Perceptions and Acceptance of a Prophylactic Vaccine for Human Immunodeficiency Virus (HIV): A Qualitative Study.

BACKGROUND: Despite advances in human immunodeficiency virus (HIV) prevention methods, such as the advent of pre-exposure prophylaxis (PrEP), the number of people with newly acquired HIV remains high, particularly in at-risk groups. A prophylactic HIV vaccine could contribute to reduced disease prevalence and future transmission and address limitations of existing options, such as suboptimal long-term adherence to PrEPs. METHODS: This qualitative study aimed to capture perceptions towards and acceptance of prophylactic HIV vaccination in three adult populations in the United States: the general population, 'at-risk' individuals (e.g. men who have sex with men, transgender individuals, gender-nonconforming individuals, and individuals in a sexual relationship with a person living with HIV), and parents/caregivers of children aged 9-17 years. Interviews were conducted with 55 participants to explore key drivers and barriers to HIV vaccine uptake, and a conceptual model was developed. RESULTS: The sample was diverse; participants were 51% female, aged 20-57 years (mean 37 years), 33% with high school diploma as highest education level, and identified as White (42%), Black or African American (35%), of Hispanic, Latino, or Spanish origin (22%), or other races/ethnicities (8%) [groupings are not mutually exclusive]. Perceptions were influenced by individual, interpersonal, community, institutional, and structural factors. Overall, 98% of participants thought vaccination would be beneficial in preventing HIV. Key considerations/barriers included perceived susceptibility, i.e. whether participants felt there was a risk of contracting HIV (discussed by 90%); the clinical profile of the vaccine (e.g. the adverse effect profile [98%], and vaccine efficacy [85%], cost [73%] and administration schedule [88%]); and concerns around potential vaccine-induced seropositivity (VISP; 62%). Stigma was not found to be an important barrier, with a general view that vaccination status was personal. Participants in the 'at-risk' group were the most likely to accept an HIV vaccine (70%). Unique concerns in the subgroups included how a potential vaccine's clinical profile compared with PrEP, voiced by those receiving/considering PrEP, and considerations of children's views on the topic, voiced by parents/caregivers. CONCLUSIONS: Understanding these factors could help develop HIV vaccine research strategies and contribute toward public health messaging to support future HIV vaccination programs.

Insurer costs of COVID-19 by disease severity and duration.

OBJECTIVES: To analyze US commercial insurance payments associated with COVID-19 as a function of severity and duration of disease. STUDY DESIGN: Retrospective database analysis. METHODS: Patients with COVID-19 between April 1, 2020, and June 30, 2021, in the Merative MarketScan Commercial database were identified and stratified as having asymptomatic, mild, moderate (with and without lower respiratory disease), or severe/critical (S/C) disease based on the severity of the acute COVID-19 infection. Duration of disease (DOD) was estimated for all patients. Patients with DOD longer than 12 weeks were defined as having post-COVID-19 condition (PCC). Outcomes were all-cause payments (ACP) and disease-specific payments (DSP) for the entire DOD. Variables included demographic and comorbidities at the time of acute disease. Adjusted payments by disease severity were estimated using generalized linear models (γ distribution with log link). RESULTS: A total of 738,339 patients were included (374,401 asymptomatic, 156,220 mild, 180,213 moderate, and 27,505 S/C cases). DSP increased from $217 (95% CI, $214-221) for asymptomatic cases to $2744 (95% CI, $2678-$2811) for moderate cases with lower respiratory disease and $28,250 (95% CI, $26,963-$29,538) for S/C cases. ACP increased from $505 (95% CI, $497-$512) for asymptomatic cases to $46,538 (95% CI, $44,096-$48,979) for S/C cases. The DSP and ACP further increased by $50,736 (95% CI, $45,337-$56,136) and $94,839 (95% CI, $88,029-$101,649), respectively, in S/C cases with PCC vs a DOD of fewer than 4 weeks. CONCLUSIONS: COVID-19 payments for S/C cases were more than 10-fold greater than those of moderate cases and further increased by nearly $95,000 in S/C cases with PCC vs a DOD of fewer than 4 weeks.

Impact of Invasive Escherichia Coli Disease on Clinical Outcomes and Medical Resource Utilization Among Asian Patients in the United States.

INTRODUCTION: Invasive Escherichia coli disease (IED) can lead to sepsis and death and is associated with a substantial burden. Yet, there is scarce information on the burden of IED in Asian patients. METHODS: This retrospective study used US hospital data from the PINC AI™ Healthcare database (October 2015-March 2020) to identify IED cases among patients aged ≥ 60 years. IED was defined as a positive E. coli culture in blood or other normally sterile body site (group 1 IED) or positive culture of E. coli in urine with signs of sepsis (group 2 IED). Eligible patients with IED were classified into Asian and non-Asian cohorts based on their reported race. Entropy balancing was used to create cohorts with similar characteristics. Outcomes following IED were descriptively reported in the balanced cohorts. RESULTS: A total of 646 Asian and 19,127 non-Asian patients with IED were included (median age 79 years; 68% female after balancing). For both cohorts, most IED encounters had community-onset (> 95%) and required hospitalization (Asian 96%, mean duration 6.9 days; non-Asian 95%, mean duration 6.8 days), with frequent admission to intensive care (Asian 35%, mean duration 3.3 days; non-Asian 34%, mean duration 3.5 days), all standardized differences [SD] < 0.20. Compared to non-Asian patients, Asian patients were more likely to be discharged home (54% vs. 43%; SD = 0.22), and less likely to be discharged to a skilled nursing facility (24% vs. 31%; SD = 0.16). In-hospital fatality rates during the IED encounter were similar across cohorts (Asian 9%, non-Asian 10%; SD = 0.01). Most E. coli isolates showed resistance to ≥ 1 antibiotic (Asian 61%; non-Asian 64%) and 36% to ≥ 3 antibiotic classes (all SD < 0.20). CONCLUSION: IED is associated with a substantial burden, including need for intensive care and considerable mortality, in Asian patients in the USA that is consistent with that observed for non-Asian patients.

The fate of coronary dissections left after sirolimus-coated balloon angioplasty: A prespecified subanalysis of the EASTBOURNE study.

OBJECTIVES: We sought to understand the clinical outcomes of dissections left untreated after sirolimus drug-coated balloon (DCB) angioplasty. BACKGROUND: DCB may be a valuable alternative to stents for the treatment of native coronary lesions, but the risk of having a dissection after DCB-angioplasty is not negligible. While type A and B dissections can be safely treated conservatively, some debate exists regarding type C dissections. We previously showed the safety of dissections left untreated after second-generation paclitaxel-DCB. However, the fate of dissections after sirolimus-DCB angioplasty has not been investigated so far. METHODS: EASTBOURNE is a prospective, multicenter, international, investigator-driven study aiming to explore the safety and efficacy of a novel sirolimus-DCB. This study enrolled a consecutive, all-comer population of coronary artery disease patients and is the largest prospective study on DCB so far. Primary endpoints of the study, target-lesion revascularization (TLR), and other clinical endpoints at 12 months, have been presented elsewhere. This is a prespecified subgroup analysis of the patients left with not-flow limiting dissection after DCB angioplasty, with complete 12 months follow-up and comparison between patients left with a dissection versus patients with DCB used for de novo lesions. RESULTS: Between September 2016 and November 2020, a total of 2123 patients were enrolled at 38 study centers. Seventy-three patients were left with nonflow limiting dissections (43 type A, 27 type B, 3 type C) and underwent complete 1-year clinical follow-up. In the nondissection group, 1110 patients had de-novo coronary artery disease while 900 had in-stent restenosis. Baseline characteristics were similar between the groups, while the dissection group was associated with longer lesions (23.8 vs. 18.4 mm, p < 0.001) and more frequent use of predilation (100 vs. 91.4%, p = 0.016). At 12-month follow-up, no significant differences among the groups were found, with a total of 1.25% TLR in the dissection cohort versus 5.6% in the de-novo cohort (p = 0.13), and an overall rate of major adverse cardiovascular events of 4.4% versus 10.1% (p = 0.18). Total death (1.5 vs. 2.6, p = 0.87), cardiac death, myocardial infarction (0% vs. 2.5%, p = 0.35), and bleedings did not differ significantly among the groups as well. CONCLUSIONS: In this subgroup analysis of the EASTBOURNE study of consecutive patients treated with new-generation sirolimus DCB, dissections left untreated after angioplasty did not lead to an increase in adverse events.

Health care costs of COVID-19 vs influenza and pneumonia.

OBJECTIVES: To estimate payments for the treatment of COVID-19 compared with that of influenza or viral pneumonia (IP), from the perspective of the US payer. STUDY DESIGN: Retrospective cohort analysis. METHODS: Patients with COVID-19 during the period from October 1, 2020, to February 1, 2021, or IP during the period from October 1, 2018, to February 1, 2019, in the IBM MarketScan databases were identified. The index was defined as the date of the first COVID-19 or IP diagnosis. Patients with COVID-19 were stratified by severity. Variables for all patients included demographics and comorbidities at the time of index and duration of disease. IP and COVID-19 cohorts were matched using propensity scores, and inflation-adjusted all-cause payments (ACP), and disease-specific payments (DSP) for IP vs COVID-19 were estimated using generalized linear models. RESULTS: Matched cohorts included 6332 Medicare (female, 58.5%; mean [SD] age, 75.3 [7.6] years), and 397,532 commercially insured patients (female, 57.6%; mean [SD] age, 34.7 [16.7] years). ACP and DSP were significantly higher in the COVID-19 cohort vs IP cohort. Payments for severe/critical COVID-19 were significantly greater than those for IP, with adjusted marginal incremental DSP and ACP of $24,852 (95% CI, $21,573-$28,132) and $50,325 (95% CI, $43,932-$56,718), respectively. IP was significantly less expensive than moderate COVID-19 for commercial payers but not Medicare. IP was more expensive than mild COVID-19 for all payers. CONCLUSIONS: Payments associated with severe/critical COVID-19 significantly exceeded those associated with IP. For Medicare, IP was more expensive than mild or moderate COVID-19. For commercial payers, IP was less expensive than moderate COVID-19 but more expensive than mild COVID-19.

Clinical burden of invasive Escherichia coli disease among older adult patients treated in hospitals in the United States.

BACKGROUND: Invasive extraintestinal pathogenic Escherichia coli disease (IED) can lead to severe outcomes, particularly among older adults. However, the clinical burden of IED in the U.S. has not been well characterized. METHODS: IED encounters among patients ≥ 60 years old were identified using the PINC AI™ Healthcare Database (10/01/2015-03/31/2020) by either a positive E. coli culture in blood or another normally sterile body site and ≥ 1 sign of systemic inflammatory response syndrome or signs of sepsis, or a positive E. coli culture in urine with urinary tract infection and signs of sepsis. Medical resource utilization, clinical outcomes, and E. coli isolate characteristics were descriptively reported during the first IED encounter and during the following year (observation period). RESULTS: Overall, 19,773 patients with IED were included (mean age: 76.8 years; 67.4% female; 78.5% with signs of sepsis). Most encounters involved community-onset IED (94.3%) and required hospitalization (96.5%; mean duration: 6.9 days), with 32.4% of patients being admitted to the intensive care unit (mean duration: 3.7 days). Most E. coli isolates were resistant to ≥ 1 antibiotic category (61.7%) and 34.4% were resistant to ≥ 3 antibiotic categories. Following their first IED encounter, 34.8% of patients were transferred to a skilled nursing/intermediate care facility, whereas 6.8% had died. During the observation period, 36.8% of patients were rehospitalized, 2.4% had IED recurrence, and in-hospital death increased to 10.9%. CONCLUSIONS: IED is associated with substantial clinical burden at first encounter with considerable long-term consequences. Findings demonstrate the need for increased IED awareness and highlight potential benefits of prevention.

Enhancement and external validation of algorithms using diagnosis codes to identify invasive Escherichia coli disease.

OBJECTIVE: To assess the predictive accuracy of code-based algorithms for identifying invasive Escherichia coli (E. coli) disease (IED) among inpatient encounters in US hospitals. METHODS: The PINC AI Healthcare Database (10/01/2015-03/31/2020) was used to assess the performance of six published code-based algorithms to identify IED cases among inpatient encounters. Case-confirmed IEDs were identified based on microbiological confirmation of E. coli in a normally sterile body site (Group 1) or in urine with signs of sepsis (Group 2). Code-based algorithm performance was assessed overall, and separately for Group 1 and Group 2 based on sensitivity, specificity, positive and negative predictive value (PPV and NPV) and F1 score. The improvement in performance of refinements to the best-performing algorithm was also assessed. RESULTS: Among 2,595,983 encounters, 97,453 (3.8%) were case-confirmed IED (Group 1: 60.9%; Group 2: 39.1%). Across algorithms, specificity and NPV were excellent (>97%) for all but one algorithm, but there was a trade-off between sensitivity and PPV. The algorithm with the most balanced performance characteristics included diagnosis codes for: (1) infectious disease due to E. coli OR (2) sepsis/bacteremia/organ dysfunction combined with unspecified E. coli infection and no other concomitant non-E. coli invasive disease (sensitivity: 56.9%; PPV: 56.4%). Across subgroups, the algorithms achieved lower algorithm performance for Group 2 (sensitivity: 9.9%-61.1%; PPV: 3.8%-16.0%). CONCLUSIONS: This study assessed code-based algorithms to identify IED during inpatient encounters in a large US hospital database. Such algorithms could be useful to identify IED in healthcare databases that lack information on microbiology data.

Economic burden of invasive Escherichia coli disease among older adult patients treated in hospitals in the United States.

BACKGROUND: Although invasive Escherichia coli disease (IED) can lead to severe clinical outcomes, little is known about the associated medical resource use and cost burden of IED in US hospitals. OBJECTIVE: To comprehensively describe medical resource use and costs associated with IED during the initial IED event and over the subsequent 12 months. METHODS: Patients aged 60 years or older with 1 or more IED encounters were identified from the PINC AI Healthcare US hospital database (October 1, 2015, to March 31, 2020). The index encounter was defined as the first encounter with a positive E coli culture in a normally sterile site (group 1 IED) or positive E coli culture in urine with signs of sepsis (group 2 IED). Encounters with a positive culture from other bacteria or fungal pathogens were excluded. Outcomes were descriptively reported between admission and discharge for the index encounter and more than 1 - year post-index discharge. Medical resource use and costs included inpatient admissions and outpatient hospital services; costs were reported from a hospital's perspective (ie, charged amount) in 2021 USD. RESULTS: A total of 19,773 patients were identified (group 1 IED = 51.8%; group 2 IED = 48.2%). Mean age was 76.8 years, 67.4% were female, and 82.1% were White. Most index encounters were community-onset (94.3%) and led to hospitalization (96.5%) (mean inpatient days = 6.9 days). During the 1 - year post-index, 36.8% of patients had 1 or more all-cause hospitalizations. Mean [median] total all-cause hospital costs (as captured through the PINC AI Healthcare database) amounted to $16,760 [$11,340] during the index encounter and $10,942 [$804] during the 1 - year post-index; these costs were higher in the presence of sepsis and multidrug resistance and among hospital-onset IED. CONCLUSIONS: IED is associated with a substantial medical resource use and economic burden both during the initial encounter and over the following year in older adults. This highlights the critical need and potential benefits of preventive measures that may reduce the incidence of IED and associated economic burden. DISCLOSURES: This study was funded by Janssen Global Services, LLC. Dr Hernandez-Pastor is an employee of Janssen Pharmaceutica NV. Dr Geurtsen is an employee of Janssen Vaccines & Prevention BV. Dr Baugh is an employee of Janssen Research & Development, LLC. Dr El Khoury is an employee of Janssen Global Services, LLC. Dr Kalu and Dr Krishnarajah are employees of Janssen Scientific Affairs, LLC. Dr Gauthier-Loiselle, Ms Bungay, and Mr Cloutier are employees of Analysis Group, Inc., a consulting company that provided paid consulting services to Janssen Global Services, LLC. Dr Saade received consultation and speaker fees from Janssen.

Economic Burden of COVID-19: A Systematic Review.

Objective: To review and qualitatively synthesize the evidence related to the economic burden of COVID-19, including healthcare resource utilization and costs. Methods: A systematic review of studies that assessed the economic burden [eg, direct costs, productivity, macroeconomic impact due to non-pharmaceutical interventions (NPIs) and equity] of COVID-19 was conducted by searches in EMBASE, MEDLINE, MEDLINE-IN-PROCESS, and The Cochrane Library, as well as manual searches of unpublished research for the period between January 2020 to February 2021. Single reviewer data extraction was confirmed independently by a second reviewer. Results: The screening process resulted in a total of 27 studies: 25 individual publications, and 2 systematic literature reviews, of narrower scopes, that fulfilled the inclusion criteria. The patients diagnosed with more severe COVID-19 were associated with higher costs. The main drivers for higher costs were consistent across countries and included ICU admission, in-hospital resource use such as mechanical ventilation, which lead to increase costs of $2082.65 ± 345.04 to $2990.76 ± 545.98. The most frequently reported indirect costs were due to productivity losses. On average, older COVID-19 patients incurred higher costs when compared to younger age groups. An estimation of a 20% COVID-19 infection rate based on a Monte Carlo simulation in the United States led to a total direct medical cost of $163.4 billion over the course of the pandemic. Conclusion: The COVID-19 pandemic has generated a considerable economic burden on patients and the general population. Preventative measures such as NPIs only have partial success in lowering the economic costs of the pandemic. Implementing additional preventative measures such as large-scale vaccination is vital in reducing direct and indirect medical costs, decreased productivity, and GDP losses.

Acute Multiple In-Stent Thromboses in a Patient With Clopidogrel-Fluconazole Interaction.

Clopidogrel is an anti-platelet that exerts its function by selectively inhibiting the binding of adenosine di-phosphate (ADP) to the P2Y12 receptor. Fluconazole is a fungistatic agent that alters fungal cell membranes. Both of these drugs act on the cytochrome P450 2C19. We report the case of an 83-year-old male that presented two days following coronary angioplasty with stent thrombosis, following the concomitant use of clopidogrel and fluconazole. We aim to study the interaction between clopidogrel and fluconazole. We hypothesize that fluconazole decreases the therapeutic level of clopidogrel, requiring an increase in dosage to achieve the same anti-thrombotic effect.

Heart Failure Associated With Ventricular Septal Defect, Mitral Valve Prolapse, Non-stenotic Bicuspid Aortic Valve, and Patent Foramen Ovale.

Ventricular septal defect (VSD) and bicuspid aortic valve (BAV) are the two most common congenital heart defects. BAV may occur sporadically or in association with other cardiac malformations. VSDs have decreased incidence in the adult population due to spontaneous closure. Mitral valve prolapse (MVP) and patent foramen ovale (PFO) can be associated with these conditions but the simultaneous association of these defects has never been reported in the literature. We report the case of a 35-year-old male patient with persistent VSD, BAV, and PFO associated with new-onset heart failure and MVP. We aim to study the association between the coexistence of structural heart malformations and the increased risk of heart failure.

Congenital Partial Absence of Pericardium in an Elderly Patient.

Patients with a complete absence of pericardium require no intervention as they are mostly asymptomatic. Due to the risk of herniation, patients with partial absence of pericardium tend to present with symptoms and may benefit from treatment. We report a case of an elderly patient who presented for severe colitis and was incidentally found to have a partial absence of the pericardium on the right side of the heart.

Transitioning from Once-Monthly to Once-Every-3-Months Paliperidone Palmitate Among Veterans with Schizophrenia.

PURPOSE: Compared to once-monthly paliperidone palmitate (PP1M), once-every-3-months paliperidone palmitate (PP3M) reportedly increases treatment adherence. The objective of this study was to compare treatment patterns, utilization, and costs among Veterans Health Administration (VHA) patients with schizophrenia who transitioned to PP3M versus those remaining on PP1M. PATIENTS AND METHODS: Adult VHA patients with ≥2 health care encounters (inpatient or outpatient) that included a schizophrenia diagnosis who initiated PP1M between January 1, 2015, and March 31, 2018 (identification period) were included in this exploratory retrospective cohort study. Propensity scores were used to match cases (PP1M users who transitioned to PP3M during the identification period) with controls (any patient initiating PP1M during the identification period). Data were assessed until death, health plan disenrollment, or study end. Outcomes were compared using chi-square and t-tests. RESULTS: A total of 257 eligible PP3M and 2973 eligible PP1M patients were identified among adult VHA patients; mean ages were 53.1 and 53.7 years, respectively. After propensity score matching, the PP3M and PP1M cohorts each held 111 patients. Comorbidities of patients treated with PP3M versus PP1M, respectively, included anxiety (12.5% vs 20%; standardized difference [STD] = 20.6), tobacco use (28.4% vs 43.2%; STD = 31.2), depressive disorder (26.5% vs 36.2%; STD = 21.1), and substance abuse (37.4% vs 44.2%; STD = 13.9). For the PP3M cohort, adherence (proportion of days covered ≥80%) to any antipsychotic agent was higher (78.4% vs 57.7%, P = 0.0009), and all-cause inpatient lengths of stay (LOS) were shorter (3.0 vs 8.3 days, P = 0.0354). Increased all-cause pharmacy costs with PP3M were offset by reduced all-cause medical costs, resulting in overall health care cost-neutrality. CONCLUSION: Relative to those remaining on PP1M, VHA patients with schizophrenia who transitioned to PP3M experienced improved antipsychotic medication adherence and significantly shorter all-cause inpatient LOS; costs remained neutral.

Rare Case of a Giant Left Atrium With Cerebrovascular Accident.

Left atrium enlargement is very common in patients with valvular heart disease and atrial fibrillation but an extremely dilated left atrium is a very rare condition and rarely reported in the literature. It is a risk factor for ischemic cerebrovascular accidents due to blood stasis as the cavity diameter increases. We are reporting a case of rarely seen severely dilated left atrium with a normal functioning prosthetic mechanical mitral valve with a cerebrovascular accident on anti-vitamin K and aspirin. The patient had a left atrium diameter of 12.7 cm, an area of 200 cm square, and a volume of 2000 cc. We elected to keep the international normalized ratio (INR) slightly above the therapeutic range in order to decrease the risk of ischemic events. It might be necessary to do the same for patients with a similar condition to decrease the stroke rates.

Long-Acting Injectable Antipsychotic Use in Patients with Schizophrenia and Criminal Justice System Encounters.

Background: Nonadherence to medication is prevalent in persons diagnosed with schizophrenia, thus increasing the likelihood of relapse, poor health outcomes, hospitalization, high treatment costs, and high rates of both violent and non-violent offenses. Objective: To assess the association between long-acting injectable (LAI) antipsychotic use and criminal justice system encounters in patients with schizophrenia or schizoaffective disorder. Methods: This retrospective follow-up study was conducted among patients aged ≥18 years treated for schizophrenia or schizoaffective disorder at a community mental health center in Akron, Ohio, between January 1, 2010, and June 15, 2016. The incidence of criminal justice system encounters at 6 months, 1 year, and 2 years pre- versus post-LAI antipsychotic initiation was assessed. A subanalysis was conducted for individuals with a history of prior arrest. Results: Overall, the risk ratio (RR) of having an encounter with the criminal justice system was significantly lower for patients treated with LAI antipsychotics 1 year after initiation of treatment compared with a similar time period prior to initiation (RR [95% confidence interval (CI)]: 0.74 [0.59-0.93]; P<0.01) and 2 years (0.74 [0.62-0.88]; P<0.0001). Statistically significant reductions in criminal justice system encounters after treatment than before treatment were observed in the once-monthly paliperidone palmitate (PP1M) cohort. The incidence of arrests was lower in the 6-month (27 vs 85 arrests), 1-year (46 vs 132 arrests) and 2-year (88 vs 196 arrests) periods post-index LAI medication than in the corresponding periods pre-index LAI medication among individuals with a history of prior arrest. Conclusions: Patients with schizophrenia or schizoaffective disorder who were initiated on a LAI antipsychotic medication, specifically PP1M, were less likely to have an encounter with the criminal justice system compared with a similar time period before the initiation of LAI treatment.

Projecting the Long-Term Economic Impact of Once-Monthly Paliperidone Palmitate Versus Oral Atypical Antipsychotics in Medicaid Patients with Schizophrenia.

BACKGROUND: Recent evidence has demonstrated that, over 12 months, pharmacy costs associated with switching nonadherent recently relapsed patients from oral atypical antipsychotics (OAAs) to once-monthly paliperidone palmitate (PP1M) were offset by reduced relapse rates and schizophrenia-related health care costs. In addition, earlier use of PP1M may generate greater cost savings. OBJECTIVE: To project the long-term economic impact when a proportion of nonadherent patients with a recent relapse switch from OAAs to PP1M. METHODS: A 36-month decision-tree model with twelve 3-month cycles was developed from a Medicaid payer's perspective. The target population was nonadherent, recently relapsed OAA patients. At equal adherence, probability of relapse was equal between PP1M and OAAs, and OAA patients were nonadherent until treatment switch. Event rates (adherence, relapse, and switch) and cost inputs (pharmacy and relapse) were based on the literature, and rates remained constant. Outcomes included number of relapses, pharmacy costs, and relapse costs (2017 U.S. dollars) at years 1, 2, and 3. One-way sensitivity (OSA) and probabilistic sensitivity analyses (PSA) evaluated the effect of varying model inputs on health plan and per-patient level costs. RESULTS: Based on a hypothetical health plan of 1 million members, 3,037 OAA patients were recently relapsed and nonadherent. Compared with continuing OAAs, switching 5% of patients (n = 152) to PP1M resulted in net cost savings of $674,975, $723,298, and $562,310 at the plan level; $4,445, $4,764, and $3,703 per patient switched per year; and $0.0562, $0.0603, and $0.0469 per member per month in years 1, 2, and 3, respectively, resulting in total plan-level savings of > $1.9 million over 3 years. A total of 221 relapses were avoided (year 1: 92; year 2: 72; and year 3: 57). In years 1, 2, and 3, respectively, total annual plan-level schizophrenia-related costs were $114.1 million, $107.2 million, and $105.8 million when all patients switched to PP1M before any subsequent relapse (n = 3,037); $123.4 million, $109.6 million, and $106.7 million when patients switched to PP1M after a first subsequent relapse (n = 2,631); and $127.6 million, $121.6 million, and $117.0 million when all patients remained on OAAs. The cost per patient switched to PP1M was lower when all patients received PP1M before a subsequent relapse versus after their first subsequent relapse at all years (year 1: $37,559 vs. $45,089; year 2: $35,288 vs. $36,321; and year 3: $34,826 vs. $35,155). OSA demonstrated consistent net cost savings per patient switched, ranging from $640 to $10,484 (year 1); $1,774 to $9,245 (year 2); and $1,354 to $7,026 (year 3). PSA demonstrated 96.3%, 99.7%, and 99.7% of iterations were cost saving in years 1, 2 and 3, respectively. CONCLUSIONS: Pharmacy costs associated with switching nonadherent OAA patients with a recent relapse to PP1M were offset by reduced relapse rates and health care costs at years 1, 2, and 3, with earlier use of PP1M resulting in increased cost savings at all years. DISCLOSURES: This research was funded by Janssen Scientific Affairs. Pilon, Morrison, Lefebvre, and Shak are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs to conduct this study. El Khoury and Kim are employees of Janssen Scientific Affairs. At the time this study was conducted, Llaneza was an employee of HireGenics, which provided services to Janssen Scientific Affairs for the study. Part of the material in this manuscript was presented at the Academy of Managed Care Pharmacy 2019 Annual Meeting; March 25-29, 2019; San Diego, CA.

Are Medicaid Coverage Gaps Associated with Higher Health Care Resource Utilization and Costs in Patients with Schizophrenia?

The objective was to assess the association of Medicaid coverage gaps with health care resource utilization (HRU) and costs of patients with schizophrenia. Patients with schizophrenia were identified from the Medicaid database. The beginning of the first eligible gap was defined as the index date. Per-patient per-month (PPPM) HRU and costs before versus after a gap were assessed, and the association between gap duration and PPPM HRU and costs was examined up to 12 months post index. Together with 95% confidence intervals, HRU differences were reported in rate ratios (RRs), and cost differences were reported in 2016 US dollars. A subgroup of males with substance use disorder (SUD; risk factors for incarceration) also was analyzed. Total PPPM health care costs increased significantly by $711.04 following a coverage gap (P < 0.001). Gaps of 180-365 days were associated with a significant increase in inpatient visits (RR = 1.27; P < 0.001) relative to gaps of <90 days. Gaps of 90-179 days were associated with significantly more PPPM inpatient visits (RR = 1.14; P = 0.024) relative to a gap of <90 days. Inpatient costs were particularly increased for gaps of 180-365 days versus those of <90 days (cost difference = $101.81 PPPM; P = 0.0008). Similar results were found in male patients with SUD, in whom HRU and cost differences appeared larger. In patients with schizophrenia, longer Medicaid coverage gaps were associated with increases in inpatient admissions, emergency room visits, and inpatient costs, particularly among patients with risk factors for incarceration. These results support policies that aim to facilitate Medicaid reinstatement for patients with schizophrenia.

Real-World Analysis of Switching Patients with Schizophrenia from Oral Risperidone or Oral Paliperidone to Once-Monthly Paliperidone Palmitate.

PURPOSE: Reducing the dosing frequency of antipsychotics (APs) with long-acting injectables (LAIs) such as once-monthly paliperidone palmitate (PP1M) can improve adherence and clinical outcomes for schizophrenia patients. This US study compared physical and psychiatric comorbidity-related outcomes, AP adherence, healthcare resource utilization (HRU), and costs pre- and post-transition to PP1M among schizophrenia patients treated with oral risperidone/paliperidone pre-PP1M transition. METHODS: Health insurance claims from the IQVIA™ PharMetrics Plus database (01/01/2012-07/31/2018) were used to identify adults with ≥ 2 schizophrenia diagnoses, ≥ 1 claim for PP1M, and ≥ 30 days of treatment with oral risperidone/paliperidone in the 60 days before the first PP1M claim (i.e., the index date). Comorbidity-related outcomes, adherence to APs (measured via the proportion of days covered [PDC]), all-cause per-patient-per-month (PPPM) HRU, and all-cause PPPM medical, pharmacy, and total costs (i.e., sum of medical and pharmacy costs) during the 6-month periods pre- and post-transition to PP1M were compared using generalized estimating equation models adjusted for repeated measurements. Analyses were replicated in the subset of patients with ≥ 1 all-cause inpatient stay pre-PP1M transition. FINDINGS: Among 427 schizophrenia patients transitioning from oral risperidone/paliperidone to PP1M, the mean age was 41.1 years and 37.9% were female. Following the PP1M transition, patients were less likely to have claims with a diagnosis for psychoses (odds ratio [OR] 0.41; P < 0.001), hypertension (OR 0.80; P = 0.011), depression (OR 0.70; P < 0.001), drug abuse (OR 0.60; P < 0.001), substance-related and addictive disorders (OR 0.73; P = 0.003), bipolar and related disorders (OR 0.59; P < 0.001), sleep-wake disorders (OR 0.68; P = 0.017), anxiety disorders (OR 0.78; P = 0.034), and other conditions that may require a focus of clinical attention (OR 0.58; P < 0.001). Mean PDC by APs was higher post-PP1M (mean = 0.81) versus pre-PP1M (mean = 0.68) transition. Post-PP1M, patients were less likely to have an all-cause emergency room visit (OR 0.51; P < 0.001) or inpatient stay (OR 0.39; P < 0.001) compared to pre-PP1M. All-cause total healthcare costs remained similar post- versus pre-transition to PP1M (mean monthly cost difference [MMCD] = $228; P = 0.260). Pharmacy costs increased post-PP1M (MMCD = $960; P < 0.001), but were offset by decreasing medical costs (MMCD = - $732; P < 0.001), largely driven by lower costs related to inpatient stays (MMCD = - $695; P < 0.001) and emergency room visits (MMCD = - $63; P < 0.001). For patients with ≥ 1 all-cause inpatient stay pre-PP1M transition (N = 177), a more pronounced improvement in comorbidity-related outcomes, a more pronounced reduction in HRU, and a reduction in total healthcare costs (MMCD = - $1308; P < 0.001) were observed post-transition to PP1M. IMPLICATIONS: Among schizophrenia patients in the US, transitioning to PP1M following oral risperidone/paliperidone treatment was associated with improved comorbidity-related outcomes, higher adherence, and a reduction in HRU, while remaining cost neutral. Furthermore, patients with ≥ 1 all-cause inpatient stay pre-PP1M transition had significantly lower total healthcare costs post-PP1M transition.

The Predicted Long-Term Benefits of Ensuring Timely Treatment and Medication Adherence in Early Schizophrenia.

The impact of initiatives aimed at reducing time in untreated psychosis during early-stage schizophrenia will be unknown for many years. Thus, we simulate the effect of earlier treatment entry and better antipsychotic drug adherence on schizophrenia-related hospitalizations, receipt of disability benefits, competitive employment, and independent/family living over a ten-year horizon. We predict that earlier treatment entry reduces hospitalizations by 12.6-14.4% and benefit receipt by 7.0-8.5%, while increasing independent/family living by 41.5-46% and employment by 42-58%. We predict larger gains if a pro-adherence intervention is also used. Our findings suggest substantial benefits of timely and consistent early schizophrenia care.

Health Outcomes Among Patients Diagnosed with Schizophrenia in the US Veterans Health Administration Population Who Transitioned from Once-Monthly to Once-Every-3-Month Paliperidone Palmitate: An Observational Retrospective Analysis.

INTRODUCTION: There is limited literature on treatment patterns, healthcare resource utilization (HRU), and costs among patients who transition from once-monthly paliperidone palmitate (PP1M) to once-every-3-month paliperidone palmitate (PP3M) in a real-world setting. Hence, this study compared treatment patterns, HRU, and costs 12-month pre- and post-PP3M transition among Veteran's Health Administration (VHA) patients with schizophrenia. METHODS: Patients with schizophrenia (aged ≥ 18 years) who initiated PP1M and transitioned per on-label criteria to PP3M (no treatment gap of > 45 days in PP1M during the 4 months prior, same dose strength of the last two PP1M claims, and appropriate dose conversion from last PP1M to first PP3M claim) from January 2015 to March 2017 were included from the VHA database. The first transition date to PP3M was identified as the index date. Patients were required to have 12-month pre- and post-PP3M continuous health plan eligibility. Outcomes were compared using the Wilcoxon-signed rank and McNemar's test, appropriately. RESULTS: The study included 122 patients [mean (SD) age: 54 (13.7) years]. Pre- and post-PP3M transition, 64.8% and 61.5% of patients were adherent (proportion of days covered ≥ 80%) to PP1M and PP3M, respectively. Comparison of HRU outcomes pre- and post-PP3M transition exhibited lower all-cause outpatient (37.5 vs. 31.1, p < 0.0001) and pharmacy visits (56.1 vs. 46.7, p < 0.0001). Similar trends were seen for mental health and schizophrenia-related outpatient and pharmacy HRU. Comparison of cost outcomes resulted in lower all-cause outpatient ($27,221 vs. $22,356, p = 0.0033), higher pharmacy ($16,349 vs. $17,003, p = 0.0076), lower total medical ($35,834 vs. $28,900, p = 0.0257), and no difference in total costs ($52,183 vs. $45,903, p = 0.3118). Similar trends were seen for mental health and schizophrenia-related costs. CONCLUSIONS: Transition to PP3M was associated with a decline in outpatient and pharmacy visits. All-cause medical cost reduction fully offset increased pharmacy costs among VHA patients with schizophrenia who transitioned from PP1M to PP3M. FUNDING: Janssen Scientific Affairs.