Going Forward: Potential Impact of Protein-Based COVID-19 Vaccination Coverage on Population Outcomes and Costs in the United States.

Policymakers in the United States (US) recommend coronavirus disease 2019 (COVID-19) vaccination with a monovalent 2023-2024 vaccine formulation based on the Omicron XBB.1.5 variant. We estimated the potential US population-level health and economic impacts of increased COVID-19 vaccine coverage that might be expected with the availability of a protein-based vaccine with simpler storage requirements in addition to messenger ribonucleic acid (mRNA) vaccines. A Markov model was developed to estimate 1-year COVID-19-related costs, cases, hospitalizations, and deaths with and without the availability of a protein-based vaccine option. The model population was stratified by age and risk status. Model inputs were sourced from published literature or derived from publicly available data. Our model estimated that a five-percentage-point increase in coverage due to the availability of a protein-based vaccine option would prevent over 500,000 cases, 66,000 hospitalizations, and 3000 COVID-19-related deaths. These clinical outcomes translated to 42,000 quality-adjusted life years (QALYs) gained and an incremental cost-effectiveness ratio of USD 16,141/QALY from a third-party payer perspective. In sensitivity analyses, outcomes were most sensitive to COVID-19 incidence and severity across age groups. The availability of a protein-based vaccine option in the US could reduce hospitalizations and deaths and is predicted to be cost-effective.

Cost-Effectiveness of Blood-Based Brain Biomarkers for Screening Adults with Mild Traumatic Brain Injury in the French Health Care Setting.

Two blood-based brain biomarker tests such as the combination of glial fibrillary acidic protein and ubiquitin C-terminal hydrolase-L1 (GFAP+UCH-L1) or S100B have potential to reduce the need for head computed tomography (CT) scanning in patients with mild traumatic brain injury (mTBI). We assessed the clinical and economic impact of using GFAP+UCH-L1 versus CT scan and GFAP+UCH-L1 versus S100B to screen adults with suspected mTBI presenting to an emergency department (ED). A decision model was developed to estimate costs and health outcomes of GFAP+UCH-L1, CT scan, and S100B associated with these screening protocols. Model parameters were extracted from peer-reviewed articles, clinical guidelines, and expert opinion. Analysis was performed from a French health care system perspective (costs in 2020 euros). In the model, patients with a positive biomarker receive a CT scan to confirm the presence of intracranial lesions (ICLs). Depending on clinical state and biomarker and CT results, patients were discharged immediately, kept for observation in the ED, admitted for in-hospital stay and observation, or admitted for surgical management. Incorrect test results may lead to delayed treatment and poor outcomes or overtreatment. GFAP+UCH-L1 use was associated with an overall decrease in CT scans when compared with CT screening or S100B use (325.42 and 46.43 CTs per 1000 patients, respectively). The use of GFAP+UCH-L1 resulted in modest cost savings when compared with CT scanning and with S100B. In all cases, use of GFAP+UCH-L1 marginally improved quality-adjusted life-years (QALYs) and outcomes. Thus, screening with GFAP+UCH-L1 reduced the need for CT scans when compared with systematic CT scan screening or use of S100B while maintaining similar costs and health outcomes.

Cost-Effectiveness of Respiratory Syncytial Virus Preventive Interventions in Children: A Model Comparison Study.

OBJECTIVES: Model-based cost-effectiveness analyses on maternal vaccine (MV) and monoclonal antibody (mAb) interventions against respiratory syncytial virus (RSV) use context-specific data and produce varied results. Through model comparison, we aim to characterize RSV cost-effectiveness models and examine drivers for their outputs. METHODS: We compared 3 static and 2 dynamic models using a common input parameter set for a hypothetical birth cohort of 100 000 infants. Year-round and seasonal programs were evaluated for MV and mAb interventions, using available evidence during the study period (eg, phase III MV and phase IIb mAb efficacy). RESULTS: Three static models estimated comparable medically attended (MA) cases averted versus no intervention (MV, 1019-1073; mAb, 5075-5487), with the year-round MV directly saving ∼€1 million medical and €0.3 million nonmedical costs, while gaining 4 to 5 discounted quality-adjusted life years (QALYs) annually in <1-year-olds, and mAb resulting in €4 million medical and €1.5 million nonmedical cost savings, and 21 to 25 discounted QALYs gained. In contrast, both dynamic models estimated fewer MA cases averted (MV, 402-752; mAb, 3362-4622); one showed an age shift of RSV cases, whereas the other one reported many non-MA symptomatic cases averted, especially by MV (2014). These differences can be explained by model types, assumptions on non-MA burden, and interventions' effectiveness over time. CONCLUSIONS: Our static and dynamic models produced overall similar hospitalization and death estimates, but also important differences, especially in non-MA cases averted. Despite the small QALY decrement per non-MA case, their larger number makes them influential for the costs per QALY gained of RSV interventions.

Clinical and economic impacts of large volume delayed sampling and pathogen reduction technology platelet processing strategies in the United States.

BACKGROUND: Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are strategies for platelet processing to minimize transfusion of contaminated platelet components (PCs). This study holistically compares the economic and clinical impact of LVDS and PRT in the United States. STUDY DESIGN AND METHODS: A decision model was constructed to simulate collection, processing, and use of PCs and to compare processing strategies: PRT with 5-day shelf life, LVDS with 7-day shelf life (LVDS7), and LVDS with 5-day shelf life extended to 7 days with secondary testing (LVDS5/2). Target population was adults requiring two or more transfusions. Collection, processing, storage, and distribution data were obtained from the National Blood Collection and Utilization Survey and published literature. Patient outcomes associated with transfusions were obtained from AABB guidelines, meta-analyses, and other published clinical studies. Costs were obtained from reimbursement schedules and other published sources. RESULTS: Given 10,000 donated units, 9512, 9511, and 9651 units of PRT, LVDS5/2, and LVDS7 PCs were available for transfusion, respectively. With these units, 1502, 2172, and 2329 transfusions can be performed with similar levels of adverse events. Assuming 30 transfusions a day, a hospital would require 69,325, 47,940, and 45,383 units of PRT, LVDS5/2, and LVDS7 platelets to perform these transfusions. The mean costs to perform transfusions were significantly higher with PRT units. CONCLUSIONS: Compared with PRT, LVDS strategies were associated with lower costs and higher PC availability while patients experienced similar levels of adverse events. Increased utilization of LVDS has the potential to improve efficiency, expand patient access to platelets, and reduce health care costs.

Mild traumatic brain injury in the United States: demographics, brain imaging procedures, health-care utilization and costs.

Objective: To characterize mild traumatic brain injury (mTBI) patients in the USA, describing location of diagnosis, timing, and modality of imaging procedures, health-care resource utilization (HRU) and costs in the 12-month period post-diagnosis. Research Design: Retrospective claims analysis Methods: Anonymized data from the OptumHealth Care Solutions claims database (2006-2016). The index date was the first date with an mTBI diagnosis. HRU and costs (2016 USD) were assessed in the 12-month post-index period. Results: A total of 80,004 patients with mTBI were included: 60% were under 26 years and 54% were male. Mild TBI was most frequently diagnosed in an emergency department (ED) for all age groups, except patients aged 11-17 years, for whom the outpatient setting was the most frequent place of diagnosis. Almost half (47%) received brain imaging on the index date, with 98% of which receiving computed tomography. Mean follow-up health-care costs were $13,564 (SD = $41,071), primarily from inpatient ($4,675, SD = $29,982) and non-ED outpatient/physician office visits ($4,207, SD = $12,697). Older patients had greater HRU and higher health-care costs. Conclusions: The findings of this claims-based study show substantial HRU and costs associated with mTBI diagnosis during a 12-month follow-up period.

Economic and clinical benefits of early identification of acute kidney injury using a urinary biomarker.

Purpose: To evaluate the budget impact of adding a diagnostic test of tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7 ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury (AKI), to the current standard of care (SOC) in a hospital setting.Materials and methods: A budget impact model (2017 USD) was developed from the perspective of a hypothetical US hospital system serving 10,000 inpatients annually. The model estimated the impact of assessing the risk of AKI using SOC vs a combination of SOC and the US Food and Drug Administration-approved assay [TIMP-2]·[IGFBP7] over a 1-year period. Potential cost implications were assessed using estimates for payer mix among patients, diagnostic efficacy, and patient healthcare resource utilization. The model also considered provider adoption rates and the estimated costs of [TIMP-2]·[IGFBP7].Results: Compared to SOC alone, adding [TIMP-2]·[IGFBP7] to SOC was associated with a $1,855 reduction in uncompensated care per patient tested, which, after accounting for the additional costs of the test ($277), resulted in net savings of $1,578 per patient tested. The findings were robust to input parameter variations, as demonstrated by deterministic and probabilistic sensitivity analyses. In the probabilistic sensitivity analyses, net cost savings to the hospital ranged from $50,308-$3,971,514, or $101-$7,943 per tested patient (mean = $1,710; 95% confidence interval = $1,691-$1,729).Conclusions: The introduction of [TIMP-2]·[IGFBP7] as a novel tool in the identification of AKI risk may result in considerable cost savings from a hospital perspective under this model's base-case assumptions. Further prospective studies are needed to confirm these findings in a real-world setting.Key points for decision makersAn economic model was constructed to determine the budget impact of adding a diagnostic test ([TIMP-2]·[IGFBP7]), which identifies patients at risk of moderate-to-severe acute kidney injury, to the current standard of care (SOC) in a hospital setting.According to the present model, the use of [TIMP-2]·[IGFBP7] to identify acute kidney injury risk may reduce costs for hospitals by ∼$1,578 per patient tested.

Comparative Cost-Effectiveness of Clinic, Home, or Ambulatory Blood Pressure Measurement for Hypertension Diagnosis in US Adults.

Previous cost-effectiveness models found ambulatory blood pressure monitoring (ABPM) to be a favorable strategy to diagnose hypertension; however, they mostly focused on older adults with a positive clinic blood pressure (BP) screen. We evaluated the cost-effectiveness of 3 methods of BP measurement for hypertension diagnosis in primary care settings among 14 age- and sex-stratified hypothetical cohorts (adults ≥21 years of age), accounting for the possibility of both false-positive (white-coat hypertension) and false-negative (masked hypertension) clinic measurements. We compared quality-adjusted life-years and lifetime costs ($US 2017 from the US healthcare perspective) associated with clinic BP measurement, home BP monitoring, and ABPM under 2 scenarios: positive and negative initial screen. Model parameters were obtained from published literature, publicly available data sources, and expert input. In the screen-positive scenario, ABPM was the dominant strategy among all age and sex groups. Compared with clinic BP measurement, ABPM was associated with cost-savings ranging from $77 (women 80 years of age) to $5013 (women 21 years of age). In the screen-negative scenario, ABPM was the dominant strategy in all men and women <80 years of age with cost-savings ranging from $128 (women 70 years of age) to $2794 (women 21 years of age). Sensitivity analyses showed that results were sensitive to test specificity and antihypertensive medication costs. ABPM is recommended as the diagnostic strategy of choice for most adults in primary care settings regardless of initial screening results.

Antihypertensive adherence and outcomes among community-dwelling Medicare beneficiaries: the Atherosclerosis Risk in Communities Study.

RATIONALE, AIMS, AND OBJECTIVES: Despite proven benefits for reducing incidence of major cardiac events, antihypertensive drug therapy remains underutilized in the United States. This analysis assesses antihypertensive drug adherence, utilization predictors, and associations between adherence and outcomes (a composite of cardiovascular events, Medicare inpatient payments, and inpatient days). METHODS: The sample consisted of Atherosclerosis Risk in Communities Study cohort participants reporting hypertension without prevalent cardiovascular disease during 2006 to 2007 annual follow-up calls. Atherosclerosis Risk in Communities records were linked to Medicare claims through 2012. Antihypertensive medication adherence was measured as more than 80% proportion days covered by using Medicare Part D claims. Standard and hierarchical regression models were used to evaluate adjusted associations between person characteristics and adherence and between adherence and outcomes. RESULTS: Among 1826 hypertensive participants with Part D coverage, 31.5% had no antihypertensive class with more than 80% proportion days covered in the 3 months preceding the report of hypertension in 2006 to 2007. After adjustment for confounders, positive predictors of use included female gender and diabetes; negative predictors were African-American race and current smoking. Adjusted association between receiving no therapy and a composite endpoint of cardiovascular outcomes through 2012 was not statistically significant (hazard ratio: 0.93; 95% confidence interval: 0.72, 1.22) nor was the adjusted association with Medicare inpatient days or payments (incremental difference at 48 months in payments: $1217; 95% CI: -$2030, $4463). CONCLUSIONS: Despite having medical and prescription coverage, nearly a third of hypertensive participants were not adherent to antihypertensive drug therapy. Differences in clinical outcomes associated with nonadherence, though not statistically significant, were consistent with results from randomized trials. The approach provides a model framework for rigorous assessment of detailed data that are increasingly available through emerging sources.

Psychometric Properties of the Four-Item Morisky Green Levine Medication Adherence Scale among Atherosclerosis Risk in Communities (ARIC) Study Participants.

OBJECTIVES: To evaluate the reliability and factorial validity of the four-item Morisky Green Levine Medication Adherence Scale (MGLS) among Atherosclerosis Risk in Communities (ARIC) Study participants. METHODS: We used the cross-sectional visit 5 data from the ARIC Study to assess the measurement properties of the MGLS. We measured the internal consistency using Cronbach α (where α > 0.70 is considered reliable for group-level measurement), the response frequency, and the inter item correlation. Factor analysis of the MGLS and five other adherence items in the survey was conducted using a polychoric correlation matrix to examine the dimensionality that underlies the MGLS. A vanishing tetrad test was conducted to assess conformity with an effect indicator model. RESULTS: Among the ARIC visit 5 participants, 6,261 (96%) responded to the MGLS and other questions related to medication adherence in the survey (mean age 76 ± 5 years, 59% women). The Cronbach α for the MGLS was 0.47. The inter-item correlations ranged from 0.11 to 0.26. In the factor analysis of the medication adherence survey questions, a three-factor solution was used. One factor captured the extent of nonadherence, whereas other factors focused on the reasons for nonadherence. The MGLS items spread out across the factors that reflect the extent of as well as the reasons for nonadherence. The results of the vanishing tetrad test indicated that the MGLS consists of items other than effect indicators (P < 0.0001). CONCLUSIONS: The low reliability together with the factor analysis findings imply that the MGLS may reflect causes as well as the extent of medication adherence. The findings suggest that the MGLS, as presently used, lacks consistency in an elderly population.

Association of inpatient vs outpatient onset of ST-elevation myocardial infarction with treatment and clinical outcomes.

IMPORTANCE: Reperfusion times for ST-elevation myocardial infarction (STEMI) occurring in outpatients have improved significantly, but quality improvement efforts have largely ignored STEMI occurring in hospitalized patients (inpatient-onset STEMI). OBJECTIVE: To define the incidence and variables associated with treatment and outcomes of patients who develop STEMI during hospitalization for conditions other than acute coronary syndromes (ACS). DESIGN, SETTING, AND PARTICIPANTS: Retrospective observational analysis of STEMIs occurring between 2008 and 2011 as identified in the California State Inpatient Database. EXPOSURES: STEMIs were classified as inpatient onset or outpatient onset based on present-on-admission codes. Patients who had a STEMI after being hospitalized for ACS were excluded from the analysis. MAIN OUTCOMES AND MEASURES: Regression models were used to evaluate associations among location of onset of STEMI, resource utilization, and outcomes. Adjustments were made for patient age, sex, comorbidities, and hospital characteristics. The analysis allowed for the location of inpatient STEMI to have a multiplicative rather than an additive effect for resource utilization since these measures were highly skewed. RESULTS: A total of 62,021 STEMIs were identified in 303 hospitals, of which 3068 (4.9%) occurred in patients hospitalized for non-ACS indications. Patients with inpatient-onset STEMI were older (mean, 71.5 [SD, 13.5] years vs 64.9 [SD, 14.1] years; P < .001) and more frequently female (47.4% vs 32%; P < .001) than those with outpatient-onset STEMI. Patients with inpatient-onset STEMI had higher in-hospital mortality (33.6% vs 9.2%; adjusted odds ratio (AOR), 3.05; 95% CI, 2.76-3.38; P < .001), were less likely to be discharged home (33.7% vs 69.4%; AOR, 0.38; 95% CI, 0.34-0.42; P < .001), and were less likely to undergo cardiac catheterization (33.8% vs 77.8%; AOR, 0.19; 95% CI, 0.16-0.21; P < .001) or percutaneous coronary intervention (21.6% vs 65%; AOR, 0.23; 95% CI, 0.21-0.26; P < .001). Length of stay and inpatient charges were higher for inpatient-onset STEMI (mean length of stay, 13.4 days [95% CI, 12.8-14.0 days] vs 4.7 days [95% CI, 4.6-4.8 days]; adjusted multiplicative effect, 2.51; 95% CI, 2.35-2.69; P < .001; mean inpatient charges, $245,000 [95% CI, $235,300-$254,800] vs $129,000 [95% CI, $127,900-$130,100]; adjusted multiplicative effect, 2.09; 95% CI, 1.93-2.28; P < .001). CONCLUSIONS AND RELEVANCE: Patients who had a STEMI while hospitalized for a non-ACS condition, compared with those with onset of STEMI as an outpatient, were less likely to undergo invasive testing or intervention and had a higher in-hospital mortality rate.