initiating LAI (no prior LAI therapy) between 1 January 2013 and 30 June 2014; and “oral”, defined as changing from one oral antipsychotic to another during the same period. The first day of LAI or the new oral antipsychotic was the index date. A linear regression model was conducted to estimate hospitalization costs. RESULTS: The final sample included 2,861 (36.7 percent) LAI and 4,926 (63.3 percent) oral users. Compared to oral users, LAI patients were younger (mean (Standard Deviation, SD): 39.9 (13.2) versus 42.7 (13.1); p<.001) and had a lower mean Charlson Comorbidity Index score (mean (SD): 1.1 (1.9) versus 1.7 (2.3); p<.001). Of the 877 LAI initiators and 1,688 oral users who were hospitalized during the 1-year post-index follow-up period, the unadjusted mean hospitalization costs for LAI and oral users were USD32,626 and USD36,048, respectively. After adjusting for patient demographic and clinical characteristics, baseline medication use, and baseline ED or hospitalizations, the adjusted average hospitalization costs were USD1,170 lower in LAI initiators than oral users. None of the unadjusted or adjusted differences were statistically significant. CONCLUSIONS: This real-world study suggests that among hospitalized patients, hospitalization costs are lower in LAI initiators than in oral antipsychotic users, although the difference is not statistically significant. Our study is limited as our results are reflective of a multi-state Medicaid population. Future studies are warranted to confirm the results in non-Medicaid patient populations.