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AbstractDiglycolamide (DGA) resin, a product produced by Eichrom Technologies, Inc. employs TODGA (N,N,N′,N′-tetraoctyldiglycolamide) as the active extractant, which will be used by Savannah River National Laboratory to extract trivalent actinides and lanthanides from dissolved irradiated Mark-18A targets. The final form of the extracted material will be an oxide suitable for shipment. A two-step process was developed and validated for the direct recovery of actinides and lanthanides loaded on I-grade DGA resin as nitrates by thermally drying and decomposing resin loaded with Nd(III), a surrogate for trivalent actinides and lanthanides, under inert conditions followed by calcining the resultant residue in air to provide an oxide product. A stepwise heating profile up to 385°C under argon gas flow resulted in 85% to 89% mass loss during the resin drying and decomposition step, and calcination of the resultant Nd-loaded resin residue provided an overall material mass loss of ≥ 98%. Recoveries from resin saturated with Nd(III) from 7 M and 0.35 M nitric acid subjected to this process were 30.7 mg and 27.6 mg Nd/g dry resin, respectively, representing an average of 96.1% of Nd retained in the resin bed. [ABSTRACT FROM AUTHOR]

We overview plasma-enhanced chemical vaper deposition (PECVD) of high-quality thin-film silicon. In PECVD, such a film is grown by the deposition of precursors, which is generated by the gas-phase reactions of source gases in plasma. The growth of the film depends on the surface reactions of precursors and the reactions in the growing film, i.e., in-film reactions, which influences the film structure and properties. The in-film reactions also take place after the growth, i.e., post-growth annealing. So, the reactions should be properly controlled throughout the growth and annealing for the high-quality film formation. Here, the growth kinetics and related reactions are presented for devicegrade hydrogenated amorphous silicon (a-Si:H) films. [ABSTRACT FROM AUTHOR]

Our cost of illness study aimed to provide an estimate of the burden related to systemic lupus erythematosus (SLE) in the Mexican context. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

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.

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.

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.

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.

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.