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Backgrounds: 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 [€11679.26]). 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 (€2501.46) and $3,940.33 (€3629.06), respectively. Over the long-time horizon, abrocitinib therapy yields higher QALYs (6.60 versus 6.53) and incurs a lower cost ($22,765.15 [€20966.81] versus $30,683.38 [€28259.54]) 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.

Plasma cells known as "Mott cells" present non-secretable accumulations of immunoglobulins called "Russell bodies". Its presence is related to hematological neoplasms, but it can appear in chronic inflammatory processes. The most common occurrence within the digestive tract is the gastric antrum associated with H. pylori infection. Our patient is added the rare extragastric cases where the association with H. pylori is inconsistent. We have found a frequent appearance of lower digestive and urological neoplasms in relation to these cases, justified by the expression of circulating cytokines in the tumor area that lead to the overactivation of plasma cells. This possible association could lead us to know data about the tumor environment and serve us for early diagnosis or future therapeutic targets., (Copyright © 2024 Sociedad Española de Anatomía Patológica. Publicado por Elsevier España, S.L.U. All rights reserved.)

Effective and robust catalyst is the core of water splitting to produce hydrogen. Here, we report an anionic etching method to tailor the sulfur vacancy (V S ) of NiS 2 to further enhance the electrocatalytic performance for hydrogen evolution reaction (HER). With the V S concentration change from 2.4% to 8.5%, the H* adsorption strength on S sites changed and NiS 2 -V S 5.9% shows the most optimized H* adsorption for HER with an ultralow onset potential (68 mV) and has long-term stability for 100 h in 1 M KOH media. In situ attenuated-total-reflection Fourier transform infrared spectroscopy (ATR-FTIRS) measurements are usually used to monitor the adsorption of intermediates. The S- H* peak of the NiS 2 -V S 5.9% appears at a very low voltage, which is favorable for the HER in alkaline media. Density functional theory calculations also demonstrate the NiS 2 -V S 5.9% has the optimal |ΔG H* | of 0.17 eV. This work offers a simple and promising pathway to enhance catalytic activity via precise vacancies strategy., (© 2024. The Author(s).)

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.

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.

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.

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.

Introduction: In 2018, gastric cancer (GC) was estimated to account for over 1.03 million new cases globally, making it one of the most frequently diagnosed malignancies. In Spain, about 6,913 new cases were diagnosed in 2022. GC is an aggressive cancer originating in the stomach and ranks fifth in cancer incidence and third in cancer-related deaths worldwide. Despite treatment, only 25% of patients survive more than 5 years after diagnosis., Methods: To estimate the economic impact of premature mortality due to GC, the human capital method was employed. This approach involved collecting data on mortality rates, average salaries, and unemployment rates. The study spanned a 10-year period, from 2013 to 2022, to integrate the latest and most pertinent data for analysis. The goal was to quantify the economic consequences GC-related deaths, providing valuable information for policy makers and healthcare professionals., Results: GC caused 51,814 deaths over the study period with a slight annual decline, predominantly affecting men. Approximately 23% of deaths occurred among people of working age, amounting to a total of 122,632 YPLL. In economic terms, GC deaths accounted for costs of €1,239.34 million in 2013, rising to €1,242.04 million by 2021, for a total of €11,469.07 million over the study period., Conclusions: The incidence of gastrointestinal cancers has decline in some types, but they remain a substantial public health challenge. These findings underline the significant health and economic challenges posed by GC, highlighting the need for targeted interventions to mitigate its impact on both individuals and healthcare systems.

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.

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.

Objectives: Implantable cardioverter defibrillator (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) is underutilized in developing countries. The Improve SCA study has identified a subset of 1.5 primary prevention (1.5PP) patients with a higher risk of SCA and a significant mortality benefit from ICD therapy. From the perspective of China's healthcare system, we evaluated the cost-effectiveness of ICD therapy vs. no ICD therapy among 1.5PP patients with a view to informing clinical and policy decisions., Methods: A published Markov model was adjusted and verified to simulate the course of the disease and describe different health states of 1.5PP patients. The patient characteristics, mortality, utility and complication estimates were obtained from the Improve SCA study and other literature. Cost inputs were sourced from government tender prices, medical service prices and clinical experts' surveys in 9 Chinese public hospitals. For both ICD and no ICD therapy, the total medical costs and quality-adjusted life-years (QALYs) were modelled over a lifetime horizon and the incremental cost-effectiveness ratio (ICER) was calculated. Deterministic and probabilistic sensitivity analyses were performed to assess the uncertainty of the model parameters. We used the willingness-to-pay (WTP) threshold recommended by China Guidelines for Pharmacoeconomic Evaluations, one to three times China's GDP per capita (CNY85,698-CNY257,094) in 2022 Chinese Yuan., Results: The incremental cost effectiveness ratio (ICER) of ICD therapy compared to no ICD therapy is 139,652 CNY/QALY, which is about 1-2 times China's GDP per capita. The probability that ICD therapy is cost effective was 92.1%. Results from sensitivity analysis supported the findings of the base case., Conclusions: ICD therapy compared to no ICD therapy is cost-effective for the 1.5PP patients in China.

Introduction: Our cost-of-illness (COI) model adopted the perspective of both payer and society over a time horizon of 5 years to measure the economic burden of systemic lupus erythematosus (SLE) in Malaysia., Methodology: Our COI model utilized a prevalence-based model to estimate the costs and economic consequences of SLE in Malaysia. The clinical parameters were obtained from published literature and validated using the Delphi panel. Direct and indirect medical costs were measured, including disease management, transient events, and indirect costs. One-way sensitivity analysis was also performed., Results: The number of target Malaysian patients with SLE in the COI model was 18,121. At diagnosis, the numbers of SLE patients with mild, moderate, and severe phenotypes were 2,582, 13,897, and 1,642, respectively. The total SLE cost in Malaysia over 5 years from both payer and society perspectives was estimated at MYR 678 million and 2 billion, respectively. The results showed a considerable cost burden due to productivity losses resulting from SLE-related morbidity and mortality. Over a 5-year time horizon, the costs per patient per year from the payer and society perspectives were MYR 7,484 ($4766) and 24,281($15,465), respectively., Conclusion: Our study demonstrated the substantial economic burden of SLE in Malaysia over a time horizon of 5 years. It affects adults of working age, in addition to the costs of SLE management and its consequences, such as flares, infection, and organ damage. Our COI model indicated that disease management costs among patients with higher disease severity were higher than those among patients with a mild phenotype. Hence, more attetion should be paid to limiting the progression of SLE and the occurrence of flares, with the need for further economic evaluation of novel treatments that could lead to better outcomes.

Aims: Our cost-of-illness (COI) model adopted payer and societal perspectives over five years to measure the economic burden of Systemic Lupus Erythematosus (SLE) in Colombia., Materials and Methods: A prevalence-based model was constructed to estimate costs and economic consequences for SLE patients in Colombia. The model included four health states: three phenotypes of SLE representing mild, moderate, and severe states and death. The clinical inputs were captured from the published literature and validated by the Delphi panel. Our model measured direct medical and indirect costs, including disease management, transient events, and indirect costs. One-way sensitivity analysis was also performed., Results: The number of Colombian SLE patients was 37,498. The number of SLE patients with mild, moderate, and severe phenotypes was 5343, 28757 and 3,397, respectively. SLE-patients with moderate (Colombian pesos; COP 146 billion) and severe phenotypes (COP276 billion) incurred higher costs than those with mild phenotypes (COP2 billion), over 5 years. The total SLE cost in Colombia over five years from the payer and societal perspectives was estimated to be COP 915 billion and 8 trillion, respectively. The costs per patient per year from the payer and societal perspectives were COP 4,881,902 ($3,510) and COP 46,637,054 ($33,528), respectively., Conclusion: The burden of SLE in Colombia over five years is substantially high, mainly due to the consequences of economic loss because it affects women and men of working age, in addition to the costs of SLE management and its consequences, such as flares, infection, and organ damage. Our COI indicated that disease management costs among patients with moderate and severe SLE were substantially higher than those among patients with a mild phenotype. Therefore, more attention should be paid to limiting the progression of SLE and the occurrence of flares, with the need for further economic evaluation of novel treatment strategies that help in disease control.

Aim: The current study compared preparation time, errors, satisfaction, and preference for a prefilled syringe (PFS) versus two RSV vaccines requiring reconstitution (VRR1 and VRR2) in a randomized, single-blinded time and motion study., Methods: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare the number of preparation errors and satisfaction scores, respectively., Results: Sixty-three pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the United States. The least squares mean preparation time per dose for PFS was 141.8 s (95% CI = 156.8-126.7; p  <.0001) faster than for VRR1, 103.6 s (95% CI = 118.7-88.5; p  <.0001) faster than for VRR2, and 122.7 s (95% CI = 134.2-111.2; p  <.0001) faster than the pooled VRRs. Overall satisfaction (combined "Very" and "Extremely") was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine., Limitations: The study is limited by the inability to completely blind observers. To minimize the effects of order, we utilized a 3-sequence block design; however, the order in which the vaccines were prepared may have affected outcomes. Participants were assessed once, whereas if repeated preparations were performed there may have been trained efficiencies gained for each vaccine., Conclusion: PFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.

Aims: The increasing prevalence of end-stage renal disease (ESRD) in the United States (US) represents a considerable economic burden due to the high cost of dialysis treatment. This review examines data from real-world studies to identify cost drivers and explore areas where dialysis costs could be reduced., Methods: We identified and synthesized evidence published from 2016-2023 reporting direct dialysis costs in adult US patients from a comprehensive literature search of MEDLINE, Embase, and grey literature sources (e.g. US Renal Data System reports)., Results: Most identified data related to Medicare expenditures. Overall Medicare spending in 2020 was $29B for hemodialysis and $2.8B for peritoneal dialysis (PD). Dialysis costs accounted for almost 80% of total Medicare expenditures on ESRD beneficiaries. Private insurance payers consistently pay more for dialysis; for example, per person per month spending by private insurers on outpatient dialysis was estimated at $10,149 compared with Medicare spending of $3,364. Dialysis costs were higher in specific high-risk patient groups (e.g. type 2 diabetes, hepatitis C). Spending on hemodialysis was higher than on PD, but the gap in spending between PD and hemodialysis is closing. Vascular access costs accounted for a substantial proportion of dialysis costs., Limitations: Insufficient detail in the identified studies, especially related to outpatient costs, limits opportunities to identify key drivers. Differences between the studies in methods of measuring dialysis costs make generalization of these results difficult., Conclusions: These findings indicate that prevention of or delay in progression to ESRD could have considerable cost savings for Medicare and private payers, particularly in patients with high-risk conditions such as type 2 diabetes. More efficient use of resources is needed, including low-cost medication, to improve clinical outcomes and lower overall costs, especially in high-risk groups. Widening access to PD where it is safe and appropriate may help to reduce dialysis costs.

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.

Objectives: Patients with previously treated microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) tumours have limited chemotherapeutic treatment options. Pembrolizumab received approval from the EMA in 2022 for the treatment of colorectal, endometrial, gastric, small intestine, and biliary MSI-H/dMMR tumour types. This approval was supported by data from the KEYNOTE-164 and KEYNOTE-158 clinical trials. This study evaluated the cost-effectiveness of pembrolizumab compared with standard of care (SoC) for previously treated MSI-H/dMMR solid tumours in line with the approved EMA label from a UK healthcare payer perspective., Methods: A multi-tumour partitioned survival model was built consisting of pre-progression, progressed disease, and dead health states. Pembrolizumab survival outcomes were extrapolated using Bayesian hierarchical models (BHMs) fitted to pooled data from KEYNOTE-164 and KEYNOTE-158. Comparator outcomes were informed by published sources. Tumour sites were modelled independently and then combined, weighted by tumour site distribution. A SoC comparator was used to formulate the overall cost-effectiveness result with pembrolizumab as the intervention. SoC comprised a weighted average of the comparators by tumour site based on market share. Drug acquisition, administration, adverse events, monitoring, subsequent treatment, end-of-life costs, and testing costs were included. Sensitivity and scenario analyses were performed, including modelling pembrolizumab efficacy using standard parametric survival models., Results: Pembrolizumab, at list price, was associated with £129,469 in total costs, 8.30 LYs, and 3.88 QALYs across the pooled tumour sites. SoC was associated with £28,222 in total costs, 1.14 LYs, and 0.72 QALYs across the pooled tumour sites. This yields an incremental cost-effectiveness ratio (ICER) of £32,085 per QALY. Results were robust to sensitivity and scenario analyses., Conclusions: This model demonstrates pembrolizumab provides a valuable new alternative therapy for UK patients with MSH-H/dMMR cancer at the cost of £32,085 per QALY, with confidential discounts anticipated to improve cost-effectiveness further.

Aims: Our study aims to provide an enhanced comprehension of systemic lupus erythematosus (SLE) burden in United Arab Emirates (UAE), over a five-year period from payer and societal perspective., Materials and Methods: A Markov model was established to simulate the economic consequences of SLE among UAE population. It included four health states: i) the three phenotypes of SLE, representing mild, moderate, and severe states, and ii) death. Clinical parameters were retrieved from previous literature and validated using the Delphi panel-the most common clinical practice within the Emirati healthcare system. We calculated the disease management, transient events, and indirect costs by macro costing. One-way sensitivity analysis was conducted., Results: The estimated number of SLE patients in our study was 13,359. The number of SLE patients with mild, moderate, and severe phenotypes was 3,914, 8,109, and 1,336, respectively. Disease management costs, including treatment of each phenotype and disease follow-up, were AED 2 billion ($0.89 billion), whereas the costs of transient events (infections, flares, and consequences of SLE-related organ damage) were AED 1 billion ($0.44 billion). The productivity loss costs among adult-employed patients with SLE in the UAE were estimated at AED 7 billion ($3.1 billion). The total SLE cost over five years from payer and societal perspectives is estimated at AED 3 ($1.3 billion) and 10 billion ($4.4 billion), respectively. Additionally, the costs per patient per year from the payer and societal perspectives were AED 45,960 ($20,610) and AED 148,468 ($66,578), respectively., Conclusion: Our findings demonstrate that the burden of SLE in the UAE is enormous, mainly because of the costly complications and productivity loss. More awareness should be created to limit the progression of SLE and reduce the occurrence of flares, necessitating further economic evaluations of novel treatments that could help reduce the economic consequences of SLE in the UAE.

Background: Triple Negative Breast Cancer (TNBC) is an aggressive subtype of breast cancer that can impact patients' employment and workforce participation. This study estimates how the employment effects of TNBC impact government tax revenue and public benefits expenditure in Switzerland, representing the fiscal burden of disease (FBoD), and likely consequences of introducing new treatment options., Methods: A four-state cohort model was used to calculate fiscal effects for two treatments: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab monotherapy (P + C→P) and neoadjuvant chemotherapy alone (C). Lifetime present values of tax revenue, social benefit payments, and healthcare costs were calculated for the average population and those undergoing treatment to assess the FBoD., Results: An average TNBC patient treated with C and P + C→P is expected to generate CHF128,999 and CHF97,008 less tax than the average population, respectively, and require increased social benefit payments. Compared to C, 75% of the incremental healthcare costs of P + C→P are estimated to be offset through tax revenue gains., Conclusions: This analysis demonstrates that 75% of the additional costs of a new TNBC treatment option can be offset by gains in tax revenue. Fiscal analysis can be a useful tool to complement existing methods for evaluating new treatments.

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.

Objectives: To assess the potential clinical impact and cost-effectiveness of coronavirus disease 2019 (COVID-19) mRNA vaccines updated for Autumn 2023 in adults aged ≥60 years and high-risk persons aged 30-59 years in Germany over a 1-year analytic time horizon (September 2023-August 2024)., Methods: A compartmental Susceptible-Exposed-Infected-Recovered model was updated and adapted to the German market. Numbers of symptomatic infections, a number of COVID-19 related hospitalizations and deaths, costs, and quality-adjusted life-years (QALYs) gained were calculated using a decision tree model. The incremental cost-effectiveness ratio of an Autumn 2023 Moderna updated COVID-19 (mRNA-1273.815) vaccine was compared to no additional vaccination. Potential differences between the mRNA-1273.815 and the Autumn Pfizer-BioNTech updated COVID-19 (XBB.1.5 BNT162b2) vaccines, as well as societal return on investment for the mRNA-1273.815 vaccine relative to no vaccination, were also examined., Results: Compared to no autumn vaccination, the mRNA-1273.815 campaign is predicted to prevent approximately 1,697,900 symptomatic infections, 85,400 hospitalizations, and 4,100 deaths. Compared to an XBB.1.5 BNT162b2 campaign, the mRNA-1273.815 campaign is also predicted to prevent approximately 90,100 symptomatic infections, 3,500 hospitalizations, and 160 deaths. Across both analyses we found the mRNA-1273.815 campaign to be dominant., Conclusions: The mRNA-1273.815 vaccine can be considered cost-effective relative to the XBB.1.5 BNT162b2 vaccine and highly likely to provide more benefits and save costs compared to no vaccine in Germany, and to offer high societal return on investment.

Background: Our cost-of-illness (COI) model adopted both payer and societal perspectives over a time horizon of 5 years to measure the economic burden of systemic lupus erythematosus (SLE) in Taiwan., Methodology: A prevalence-based model was established to estimate the economic consequences of SLE after diagnosis in Taiwan. The model included four health states: (i) the three phenotypes representing mild, moderate, and severe SLE, and (ii) death. The inputs were obtained from a literature review of all the clinical trials and validated using a Delphi panel. The Delphi panel's insights included commonly used treatment strategies for patients with SLE within the Taiwanese healthcare system. The costs mentioned in this model are disease management, monitoring, transient event, and indirect costs. One-way sensitivity analyses were conducted to assess the model uncertainty., Results: The number of patients with SLE in our COI model was 20,189. At diagnosis, the number of SLE patients with mild, moderate, and severe phenotypes was 5,916, 12,255, and 2019, respectively. The total SLE cost in Taiwan over 5 years from both payer and societal perspectives was estimated at TWD 3.9 and 47 billion, respectively. The costs per patient per year from the payer and societal perspective were TWD 38,775 ($2,758) and TWD 466,119 ($33,152), respectively., Conclusion: The findings demonstrated that the burden of SLE in Taiwan over a time horizon of 5 years is substantially high, mainly due to the consequences of economic loss as it affects women and men during their working age, in addition to the costs of SLE management and its consequences, such as flares, infection, and organ damage. Therefore, more attention should be paid to limiting the progression of SLE and the occurrence of flares, and further economic evaluations are necessary to assess novel treatment strategies that could control the disease.

Aims: Our cost of illness study aimed to provide an estimate of the burden related to systemic lupus erythematosus (SLE) in the Mexican context., Methods: Our model was used to simulate the resource utilization and economic consequences over a period of 5 years for patients with SLE in Mexico. The model simulated four health states-three phenotypes of SLE, including mild, moderate, and severe states, and death. Clinical parameters were retrieved from the literature. Resource utilization in our model represents the most common practice in the Mexican healthcare system. These include disease management, transient events (e.g. infections, flares, and complications due to SLE-related organ damage), and indirect costs. Direct non-medical costs were not considered. One-way sensitivity analysis was performed., Results: The number of targeted Mexican SLE patients was 57,754. The numbers of SLE patients diagnosed with mild, moderate, and severe phenotypes were 8,230, 44,291, and 5,233, respectively. Disease management costs, including the treatment of each phenotype and disease follow-up, were MXN 4 billion ($ 415 million); the costs of transient events (infections, flares, and consequences of SLE-related organ damage) were MXN 5 billion ($ 478 million). Productivity loss costs among adult employed Mexican patients with SLE were estimated at MXN 17 billion ($ 1.6 billion). The total SLE cost in Mexico over 5 years from the payer and societal perspectives is estimated at MXN 9 billion ($ 893 million) and 26 billion ($ 2.5 billion), respectively. Over 5 years, the costs per patient per year from the payer and societal perspectives were MXN 32,131($ 3,095) and MXN 91,661($ 8,830), respectively., Conclusion: The findings pointed out the substantial economic burden associated with SLE, including the costs of disease progression and SLE transient events, such as flare-ups, infections, and organ damage, in addition to productivity loss due to work capacity impairment.

Aims: Migraine is the most common disabling headache disorder and is characterized by recurrent throbbing head pain and symptoms of photophobia, phonophobia, nausea, and vomiting. Rimegepant 75 mg, an oral lyophilisate calcitonin gene-related peptide antagonist, is the first treatment approved for both the acute and preventative treatment of migraine, and the first acute therapy approved in over 20-years. The objective was to assess the cost-utility of rimegepant compared with best supportive care (BSC) in the UK, for the acute treatment of migraine in the adults with inadequate symptom relief after taking at least 2 triptans, or for whom triptans are contraindicated or not tolerated., Materials and Methods: A de novo model was developed to estimate incremental costs and quality-adjusted life years (QALYs), structured as a decision tree followed by Markov model. Patients received rimegepant or BSC for a migraine attack and were assessed for response (pain relief at 2-h). Responders and non-responders followed different pain trajectories over 48-h cycles. Non-responders discontinued treatment while responders continued treatment for subsequent attacks, with a proportion discontinuing over time. Data sources included a post-hoc pooled analysis of the phase 3 acute rimegepant trials (NCT03235479, NCT03237845, NCT03461757), and a long-term safety study (NCT03266588). The analysis was conducted from the perspective of the UK National Health Service and Personal Social Services over a 20-year time horizon., Results: Rimegepant resulted in an incremental cost-utility ratio (ICUR) of £10,309 per QALY gained vs BSC, which is cost-effectiveness at a willingness to pay threshold of £30,000/QALY. Rimegepant generated +0.44 incremental QALYs and higher incremental lifetime costs (£4,492). Improved QALYs for rimegepant were a result of less time spent with severe and moderate headache pain., Conclusion: This study highlights the economic value of rimegepant which was found to be cost-effective for the acute treatment of migraine in adults unsuitable for triptans.

Introduction: SLE imposes a significant morbidity and mortality as well as a substantial burden on the healthcare system. The model aimed to measure the cost-effectiveness of anifrolumab implementation against belimumab as an add-on-therapy to the standard of care (SoC) over a lifetime horizon for Emirati patients., Methodology: A microsimulation model was used to assess the cost-effectiveness of anifrolumab against belimumab (IV/SC) as an add-on therapy to SoC in a hypothetical cohort of adult Emirati patients with systemic lupus erythematosus (SLE) over a lifetime horizon. The clinical data was captured from published clinical trials as; TULIP-1, TULIP-2, BLISS-52, BLISS-76 and BLISS-SC. Health utility scores were constructed according to a linear regression model from the pooled data of the two TULIP Phase III trials of anifrolumab. Our model captures direct SLE-related medical costs from the Dubai Health Authority. Sensitivity analyses were conducted to assess model uncertainty., Results: Using BICLA as a response criterion in the Johns Hopkins cohort, anifrolumab was found to be more effective than belimumab (IV/SC; the incremental discounted QALY of anifrolumab against belimumab was 0.42). The incremental cost-effectiveness ratio (ICER) of anifrolumab against belimumab IV and belimumab SC were AED 466,371 ($209,135) and AED 252,612 ($113,279), respectively, these ICERs are below the cost-effectiveness threshold in the United Arab Emirates (UAE) (three times gross domestic product capita; AED 592,278). In the Toronto lupus cohort, the ICER of anifrolumab against belimumab IV and belimumab SC were AED 491,403 ($220,360) and AED 276,642 ($124,055), respectively (anifrolumab was a cost-effective option vs. belimumab IV and belimumab SC)., Conclusion: The addition of anifrolumab to SoC is a cost-effective option versus belimumab for the treatment of adult patients with active, autoantibody-positive SLE, despite being allocated to SoC. Cost-effectiveness was demonstrated by a reduction in complications and organ damage, which reflected costs and outcomes.

Aim: To 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 Methods: A 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., Results: In 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., Limitations: There 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., Conclusion: This 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.

Hydrophobic organic contaminated polycyclic aromatic hydrocarbons (PAHs), polychlorinated biphenyls (PCBs) and CHNS (carbon, hydrogen, nitrogen and sulphur species) are explosively associated with road dust particles. A few organic contaminants are toxic in nature and have an unpleasant effect on human health. The International Agency for Research on Cancer (IARC), the US Department of Health and Human Services (HHS) and the United States-Environmental Protection Agency has considered several PAHs and PCBs as carcinogens for human beings. In the proposed study, the anthropogenic contaminants present in road dust were assessed in six representative diversified sites i.e. industrial, commercial, office, residential, construction and traffic intersection in Delhi NCR, India. Roadside dust samples were gathered in premonsoon, monsoon and postmonsoon seasons and characterized for PAHs, PCBs and CHNS. The concentration of total PAHs (16 Nos) and PCBs (6 Nos) of the selected sites ranged from 0.27 µg/kg to 605.80 µg/kg and 0.01 µg/kg to 41.26 µg/kg, respectively. The Fourier transform infrared spectroscopy-attenuated total reflectance study suggested that the presence of O = C = O, Si-O, carbonyl, acidic or aliphatic esters group were associated with road dust particles. Hydrogen and sulphur concentrations were not detected in the selected road dust samples. Carbon and nitrogen concentrations varied from 2.24% to 16.82% and 0.69% to 14.5%, respectively, seasonally. In the premonsoon season, road dust was distinguishably contaminated as compared to monsoon and postmonsoon season, which might be due to movement of contaminated road dust from adjacent locations. It was perceived that Delhi NCR organic contamination in road dust was much below as compared to other countries. It may be concluded that due to the presence of significant amounts of carbon and nitrogen concentrations in the road dust, to a greater extent, road dust can be fertile and might be advantageous for green belt development to mitigate air pollution. The utilization of road dust will further bring down the burden of landfill sites and may lead towards sustainability., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: In Canada, a persistent barrier to achieving healthcare system efficiency has been patient days accumulated by individuals with an alternate level of care (ALC) designation. Transitional care units (TCUs) may address the capacity pressures associated with ALC. We sought to assess the cost-effectiveness of a nursing home (NH) based TCU leveraging existing infrastructure to support a hospitalized older adult's transition to independent living at home., Methods: This case-control study included frail, older adults who received care within a function-focused TCU following a hospitalization between 1 March 2018 and 30 June 2019. TCU patients were propensity score matched to hospitalized ALC patients ("usual care"). The primary outcome was days without requiring institutional care six months following discharge, defined as institutional-free days. This was calculated by excluding all days in hospitals, rehabilitation facilities, complex continuing care facilities and NHs. Using the total direct cost of care up to discharge from TCU or hospital, the incremental cost-effectiveness ratio was calculated., Results: TCU patients spent, on average, 162.0 days institution-free (95% CI: 156.3-167.6d) within six months days post-discharge, while usual care patients spent 140.6 days institution-free (95% CI: 132.3-148.8d). TCU recipients had a lower total cost of care, by CAN$1,106 (95% CI: $-6,129-$10,319), due to the reduced hospital length of stay (mean [SD] 15.6d [13.3d] for TCU patients and 28.6d [67.4d] days for usual care). TCU was deemed the more cost-effective model of care., Limitations: The main limitation was the potential inclusion of patients not eligible for SAFE in our usual group. To minimize this selection bias, we expanded the geographical pool of ALC patients to patients with SAFE admission potential in other area hospitals., Conclusions: Through rehabilitative and restorative care, TCUs can reduce hospital length of stay, increase potential for independent living, and reduce risk for subsequent institutionalization.

Objective: This real-world retrospective database study quantified the costs of biomarker testing in a US population of patients with lung or thyroid cancers., Materials and Methods: The commercial claims IBM Marketscan database, a de-identified real-world dataset, was used to identify patients diagnosed with lung or thyroid cancer between 1/2015 and 12/2019. Eligible patients were 18 years or older with two or more lung or thyroid diagnosis codes. Patients were excluded who had evidence of prior cancer diagnoses. Subgroup analyses evaluated eligible patients with metastatic disease. Descriptive statistics were used to evaluate commercial insurance plan payer and patient out-of-pocket costs for diagnostic testing overall as well as by test procedure code and payer type. Costs were adjusted to 2020 US dollars., Results: A total of 23,633 patients with lung cancer were eligible, 13,320 of whom had metastatic disease. There were 36,867 patients with thyroid cancer, 2,241 of whom had metastatic disease. Biomarker codes were observed among 68.4/75.8% (lung/metastatic lung) and 18.2/42.3% (thyroid/metastatic thyroid). Few patients had codes for comprehensive biomarker tests (5.2/6.7% lung/metastatic lung, 0.3/2.2% thyroid/metastatic thyroid) Among those with biomarker tests, the median per-patient total payer lifetime costs of all biomarker testing were $394/$462 (lung/metastatic lung) and $148/$232 (thyroid/metastatic thyroid). Total lifetime biomarker costs for payers ranged from a median of $128 (consumer-driven health plans) to $477 (preferred provider organizations). Median lifetime patient out-of-pocket costs were $0.00 for both tumor types and all payer types except for consumer-driven health plans ($12 for thyroid and $10 for metastatic lung)., Conclusions: While comprehensive testing adds to the cost of biomarker testing, these data suggest the relatively low lifetime cost of biomarker testing for both payers and patients. Costs for biomarker testing should not be a limitation to access among these populations with commercial insurance plans in the US.

Aim: To assess the cost-efficiency and expanded access of three rituximab biosimilars versus the reference rituximab from the perspective of the Jordanian national health payer., Methods: A 1-year cost-efficiency and expanded access model of conversion from reference rituximab (Mabthera) to the approved biosimilars (Truxima, Rixathon, and Tromax) to assess five metrics: total annual cost to treat a hypothetical patient; head-to-head cost comparison; changes in patients' access to rituximab; number-needed-to-convert (NNC) to provide an additional 10 patients access to a rituximab treatment; and relative amount of Jordanian Dinar (JOD) spent on rituximab options. The model included rituximab doses at 100 mg/10 ml and 500 mg/50 ml and considered both cost-saving and cost-wastage scenarios. Costs of treatments were based on the fiscal year 2022 tender prices received by the Joint Procurement Department (JPD)., Results: Rixathon was associated with the lowest average annual cost per patient (JOD2,860) across all six indications among all rituximab comparators, followed by Truxima (JOD4,240), Tromax (JOD4,365) and reference Mabthera (JOD11,431). The highest percentage of patient access to rituximab treatment (321%) was achieved when switching patients from Mabthera to Rixathon in the RA and PV indications. At four patients, Rixathon was associated with the lowest NNC to provide an additional 10 patients access to rituximab treatment. For each JOD1 spent on Rixathon, an additional JOD3.21 must be spent on Mabthera, an additional JOD0.55 on Tromax, and an additional JOD0.53 on Truxima., Conclusion: Rituximab biosimilars were associated with cost savings in all approved indications in Jordan compared to reference rituximab. Rixathon was associated with the lowest annual cost, the highest percentage of expanded patient access for all six indications, and the lowest NNC providing 10 additional patients with access.

Aims: To describe clinical complications, treatment use, healthcare resource utilization (HCRU), and costs among patients with transfusion-dependent β-thalassemia (TDT) in the United States., Materials and Methods: Merative MarketScan Databases were used to identify patients with β-thalassemia between 1 March 2010, and 1 March 2019. Patients were eligible for inclusion with ≥1 inpatient claim or ≥2 outpatient claims for β-thalassemia and ≥8 red blood cell transfusions (RBCTs) during any 12-month period after and including the date of the first qualifying β-thalassemia diagnosis code. Matched controls consisted of individuals without β-thalassemia. Clinical and economic outcomes of patients were assessed during ≥12 months of follow-up, defined as the period from the index date (i.e. the first RBCT) to either the end of continuous enrollment in benefits, inpatient death, or 1 March 2020., Results: Overall, 207 patients with TDT and 1035 matched controls were identified. Most patients received iron chelation therapy (ICT) (91.3%), with a mean of 12.1 (standard deviation [SD] = 10.3) ICT claims per-patient-per-year (PPPY). Many also received RBCTs, with a mean of 14.2 (SD = 4.7) RBCTs PPPY. TDT was associated with higher annual ($137,125) and lifetime ($7.1 million) healthcare costs vs. matched controls ($4183 and $235,000, respectively). Annual costs were driven by ICT (52.1%) and RBCT use (23.6%). Patients with TDT had 7-times more total outpatient visits/encounters, 3-times more prescriptions, and 33-times higher total annual costs than matched controls., Limitations: This analysis may underestimate the burden of TDT, as indirect healthcare costs (e.g. absenteeism, presenteeism, etc.) were not included. Results may not be generalizable to patients excluded from this analysis, including those with other types of insurance or without insurance., Conclusions: Patients with TDT have high HCRU and direct healthcare costs. Treatments that eliminate the need for RBCTs could reduce the clinical and economic burden of managing TDT.

Aims: The National Health Service (NHS) in England is facing extreme capacity pressures. The backbone of prostate cancer care is gonadotropin-releasing hormone agonist (GnRHa) therapy, commonly administered every month or 3 months. We estimated the cost and capacity savings associated with increased use of 6-monthly GnRHa therapy in England., Methods: A capacity and cost-minimization model including a societal perspective was developed (in Microsoft Excel) to generate cost and capacity estimates for GnRHa drug acquisition and administration for "Current practice" and for a "Base case" scenario. In the "Base case" scenario, 50% of patients who were receiving monthly or 3-monthly GnRHa therapy in "Current practice" switched/transitioned to a 6-monthly formulation. Cost/capacity estimates were calculated per patient per administration and scaled to annualized population levels. Sensitivity analyses were conducted to assess the impact of individual model assumptions: 1 tested the impact of drug acquisition costs; 2 and 3 tested the level of nurse grade and the time associated with treatment administration, respectively; 4 tested the rate of switch/transition to 6-monthly GnRHa therapy; and 5 tested differing diagnostic patterns following the coronavirus disease 2019 pandemic., Results: Compared with "Current practice", the "Base case" scenario was associated with annual cost savings of £5,164,296 (148,478 fewer appointments/year and 37,119 fewer appointment-hours/year). The largest savings were in drug administration (£2.2 million) and acquisition (£1.6 million) costs. Annual societal cost savings totaled £1.4 million, mainly in reduced appointment-related travel, productivity and leisure time opportunity losses. Increased use of 6-monthly versus monthly or 3-monthly GnRHa therapy consistently achieved system-wide annual cost and capacity savings across all sensitivity analysis scenarios., Conclusions: Our holistic model suggests that switching/transitioning men from monthly or 3- monthly GnRHa therapy to a 6-monthly formulation can reduce NHS cost and capacity pressures and the societal and environmental costs associated with prostate cancer care.

Background: Pimavanserin (PIM) is the only FDA-approved atypical antipsychotic (AAP) for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Comparative real-world analyses demonstrating its benefits are needed., Objectives: To evaluate health care resource utilization (HCRU) outcomes among PDP patients treated with PIM vs. other-AAPs., Methods: Retrospective cohort analysis of Parts A, B, and D claims from 100% Medicare sample from 01 January 2013-31 December 2019 was conducted. PDP Patients initiating (i.e. index date) continuous monotherapy (PIM vs. other-AAPs) for ≥12-months during 01 January 2014-31 December 2018 without 12-months pre-index AAP use were selected after 1:1 propensity score matching (PSM) on 31 variables (sex, race, region, age, and 27 Elixhauser comorbidities). HCRU outcomes included: annual all-cause and psychiatric hospitalization (short-term stay, long-term stay, and SNF-stay [skilled nursing facility]) rates, annual all-cause and psychiatric-ER visit rates, mean per-patient-per-year (PPPY) hospitalizations, and average length of stay (ALOS). PIM and other-AAPs were compared using generalized linear models (GLM) controlled for demographic characteristics, comorbidities, coexisting-dementia, and coexisting insomnia., Results: Of 12,164 PDP patients, 48.41% ( n  = 5,889) were female, and mean age was 77 (±8.14) years. Among 1:1 matched patients ( n  = 842 in each), 37.8% ( n  = 319) on PIM vs. 49.8% ( n  = 420) on other-AAPs ( p  < .05) reported ≥1 all-cause hospitalizations, respectively. Specifically, short-term and SNF-stay among PIM patients vs. other-AAPs were: 34% ( n  = 286) vs. 46.2% ( n  = 389) and 20.2% ( n  = 170) vs. 31.8% ( n  = 267) ( p  < .05), respectively. Similarly, 9.6% ( n  = 81) of PIM vs. 14.6% ( n  = 123) of other-AAPs patients had ≥1 psychiatric hospitalization ( p  < .05). Furthermore, ≥1 all-cause and psychiatric ER visit among PIM vs. other-AAPs were 61.6% ( n  = 519) vs. 69.4% ( n  = 584) and 5.2% ( n  = 43) vs. 10.2% ( n  = 86) ( p  < .05), respectively. PIM also had significantly lower ALOS, and mean PPPY short-term hospitalization and SNF-stays., Conclusions: In this analysis of PDP patients, PIM monotherapy resulted in nearly 12% and 7% lower all-cause hospitalizations and ER visits vs. other-AAPs.

Objectives: Paediatric growth hormone deficiency (pGHD) manifests as growth failure associated with inadequate growth hormone (GH) production. Daily injections of recombinant human GH (dGH) [somatropin] is the current standard of care, which has been shown to be well tolerated and effective, but associated with suboptimal adherence, leading to reduced effectiveness. Somatrogon, a once-weekly injectable long-acting human GH, has demonstrated clinical non-inferiority and significantly lower life interference (i.e. treatment burden) vs. somatropin in two Phase 3 studies. This work evaluated cost-effectiveness and cost-utility of somatrogon vs dGHs from an Irish payer perspective., Methods: A Markov model was developed for patients starting somatrogon or dGHs treatment at 3-12 years and continuing up to achievement of near adult height (NAH), with growth driven by trial-based height velocity (HV) and treatment-specific adherence. Patients could discontinue treatment at the end of Year 1 (4%). DGH adherence (95.3%-65% over treatment duration) and adherence-growth relationship were based on published evidence. Higher Year 1 adherence of 4%, tapering over time, for somatrogon vs. dGHs was based on clinical consultation. Treatment costs, monitoring costs and costs due to different wastage types (device setting and adherence) were sourced from local data. Health utilities based on height and injection frequency were derived from published literature. Scenario analysis, deterministic and probabilistic sensitivity analysis were performed., Results: Somatrogon treatment led to 1.87-3.66 cm greater NAH gain and 0.21-0.50 higher quality adjusted life years (QALYs) vs. dGHs, across the base case and scenarios evaluated. Somatrogon treatment was associated with cost savings of €5,699-€21,974 and lower cost per cm gained vs. dGHs (€197-€527), per patient. Somatrogon was cost-effective vs. dGHs, with the result consistent across the sensitivity analyses conducted., Conclusion: Somatrogon weekly injections were estimated to result in higher NAH, higher QALYs, lower overall costs and lower costs per cm gained than dGHs, in pGHD.

Background: Pimavanserin (PIM) is the only FDA approved atypical antipsychotic (AAP) for the treatment of Parkinson's Disease Psychosis (PDP) while other off-label AAPs like quetiapine (QUE) are also used. Real-world comparative effects of PIM and QUE on health resource utilization (HCRU) may provide insights about their relative benefits., Objectives: To examine annual HCRU among newly initiated PIM or QUE monotherapy among patients with PDP., Methods: Retrospective analysis of 100% Medicare (Parts A, B, and D) claims of patients with PDP during 1 January 2013 to 31 December 2019 was conducted. Treatment-naive patients with first prescription for PIM or QUE from 1 January 2014 to 31 December 2018 were selected if they had ≥12-months continuous monotherapy and had no prior AAP use for ≥12-month pre-index. Post-index 12-month HCRU was compared between 1:1 propensity score matched (PSM) PIM or QUE cohorts. HCRU outcomes included: rates of all-cause and psychiatric-related inpatient hospitalizations by stay-type [i.e., long-term stays (LT-stays), short-term stays (ST-stays), skilled nursing facility stays (SNF-stays)], outpatient hospitalizations, emergency room (ER) visits, and office visits. Relative risk and 95% confidence intervals are reported [RR (95% CI)]., Results: A total of 842 and 7,116 were treated with PIM and QUE, respectively. Mean age and gender distribution were similar among both groups. After PSM, those on PIM (n=842) had significantly lower RR for all-cause: inpatient hospitalizations [RR=0.78 (0.70-0.87)], ST-stays [RR=0.75 (0.66-0.84)], SNF-stays [RR=0.64 (0.54-0.76)], and ER visits [RR=0.91 (0.84-0.97)] vs. QUE (n=842). PIM patients had slightly higher RR for all-cause office visits [RR=1.03 (1.01-1.05)] vs. QUE. Psychiatric-related inpatient hospitalizations were also lower for PIM vs. QUE: [RR=0.63 (0.48-0.82)] ST-stays [RR=0.61 (0.43-0.86)], SNF-stay [RR=0.69 (0.47-1.02)], and ER visits [RR=0.53 (0.37-0.76)]., Conclusions: In this analysis of PDP patients, PIM monotherapy resulted in nearly 22% and 37% lower all-cause hospitalizations and psychiatric-related inpatient hospitalizations compared to QUE.

Introduction: BK virus associated hemorrhagic cystitis(BKV-AHC) is a serious complication observed after allogeneic stem cell transplantation and the current therapeutic options are scarce with substantial renal side effects. Although the guidelines recommend intravenous cidofovir application with caution to nephrotoxicity, there are few studies which investigated intravesical administration and reported similar therapeutic results with less renal side effects., Methods: We administered low dose, daily and consecutive (75 mg/day, for 5 days) intravesical cidofovir to 25 patients with BKV-AHC that developed after (ASCT)., Results: The response rate in our cohort was 92% and relapse was not encountered in 84% of the patient population during one year of follow-up. The median BK urine viral load significantly decreased from 260,000,000 IU/mL to 53,000,000 IU/mL after a week of treatment (p = 0.0001). Rise in serum creatinine was observed in 5 patients during treatment and post-treatment nephrotoxicity was seen in only 1 patient., Conclusions: Daily low dose intravesical cidofovir might be an effective treatment option for BKV-AHC after ASCT with favorable less systemic side effects., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.)

Aims: To assess, within the Italian healthcare system, the cost-effectiveness of baricitinib versus dupilumab, both in combination with topical corticosteroids (TCS), in adults with moderate to severe atopic dermatitis (AD) who are eligible for but have failed, have contraindications to, or cannot tolerate ciclosporin., Materials and Methods: Using the perspective of the Italian healthcare payer, direct medical costs associated with each intervention were estimated over a lifetime horizon. A Markov cohort model utilized the proportions of patients with ≥75% improvement Eczema Area and Severity Index obtained from clinical trials. Health outcomes were evaluated in quality-adjusted life years (QALYs) to assess the cost effectiveness of baricitinib against a willingness-to-pay threshold of €35,000 per QALY gained., Results: In the base case, with secondary censoring applied, patients treated with dupilumab or baricitinib, in combination with TCS, accumulated total costs of €135,780 or €129,586, and total QALYs of 18.172 or 18.133, respectively. The incremental cost-effectiveness ratio of dupilumab versus baricitinib was estimated at €160,905/QALY., Limitations: Core assumptions were needed to extrapolate available short-term clinical trial data to lifelong data, adding uncertainty. Benefits of baricitinib seen in clinical trials and not assessed in dupilumab clinical trials were not included. Discontinuation rates for each treatment were derived from different sources potentially introducing bias. Results may not be generalizable to other populations., Conclusions: This cost-effectiveness analysis shows that, from the Italian healthcare payer perspective, in the treatment of patients with moderate to severe AD who have experienced failure on, are intolerant to, or have contraindication to ciclosporin, dupilumab cannot be considered cost-effective when compared with baricitinib. Given its oral administration, favorable risk/benefit profile and lower acquisition cost compared with dupilumab, baricitinib may offer a valuable, cost-effective treatment option-after failure on conventional systemic agents-for patients with moderate to severe AD in Italy.

Background: As innovative oncology medicines are rapidly developed, there is increasing pressure on payers to offer patients timely access to life-saving therapies. The uncertainty surrounding these therapies when phase III clinical trials are pending has necessitated new, adapted pathways to market access, with timelines that greatly vary by country. Understanding differences between pathways may identify opportunities to expedite patient access universally., Objectives: To describe early access pathways for new oncology medicines among selected countries with established health technology assessment (HTA) frameworks and publicly funded health systems, with a special focus on real-world evidence (RWE)., Methods: We reviewed the HTA agency websites of the selected OECD countries: National Institute for Health and Care Excellence (NICE) for England and Wales; Haute Autorité de Santé (HAS) for France; IQWiG and G-BA for Germany; Agenzia Italiana del Farmaco (AIFA) for Italy; Pharmaceutical Benefits Advisory Committee (PBAC) for Australia; and CADTH and Institut National d'Excellence en Santé et Services Sociaux (INESSS) for Canada as the primary source of evidence., Results: Processes for early patient access to innovative oncology therapies varied across selected countries; however, most countries have an established pathway for publicly funded early access (England and Wales, France, Germany, Italy, and Australia). The utilization of RWE to support earlier access (coverage with evidence) also varied by country, with some HTA organizations being actively engaged in these agreements (NICE, AIFA, and HAS) and others having no established processes in place (G-BA and CADTH/INESSS)., Conclusions: This review of early access pathways for novel oncology medicines found substantial variability between countries of interest. Coverage with evidence frameworks may provide a unique opportunity for industry and payers to collaborate on earlier access to innovative cancer therapies with life-saving potential.

Objective: To determine the cost of wound care and prevalence of chronic wounds for Medicare beneficiaries in the aggregate, by wound type, and by setting between the years 2014 and 2019., Methods: This retrospective analysis of Medicare claims data included beneficiaries who experienced episodes of care for diabetic foot ulcers and infections; arterial ulcers; skin disorders and infections; surgical wounds and infections; traumatic wounds; venous ulcers and infections; unspecified chronic ulcers; and others. The 2014 data were based on a Medicare 5% Limited Data Set whereas for 2019 the data used were for all fee-for-service Medicare beneficiaries. Three methods were used to generate expenditure estimates: (a) a low (Medicare provider payments when the wound was a primary diagnosis, excluding any kind of deductible); (b) mid (primary plus secondary diagnosis with weighted attribution); and (c) high (primary or secondary diagnosis). The main outcomes were the prevalence of each wound type, Medicare expenditure for each wound type and aggregate, and expenditure by type of service., Results: Over the 5-year period the number of Medicare beneficiaries with a wound increased from 8.2 million to 10.5 million. Wound prevalence increased by 13% from 14.5% to 16.4%. Over the 5-year period, the Medicare beneficiaries with the largest increase in chronic wound prevalence were those aged <65 years (males: 12.5% to 16.3%; females: 13.4% to 17.5%). The largest changes in terms of wound prevalence were increases in arterial ulcers (0.4% to 0.8%), skin disorders (2.6% to 5.3%), and decreases in traumatic wounds (2.7% to 1.6%). Expenditures decreased regardless of the three methods used with a reduction of $29.7 billion to $22.5 billion for the most conservative method. Except for venous ulcers in which costs per Medicare beneficiary increased from $1206 to $1803, cost per wound decreased with surgical wounds remaining the most expensive to treat (2014: $3566; 2019: $2504), and the largest decrease for arterial ulcers ($9651 to $1322). Hospital outpatient fees saw the largest reduction ($10.5 billion to $2.5 billion) although home health agency expenditures decreased from $1.6 billion to $1.1 billion. Physician offices saw an increase from $3.0 billion to $4.1 billion and durable medical equipment increased from $0.3 billion to $0.7 billion., Conclusions: It appears that chronic wound care expenditures have shifted to the physician's office from the hospital-based outpatient department. Given that the prevalence of chronic wounds is increasing, especially among the disabled under 65, it will be important to know whether these shifts have positively or negatively affected outcomes.

Aims: To assess the potential clinical impact and cost-effectiveness of COVID-19 mRNA vaccines updated for fall 2023 in adults aged ≥18 years over a 1-year analytic time horizon (September 2023-August 2024)., Materials and Methods: A compartmental Susceptible-Exposed-Infected-Recovered model was updated to reflect COVID-19 cases in summer 2023. The numbers of symptomatic infections, COVID-19-related hospitalizations and deaths, and costs and quality-adjusted life-years (QALYs) gained were calculated using a decision tree model. The incremental cost-effectiveness ratio (ICER) of a Moderna updated mRNA fall 2023 vaccine (Moderna Fall Campaign) was compared to no additional vaccination. Potential differences between the Moderna and the Pfizer-BioNTech fall 2023 vaccines were also examined., Results: Base case results suggest that the Moderna Fall Campaign would decrease the expected 64.2 million symptomatic infections by 7.2 million (11%) to 57.0 million. COVID-19-related hospitalizations and deaths are expected to decline by 343,000 (-29%) and 50,500 (-33%), respectively. The Moderna Fall Campaign would increase QALYs by 740,880 and healthcare costs by $5.7 billion relative to no vaccine, yielding an ICER of $7700 per QALY gained. Using a societal cost perspective, the ICER is $2100. Sensitivity analyses suggest that vaccine effectiveness, COVID-19 incidence, hospitalization rates, and costs drive cost-effectiveness. With a relative vaccine effectiveness of 5.1% for infection and 9.8% for hospitalization for the Moderna vaccine versus the Pfizer-BioNTech vaccine, use of the Moderna vaccine is expected to prevent 24,000 more hospitalizations and 3300 more deaths than the Pfizer-BioNTech vaccine., Limitations and Conclusions: As COVID-19 becomes endemic, future incidence, including patterns of infection, are highly uncertain. The effectiveness of fall 2023 vaccines is unknown, and it is unclear when a new variant that evades natural or vaccine immunity will emerge. Despite these limitations, our model predicts the Moderna Fall Campaign vaccine is highly cost-effective across all sensitivity analyses.

There is an ongoing debate among researchers and policy-makers on how to make transparency a powerful tool of healthcare systems. This study addresses how the availability and accessibility of information about medical services to the general population affects healthcare outcomes in Russia. A systematic review was conducted and reported according to the Preferred Reporting Items for Systematic Reviewing and Meta-Analysis (PRISMA) guidelines. Transparency indicators of health facilities used in the world's most efficient healthcare systems are also reviewed. Although the increase of transparency in the Russian healthcare system is considered as a tool for improving its efficiency, very little has been done to improve the actual level of transparency. The existing institutional specifics of the Russian healthcare system impose serious restrictions on acceptable levels of transparency. In the reviewed empirical Russian studies, transparency is often viewed simplistically as either information available on the websites of medical organizations or issues related to the amount of accessible indicators of compulsory medical statistical reporting. The novelty of this study consists in (a) reviewing the most recent studies on the topic and (b) including studies in Russian in the analysis. We elaborate on general and specific policy implications for improving transparency-driven outcomes in the Russian healthcare system.

Trichomes that originate from plant aerial epidermis act as mechanical and chemical barriers against herbivores. Although several regulators have recently been identified, the regulatory pathway underlying multicellular trichome formation remains largely unknown in tomato. Here, we report a novel HD-ZIP IV transcription factor, Lanata (Ln), a missense mutation which caused the hairy phenotype. Biochemical analyses demonstrate that Ln separately interacts with two trichome regulators, Woolly (Wo) and Hair (H). Genetic and molecular evidence demonstrates that Ln directly regulates the expression of H. The interaction between Ln and Wo can increase trichome density by enhancing the expression of SlCycB2 and SlCycB3, which we previously showed are involved in tomato trichome formation. Furthermore, SlCycB2 represses the transactivation of the SlCycB3 gene by Ln and vice versa. Our findings provide new insights into the novel regulatory network controlling multicellular trichome formation in tomato., (© 2022 The Authors. New Phytologist © 2022 New Phytologist Foundation.)

Background: Bovine Respiratory Disease (BRD) is a multifactorial and economically important illness of cattle. The current study was designed to characterize the major bacterial pathogens associated with BRD and determine the antibiotic susceptibility patterns of isolates. Samples were collected from 400 pneumonic cases of cattle., Results: Laboratory assay revealed isolation of 376 (94.0%) bacterial pathogens. The most prevalent bacterial pathogens recovered were Mannheimia haemolytica (M. haemolytica) followed by Pasteurella multocida (P. multocida), Histophilus somni (H. somni), and Bibersteinia trehalosi (B. trehalosi) from 191 (50.80%), 81 (21.54%), 56 (14.89%), and 48 (12.77%) samples, respectively. M. haemolytica strains were confirmed using multiplex PCR assay through the amplification of PHSSA (~ 325 bp) and Rpt2 (~ 1022 bp) genes. Capsular typing of P. multocida revealed amplification of serogroup A (hyaD-hyaC) gene (~ 1044 bp) and serogroup D (dcbF) gene (~ 657 bp). B. trehalosi isolates displayed amplification of the sodA gene (~ 144 bp). Besides, serotyping of M. haemolytica showed the distribution of serotype A:1 (82.20%), A:2 (10.47%), and A:6 (7.33%). Whereas, biotyping of P. multocida revealed a higher prevalence of biotype A:3 (83.95%), then A:1 (8.64%), A:2 (4.94%), and A:12 (2.47%). The majority of the retrieved isolates showed remarkable susceptibility to enrofloxacin, ciprofloxacin, sulfamethoxazole-trimethoprim, florfenicol, and ceftiofur (100%). Besides, varying degree of antimicrobial resistance was observed against streptomycin, gentamicin, penicillin-G, and ampicillin., Conclusions: The current findings confirmed that M. haemolytica (A:1) strain is the most common bacterial pathogen identified from BRD cases in the study areas of Ethiopia. Hence, continuous outbreak monitoring and evaluation of antibiotics susceptibility patterns of bacterial pathogens associated with BRD are indispensable to reduce the impact of BRD in the study areas. Further investigation of bacterial pathogens and genotypic analysis of pathogens from a wider area of the country is essential to design a cost-efficient control strategy., (© 2022. The Author(s).)

Objective: Emerging SARS-COV-2 variants are spurring the development of adapted vaccines as public health authorities plan for fall vaccinations. This study estimated the number of infections and hospitalizations prevented by three potential booster strategies for adults (≥18 years) in the United States: boosting with either Moderna's (1) licensed first generation monovalent vaccine mRNA-1273 (ancestral strain) or (2) candidate bivalent vaccine mRNA-1273.214 (ancestral + BA.1 variant of concern [VOC]) starting in September 2022, or (3) Moderna's updated candidate bivalent vaccine mRNA-1273.222 (ancestral + BA.4/5 VOC) starting November 2022 due to longer development time., Methods: An age-stratified, transmission dynamic, Susceptible-Exposed-Infection-Recovered (SEIR) model, adapted from previous literature, was used to estimate infections over time; the model contains compartments defined by SEIR and vaccination status. A decision tree was used to estimate clinical consequences of infections. Calibration was performed so the model tracks the actual course of the pandemic to present time., Results: Vaccinating with mRNA-1273(Sept), mRNA-1273.214(Sept), and mRNA-1273.222(Nov) is predicted to reduce infections by 34%, 40%, and 18%, respectively, and hospitalizations by 42%, 48%, and 25%, respectively, over 6 months compared to no booster. Sensitivity analyses around transmissibility, vaccine coverage, masking, and waning illustrate that boosting with mRNA-1273.214 in September prevented more cases of infection and hospitalization than the other vaccines., Limitations and Conclusions: With the emergence of new variants, key characteristics of the virus that affect estimates of spread and clinical impact also evolve, making parameter estimation difficult. Our analysis demonstrated that boosting with mRNA-1273.214 was more effective over 6 months in preventing infections and hospitalizations with a BA.4/5 subvariant than the tailored vaccine, simply because it could be deployed 2 months earlier. We conclude that there is no advantage to delay boosting until a more effective BA.4/5 vaccine is available; earlier boosting with mRNA-1273.214 will prevent the most infections and hospitalizations.

Aims: To assess the impact of belumosudil on the cost of care in chronic graft-versus-host disease (cGVHD) patients who have failed at least two prior lines of systemic therapy using a budget impact model., Methods: A budget impact model with a 5-year time horizon was constructed in Microsoft Excel. The base case model uses the US prevalence rate of 3 L/4L + cGVHD patients from literature and secondary sources, with the potential for user-defined inputs, including model perspectives. The model includes data for two perspectives: the national US population and a hypothetical US private payer health insurance plan with 10 million (Mil) members. Additional model inputs include market share of cGVHD treatments, their associated adverse event rates, and healthcare resource utilization., Results: The potential annual budget impact for the US national and payer plans was evaluated for cGVHD patients. Based on belumosudil utilization increasing to 55% in 3 L and 4 L + by 2026, cost savings of ∼5.5% and 6.7% ($128.8 and $4.9 Mil USD) were observed from national and payer perspectives, respectively. Cost savings in 2026 were derived from fewer AEs ($108.4 and $3.9 Mil USD, for national and payer perspectives; e.g. neutropenia, and thrombocytopenia) and reduced HCRU ($65.1 and $2.3 Mil USD, for national and payer perspectives; e.g. emergency room visits, ICU stays, etc.)., Limitations: Results from the model were dependent on the available data inputs and assumptions. Real-world values may differ from the assumed performance of treatments, market growth, and treatment dosing and duration., Conclusion: The model results suggest that the introduction of belumosudil to treat cGVHD would be associated with substantial cost savings when evaluating a scenario with versus without belumosudil from a US payer perspective.

Objective: The PULsE-AI trial sought to determine the effectiveness of a screening strategy that included a machine learning risk prediction algorithm in conjunction with diagnostic testing for identification of undiagnosed atrial fibrillation (AF) in primary care. This study aimed to evaluate the cost-effectiveness of implementing the screening strategy in a real-world setting., Methods: Data from the PULsE-AI trial - a prospective, randomized, controlled trial conducted across six general practices in England from June 2019 to February 2021 - were used to inform a cost-effectiveness analysis that included a hybrid screening decision tree and Markov AF disease progression model. Model outcomes were reported at both individual- and population-level (estimated UK population ≥30 years of age at high-risk of undiagnosed AF) and included number of patients screened, number of AF cases identified, mean total and incremental costs (screening, events, treatment), quality-adjusted-life-years (QALYs), and incremental cost-effectiveness ratio (ICER)., Results: The screening strategy was estimated to result in 45,493 new diagnoses of AF across the high-risk population in the UK (3.3 million), and an estimated additional 14,004 lifetime diagnoses compared with routine care only. Per-patient costs for high-risk individuals who underwent the screening strategy were estimated at £1,985 (vs £1,888 for individuals receiving routine care only). At a population-level, the screening strategy was associated with a cost increase of approximately £322 million and an increase of 81,000 QALYs. The screening strategy demonstrated cost-effectiveness versus routine care only at an accepted ICER threshold of £20,000 per QALY-gained, with an ICER of £3,994/QALY., Conclusions: Compared with routine care only, it is cost-effective to target individuals at high risk of undiagnosed AF, through an AF risk prediction algorithm, who should then undergo diagnostic testing. This AF risk prediction algorithm can reduce the number of patients needed to be screened to identify undiagnosed AF, thus alleviating primary care burden.

Aim: This economic analysis evaluated the cost-effectiveness of nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of platinum-doublet chemotherapy (PDC) compared with four cycles of PDC as first-line treatment for patients with advanced NSCLC in the United States (US)., Methods: A partitioned survival model was constructed with three mutually exclusive health states: progression free, progressed disease, and death. The analysis was conducted from a US healthcare payer perspective, using a time horizon of 25 years. Costs and outcomes were discounted at 3% annually. Survival outcomes from CheckMate 9LA were extrapolated with longer follow-up data from CheckMate 227 Part 1 (NIVO + IPI) and validated against data from other relevant clinical trials and real-world registries. Health-related quality of life utility values were derived from EQ-5D-3L data collected in CheckMate 9LA. US-specific costs (2020 dollars) were used for disease management; drug acquisition, administration, and monitoring; end-of-life care; adverse events; and subsequent treatments. Model outcomes included life years (LYs) gained, quality-adjusted LYs (QALYs) gained, and incremental cost-effectiveness ratio (ICER) for NIVO + IPI + PDC versus PDC. Sensitivity and scenario analyses were conducted., Results: NIVO + IPI + PDC was associated with higher projected health benefits than PDC, including gains in LYs (3.71 vs 1.89) and QALYs (2.86 vs 1.37), and higher costs ($317,581 vs $119,909). The ICER was $132,960/QALY gained. NIVO + IPI + PDC had a 78-100% probability of being cost-effective at a willingness-to-pay threshold of $150,000-$250,000/QALY. Sensitivity and scenario analyses indicated that the results were robust to changes in key parameters., Limitations: The inherent limitation in extrapolating clinical trial data was mitigated using data from the more mature CheckMate 227 Part 1 trial and validating the outcomes against data from other relevant trials and real-world registries., Conclusion: NIVO + IPI + PDC (two cycles) provides a new first-line treatment option for patients with advanced NSCLC that is cost-effective within a range considered acceptable in the US.

Objectives: This study aimed to analyze the impact of glaucoma in ambulatory centers and hospitals in Spain over the past decade, in terms of incidence and medical costs., Methods: Administrative data of glaucoma patients from ambulatory centers and hospitals in Spain and registered between 2011 and 2020 was obtained from a Spanish National discharge database. Medical costs obtained were based on the diagnosis-related group-based hospital payment systems, determined by the Spanish Ministry of Health., Results: Data from 100,734 ambulatory care visits and 11,408 hospital admissions related to glaucoma were obtained from the database. Most of the cases were registered in patients over 65 years of age. The incidence of glaucoma in ambulatory centers was 2.2 per 10,000 persons over the study period; in hospitals, the incidence was 0.2 per 10,000 persons. The incidence of glaucoma in ambulatory settings increased significantly over the study period, while the incidence in hospitals decreased over the same period. Most ambulatory visits and hospital admissions were programmed or non-urgent. The mean cost per ambulatory visit was €954, €5.5 million in total annually; the mean cost per hospital admission was €3,727, €4.1 million in total annually. The annual cost of ambulatory care increased significantly over the study period, while the annual cost of hospital care decreased significantly., Conclusions: The medical costs of glaucoma in Spanish hospitals decreased over the study period, while the costs of ambulatory care increased. This shift in the management of glaucoma should be considered in future resource allocation decisions.

Aims: A third of non-valvular atrial fibrillation (NVAF) patients are non-adherent to direct oral anticoagulants (DOACs). Estimates of the economic value of full adherence and the cost of two types of adherence improving interventions are important to healthcare planners and decision-makers., Methods: A cost-utility analysis estimated the impact of non-adherence over a 20-year horizon, for a patient cohort with a mean age of 77 years, based on data from the Stockholm Healthcare database of NVAF patients with incident stroke between 2011 and 2018. Adherence was defined using a medication possession ratio (MPR) cut-off of 90%; primary outcomes were the number of ischemic strokes and associated incremental cost-utility ratio., Results: Hypothetical comparisons between cohorts of 1,000 patients with varying non-adherence levels and full adherence (MPR >90%) predicted an additional number of strokes ranging from 117 (MPR = 81-90%) to 866 (MPR <60%), and years of life lost ranging from 177 (MPR = 81- 90%) to 1,318 (MPR < 60%; discounted at 3%). Chronic disease co-management intervention occurring during each DOAC prescription renewal and patient education intervention at DOAC initiation will be cost-saving to the health system if its cost is below SEK 143 and SEK 4,655, and cost-effective if below SEK 858 and SEK 28,665, respectively., Conclusion: Adherence improving interventions for NVAF patients on DOACs such as chronic disease co-management and patient education can be cost-saving and cost-effective, within a range of costs that appear reasonable to the Swedish healthcare system.

Aims: The COVID-19 pandemic has claimed the lives of more than 800,000 people in the United States (US) and has been estimated to carry a societal cost of $16 trillion over the next decade. The availability of COVID-19 vaccines has had a profound effect on the trajectory of the pandemic, with wide-ranging benefits. We aimed to estimate the total societal economic value generated in the US from COVID-19 vaccines., Methods: We developed a population-based economic model informed by existing data and literature to estimate the total societal value generated from COVID-19 vaccines by avoiding COVID-19 infections as well as resuming social and economic activity more quickly. To do this, we separately estimated the value generated from life years saved, healthcare costs avoided, quality of life gained, and US gross domestic product (GDP) gained under a range of plausible assumptions., Results: Findings from our base case analysis suggest that from their launch in December 2020, COVID-19 vaccines were projected to generate $5.0 trillion in societal economic value for the US from avoided COVID-19 infections and resuming unrestricted social and economic activity more quickly. Our scenario analyses suggest that the value could range between $1.8 and $9.9 trillion. Our model indicates that the most substantial sources of value are derived from reduction in prevalence of depression ($1.9 trillion), gains to US GDP ($1.4 trillion), and lives saved from fewer COVID-19 infections ($1.0 trillion)., Limitations: Constructed as a projection from December 2020, our model does not account for the Delta or future variants, nor does it account for improvements in COVID-19 treatment., Conclusions: The magnitude of economic benefit from vaccination highlights the need for coordinated policy decisions to support continued widespread vaccine uptake in the US.