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AIMS: To compare healthcare resource utilization (HRU) and costs between patients with or without melanoma recurrence and between patients with distant or locoregional melanoma recurrence. METHODS: Patients aged ≥65 years with completely resected, stage IIB/IIC or III melanoma were identified from Surveillance, Epidemiology, and End Results-Medicare data and stratified based on whether they experienced a recurrence, and whether it was distant or locoregional (separately for each stage). The index date was the date of recurrence (recurrence group) or a randomly assigned date (non-recurrence group). Patients in the recurrence and non-recurrence groups were propensity score-matched 1:1 based on patient characteristics; HRU and healthcare costs were compared between the 2 groups and between patients with distant or locoregional recurrence during the ≤24 months following index. RESULTS: After matching, 507 pairs of patients with recurrent or non-recurrent stage IIB/IIC melanoma (236 patients with distant recurrence, 271 with locoregional) and 141 pairs of patients with recurrent or non-recurrent stage III melanoma (50 patients with distant recurrence, 91 with locoregional) were included. During the first year following recurrence, unadjusted HRU was generally higher in patients with versus without recurrence and patients with distant versus locoregional recurrence among both stage IIB/IIC and III cohorts. Patients who experienced recurrence incurred $6,474 (stage IIB/IIC) or $6,112 (stage III) per patient per month (PPPM) more in unadjusted, all-cause, total healthcare costs than patients without recurrence (both p < 0.001). Patients with distant recurrence incurred $7,292 (stage IIB/IIC) or $5,436 (stage III) PPPM more in unadjusted, all-cause, total healthcare costs than patients with locoregional recurrence (both p < 0.05). LIMITATIONS: Melanoma recurrence was identified using a claims-based algorithm. CONCLUSIONS: Economic burden is higher in patients with versus without melanoma recurrence and patients with distant versus locoregional recurrence. There is a high unmet need for adjuvant therapies that may help to prevent or delay recurrence.
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Medicare , Melanoma , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Programa de VERF , Humanos , Melanoma/cirugía , Melanoma/economía , Melanoma/patología , Anciano , Femenino , Masculino , Medicare/economía , Estados Unidos , Anciano de 80 o más Años , Neoplasias Cutáneas/cirugía , Neoplasias Cutáneas/economía , Neoplasias Cutáneas/patología , Puntaje de Propensión , Gastos en Salud/estadística & datos numéricos , Revisión de Utilización de Seguros , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricosRESUMEN
OBJECTIVE: In the absence of head-to-head clinical trials, matching-adjusted indirect comparison (MAIC) was used to compare 2 Bruton tyrosine kinase inhibitors (BTKis) approved for the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL). This analysis compares the efficacy and safety of acalabrutinib versus ibrutinib using a more mature dataset than a previously published MAIC. METHODS: Individual patient data from 122 patients treated with acalabrutinib in a phase 2 study were weighted to match aggregate baseline characteristics of patients pooled from 3 separate trials of ibrutinib. Patients were matched on Eastern Cooperative Oncology Group performance status, simplified Mantle Cell Lymphoma International Prognostic Index, lactate dehydrogenase, prior lines of therapy, tumor burden, and blastoid histology. Outcomes assessed included progression-free survival (PFS), overall survival (OS), and adverse events. RESULTS: After matching, differences in PFS between acalabrutinib (median 17.8 months) and ibrutinib (median 12.8 months) were not statistically significant (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.74-1.15; P = 0.48). Similarly, after matching, OS differences between acalabrutinib (median 36.5 months) and ibrutinib (median 27.9 months) did not reach statistical significance (HR, 0.87; 95% CI, 0.64-1.17; P = 0.35). Acalabrutinib was associated with an improved safety profile compared with ibrutinib, with statistically significantly lower rates of grade ≥3 atrial fibrillation and thrombocytopenia. CONCLUSIONS: This comparison of 2 BTKis used in the treatment of R/R MCL showed that PFS and OS risk was not statistically different between the treatments; however, acalabrutinib had an improved safety profile compared with ibrutinib.
Mantle cell lymphoma (MCL) is an aggressive and rare type of cancer that affects lymphoid cells and often returns after previously responding to treatment (relapsed) or stops responding to treatment (refractory). Acalabrutinib and ibrutinib belong to a class of drugs referred to as Bruton tyrosine kinase inhibitors and are approved for the treatment of relapsed or refractory MCL. There is currently no direct head-to-head trial available to compare the efficacy and safety of acalabrutinib and ibrutinib in patients with relapsed or refractory MCL. To compare these drugs, the authors used a method referred to as a matching-adjusted indirect comparison (MAIC), which allows for comparison of the efficacy and safety of acalabrutinib versus ibrutinib using data from different clinical trials. This MAIC study found that there were no statistically significant differences in survival outcomes in patients with relapsed or refractory MCL who were treated with either acalabrutinib or ibrutinib. However, acalabrutinib was associated with an improved safety profile compared with ibrutinib. When there are many treatment options available for patients, knowing how different treatments compare in terms of efficacy and safety may help patients and physicians choose the most appropriate therapy. Although direct comparisons are the most accurate way to compare different treatments, when they are unavailable, MAIC studies can help patients and healthcare providers in the decision-making process.
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OBJECTIVE: Conduct a comprehensive analysis of the health and economic outcomes of patients with a COVID-19-associated hospitalization in the US during the predominance of the XBB and JN.1 Omicron lineages. METHODS: This analysis used data from the PINC AI Healthcare Database (PHD) for all patients with a hospital admission date occurring between February 4, 2023, and February 29, 2024 with an ICD-10-CM code U07.1 "COVID-19" in any position. The data were used to estimate the mean and median length of stay (LOS), mean and median hospitalization cost, and proportion of patients that died in the hospital, by age and level of care (normal ward, intensive care [ICU], invasive mechanical ventilation [IMV]). RESULTS: LOS, hospitalization costs, and inpatient mortality increased with both the level of care and age. Patients not receiving ICU care had the shortest LOS, lowest inpatient mortality, and lowest hospitalization costs. LOS, hospitalization costs, and inpatient mortality were higher for those receiving ICU care and highest for those receiving IMV in the ICU. Within each level of care (normal ward, ICU without IMV, and ICU with IMV), the LOS, inpatient mortality, and hospitalization cost generally increased with age, indicating that older adults with COVID-19 required a longer recovery period, have a higher likelihood of death, and accrue higher costs. However, the proportion of pediatric patients with an ICU admission and/or IMV usage remained high. LIMITATIONS: The PHD data may not be representative of all hospitalized patients in the US. CONCLUSIONS: These findings suggest that COVID-19 continues to have severe and costly consequences in all age groups, but particularly for older adults including long LOS, ICU admission, need for IMV, mortality, and high hospital costs.
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COVID-19 , Mortalidad Hospitalaria , Hospitalización , Tiempo de Internación , SARS-CoV-2 , Humanos , COVID-19/economía , COVID-19/mortalidad , Estados Unidos , Tiempo de Internación/economía , Tiempo de Internación/estadística & datos numéricos , Persona de Mediana Edad , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Anciano , Masculino , Femenino , Adulto , Factores de Edad , Unidades de Cuidados Intensivos/economía , Unidades de Cuidados Intensivos/estadística & datos numéricos , Respiración Artificial/economía , Respiración Artificial/estadística & datos numéricos , Adulto Joven , Adolescente , Costos de Hospital/estadística & datos numéricos , Anciano de 80 o más AñosRESUMEN
Spatial neglect in stroke survivors is associated with a decrease in quality of life. This disorder occurs in 20-80% of stroke survivors and up to 1/3 of stroke survivors will continue to experience chronic impairment. Occupational therapists are uniquely qualified to treat stroke survivors with spatial neglect due to their holistic approach but access to therapy is limited. Diagnostic coding is used to help determine appropriate reimbursement and continuation of care including rehabilitation services. The objectives of this study were to 1) identify the prevalence of diagnostic coding for spatial neglect in stroke survivors, and 2) identify the prevalence and types of rehabilitation for patients with diagnostic coding for spatial neglect. We completed a retrospective cohort analysis using 2018 and 2019 5% Medicare Limited Data Sets from the Centers for Medicare and Medicaid Services. We extracted all ischemic stroke survivors and stratified them by the presence of a secondary diagnostic code indicating spatial neglect. Rehabilitation Current Procedural Terminology codes were used to identify stroke survivors who received rehabilitation. Despite recommendations from clinical practice, only 4.9% had a diagnostic code for spatial neglect. Of those formally diagnosed, only 2.3% received outpatient occupational therapy after being discharged from acute care.
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OBJECTIVE: Liquid biopsy (LB) is a non-invasive technique to detect genetic alterations by next-generation sequencing (NGS) when tissue biopsy is not available. This study aims to estimate in the Spanish setting, the cost-effectiveness of using FoundationOne Liquid CDx (F1L CDx), a novel blood-derived LB test based on NGS, versus non-molecular diagnosis (non-mDx) in patients with advanced non-small cell lung cancer (NSCLC) in whom tissue sampling is not feasible. METHODS: A joint model was developed combining a decision-tree with partitioned survival models to calculate the costs and health outcomes over a lifetime horizon, comparing F1L CDx in LB versus non-mDx. Only direct costs (expressed in of 2023) were included and a 3% discount rate for future costs and effects was considered. Health outcomes were expressed in Life Years (LYs) and Quality-Adjusted Life Years (QALYs). Utilities and treatment efficacy were obtained from the literature. An expert panel of 11 Spanish oncologists determined the treatment allocation and validated all model inputs and assumptions. Several sensitivity analyses were performed to assess the robustness of the results. RESULTS: In a hypothetical cohort of 1,000 patients, LB using F1L CDx would detect 386 alterations, so those patients could be treated with targeted therapies or enrolled in clinical trials. Cost-effectiveness results showed that F1L CDx provides greater effectiveness than non-mDx (+383.95 LYs and +305.94 QALYs), with an additional cost of 2,898,308. The incremental cost-utility ratio was 9,473/QALY gained. The probabilistic sensitivity analysis confirmed the robustness of the cost-effectiveness results. LIMITATIONS: Various limitations inherent to cost-effectiveness analyses were described. CONCLUSION: LB with F1L CDx test is a cost-effective strategy in Spain for patients with advanced NSCLC without tissue sample available for molecular diagnosis, improving the personalized treatment of these patients.
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Carcinoma de Pulmón de Células no Pequeñas , Análisis Costo-Beneficio , Neoplasias Pulmonares , Años de Vida Ajustados por Calidad de Vida , Humanos , Carcinoma de Pulmón de Células no Pequeñas/genética , Carcinoma de Pulmón de Células no Pequeñas/patología , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/tratamiento farmacológico , Biopsia Líquida/métodos , Biopsia Líquida/economía , España , Secuenciación de Nucleótidos de Alto Rendimiento/economía , Secuenciación de Nucleótidos de Alto Rendimiento/métodos , Árboles de Decisión , Masculino , Modelos Econométricos , Análisis de Costo-EfectividadRESUMEN
BACKGROUND: In 2003, the WHO aimed for a 75% or higher influenza vaccination rate among at-risk populations. However, this target was achieved in a few groups during selected seasons in some European countries, and never in Germany. Adults with underlying conditions (UCs) are a critical negleted group for influenza vaccination. This study aimed to identify data gaps in influenza burden and vaccination coverage among adults under 60 with UCs in Germany and bridge these gaps using real-world data. MATERIAL AND METHODS: We conducted systematic research and analyses using German administrative and claims databases from June 2016 to April 2024. We report on epidemiology, direct care costs, indirect costs from work incapacity, vaccination coverage rates, and describe data gaps. RESULTS: Influenza data for high-risk populations are limited. Comprehensive data on influenza epidemiology and vaccination coverage rates (VCR) is available, though with a delay in data availability. Before and after the pandemic, individuals aged 50-59 had the highest rates of influenza-related hospitalization and ICU admission compared to younger age groups. Across all age groups and seasons, individuals with UC experienced higher rates of medically attended influenza cases, hospitalizations, and healthcare costs, with those aged 35-59 being particularly vulnerable. Vaccine coverage was higher in adults aged 35-59 compared to those aged 18-24, and in females compared to males. LIMITATIONS: Discrepancies of vaccination status, limited data availability, and variations among the extent of UCs. CONCLUSION: In Germany, recent policy measures have mainly targeted those aged 60 and above. While this elderly population experiences the highest disease-related impact, influenza can also lead to substantial healthcare resource utilization (HCRU) and costs in younger populations with chronic UCs; Facilitating vaccination access for this group, such as through pharmacies, is essential. Definition of quantifiable vaccination targets and measures to increase vaccination rates based on these targets are required.
The research analysed real-world data on the impact of influenza among adults under 60 years old with underlying medical conditions in Germany. The key findings include: Low vaccination rates: The flu vaccination rate among adults with underlying conditions, such as asthma, diabetes, and heart disease, is low.High disease burden: This group has a significantly higher risk of severe influenza complications, experiencing notable rates of illness, hospitalization, and healthcare costs due to the flu. Given the high disease burden and low vaccine coverage, there is a need for improved public health strategies to increase flu vaccine access and uptake among this vulnerable population. These findings contribute to growing evidence supporting the importance of influenza vaccination for adults with underlying medical conditions. The insights provided can inform policymakers, healthcare providers, and public health officials working to improve vaccination rates and protect the health of these vulnerable populations.
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Vacunas contra la Influenza , Gripe Humana , Cobertura de Vacunación , Humanos , Gripe Humana/prevención & control , Gripe Humana/economía , Gripe Humana/epidemiología , Alemania , Persona de Mediana Edad , Adulto , Cobertura de Vacunación/estadística & datos numéricos , Cobertura de Vacunación/economía , Femenino , Masculino , Vacunas contra la Influenza/economía , Vacunas contra la Influenza/administración & dosificación , Adulto Joven , Factores de Edad , Hospitalización/estadística & datos numéricos , Hospitalización/economía , Adolescente , Revisión de Utilización de Seguros , Enfermedad CrónicaRESUMEN
AIMS: Pembrolizumab has demonstrated significantly prolonged disease-free survival and overall survival (OS) among adult patients post-nephrectomy who have an intermediate-high risk, high-risk, or M1 stage with no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The aim of this study was to evaluate the cost-effectiveness of pembrolizumab for patients with RCC post-nephrectomy versus observation in Switzerland. MATERIALS AND METHODS: A previously published Markov model was adapted for the Swiss setting to estimate the cost-effectiveness of adjuvant pembrolizumab versus observation from the Swiss statutory health insurance perspective. Transition probabilities between model states were estimated using survival curves from KEYNOTE-564 (data cut-off: 14 June 2021). Outcomes included costs (2022 Swiss francs [CHF]), quality-adjusted life-years (QALYs), and life-years (LYs), measured over a lifetime horizon. Costs included drug acquisition and administration for adjuvant and subsequent therapy. Both costs and effectiveness were discounted at 3.0% annually. Cost-effectiveness was evaluated at a hypothetical willingness-to-pay (WTP) threshold of CHF 100,000. Sensitivity was assessed through scenario analyses as well as deterministic and probabilistic sensitivity analyses. RESULTS: Over a lifetime horizon, the total incremental cost for pembrolizumab versus observation was CHF 59,089, providing incremental gains of 0.90 QALYs (1.07 LYs); the incremental cost-effectiveness ratio was CHF 65,299/QALY. Pembrolizumab was deemed cost-effective versus observation, with a 69.9% probability of cost-effectiveness. LIMITATIONS: A more recent interim analysis data cut from KEYNOTE-564 with median follow up of 57.2 months has since been published; however, these were not available at the time of analysis. It would likely have minimal impact on transition probabilities from disease-free, and the current approach remains conservative for predicting OS for pembrolizumab. CONCLUSIONS: As an adjuvant treatment of RCC post-nephrectomy, pembrolizumab was found to be cost-effective versus observation in Switzerland at a WTP threshold of CHF 100,000/QALY. Policy makers should consider pembrolizumab as an adjuvant treatment for patients with RCC post-nephrectomy when making decisions regarding resource allocation.
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Anticuerpos Monoclonales Humanizados , Antineoplásicos Inmunológicos , Carcinoma de Células Renales , Análisis Costo-Beneficio , Neoplasias Renales , Cadenas de Markov , Nefrectomía , Años de Vida Ajustados por Calidad de Vida , Humanos , Carcinoma de Células Renales/tratamiento farmacológico , Carcinoma de Células Renales/cirugía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/economía , Neoplasias Renales/tratamiento farmacológico , Neoplasias Renales/cirugía , Neoplasias Renales/economía , Suiza , Antineoplásicos Inmunológicos/economía , Antineoplásicos Inmunológicos/uso terapéutico , Nefrectomía/economía , Quimioterapia Adyuvante/economía , Modelos Econométricos , Masculino , Femenino , Supervivencia sin Enfermedad , Persona de Mediana EdadRESUMEN
OBJECTIVES: To elucidate unmet needs in high-risk endometrial cancer (EC), this study described perioperative treatment patterns in Medicare beneficiaries with high-risk EC and quantified the impact of disease recurrence on clinical and economic outcomes among patients receiving adjuvant therapy. METHODS: Patients aged ≥66 years with high-risk EC (stage I/II EC of non-endometrioid histology or stage III/IVA EC of any histology) receiving hysterectomy with bilateral salpingo-oophorectomy from SEER-Medicare data (2007-2019) were identified; perioperative treatment patterns were described. Post-operative treatment patterns were described among patients receiving adjuvant therapy; overall survival (OS), all-cause and EC-related healthcare resource utilization and costs were evaluated from recurrence date (using a claims-based algorithm developed with clinical input) for recurrent patients and from a frequency-matched date for non-recurrent patients. RESULTS: Of 2,279 patients receiving EC surgery, 3.1% received neoadjuvant therapy and 55.3% received adjuvant therapy. Among 1,199 patients receiving adjuvant therapy, systemic adjuvant therapy with radiation (38.9%) was most common. Median OS was 1.4 years among 378 (31.5%) recurrent patients identified over a median follow-up of 3.7 years. Recurrent patients had significantly higher per-patient-year rates of all-cause outpatient visits (37.7 vs. 22.6), EC-related outpatient visits (14.5 vs. 3.0), and all-cause hospitalizations (1.3 vs. 0.4) than non-recurrent patients, and an excess of $84,562 and $62,128 in all-cause and EC-related annual costs, predominantly driven by hospitalizations. CONCLUSIONS: Our findings highlight the considerable clinical and economic burden experienced by patients with high-risk EC experiencing recurrence and emphasize the unmet need for novel therapies in early settings to mitigate this burden.
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Neoplasias Endometriales , Histerectomía , Medicare , Recurrencia Local de Neoplasia , Programa de VERF , Humanos , Femenino , Neoplasias Endometriales/patología , Neoplasias Endometriales/cirugía , Neoplasias Endometriales/economía , Neoplasias Endometriales/mortalidad , Neoplasias Endometriales/terapia , Estados Unidos , Anciano , Medicare/economía , Histerectomía/economía , Anciano de 80 o más Años , Estadificación de Neoplasias , Revisión de Utilización de Seguros , Quimioterapia Adyuvante/economía , Atención Perioperativa/economía , Salpingooforectomía/economía , Terapia Neoadyuvante/estadística & datos numéricosRESUMEN
AIMS: This study evaluated the association between provider types for patients with newly diagnosed Huntington's disease (HD) and healthcare resource utilization (HCRU), costs, and treatment patterns. MATERIALS AND METHODS: This retrospective analysis used MarketScan databases (1 January 2017-31 December 2021) to identify provider types who diagnosed and managed US adult patients with HD. Patients with continuous enrollment 6 months pre- and 12 months post-diagnosis were included. Outcomes evaluated over 12 months post-diagnosis included hospitalizations, outpatient visits, antipsychotic or vesicular monoamine transporter 2 (VMAT2) inhibitor use, and total healthcare costs. RESULTS: Three hundred and forty eligible patients had a mean age at diagnosis of 49 years. 56.5% were female; 71.5% had a Charlson Comorbidity Index of 0. Patients were diagnosed by neurologists (48.5%), primary care providers (PCPs) (35.6%), psychiatrists (3.5%), or other providers (12.4%). Patients diagnosed by PCPs or neurologists received significantly more follow-ups by the same diagnosing provider type (p < 0.05). All-cause and HD-related outpatient visits at 12-month follow-up had more patients diagnosed by PCPs (23.9, 5.1) than neurologists (18.0, 2.4), psychiatrists (16.7, 1.67), or others (15.3, 2.4). HD-related mean costs totaled $2,489 ($1,179 inpatient and $1,310 outpatient). Patients diagnosed by neurologists had significantly lower HD-related total non-medication costs vs. those diagnosed by PCPs (-$2,256; p < 0.05). Among patients diagnosed by neurologists vs. PCPs, similar proportions received antipsychotics within the first year (55 vs. 52%, respectively); more patients managed by neurologists received VMAT2 inhibitors (12 vs. 7%, respectively). LIMITATIONS: Our study includes limitations inherent to retrospective claims studies. CONCLUSIONS: Patients with HD are most often diagnosed by neurologists or PCPs; the same diagnosing provider type typically manages follow-up. Patients diagnosed by neurologists had significantly fewer HD-related outpatient visits, lower HD-related non-drug costs, and more frequently received VMAT2 inhibitors vs. those diagnosed by PCPs. Our findings show an integrated care team may provide evidence-based, personalized care for patients with HD.
Huntington's disease is a rare disease that is caused by changes in genes. Symptoms of Huntington's disease are irritability, depression, loss of memory, and issues with movement. The symptoms are different for each person and can happen at different times during the disease. A team of doctors that can help with all the symptoms is important for treating Huntington's disease. In our study we looked at which type of doctor was diagnosing Huntington's disease and if the patient continued to see the same type of doctor. We also looked at whether the costs of the disease were related to the type of doctor that diagnosed the disease. We found that most patients were diagnosed by a primary care doctor or a neurologist (brain doctor), and they continued to see the same doctor. Patients who saw a neurologist had less doctor visits for their HD and also less costs for their HD. These results show having a team of doctors that can help with all symptoms of HD may make it easier for patients to receive the best care for their symptoms.
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Enfermedad de Huntington , Humanos , Enfermedad de Huntington/tratamiento farmacológico , Enfermedad de Huntington/economía , Femenino , Masculino , Estudios Retrospectivos , Persona de Mediana Edad , Adulto , Neurólogos , Aceptación de la Atención de Salud/estadística & datos numéricos , Psiquiatría , Estados Unidos , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Gastos en Salud/estadística & datos numéricos , Antipsicóticos/uso terapéutico , Antipsicóticos/economía , Comorbilidad , Revisión de Utilización de SegurosRESUMEN
AIMS: Patients with medication-refractory restless legs syndrome (RLS) have limited therapeutic options available for symptom relief. Tonic motor activation (TOMAC) presents a novel, non-invasive therapy for this patient population. The aim of this study was to conduct an updated cost-effectiveness analysis of TOMAC therapy based on recently available longer-term follow-up data. MATERIALS AND METHODS: A previously published decision-analytic Markov model was utilized to project strategy-specific costs and outcomes over three-years and lifetime for TOMAC compared to status quo treatment (control). Cohort characteristics were based on 24-week clinical data from the extension cohort of the RESTFUL study, which included longer-term follow-up of RESTFUL completers who were assigned to continue or discontinue TOMAC use (TOMAC and control, respectively). The primary analysis outcome was the incremental cost-effectiveness ratio (ICER) in $ per quality-adjusted life year (QALY) gained, calculated using change in International RLS Study Group Rating Scale (IRLS) score as the effect measure. Extensive sensitivity analyses were performed. RESULTS: TOMAC treatment improved IRLS by 5.9 versus control, resulting in estimated utility improvement of +0.05. Over three-years and lifetime, TOMAC added 0.14 and 0.73 QALYs, at incremental costs of $6,751 and $27,440, resulting in projected ICERs of $47,609 and $37,823 per QALY gained, respectively. TOMAC was found to be cost-effective across all tested sensitivity analyses. LIMITATIONS AND CONCLUSION: The inclusion of longer follow-up data in the current analysis confirms earlier exploratory cost-effectiveness findings and suggest TOMAC therapy may provide a high-value treatment option for patients with medication-refractory RLS.
Restless Legs Syndrome (RLS) is a is a neurological disorder, usually chronic, that causes an overwhelming urge to move one's legs, with pronounced implications for patients' quality of life. While pharmaceutical treatment options exist, a substantial proportion of patients are considered refractory to drug treatment. Tonic motor activation (TOMAC) therapy is a novel non-invasive neurostimulation approach that was recently cleared for market in the United States. This study sought to provide an updated economic analysis based on recently available data with longer follow-up. The findings of this study, based on data from the RESTFUL Extension study, suggest TOMAC therapy can be a high-value treatment alternative for refractory patients, providing meaningful quality of life improvement at costs that render it cost-effective in the United States. Future data with further extended follow-up will be useful to further broaden the evidence base underpinning these findings.
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Análisis Costo-Beneficio , Cadenas de Markov , Años de Vida Ajustados por Calidad de Vida , Síndrome de las Piernas Inquietas , Humanos , Síndrome de las Piernas Inquietas/tratamiento farmacológico , Síndrome de las Piernas Inquietas/economía , Masculino , Femenino , Persona de Mediana Edad , Anciano , Modelos EconométricosRESUMEN
AIMS: To determine the clinical and economic implications of first-line or drug-naïve catheter ablation compared to antiarrhythmic drugs (AADs), or shorter AADs-to-Ablation time (AAT) in atrial fibrillation (AF) patients in France and Italy, using a patient level-simulation model. MATERIALS AND METHODS: A patient-level simulation model was used to simulate clinical pathways for AF patients using published data and expert opinion. The probabilities of adverse events (AEs) were dependent on treatment and/or disease status. Analysis 1 compared scenarios of treating 0%, 25%, 50%, 75% or 100% of patients with first-line ablation and the remainder with AADs. In Analysis 2, scenarios compared the impact of delaying transition to second-line ablation by 1 or 2 years. RESULTS: Over 10 years, increasing first-line ablation from 0% to 100% (versus AAD treatment) decreased stroke by 12%, HF hospitalization by 29%, and cardioversions by 45% in both countries. As the rate of first-line ablation increased from 0% to 100%, the overall 10-year per-patient costs increased from 13,034 to 14,450 in Italy and from 11,944 to 16,942 in France. For both countries, the scenario with no delay in second-line ablation had fewer AEs compared to the scenarios where ablation was delayed after AAD failure. Increasing rates of first-line or drug-naïve catheter ablation, and shorter AAT, resulted in higher cumulative controlled patient years on rhythm control therapy. LIMITATIONS: The model includes assumptions based on the best available clinical data, which may differ from real-world results, however, sensitivity analyses were included to combat parameter ambiguity. Additionally, the model represents a payer perspective and does not include societal costs, providing a conservative approach. CONCLUSION: Increased first-line or drug-naïve catheter ablation, and shorter AAT, could increase the proportion of patients with controlled AF and reduce AEs, offsetting the small investment required in total AF costs over 10 years in Italy and France.
This study created an individual patient level simulation to estimate the clinical and economic implications of catheter ablation, which is a non-pharmacological option to treat patients with atrial fibrillation (AF). This study examines the impact of the updated 2020 ESC guidelines to managing AF in Italian and French patients comparing antiarrhythmic drug treatment to first- and second-line catheter ablation. Differences in AF-related adverse events (AEs) such as stroke, hospitalization, cardioversions, and bleeding events were considered in the model to inform the overall per-patient costs. The model was tested with 50,000 patient simulations to limit random effects. The results of the patient simulation model revealed that as the frequency of utilizing first-line catheter ablation increased from 0% to 100% compared to pharmacological treatment, AEs were reduced in both countries, resulting in a slightly increased 10-year-per-patient cost. Additionally, for patients who fail first-line pharmacological treatment, those who receive second-line catheter ablation in the next year, versus a delay of one or two years, had the highest rate of cumulative controlled patient years on rhythm control therapy and the lowest AE rate by year 10 of the model. Overall, 10-year per-patient costs were similar, regardless of whether second-line ablation was delivered with no delay or a one-or two-year delay. In conclusion, increased use of first-line catheter ablation and earlier second-line catheter ablation can reduce the rates of adverse clinical events and increase the proportion of patients with controlled AF for a similar investment in per-patient costs over 10-years.
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This study examined the effect of women's educational level on their perceptions regarding the deadliness of malaria in children. The regression results revealed that women with primary education did not differ statistically from the reference category (i.e. women with no education) in terms of their likelihood of perceiving malaria as a deadly disease in children. In contrast, women with secondary education were 4.3 percentage points more likely to perceive malaria as a deadly disease compared to the reference category. Similarly, women with higher education were 8 percentage points more likely to perceive malaria as a deadly disease compared to the reference category. These results highlight the crucial role of women's education in shaping their perceptions of disease in children, which also has implications for child health outcomes.
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Escolaridad , Conocimientos, Actitudes y Práctica en Salud , Malaria , Humanos , Nigeria , Femenino , Adulto , Niño , Adolescente , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto JovenRESUMEN
AIMS: To understand treatment patterns, healthcare resource utilization (HCRU), and the economic burden of diffuse large B-cell lymphoma (DLBCL) in elderly adults in the US. MATERIALS AND METHODS: This retrospective database analysis utilized US Centers for Medicare and Medicaid Services Medicare fee-for-service administrative claims data from 2015 to 2020 to describe DLBCL patient characteristics, treatment patterns, HCRU, and costs among patients aged ≥66 years. Patients were indexed at DLBCL diagnosis and required to have continuous enrollment from 12 months pre-index until 3 months post-index. HCRU and costs (USD 2022) are reported as per-patient per-month (PPPM) estimates. RESULTS: A total of 11,893 patients received ≥1-line (L) therapy; 1,633 and 391 received ≥2 L and ≥3 L therapies, respectively. Median (Q1, Q3) age at 1 L, 2 L, and 3 L initiation, respectively, was 76 (71, 81), 77 (72, 82), and 77 (72, 82) years. The most common therapy was R-CHOP (70.9%) for 1 L and bendamustine ± rituximab for 2 L (18.7%) and 3 L (17.4%). CAR T was used by 14.8% of patients in 3 L. Overall, 39.6% (1 L), 42.1% (2 L), and 47.8% (3 L) of patients had all-cause hospitalizations. All-cause mean (median [Q1-Q3]) costs PPPM during each line were $22,060 ($20,121 [$16,676-$24,597]) in 1 L, $30,027 ($20,868 [$13,416-$31,016]) in 2 L, and $47,064 ($25,689 [$15,555-$44,149]) in 3 L, with increasing costs driven primarily by inpatient expenses. Total all-cause 3 L mean (median [Q1-Q3]) costs PPPM for patients with and without CAR T were $153,847 ($100,768 [$26,534-$253,630]) and $28,466 ($23,696 [$15,466-$39,107]), respectively. CONCLUSIONS: No clear standard of care exists in 3 L therapy for older adults with relapsed/refractory DLBCL. The economic burden of DLBCL intensifies with each progressing line of therapy, thus underscoring the need for additional therapeutic options.
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Revisión de Utilización de Seguros , Linfoma de Células B Grandes Difuso , Medicare , Humanos , Linfoma de Células B Grandes Difuso/economía , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Estados Unidos , Estudios Retrospectivos , Anciano , Masculino , Femenino , Anciano de 80 o más Años , Medicare/economía , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Aceptación de la Atención de Salud/estadística & datos numéricos , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Gastos en Salud/estadística & datos numéricos , Factores de Edad , Doxorrubicina/uso terapéutico , Doxorrubicina/economía , Rituximab/economía , Rituximab/uso terapéuticoRESUMEN
AIMS: Food allergies impose a large clinical and financial burden on patients and the health care system. However, little is known about the factors associated with health care resource use and costs. The aim of this study was to investigate health care resource use and costs in individuals with food allergies utilizing health care in the United States. METHODS: We conducted a retrospective analysis of insurance claims data from the Merative MarketScan Research Databases (indexed from 1 January 2015 to 30 June 2022). All-cause and food allergy-related health care resource use, direct medical, and out-of-pocket costs for medical services were estimated for 12 months post-index using International Classification of Diseases [ICD] codes. RESULTS: Of 355,520 individuals with food allergies continuously enrolled in a health insurance plan for ≥12 months pre- and post-index, 17% had a food allergy-related emergency department visit and 0.9% were hospitalized. The top patient characteristic associated with all-cause and food allergy-related hospitalizations, all-cause costs, and food allergy-related outpatient visit costs was a Charlson Comorbidity Index score of ≥2. Food allergy-related direct medical and out-of-pocket costs were high among patients with a food allergy-related visit. Out-of-pocket cost per patient per year for outpatient visits, emergency department visits, and hospitalizations had an estimated mean of $1631 for patients with food allergy-related visits, which is â¼11% of the total costs for these services ($14,395 per patient per year). LIMITATIONS: Study limitations are primarily related to the nature of claims databases, including generalizability and reliance on ICD codes. Nevertheless, MarketScan databases provide robust patient-level insights into health care resource use and costs from a large, commercially insured patient population. CONCLUSION: The health care resource use of patients with food allergies imposes a burden on both the health care system and on patients and their families, especially if patients had comorbidities.
Some people with food allergies might need extra visits to the doctor or hospital to manage allergic reactions to food, and these visits add to the cost of medical services for both families and for health care providers. Using records of health insurance claims, we looked into the factors affecting medical visits and costs in people with food allergies in the United States. For people with food allergies, having additional medical conditions (measured using the Charleson Comorbidity Index) were linked with extra medical visits and costs. Out-of-pocket costs were high for people who visited a doctor or hospital for their food allergies (costing each person more than $1,600 per year). The total medical cost of food allergy-related care was $14,395 per person per year, paid for by families and health care providers. Our findings might help to better manage and treat people with food allergies and reduce medical costs.
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Hipersensibilidad a los Alimentos , Gastos en Salud , Revisión de Utilización de Seguros , Humanos , Hipersensibilidad a los Alimentos/economía , Masculino , Femenino , Estados Unidos , Estudios Retrospectivos , Adulto , Persona de Mediana Edad , Gastos en Salud/estadística & datos numéricos , Adolescente , Adulto Joven , Niño , Preescolar , Lactante , Comorbilidad , Anciano , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricos , Recién NacidoRESUMEN
AIM: To investigate hepatitis A-related healthcare resource use and costs in the US. METHODS: The Merative Marketscan Commercial Claims and Encounters database was retrospectively analyzed for hepatitis A-related inpatient, outpatient, and emergency department (ED) claims from January 1, 2012 to December 31, 2018. We calculated the hepatitis A incidence proportion per 100,000 enrollees, healthcare resource utilization, and costs (in 2020 USD). Results were stratified by age, gender, and select comorbidities. RESULTS: The overall hepatitis A incidence proportion was 6.1 per 100,000 enrollees. Among individuals with ≥1 hepatitis A-related claim, the majority (92.6%) had ≥1 outpatient visit related to hepatitis A; 9.1% were hospitalized and 4.2% had ≥1 ED visit. The mean (standard deviation [SD]) length of hospital stay was 5.2 (8.1) days; the mean (SD) number of outpatient and ED visits were 1.3 (1.3) and 1.1 (0.6), respectively. The incidence proportion per 100,000 was higher among adults than children (7.5 vs. 1.5), individuals with HIV than those without (126.7 vs. 5.9), and individuals with chronic liver disease than those without (143.6 vs. 3.8). The total mean (SD)/median (interquartile range, IQR) per-patient cost for hepatitis A-related care was $2,520 ($10,899)/$156 ($74-$529) and the mean cost of hospitalization was 18.7 times higher than that of outpatient care ($17,373 vs. $928). LIMITATIONS: The study data included only a commercially insured population and may not be representative of all individuals. CONCLUSIONS: In conclusion, hepatitis A is associated with a substantial economic burden among privately insured individuals in the US.
Hepatitis A is an acute liver infection caused by the hepatitis A virus. In the US, safe and effective vaccines for hepatitis A have been available since 1996. Vaccination recommendations include children (all children aged 1223 months and previously unvaccinated children aged 218 years old) and adults at risk of infection or severe disease (e.g. international travelers, men who have sex with men, persons experiencing homelessness, persons with chronic liver disease or persons with HIV infection). Since 2016, the US has experienced person-to-person outbreaks of hepatitis A, primarily affecting unvaccinated individuals who use drugs or are experiencing homelessness. To better understand the impact of hepatitis A in the US, we assessed healthcare resource use and costs in 15,435 patients with hepatitis A from 2012 to 2018 in the Merative Marketscan Commercial Claims and Encounters database. We found that slightly more than 6 per 100,000 enrollees had hepatitis A from 2012 to 2018 and the number of people treated for hepatitis A per 100,000 was highest for people living with HIV or with chronic liver disease. The majority (92.6%) of people reported at least an outpatient visit, 9.1% were hospitalized, and 4.2% had an emergency department visit. The average cost for hepatitis A-related care was $2,520 per patient and was 18.7 times higher for hospitalized patients ($17,373) than for patients treated in outpatient care ($928). Our results are limited by the generalizability of the dataset, which is a convenience sample of private insurance claims, and are therefore unlikely to capture groups at high-risk for hepatitis A, such as individuals experiencing homelessness. In conclusion, hepatitis A leads to considerable healthcare costs for privately insured individuals in the US.
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Hepatitis A , Revisión de Utilización de Seguros , Aceptación de la Atención de Salud , Humanos , Masculino , Estudios Retrospectivos , Femenino , Adulto , Estados Unidos , Persona de Mediana Edad , Hepatitis A/economía , Hepatitis A/epidemiología , Adolescente , Adulto Joven , Niño , Preescolar , Lactante , Aceptación de la Atención de Salud/estadística & datos numéricos , Factores de Edad , Tiempo de Internación/economía , Tiempo de Internación/estadística & datos numéricos , Incidencia , Comorbilidad , Factores Sexuales , Gastos en Salud/estadística & datos numéricos , Servicio de Urgencia en Hospital/estadística & datos numéricos , Servicio de Urgencia en Hospital/economía , Anciano , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricosRESUMEN
AIMS: The Nagasaki Acute Myocardial Infarction Secondary Prevention Clinical Pathway (NASP), a guideline-based regional clinical pathway, was developed to manage low-density lipoprotein cholesterol levels for patients with acute myocardial infarction (AMI) in the Nagasaki prefecture in Japan. This study aimed to summarize the perceived best practices and barriers for the dissemination and operation of the NASP. METHODS: This exploratory sequential mixed methods study was developed around the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Focus group interviews were conducted with 24 physicians with experience treating AMI in alignment with the NASP at foundation hospitals. The identified themes and insights were integrated into the development of the questionnaire. The web-based, self-administered questionnaire with a cross-sectional study design was given to 62 physicians in the Nagasaki prefecture. Mixed-method data integration of the results from both study phases was conducted through meta-inferences made from the qualitative and quantitative data. RESULTS: The best practices included the development of multi-disciplinary operation teams at medical facilities in preparation for the implementation of the NASP, the simplification of the document preparation process, and the establishment of an additional medical fees policy for the utilization of the NASP instead of patient referral documents. Practices tailored to the type of medical institute such as instructing patients on the NASP regimen during index hospitalization for acute-care hospitals, and the development of NASP instructions and manuals for primary care hospitals/outpatient clinics were also recommended. In addition, barriers to the implementation of the NASP such as missed eligible AMI patients for the NASP and the inconsistent implementation to eligible AMI patients were identified. CONCLUSIONS: This study identified the perceived best practices and barriers for the NASP. This knowledge should be considered when expanding the NASP to other institutions across Japan.
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Vías Clínicas , Grupos Focales , Infarto del Miocardio , Prevención Secundaria , Humanos , Prevención Secundaria/métodos , Japón , Estudios Transversales , Masculino , Femenino , Guías de Práctica Clínica como Asunto , LDL-Colesterol/sangre , Persona de Mediana EdadRESUMEN
AIMS: This study assessed the budget impact of resmetirom as a treatment for adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis and estimated total costs for a hypothetical private payer in the United States. MATERIALS AND METHODS: A three-year budget impact analysis based on an open cohort state transition model was developed for a hypothetical one-million-member private health plan. The comparator was Standard of Care (SOC), defined as routine care for non-cirrhotic NASH patients with moderate-to-advanced liver fibrosis. Each year, the number of resmetirom treatment-eligible patients was estimated through prevalent, incident, and diagnostic rate estimates. Costs included resources incurred by the medical and pharmacy benefits of private payers, including resmetirom drug acquisition costs, diagnosis and monitoring, other medical and other prescription costs stratified by disease progression status (i.e. non-cirrhotic vs. cirrhotic/advanced liver diseases). Resmetirom adverse event management costs were included in sensitivity analysis. Drug costs were estimated based on the average wholesale acquisition cost as of March 2024. Other costs were based on published sources and inflated to 2023 US dollars. Budget impact outcomes were presented in aggregate, net, and on a per-member per-month (PMPM) basis. RESULTS: Compared with a scenario without resmetirom, the introduction of resmetirom yielded results ranging from 50 to 238 treated patients, net budget impact of $2.2 to $9.5 million, and PMPM from $0.19 to $0.80 over years one and three. Net costs excluding resmetirom declined over time. In sensitivity analyses, results were most sensitive to diagnostic and epidemiologic inputs. LIMITATIONS: Market shares are based on internal forecasts, a short time horizon, average treatment effects, and other limitations common to BIMs. CONCLUSION: The adoption of resmetirom on the formulary for the treatment of non-cirrhotic NASH with moderate-to-advanced liver fibrosis resulted in a moderate increase in budget impact with declining costs related to NASH progression.
Non-alcoholic steatohepatitis (NASH) is a serious liver disease that can lead to significant liver damage, other health complications, and increased healthcare costs. As the disease progresses, patients typically experience worsening health outcomes. Until recently, there were no Food and Drug Administration (FDA) approved treatments for NASH in the United States. However, in March 2024, the FDA approved REZDIFFRA, a new drug specifically designed to treat NASH patients with moderate-to-advanced liver fibrosis (i.e. NASH with moderate-to-advanced scarring of the liver). Clinical trials have shown that REZDIFFRA can improve health outcomes in these patients.To identify patients who could benefit from REZDIFFRA and to estimate the associated costs, we developed a budget impact model. In this study, we detail the development of this model and present its findings. Our analysis revealed that, while REZDIFFRA is associated with higher overall costs, primarily due to the price of the drug itself, there are potential cost savings when considering the drug's ability to slow disease progression.
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Presupuestos , Cirrosis Hepática , Enfermedad del Hígado Graso no Alcohólico , Humanos , Enfermedad del Hígado Graso no Alcohólico/economía , Enfermedad del Hígado Graso no Alcohólico/tratamiento farmacológico , Cirrosis Hepática/economía , Estados Unidos , Índice de Severidad de la Enfermedad , Adulto , Progresión de la Enfermedad , Modelos Econométricos , Masculino , Análisis Costo-Beneficio , FemeninoRESUMEN
PURPOSE: Research relating to Total Hip Arthroplasty (THA) has found the anterior-based muscle-sparing (ABMS) approach improves both intraoperative and postoperative outcomes when compared to other THA approaches. This study compares the costs and outcomes of the ABMS approach and standard of care (SOC) to determine the relative cost-effectiveness. METHODS: A decision-analytic model was utilized to estimate intraoperative outcomes (i.e. length of procedure, length of stay (LOS), and transfusion rates) and 90-day postoperative complications (deep infection, periprosthetic fracture, and dislocation). Data relating to postoperative complications, intraoperative outcomes, and costs (adjusted to 2023 USD) were obtained from the literature. Model results were presented as incremental costs and complications avoided using a willingness-to-pay threshold of $100,000. We conducted both one-way sensitivity analysis (OWSA), varying each parameter individually within a specific range, and probabilistic sensitivity analysis (PSA) where parameters were varied simultaneously. In scenario analysis, ABMS was also compared to the posterior approach (PA) and direct anterior approach (DAA) individually. RESULTS: ABMS THA was found to have superior results compared to SOC THA over a 90-day time horizon since it decreased major complications by 0.00186 per patient and cost by $3,851 per patient. The PSA found the ABMS approach dominates SOC and is cost-effective in approximately 98.29% and 100% of 10,000 iterations, respectively. Comparing ABMS with only PA procedures increased cost savings per patient to $4,766 while it decreased to $3,242 when comparing ABMS to only DAA procedures. Length of procedure, LOS, and discharge disposition were the main cost drivers. CONCLUSIONS: This analysis demonstrates the ABMS approach for THA is a cost-effective technique when compared to PA and DAA, which may provide an opportunity for cost savings to the healthcare system.
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Artroplastia de Reemplazo de Cadera , Análisis Costo-Beneficio , Tiempo de Internación , Complicaciones Posoperatorias , Artroplastia de Reemplazo de Cadera/economía , Artroplastia de Reemplazo de Cadera/métodos , Humanos , Tiempo de Internación/economía , Complicaciones Posoperatorias/economía , Complicaciones Posoperatorias/prevención & control , Femenino , Técnicas de Apoyo para la Decisión , Masculino , Transfusión Sanguínea/economía , Transfusión Sanguínea/estadística & datos numéricosRESUMEN
AIMS AND BACKGROUND: Whole-genome sequencing (WGS) is increasingly applied in clinical practice and expected to replace standard-of-care (SoC) genetic diagnostics in hematological malignancies. This study aims to assess and compare the fully burdened cost ('micro-costing') per patient for Swedish laboratories using WGS and SoC, respectively, in pediatric and adult patients with acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). METHODS: The resource use and cost details associated with SoC, e.g. chromosome banding analysis, fluorescent in situ hybridization, and targeted sequencing analysis, were collected via activity-based costing methods from four diagnostic laboratories. For WGS, corresponding data was collected from two of the centers. A simulation-based scenario model was developed for analyzing the WGS cost based on different annual sample throughput to evaluate economy of scale. RESULTS: The average SoC total cost per patient was 2,465 for pediatric AML and 2,201 for pediatric ALL, while in adults, the corresponding cost was 2,458 for AML and 1,207 for ALL. The average WGS cost (90x tumor/30x normal; sequenced on the Illumina NovaSeq 6000 platform) was estimated to 3,472 based on an annual throughput of 2,500 analyses, however, with an annual volume of 7,500 analyses the average cost would decrease by 23% to 2,671. CONCLUSION: In summary, WGS is currently more costly than SoC, however the cost can be reduced by utilizing laboratories with higher throughput and by the expected decline in cost of reagents. Our data provides guidance to decision-makers for the resource allocation needed when implementing WGS in diagnostics of hematological malignancies.