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AimTo assess, from a United States (US) payer's perspective, the cost-effectiveness of gels designed to separate the endometrial surfaces (intrauterine spacers) placed following intrauterine surgery.Materials and methodsA decision tree model was developed to estimate the cost-effectiveness of intrauterine spacers used to facilitate endometrial repair and prevent the formation (primary prevention) and reformation (secondary prevention) of intrauterine adhesions (IUAs) and associated pregnancy- and birth-related adverse outcomes. Event rates and costs were extrapolated from data available in the existing literature. Sensitivity analyses were conducted to corroborate the base case results.ResultsIn this model, using intrauterine spacers for adhesion prevention led to net cost savings for US payers of $2,905 per patient over a 3.5-year time horizon. These savings were driven by the direct benefit of preventing procedures associated with IUA formation ($2,162 net savings) and the indirect benefit of preventing pregnancy-related complications often associated with IUA formation ($3,002). These factors offset the incremental cost of intrauterine spacer use of $1,539 based on an assumed price of $1,800 and the related increase in normal deliveries of $931. Model outcomes were sensitive to the probability of preterm and normal deliveries. Budget impact analyses show overall cost savings of $19.96 per initial member within a US healthcare plan, translating to $20 million over a 5-year time horizon for a one-million-member plan.LimitationsThere are no available data on the effects of intrauterine spacers or IUAs on patients' quality of life. Resultingly, the model could not evaluate patients' utility related to treatment with or without intrauterine spacers and instead focused on costs and events avoided.ConclusionThis analysis robustly demonstrated that intrauterine spacers would be cost-saving to healthcare payers, including both per-patient and per-plan member, through a reduction in IUAs and improvements to patients' pregnancy-related outcomes.

In recent years, subsurface drip irrigation has become increasingly important in view of the increasing drought. As it is a newly developed method, the effects of subsurface drip irrigation (SSDI) and surface drip irrigation (SDI) need to be compared in terms of plant growth and yield parameters as well as water savings. The CWSI is an important index that indicates the water status in the plant and is closely related to yield and plant development parameters. The aim of the study is to compare the CWSI calculated with the SDI and SSDI methods in sorghum. The relationship between CWSI and physiological parameters (leaf number (LN), leaf area index (LAI), chlorophyll content (CC)), as well as bioethanol and juice yield are also evaluated in the study. The study was designed in a randomized complete block design to include two drip irrigation methods (SDI and SSDI) and five different irrigation treatments (I0, I25, I50, I75, and I100) in three replications in Antalya in 2017. The full irrigation treatment was applied when 40% of the available soil water capacity in the soil profile of 0-90 cm was depleted, while the deficit irrigation treatments were applied at 75%, 50% and 25% of the full irrigation treatment. Consequently, the upper limit value was calculated as 5.5oC and the lower limit equation was determined as Tc-Ta = -1.96*VPD-0.08 under Mediterranean conditions for the sorghum plant. Compared to the SDI treatments, lower CWSI values were calculated for the SSDI treatments. Additionally, it was determined that as the CWSI increased in sorghum, leaf number, leaf area index, and chlorophyll content values decreased and as a result, juice and bioethanol yield decreased. It was determined that there was a high level of exponential relationship and a strong negative correlation between CWSI-irrigation, CWSI-ET, CWSI-leaf number, CWSI-LAI, CWSI-CC, CWSI-Juice yield, CWSI-bioethanol yield, and CWSI-IWP for both irrigation methods in sorghum. Considering the lower CWSI and higher bioethanol yield, it was concluded that the SSDI method is more suitable for sorghum. [ABSTRACT FROM AUTHOR]

Copyright of SHILAP Revista de Lepidopterologia is the property of Sociedad Hispano-Luso-Americana de Lepidopterologia and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

A significant facet of diabetes is obesity and both conditions present enormous dangers to the global health of populations, thus calling for novel therapeutic approaches. In this review, the author seeks to explore a burgeoning area of research that seeks to treat diabetes and obesity using multi-target drugs, specifically focusing on insulinotropic peptides and the recently developed tirzepatide. The typical therapeutic approach for managing obesity is inadequate because it targets only one or the other of the two clusters. This article as a review clearly depicts the importance of the combined interventions that focus on both disorders To avoiding a long-winded background and justification for diabetes and obesity, let us move directly to the drawbacks related to traditional treatment approaches. Traditional therapies are Intensity modulated radiation therapy IMRT, Imageguided radiation therapy IGRT and stereotactic body radiation therapy SBRT as depicted in Table 1, which can be used to introduce dual targeting therapies. The main idea and purpose of dual targeting are explained, particularly, stressing how this concept may lead to significant changes in treatment approaches. A portion of this review was solely focused on detailing the features of tirzepatide, a drug that stimulates the GLP-1 and GIP receptors. To this end it is analyzed in terms of its evolution, regulation and employment of multifaceted modes of operation. The concept of affinitization is related to tirzepatide and its action on both the GLP-1 and GIP receptors is demonstrated and compared to other medicines in terms of glycemic control or weight loss. This section summarizes findings with regards to the therapeutic outcomes, risk/benefit assessment, and side effects of the treatment regimens; as well as recommended strategies on the handling of complications associated with the use of the therapies. Further, its clinical relevance is explained by making comparison with other alternative treatment modalities. The conclusion of the review features also a prognosis on the probable future of dual targeting therapies in the treatment of diabetes and obesity. In light of two major considerations: glycemic control and weight reduction, these therapies are still valuable for wider application of therapies with comprehensive treatment value. It is also hoped that this article will help direct future research and actual clinical practice concerning the innovative possibility of dual targeting methodology. [ABSTRACT FROM AUTHOR]

Copyright of Sozialer Fortschritt is the property of Duncker & Humblot GmbH and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This article analyzes how fourth graders collaborate when working on an engineering project. Specifically, what are habits that fourth graders exhibit when working together successfully? Acting as a participant-researcher, I compared the habits of eight fourth-grade students (two groups) in a rural classroom by video-recording the students collaborating on an engineering project. The results showed that the biggest indicator of success was using inclusive language such as 'we' and 'ours.' This article emphasizes the difference between groups' use of the word "I" and the word "we." I then replicated these findings with a subsequent fourth-grade class. I suggest that we, as educators, can explicitly teach our students to use more inclusive language when collaborating. The inclusive language may help students be more successful when working on all kinds of projects, including science and engineering. [ABSTRACT FROM AUTHOR]

Copyright of Church in the World / Crkva u Svijetu is the property of University of Split, Catholic Faculty of Theology and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ObjectivesPreterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment.MethodsThe ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with masked risk predictor assessment (TREETOP; NCT02787213). All subjects were included in three arms across 500 simulated trials: standard of care (SoC, control); risk predictor/case management comprising increased outreach, education and specialist care (RP-CM, active); and multimodal management (risk predictor/case management with pharmacological treatment) (RP-MM, active). In the active arms, only subjects stratified as higher risk by the predictor were modeled as receiving the intervention, whereas lower-risk subjects received standard care. Higher-risk subjects' gestational ages at birth were shifted based on published efficacies, and dependent outcomes, calibrated using national datasets, were changed accordingly. Subjects otherwise retained their original TREETOP outcomes. Arms were compared using survival analysis for neonatal and maternal hospital length of stay, bootstrap intervals for neonatal cost, and Fisher's exact test for neonatal morbidity/mortality (significance, p

Copyright of Annals of Philosophy / Roczniki Filozoficzne is the property of John Paul II Catholic University of Lublin, Faculty of Philosophy and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The contribution deals with the question of the constitution and persistence of the "self," linking psychological and sociological approaches. The central interface of this linkage is derived from the process character of the self. It is argued that transdisciplinary work aiming at this common conceptual core will prove particularly fruitful. After discussing the status of the term "the self" in both science and everyday usage, conceptual arguments and definitions (in contrast to related terms such as ego, individual, person, or subject) are examined. A third step provides a synopsis of established approaches and arguments both from psychological and sociological perspectives, offering points of convergence for a metadisciplinary concept of the self. The proposed process character of the self is discussed with respect to language pragmatics, memory performance, and body boundedness. The final section sums up the lines of argumentation and emphasizes intended inspiration for interdisciplinary discussion. [ABSTRACT FROM AUTHOR]

BackgroundA striking aspect of evolution is that it often converges on similar trajectories. Evolutionary convergence can occur in deep time or over short time scales, and is associated with the imposition of similar selective pressures. Repeated convergent events provide a framework to infer the genetic basis of adaptive traits. The current study examines the genetic basis of secondary web loss within web-building spiders (Araneoidea). Specifically, we use a lineage of spiders in the genus Tetragnatha (Tetragnathidae) that has diverged into two clades associated with the relatively recent (5 mya) colonization of, and subsequent adaptive radiation within, the Hawaiian Islands. One clade has adopted a cursorial lifestyle, and the other has retained the ancestral behavior of capturing prey with sticky orb webs. We explore how these behavioral phenotypes are reflected in the morphology of the spinning apparatus and internal silk glands, and the expression of silk genes. Several sister families to the Tetragnathidae have undergone similar web loss, so we also ask whether convergent patterns of selection can be detected in these lineages.ResultsThe cursorial clade has lost spigots associated with the sticky spiral of the orb web. This appears to have been accompanied by loss of silk glands themselves. We generated phylogenies of silk proteins (spidroins), which showed that the transcriptomes of cursorial Tetragnatha contain all major spidroins except for flagelliform. We also found an uncharacterized spidroin that has higher expression in cursorial species. We found evidence for convergent selection acting on this spidroin, as well as genes involved in protein metabolism, in the cursorial Tetragnatha and divergent cursorial lineages in the families Malkaridae and Mimetidae.ConclusionsOur results provide strong evidence that independent web loss events and the associated adoption of a cursorial lifestyle are based on similar genetic mechanisms. Many genes we identified as having evolved convergently are associated with protein synthesis, degradation, and processing, which are processes that play important roles in silk production. This study demonstrates, in the case of independent evolution of web loss, that similar selective pressures act on many of the same genes to produce the same phenotypes and behaviors.

Personal identity include both first-person and third-person identities. The objective of the essay is to demonstrate the primitiveness of first-person identity, or self-identity, by re-examining a few wellknown thought experiments that are referred to as 'borderline cases of personal identity'. The primary goal of the essay is to demonstrate that no borderline case poses a significant challenge to first-person identity. The discussion is divided into three sections. The first section motivates the debate. Additionally, the importance of the first-person identity statement 'I am I', which is immune from error through misidentification, is established. In the second section, five well-known thought experiments are evaluated to demonstrate that none of them poses a genuine threat to first-person identity. In the third and final part, some real pathological case studies are analysed to strengthen the main argument. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To compare healthcare resource utilization (HCRU) and all-cause medical costs among individuals aged ≥50 years who received influenza and COVID-19 vaccines on the same day and those who received influenza vaccine only. Methods: We conducted a retrospective cohort study leveraging Optum's de-identified Clinformatics DataMart from 8/31/2021 to 7/31/2023. Individuals aged ≥50 years continuously enrolled in health plans for 1 year prior and until 7/31/2023 were included. Two cohorts were formed based on vaccination status between 8/31/2022 and 1/31/2023: co-administered influenza and COVID-19 vaccines (co-admin cohort) and influenza vaccine only (influenza cohort). Associations between vaccination status and all-cause, influenza-related, COVID-related, pneumonia-related, and cardiorespiratory-related hospitalization, outpatient or emergency room visits and all-cause medical costs were estimated by weighted generalized linear models, adjusting for confounding by stabilized inverse probability of treatment weighting. Results: 613,156 (mean age: 71) and 1,340,011 (mean age: 72) individuals were included in the co-admin and influenza cohorts, respectively. After weighting, the baseline characteristics were balanced between cohorts. The co-admin cohort was at statistically significant lower risk of all-cause (RR: 0.95, 95% CI: 0.93-0.96), COVID-19-related (RR: 0.59, 95% CI: 0.56-0.63), cardiorespiratory-related (RR: 0.94, 95% CI: 0.93-0.96) and pneumonia-related (RR: 0.86, 95% CI: 0.83-0.90) hospitalization but not influenza-related hospitalizations (RR: 0.91, 95% CI: 0.81, 1.04) compared with the influenza cohort. Co-administration was associated with 3% lower all-cause medical cost (cost ratio: 0.974, 95% CI: 0.968, 0.979) during the follow-up period compared to receiving influenza vaccine only. Limitations: Limitations include the potential residual confounding bias in observational data, measurement errors from claims data, and that the cohort was followed for a single season. Conclusion: Receiving co-administered COVID-19 and influenza vaccines versus only receiving influenza vaccination reduced the risk of HCRU, especially COVID-19–related hospitalization and all-cause medical costs. Increasing vaccine coverage, particularly for COVID-19, might have public health and economic benefits. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives: This study seeks to determine the association between kidney failure and heart diseases by examining how they influence the diagnosis of hyperkalemia. Methods: We employ a fuzzy regression discontinuity design (RDD) by harnessing the inherent threshold in potassium levels, which serves as a diagnostic criterion for hyperkalemia. Simultaneously, we utilize patient diagnosis data related to kidney failure and heart diseases. This approach allows us to evaluate the causal impact of both diagnoses on hyperkalemia. Results: Significant overall increases in the risk of developing hyperkalemia are evident subsequent to a diagnosis of kidney failure or heart disease. The study finds that the probability of receiving a kidney failure diagnosis increases by 11.2% regarding a cut-off of 6 mEq/L of potassium. In addition, there is a 6.8% likelihood of experiencing hyperkalemia in the case of a prior diagnosis of hypertension, and an 8.8% probability in the case of a diagnosis of depression. The findings remain robust when considering alternative parametric and non-parametric specifications as well as placebo tests. Conclusions: This study provides new empirical insights into the causal impact of kidney failure and heart disease, underscoring the significance of monitoring such patients to prevent serious complications in the future. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study is to review the influence of functional evaluation coefficient (FEC) II adjustments on reimbursement for hospitals in Japan operating under the diagnosis procedure combination/per-diem payment (DPC/PDPS) system. Methods: Publicly available information was used to describe the FEC II adjustment system and to consider its influence on reimbursement for fiscal years (FY) 2018, 2020, and 2022. Moreover, descriptive statistics and multivariate regression analysis were used to consider how the adjustment differed based on hospital and treatment-related characteristics in FY 2022. Results: In FY 2022 there were 1764 hospitals operating under the DPC/PDPS system and the FEC II adjustment was highest, on average, for hospitals in the Hokkaido/Tohoku and Chubu regions with a mean adjustment in reimbursement of 0.1033 (+10.33%), respectively, and lowest for hospitals in the Kyushu/Okinawa region with a mean adjustment of only 0.0921 (+9.21%). Based on the results of a multivariate regression analysis, hospitals in the Hokkaido/Tohoku, Kinki, or Chugoku/Shikoku regions and those that had more cases related to the nervous system, the circulatory system, hematological disorders, and traumas, burns, and poisoning had a statistically significant positive association with the FEC II adjustment. Conversely, University or Specified DPC/PDPS hospital and those having more cases related to eye, ENT, breast, mental, and musculoskeletal system/connective tissue disorders had a statistically significant negative association with the FEC II adjustment. Conclusion: The FEC II adjustment varies by hospital region, hospital type, and the kind of conditions treated by DPC/PDPS hospitals in Japan. New technologies to support DPC/PDPS hospitals that focus on the treatment of musculoskeletal system and connective tissue disorders, for example, and to allow for a reduction in the length of stay of patients may lead to a higher reimbursement for some DPC hospitals. [ABSTRACT FROM AUTHOR]

Background: Endoscopic surgery is widely performed with an increasing use of powered vascular staplers (PVS). However, few studies have examined PVS use in China, most of which have focused on clinical effects; fewer studies have examined the economic benefits of PVS. This study evaluated the clinical and economic benefits of the PVS compared to standard-of-care (SOC) staplers in lobectomy using results from a single-arm, multicenter clinical trial conducted in China and actual clinical use in a hospital collected in a real healthcare setting. Methods: Patients with lung cancer undergoing thoracoscopic lobectomy were included in the study. The clinical and economic benefits of powered vascular stapler have been evaluated from a hospital's perspective based on parameters such as bleeding occurrence, hospitalization time, secondary thoracotomy, and hospitalization costs. To compare the bleeding associated with use of PVS and SOC stapler in clinical use, PVS single-arm multi-center clinical trial data is used for the intervention group, and sampling data from hospitals is used for the control group. To ensure the outcome indicators between the two groups are comparable, we set the same inclusion criteria for the two groups of data and then used propensity score matching (PSM) to match two groups of patients according to the baseline characteristics. Results: The results show that bleeding incidence in patients with SOC stapler group is 17.33% from hospital sampling data. In contrast, in the PVS group, it is 4.00%, and these rates are statistically different (p = 0.0167). Considering converted to open thoracic surgery, the rate of the SOC stapler group is 5.78% and that of the PVS group is 4.00%. These rates are not statistically different (p = 0.6166). Regarding hospitalization days, the length of the SOC stapler group is 18.97 days, while that in the PVS group is 12.38 days, and these data are statistically different (p = 0.0002). As patients in the PVS group have reduced bleeding, they will require less resource use from blood transfusion, drug services, and surgical services. If PVS is used for transection of vessel, it can reduce the bleeding incidence by 13.33% and save 75.47 CNY in blood transfusion costs, 571.36 CNY in drug costs, and 183.38 CNY in surgical service costs per patient. From these three aspects, the hospital saves per patient 830.21 CNY. Conclusions: Compared with the SOC stapler group, the PVS group has a lower bleeding incidence and shorter hospital days for lobectomy. In terms of blood transfusion costs, drug costs, and surgical service costs, the hospital saves per patient 830.21 CNY. [ABSTRACT FROM AUTHOR]

Objective: In the absence of head-to-head clinical trials, matching-adjusted indirect comparison (MAIC) was used to compare two 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 three 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 two 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. PLAIN LANGUAGE SUMMARY: 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. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study is to examine the characteristics and quality of economic evaluations for reimbursed medical devices in Japan. Materials and methods: A pragmatic review of cost-effectiveness evaluations (CEA) and other economic evaluations for medical devices reimbursed in Japan published between January 2010 and December 2023 was conducted using the PubMed (Medline), Japan Medical Abstracts Society (ICHUSHI Web), and the Cost-Effectiveness Analysis Registry of the Tufts Medical Center databases—as well as Google Scholar. Evaluations for devices assessed under the health technology assessment system in Japan were also reviewed. Results: Thirty-nine published studies were included with 20 studies (51%) for devices used to treat cardiovascular conditions, 7 studies (18%) for devices used to treat neurological/neurovascular conditions and orthopedic conditions, respectively, and 5 studies (13%) for devices used to treat other types of conditions. The number of published studies for reimbursed medical devices increased from 2017. Nearly 60% of the studies were cost-utility analyses and many were cost-consequence analyses (26%). Although the quality of the studies conducted were good, lack of data was mentioned as a key limitation of nearly all studies—with limited data in general (33%), lack of long-term outcomes data (33%), and lack data for Japan (21%) being key issues. Moreover, lack of cost data was mentioned as a limitation for nearly half (49%) of studies. Limitations: As this was not a systematic literature review, some relevant studies may have been excluded. Moreover, some databases that are known to cover other journals were not used. Conclusions: Despite concerns about lack of sufficient outcomes data, good quality CEAs have been published for reimbursed devices in Japan. However, lack of data may still be an issue and the impact of the learning curve effect on cost-effectiveness may need to be considered more. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study is to examine factors that relate to receipt of a reimbursement premium in Japan, which is defined as an increase in the initially calculated reimbursement price based on certain criteria, or an increase in the operating profit ratio. Materials and Methods: Reimbursement submissions and decisions for newly reimbursed medical devices in Japan from fiscal year (FY) 2015 to FY 2023 were reviewed to consider their characteristics. Moreover, the relationship between reimbursement submission characteristics, as well as other characteristics such as regulatory submission category, risk class, location of the manufacturer headquarters, etc. and the receipt of a Novelty, Usefulness, or Improvement premium (hereafter "utility premium"), or an increase in the operating profit ratio, was examined using univariate and multivariate regression. Results: Among 131 unique medical devices newly reimbursed in Japan from FY 2015 to FY 2023, 57 devices (44%) received a reimbursement premium. Among those, 30 devices (53%) were devices to treat cardiovascular conditions. Based on univariate regression, therapy area, reimbursement category and method used, duration since the comparator device was listed, and estimated peak annual patients for the new device are factors that affect the receipt of a utility premium or an increase in the operating profit ratio. However, based on multivariate regression, only the therapy area, risk-related regulatory submission class, regulatory submission type (novelty), and orphan device designation are associated with the receipt of a utility premium or an increase in the operating profit ratio. Conclusions: Receipt of a utility premium can be challenging. Moreover, medical devices to treat cardiovascular conditions have benefited more from premiums. This may be due to those devices having more data on efficacy at the time of approval and listing. More opportunities for devices to obtain premiums following initial listing may be needed to adequately capture their value. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the healthcare resource utilization (HRU) and costs of patients who initiated cariprazine as their first versus subsequent atypical antipsychotic (AA) following a bipolar I disorder (BP-I) diagnosis. Methods: Adults with a BP-I diagnosis (first claim = index), commercial, Medicare Supplemental, or Medicaid insurance, and ≥1 outpatient cariprazine dispensing were identified from Merative MarketScan database. Cohorts included patients who initiated cariprazine as either their first or subsequent AA after initial BP-I diagnosis. Characteristics were balanced between cohorts using inverse probability of treatment weighting (IPTW). Outcomes evaluated post-index included all-cause and mental health (MH)–related HRU (hospitalizations, emergency department [ED] visits, outpatient visits), total healthcare costs (medical + pharmacy), and treatment patterns. HRU and healthcare costs were reported per patient-year (PPY) and compared between cohorts using rate ratios and 95% CIs estimated using nonparametric bootstrap procedures. Treatment patterns were analyzed descriptively, with standardized differences ≥10% considered important. Results: After IPTW, cohorts included 1,409 patients who initiated cariprazine first and 1,621 patients who initiated cariprazine subsequently; the average (standard deviation, SD) observation period was 678 (373) and 758 (389) days for first and subsequent initiators, respectively. Patients who initiated cariprazine first had 23% fewer all-cause hospitalizations and 28% fewer MH-related hospitalizations PPY (each comparison, p < 0.001). Rates of all-cause and MH-related outpatient visits were significantly lower in patients who initiated cariprazine first versus subsequently (each comparison, p < 0.001), while rates of ED visits were similar. Relative to subsequent initiators, first initiators incurred $2,587 and $2,130 lower all-cause and MH-related total healthcare costs PPY, respectively (each comparison, p < 0.05). Before starting cariprazine, first initiators used fewer BP-I–related medications on average than subsequent initiators (2.6 vs 3.9; standardized difference = 23.9%). Limitations: Potential coding inaccuracies and residual confounding. Conclusions: In this real-world database analysis, patients with BP-I who initiated cariprazine as their first AA had lower rates of HRU and incurred lower costs than patients who initiated cariprazine as a subsequent AA. PLAIN LANGUAGE SUMMARY: Bipolar I disorder is a costly condition. Patients with bipolar I disorder are prone to high healthcare resource use, such as frequent visits to the doctor or hospital. Many atypical antipsychotic drugs, including cariprazine, are used to treat bipolar I. However, the extent to which healthcare resource use and costs vary based on which atypical antipsychotic is prescribed first after diagnosis is unknown. In this study, we used medical insurance claims data to identify adults who received cariprazine as their first atypical antipsychotic, and those with another atypical antipsychotic before starting cariprazine, after being diagnosed with bipolar I. We then compared the number of healthcare visits and medical and drug costs after the initial bipolar I diagnosis between these two groups. Compared to patients who started cariprazine after another atypical antipsychotic, patients who used cariprazine first had fewer visits to the doctor or hospital. The number of visits to the emergency department was similar between the 2 groups. Additionally, medical and drug costs were lower for patients who used cariprazine first compared to those who used other atypical antipsychotics before cariprazine. These results suggest that starting cariprazine as the first atypical antipsychotic for bipolar I disorder may be associated with fewer hospitalizations and doctors visits as well as lower healthcare costs than starting cariprazine after other atypical antipsychotics. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims: To estimate the potential clinical impact and cost-effectiveness of a United Kingdom (UK) Autumn 2024 vaccination campaign with an updated Moderna COVID-19 vaccine in adults ≥65 years and eligible persons 6 months to 64 years of age over a 1-year time horizon (September 2024–August 2025). Materials and methods: A compartmental Susceptible-Exposed-Infected-Recovered model was adapted to reflect COVID-19 cases in the UK. Numbers of symptomatic infections, COVID-19–related hospitalizations and deaths, costs, and quality-adjusted life-years (QALYs) were predicted using a decision tree. The incremental cost-effectiveness ratio (ICER) of an updated Moderna mRNA vaccine (Moderna Autumn 2024 Campaign) was compared to No Autumn 2024 vaccine and to an updated Pfizer-BioNTech mRNA Autumn 2024 vaccine, from a healthcare perspective. Results: The Moderna Autumn 2024 Vaccination Campaign is predicted to decrease the expected 8.3 million symptomatic infections with no vaccination by 19% to 6.7 million. Hospitalizations, long COVID cases, and deaths are expected to decline by 27,000 (−38%), 59,000 (−19%), and 6,000 (−43%), respectively. The Moderna Autumn 2024 Campaign will increase QALYs by 78,000 and costs by £665 million, yielding an ICER of £8,500/QALY gained. Sensitivity analyses suggest that vaccine effectiveness (VE) and waning, symptomatic infection incidence, hospitalization rates, and mortality rates drive cost-effectiveness. Vaccination remains cost-effective when lowering the target population to ≥50 years. Use of the Moderna vaccine is expected to prevent 8,000 more hospitalizations and 1,700 more deaths than the updated Pfizer-BioNTech vaccine. Conclusions: Vaccination of the eligible population would contribute to significant reductions in hospitalizations, deaths, and long COVID in the UK in the 2024–2025 season. Expanding the target population continues to be cost-effective. Use of the Moderna Autumn 2024 Campaign is predicted to reduce SARS-CoV-2 infections and associated outcomes in a cost-effective manner and will contribute to a more resilient healthcare system in the UK. [ABSTRACT FROM AUTHOR]

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. PLAIN LANGUAGE SUMMARY: 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. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the cost-effectiveness of patent foramen ovale (PFO) closure using CARDIOFORM Septal Occluders versus AMPLATZER Septal Occluders, as well as compared to Medical Therapy Alone, from a payor perspective in the United States. Methods: An economic evaluation compared the value of CARDIOFORM, AMPLATZER, and Medical Therapy Alone. A Markov model simulated a cohort of 1,000 individuals with PFO and a history of cryptogenic stroke, with baseline demographic and clinical characteristics reflecting individuals enrolled in the REDUCE and RESPECT trials over a five-year time horizon. The costs and health consequences associated with complications and adverse events, including recurrent stroke, were compared over a time horizon of 5 years. Results: PFO closure using CARDIOFORM was economically dominant, providing both cost-savings and improved effectiveness compared to closure with AMPLATZER. It resulted in an estimated savings of over $1.3 million, an additional 24.8 quality-adjusted life-years (QALYs) gained, and 28 strokes avoided in a cohort of 1,000 patients. When compared to Medical Therapy Alone, closure with CARDIOFORM was found to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of $36,697 per QALY gained. Sensitivity and scenario analysis showed the model findings to be highly robust across reasonable changes to baseline input values and assumptions. Conclusions: The results of this analysis suggest that PFO closure using the CARDIOFORM Septal Occluder is the most cost-effective treatment strategy for patients with a PFO-associated stroke, particularly compared to AMPLATZER where it resulted in both cost-saving and improved patient outcomes. PLAIN LANGUAGE SUMMARY: Why was this study done? Patent foramen ovale (PFO) is a small opening in the heart that can allow blood clots to pass from one side to the other, increasing the risk of strokes, particularly those without a clear cause, known as cryptogenic strokes. Closing the PFO can help prevent these strokes. This study aimed to determine which treatment option is the best value for money and most effective for preventing secondary strokes in patients with PFO: using the CARDIOFORM Septal Occluder, the AMPLATZER Septal Occluder, or using only medications. What did the researchers do? We used a computer model to simulate the health outcomes and costs for 1,000 patients with PFO who had experienced a cryptogenic stroke. The model followed these patients over five years and compared three treatment strategies: closing the PFO with the CARDIOFORM device, closing it with the AMPLATZER device, and using medications alone (Medical Therapy Alone). What did the researchers find? Our findings showed that: The CARDIOFORM device was more cost-effective and provided better health outcomes than the AMPLATZER device. Using the CARDIOFORM device saved over $1.3 million, added nearly 25 more years of good-quality life (measured as quality-adjusted life years or QALYs), and prevented 28 strokes in a group of 1,000 patients. Compared to using medications alone, the CARDIOFORM device was cost-effective, with a cost of about $36,700 for each year of good-quality life gained. What do the results mean? These results suggest that using the CARDIOFORM device to close a PFO is the best strategy for preventing secondary strokes when compared to AMPLATZER and Medical Therapy Alone. This approach not only saves money but also improves patient outcomes compared to the AMPLATZER device and using medications alone. How could this study help patients? This study provides clear and well-grounded information that helps patients, healthcare providers, and policymakers make informed decisions about the best treatment strategies for preventing secondary strokes in patients with PFO. Using the CARDIOFORM device can lead to better health outcomes and cost savings, ultimately improving the quality of life for patients. [ABSTRACT FROM AUTHOR]

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. PLAIN LANGUAGE SUMMARY: 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. [ABSTRACT FROM AUTHOR]

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. PLAIN LANGUAGE SUMMARY: 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. [ABSTRACT FROM AUTHOR]

Aims: Economic studies have found that public support of basic medical research provides important long-term benefits. In response to suggestions that private pharmaceutical research and development (R&D) funding could be totally replaced by public funding, we investigate the economic implications of such a substitution in funding roles that maintain the recent pace of pharmaceutical innovation. Materials and methods: Total lifecycle R&D costs were estimated using the latest available R&D expenditures per novel molecule entering clinical trials, likelihood of approval, pre-clinical and post-approval expenditures, using a published survey and a review of publicly available financial accounts from US-listed multinational developers. This estimate was then stratified by the average number of annual FDA approvals to estimate total costs of R&D funding born by the private sector. Results: We find total lifecycle R&D costs were US$2.83 billion per approved medicine. Estimated uncapitalized costs to replace private R&D funding for one year of FDA approvals were $139.6 billion. These additional costs are equivalent to 302% of the entire National Institute for Health 2022 budget of $46.2 billion, and around 25 times NIH's estimated annual $5.6 billion currently dedicated to clinical research trials for pharmaceuticals. Further assessing the policy proposition through a literature review, we found little evidence for improvements in economic efficiency via public funding substitution, while there may be additional challenges including asymmetric information, adverse selection, yardstick competition, hold-up, under-rewarding of incremental innovation and political rent-seeking. Limitations: Our calculations may undervalue full replacement costs, by excluding non-R&D expenses for manufacturing, distribution, or financing. Conclusions: The bulk of investment in R&D is underwritten by the private sector. Political discourse portraying the NIH as the central force in bringing a new drug to market may underappreciate the pivotal role of private at-risk capital. Replacing such investment while maintaining the current innovation output in terms of approved therapies would necessitate substantial increases in taxpayer financing. [ABSTRACT FROM AUTHOR]

Aims: This study investigated the cost-utility of real-time continuous glucose monitoring (rt-CGM) versus self-monitoring of blood glucose (SMBG) in people with type 2 diabetes (T2D) receiving intensive insulin therapy in South Korea. Methods: The IQVIA Core Diabetes Model (CDM v9.5) was used, with clinical effectiveness data obtained from a large-scale real world study. Costs were obtained from South Korean sources and inflated to 2022 South Korean Won (KRW). A South Korean payer perspective was adopted over a lifetime horizon, with future costs and effects discounted at 4.5% per annum. Baseline characteristics included a mean baseline HbA1c level of 8.6% (71 mmol/mol), and a mean age of 64.4 years. A willingness-to-pay (WTP) threshold of KRW 46.0 million was used. Results: Rt-CGM led to an increase of 0.683 quality-adjusted life years (QALYs) versus SMBG (7.526 QALYs for rt-CGM versus 6.843 QALYs for SMBG). An increase in costs of KRW 16.4 million (from KRW 90.4 million to KRW 106.8 million) was associated with rt-CGM. The incremental cost-utility ratio was KRW 24.0 million per QALY gained, significantly lower than the KRW 46 million threshold. Conclusions: For individuals with T2D managed by intensive insulin therapy in South Korea, rt-CGM is cost-effective relative to SMBG. [ABSTRACT FROM AUTHOR]

Background: Defining attributes and attribute levels for a discrete choice experiment (DCE) poses a significant challenge for practitioners exploring preferences for new or unfamiliar products due to the dearth of available information and limits in stakeholder knowledge. This study outlines a comprehensive process for identifying attributes and levels in a DCE aimed at gauging public preferences for health policies related to medicinal cannabis (MC). Methods: A rigorous four-stage attribute development process was utilized and included i) the formulation of a preliminary attribute list from a scoping review and document analysis, ii) reduction of attributes via focus groups, iii) removal of inappropriate attributes using Delphi studies and research team knowledge, and iv) refinement of attribute language based on the feedback from think-aloud interviews. Results: A base attribute list formed from the scoping review and document analysis served as effective discussion stimuli in focus groups, especially for participants with limited subject knowledge. Structured focus group activities proved more effective than open-ended discussions in engaging naive participants. Delphi studies were found to be overcomplex for expert-led attribute prioritization. Think-aloud interviews during a pilot DCE were essential for assessing attribute language and clarity and understanding participants' decision-making processes. Conclusion: The development of DCE attributes measuring preferences for an unfamiliar health product requires a multi-method approach. Evaluating the outcomes from various methods of attribute development yielded a refined list of attributes that were significant to stakeholders, allowed for meaningful trade-offs, and were presented in language accessible to the target population. PLAIN LANGUAGE SUMMARY: Cannabis is being recognised for its therapeutic potential after decades of prohibition. The regulation of medicinal cannabis varies around the world. The Australian government, for example, has opted for a prescription model. Their policy was implemented after polling revealed the Australian public supported the idea of legal medicinal cannabis. However, the government has not yet sought public input on the substance of that policy. Public input into government decisions is essential to the democratic process. This study investigates what features of medicinal cannabis policy are important to the Australian public. We conducted several studies to achieve specific objectives. The first objective was to develop a large list of potential policy characteristics. A review of the literature and a document analysis of Australian consumer submissions to a government enquiry into medicinal cannabis access fulfilled that objective. Focus groups participants and medicinal cannabis experts reduced that list to policy characteristics that were important to the Australian public. Finally, interviews with 10 members of the Australian public reviewed the final list of characteristics for language clarity. The final list of six characteristics included: (1) The situations under which access to medicinal cannabis is granted? (2) Whether evidence for medicinal cannabis use is available? (3) What form of medical supervision is required? (4) How much intoxicating ingredient the medicinal cannabis includes? (5) What form the medicinal cannabis therapy is administered? and (6) If subsidies for the costs of medicinal cannabis are available? Decisions about medicinal cannabis policy were impacted by patients' medical condition. Decisions about policy were relaxed when patients were terminally ill. The final list is compatible with the characteristics of current Australian medicinal cannabis policy. Access, evidence, amount of intoxicating ingredient, and to a lesser degree therapy form of administration, are important to the provision of medicinal cannabis in Australia. Subsidies toward medicinal cannabis costs are also important but are currently unavailable to most patients. [ABSTRACT FROM AUTHOR]

Background: Biologics and JAK inhibitors were the most effective innovative systemic treatments for moderate-to-severe atopic dermatitis (AD). However, their cost-effectiveness in China remains unclear. This study aims to compare both the short- and long-term cost-effectiveness of abrocitinib and dupilumab in adults with moderate-to-severe AD from the perspective of the Chinese healthcare system. Methods: A hybrid decision tree and Markov model were developed to simulate the costs and health outcomes of interventions on both short-term and long-term horizons. Short- and long-term horizons were employed to reflect the 26-week induction treatment and model the extended 10-year maintenance treatment period, respectively. The cost-effectiveness of strategies was measured by incremental cost-effectiveness ratios (ICERs), which were then compared with the willingness-to-pay threshold (WTP) that was equivalent to the gross domestic product (GDP) per capita of China in 2023 ($12,681 [€11,679.26]). One-way and probabilistic sensitivity analyses were conducted to validate the robustness of the model. Results: Over the short-term horizon, the QALYs (quality-adjusted life years) gained were 0.43 for the abrocitinib group and 0.42 for the dupilumab group, with the costs being $2,716.01 (€2,501.46) and $3,940.33 (€3,629.06), respectively. Over the long-time horizon, abrocitinib therapy yields higher QALYs (6.60 versus 6.53) and incurs a lower cost ($22,765.15 [€20,966.81] versus $30,683.38 [€28,259.54]) compared to dupilumab. The probability of abrocitinib being cost-effective was nearly 100% under the current WTP. Both short- and long-term results showed that abrocitinib was more effective and less costly than dupilumab, making abrocitinib the dominant option. Conclusions: Abrocitinib was dominant compared to dupilumab both over the short- and long-term horizon for moderate-to-severe AD in China. Future research incorporating real-world evidence and long-term efficacy outcomes could further refine these economic evaluations. [ABSTRACT FROM AUTHOR]

Aims: Evaluate existing oncology value frameworks in terms of their methodology, structure, characteristics, and functionality using the example of enfortumab vedotin, an approved therapy for urothelial carcinoma. Methods: A search of PubMed, grey literature, and official websites of relevant international organizations was performed from January 2022 to March 2023. Results: Six frameworks were identified and analyzed, including the American Society of Clinical Oncology's assessment framework, European Society for Medical Oncology's Magnitude of Clinical Benefit Scale, the National Comprehensive Cancer Network's Evidence Blocks, Memorial Sloan Kettering Cancer Center's DrugAbacus, Institute for Clinical and Economic Review's assessment framework, and the Drug Assessment Framework. Comparisons across frameworks were challenging, owing to differing approaches, objectives, perspectives, methodology, and criteria. Based on the results of the EV-301 study (NCT03474107), the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale assigned a score of 4 out of 5 to enfortumab vedotin administered after chemotherapy and immunotherapy. The National Comprehensive Cancer Network's Evidence Blocks enabled assessment of enfortumab vedotin compared with other treatments for locally advanced or metastatic urothelial carcinoma, resulting in the positioning of enfortumab vedotin as a preferred regimen after chemotherapy and immunotherapy. Conclusions: Application of value frameworks in oncology can contribute to informed value-based decision-making. However, comparisons across frameworks should be made with caution and limited to the same lines of treatment. Enfortumab vedotin may contribute to optimizing outcomes in patients previously treated with chemotherapy and immunotherapy for locally advanced or metastatic urothelial carcinoma. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims: In advanced Parkinson's disease (aPD), adequate 24-hour control of OFF-time may not be achievable using oral/transdermal therapies. Clinical trials of foslevodopa/foscarbidopa (LDp/CDP) demonstrate meaningful reductions in OFF-time and OFF-related sleep disturbance in aPD. Previous analyses have only considered direct medical costs: this analysis considers a broader societal perspective (direct non-medical costs, informal care, loss of earnings, productivity, and tax). Methods: Inputs for the societal impact model were taken from a cost-utility model comparing LDp/CDp with best medical treatment (BMT), accepted by the UK National Institute of Health and Care Excellence (NICE). Quintiles of normalized OFF-time across a 16-hour waking day in each treatment group were applied to literature-based estimates for direct medical, non-medical, and indirect costs. The resulting state-specific cost estimates were applied to the modelled aPD patient population. Results: The model estimates the potential UK population for LDp/CDp at 17,505. Continuous 24-hour delivery of LDp/CDp results in greater time spent in OFF-time states 0–1 (0–4 hours of OFF-time/16-hour waking day) vs BMT alone. Net savings if all eligible patients receive LDp/CDp are £79.1 M in year 1, £235.4 M in year 2, rising to £262.2 M in year 3, declining to £222.9 M in year 4 and £153.7 M in year 5 as disease progresses and the efficacy of LDp/CDp declines. The estimated total net savings are £953 M after 5 years. Results are robust in scenario analyses (excluding costs of excessive sleepiness, earnings loss, productivity, and tax loss). Limitations: A NICE-accepted model was used as the economic modelling basis for the societal impact model, however, much of the data was derived from Adelphi datasets, with the potential for inconsistent definitions. Conclusion: When considered from a societal perspective, the use of LDp/CDp in aPD patients inadequately controlled on oral therapy is associated with net healthcare and societal annual savings of over £79.1 M vs BMT. [ABSTRACT FROM AUTHOR]

Background and aims: Arginase 1 deficiency (ARG1-D) is a ultrarare disease with manifestations that cause mobility and cognitive impairment that progress over time and may lead to early mortality. Diseases such as ARG1-D have a major impact also outside of the health care sector and the aim of this study was to estimate the current burden of disease associated with ARG1-D from a societal perspective. Methods: The study was performed as a web-based survey of patients with ARG1-D and their caregivers in four European countries (France, Portugal, Spain, United Kingdom). The survey was distributed at participating clinics and included questions on e.g. symptoms (including the Gross Motor Function Classification System, GMFCS, and cognitive impairment), health care use, medication, ability to work, caregiving, and impact on health-related quality-of-life (HRQoL) using the EQ-5D-5L. Results: The estimated total mean societal cost per patient and year was £63,775 (SD: £49,944). The cost varied significantly with both mobility impairment (from £49,809 for GMFCS level 1 to £103,639 for GMFCS levels 3-5) and cognitive impairment (from £43,860 for mild level to £99,162 for severe level). The mean utility score on the EQ-5D-5L for patients was 0.498 (SD: 0.352). The utility score also varied significantly with both mobility impairment (from 0.783 for GMFCS level 1 to 0.153 for GMFCS level 3-5) and cognitive impairment (from 0.738 for mild level to 0.364 for severe level). Conclusions: Similar to other studies of rare diseases, the study is based on a limited number of observations. However, the sample appear to be reasonably representative when comparing to previous studies of ARG1-D. This study shows that ARG1-D is associated with a high societal cost and significant impact on HRQoL. Earlier diagnosis and better treatment options that can postpone or withhold progression may therefore have a potential for improved HRQoL and savings for the patient, caregiver, and society. [ABSTRACT FROM AUTHOR]

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. PLAIN LANGUAGE SUMMARY: 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. [ABSTRACT FROM AUTHOR]

Aims: Respiratory syncytial virus (RSV) causes severe lower respiratory tract infections (LRTI) in infants and adults. While the clinical burden was recently estimated in adults in Germany, little is known about the economic burden. To fill this gap, this study aimed to assess hospital and outpatient healthcare resource utilization (HRU) and costs of RSV infections in adults in Germany. Methods: In this retrospective, observational study on nationwide, representative, anonymized claims data (2015–2018), we identified patients ≥18 years with ICD-10-GM-codes specific to RSV ("RSV-specific"). To increase sensitivity, patients with unspecified LRTIs (including unspecified bronchitis, bronchiolitis, bronchopneumonia, and pneumonia) during RSV seasons were also included as cases potentially caused by RSV ("RSV-possible"). RSV-related HRU (hospital days, ICU and ventilation treatment, drug dispensation) and direct costs were estimated per episode. Excess costs per episode and for follow-up periods were compared to a matched control cohort. All outcomes were reported per healthcare sector and stratified by age and risk groups as well as disease severity (ICU admission/ventilation). Results: Direct inpatient and outpatient mean episode costs were 3,473€ and 82€, respectively, with substantially higher costs for severe cases requiring intensive care and/or ventilation (10,801€). Direct costs for RSV-specific cases were higher than for RSV-possible cases (inpatients: 6,247€ vs. 3,450€; outpatients: 127€ vs. 82€). Moreover, costs were significantly higher for RSV patients than for controls and increased over time (inpatients: 5,140€ per episode vs 10,093€ per year; outpatients: 46€ per quarter vs 114€ per year). Limitations: While the number of RSV-specific cases was low, inclusion of seasonal LRTI cases likely increased the sensitivity to detect RSV cases and allowed a better estimation of the total costs of RSV. Conclusions: The economic burden of RSV-LRTI in adults in Germany is substantial, persists long-term, and is particularly high in the elderly. This highlights the need for cost-effective prevention measures. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 ∼11% 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. PLAIN LANGUAGE SUMMARY: 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. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the cost-effectiveness of budesonide/formoterol reliever and maintenance therapy compared with salmeterol/fluticasone plus salbutamol as reliever therapy for asthma patients ≥12 years from the societal perspective in China. Methods: A Markov model was developed with three health states (non-exacerbation, exacerbation, and death) with a lifetime horizon. The exacerbation rates were obtained from a prospective cohort study conducted in Chinese asthma patients. Healthcare resources utilization data were estimated based on current clinical asthma management guidelines. Asthma-related mortality, cost input and utility values were derived from public database and literature. Model robustness was assessed with one-way sensitivity and probabilistic sensitivity analyses. Results: Compared with salmeterol/fluticasone plus salbutamol, budesonide/formoterol reliever and maintenance therapy led to fewer exacerbation events (13.6 vs. 15.9) and 0.0077 quality-adjusted life years (QALY) gain at an additional cost of ¥196.38 over lifetime. The base case incremental cost-effectiveness ratio (ICER) was ¥25,409.98 per QALY gained. The variables that had most impact on the model output included drug costs and medication adherence. At a willingness-to-pay threshold of ¥257,094/QALY (3 times of gross domestic product per capita in China in 2022), the probability of budesonide/formoterol maintenance and reliever therapy being cost-effective versus salmeterol/fluticasone plus as-needed salbutamol was 83.00%. Conclusion: From the societal perspective, budesonide/formoterol reliever and maintenance therapy is likely to be a cost-effective option compared with salmeterol/fluticasone plus as-needed salbutamol for Chinese asthma patients ≥12 years. [ABSTRACT FROM AUTHOR]

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. PLAIN LANGUAGE SUMMARY: 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 12–23 months and previously unvaccinated children aged 2–18 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. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to obtain estimates for the direct medical charges associated with hospitalizations and emergency department visits of validated SLE cases in a diverse Systemic Lupus Erythematosus (SLE) population. Methods: The Georgians Organized Against Lupus (GOAL) cohort is a population-based cohort of adult SLE patients from metropolitan Atlanta, GA USA, an area having a diverse SLE population. The GOAL cohort aims to study the impact of social determinants of health (SDoH) on outcomes relevant to patients, healthcare providers, and policymakers. For this study, survey data collected during 2011-2012 was linked to the Georgia Hospital Discharge Database (HDD) to capture hospital admissions (HAs) and emergency department visits (EDVs) throughout Georgia from 2012 through 2013. Direct medical charges were summarized by HCU type among all patients, among those with actual visits, and by socio-demographics and healthcare factors. Results: Among 829 patients (94% women, 78% Black, 64% non-private insurance, 64% not-employed, mean age of 46), 170 (20.5%) and 300 (36.2%) participants had at least one HA and one EDV in 1-year of follow-up, respectively, with 111(13.4%) having both HA and EDV. On average, each patient experienced 0.38 HAs and 0.91 EDVs, with per-patient direct medical charges of $14,968 for HAs & $3,022 for EDVs, and $39,645 per HA & $3,305 per EDV. Patients with higher social vulnerability or more severe disease had higher charges for both HA and EDV (p < 0.01), likely due to the delayed care and neglected health needs leading to more advanced and costly medical treatments. Living below the federal poverty level was associated with higher charges for EDVs (p < 0.001) but with lower charges for HAs (p = 0.036). Conclusions: This study underscores the economic burden of SLE on vulnerable populations, emphasizing the importance of including socio-economic factors in healthcare planning. Policy efforts should prioritize reducing disparities in access to care and implementing preventive strategies. [ABSTRACT FROM AUTHOR]