Cost Analysis of Liver Acquisition Fees Before and After Acuity Circle Policy Implementation.

Importance: Acuity circles (AC) liver allocation policy was implemented to eliminate donor service area geographic boundaries from liver allocation and to decrease variability in median Model of End-stage Liver Disease (MELD) score at transplant and wait list mortality. However, the broader sharing of organs was also associated with more flights for organ procurements and higher costs associated with the increase in flights. Objective: To determine whether the costs associated with liver acquisition changed after the implementation of AC allocation. Design, Setting, and Participants: This single-center cost comparison study analyzed fees associated with organ acquisition before and after AC allocation implementation. The cost data were collected from a single transplant institute with 2 liver transplant centers, located 30 miles apart, in different donation service areas. Cost, recipient, and transportation data for all cases that included fees associated with liver acquisition from July 1, 2019, to October 31, 2020, were collected. Exposures: Primary liver offer acceptance with associated organ procurement organization or charter flight fees. Main Outcomes and Measures: Specific fees (organ acquisition, surgeon, import, and charter flight fees) and total fees per donor were collected for all accepted liver donors with at least 1 associated fee during the study period. Results: Of 213 included donors, 171 were used for transplant; 90 of 171 (52.6%) were male, and the median (interquartile range) age of donors was 41.0 (30.0-52.8) years in the pre-AC period and 36.9 (24.0-48.8) years in the post-AC period. There was no significant difference in the post-AC compared with pre-AC period in median (range) MELD score (24 [8-40] vs 25 [6-40]; P = .27) or median (range) match run sequence (15 [1-3951] vs 10 [1-1138]; P = .31), nor in mean (SD) distance traveled (155.83 [157.00] vs 140.54 [144.33] nautical miles; P = .32) or percentage of donors requiring flights (58.5% [69 of 118] vs 56.8% [54 of 95]; P = .82). However, costs increased significantly in the post-AC period: total cost increased 16% per accepted donor (mean [SD] of $52 966 [13 278] vs $45 725 [9300]; P < .001) and 55% per declined donor (mean [SD] of $15 865 [3942] vs $10 217 [4853]; P < .001). Contributing factors included more than 2-fold increases in the proportions of donors incurring import fees (31.4% [37 of 118] vs 12.6% [12 of 95]; P = .002) and surgeon fees (19.5% [23 of 118] vs 9.5% [9 of 95]; P = .05), increased acquisition fees (10% increase; mean [SD] of $43 860 [3266] vs $39 980 [2236]; P < .001), and increased flight expenses (43% increase; mean [SD] of $12 904 [6066] vs $9049 [5140]; P = .002). Conclusions and Relevance: The unintended consequences of implementing broader sharing without addressing organ acquisition fees to account for increased importation between organ procurement organizations must be remedied to contain costs and ensure viability of transplant programs.

Enhanced recovery in liver transplantation: A value-based approach to complex surgical care.

BACKGROUND: Value-based healthcare focuses on improving outcomes relative to cost. We aimed to study the impact of an enhanced recovery pathway for liver transplant recipients on providing value. METHODS: In total, 379 liver recipients were identified: pre-enhanced recovery pathway (2017, n = 57) and post-enhanced recovery pathway (2018-2020, n = 322). The enhanced recovery pathway bundle was defined through multidisciplinary efforts and included optimal fluid management, end-of-case extubation, multimodal analgesia, and a standardized care pathway. Pre- and post-enhanced recovery pathway patients were compared with regard to extubation rates, lengths of stay, complications, readmissions, survival, and costs. RESULTS: Pre- and post-enhanced recovery pathway recipient model for end-stage liver disease score and balance of risk scores were similar, although post-enhanced recovery pathway recipients had a higher median donor risk index (1.55 vs 1.39, P = .003). End-of-case extubation rates were 78% post-enhanced recovery pathway (including 91% in 2020) versus 5% pre-enhanced recovery pathway, with post-enhanced recovery pathway patients having decreased median intraoperative transfusion requirements (1,500 vs 3,000 mL, P < .001). Post-enhanced recovery pathway recipients had shorter median intensive care unit (1.6 vs 2.3 days, P = .01) and hospital stays (5.4 vs 8.0 days, P < .001). Incidence of severe (Clavien-Dindo ≥3) complications during the index hospitalization were similar between pre-enhanced recovery pathway versus post-enhanced recovery pathway groups (33% vs 23%, P = .13), as were 30-day readmissions (26% vs 33%, P = .44) and 1-year survival (93.0% vs 94.5%, P = .58). The post-enhanced recovery pathway cohort demonstrated a significant reduction in median direct cost per case ($11,406; P < .001). CONCLUSION: Implementation of an enhanced recovery pathway in liver transplantation is feasible, safe, and effective in delivering value, even in the setting of complex surgical care.

Current Knowledge, Barriers to Implementation, and Future Directions in Palliative Care for End-Stage Liver Disease.

End-stage liver disease (ESLD) is associated with a high degree of morbidity and mortality as well as symptom burden. Despite this, the rate of consultation with palliative care (PC) providers remains low, and invasive procedures near the end of life are commonplace. Studies show that involvement of PC providers improves patient satisfaction, and evidence from other chronic diseases demonstrates reduced costs of care and potentially increased survival. Better integration of PC is imperative but hindered by patient and provider misconceptions about its role in the care of patients with ESLD, specifically among candidates for liver transplantation. Additionally, reimbursement barriers and lack of provider knowledge may contribute to PC underutilization. In this review, we discuss the benefits of PC in ESLD, the variability of its delivery, and key stakeholders' perceptions about its use. Additionally, we identify barriers to more widespread PC adoption and highlight areas for future research.

Use of direct-acting antiviral agents in hepatitis C virus-infected liver transplant candidates.

Since the advent of direct acting antiviral (DAA) agents, chronic hepatitis C virus (HCV) treatment has evolved at a rapid pace. In contrast to prior regimen involving ribavirin and pegylated interferon, these newer agents are highly effective, well-tolerated, have shorter course of therapy and safer essentially in all HCV patients including those with advanced liver disease and following liver transplantation. Clinicians caring for HCV-infected patients on the liver transplant (LT) waitlist are often faced with a dilemma whether to treat HCV infection before or after liver transplantation. Sustained virological response (SVR) rates following HCV treatment may improve hepatic function sufficiently enough to negate the need for LT in certain patients. On the other hand, the decrease in MELD without improvement in quality of life in certain patients may lead to delay or dropout from potentially curative LT surgery list. In this context, our review focuses on the approach to and optimal timing of DAA-based treatment of HCV infection in LT candidates in the peri-transplant period.

Higher MELD score increases the overall cost on the waiting list for liver transplantation: a micro-costing analysis based study.

BACKGROUND:: The pre-transplant period is complex and includes lots of procedures. The severity of liver disease predisposes to a high number of hospitalizations and high costs procedures. Economic evaluation studies are important tools to handle costs on the waiting list for liver transplantation. OBJECTIVE:: The objective of the present study was to evaluate the total cost of the patient on the waiting list for liver transplantation and the main resources related to higher costs. METHODS:: A cost study in a cohort of 482 patients registered on waiting list for liver transplantation was carried out. In 24 months follow-up, we evaluated all costs of materials, medicines, consultations, procedures, hospital admissions, laboratorial tests and image exams, hemocomponents replacements, and nutrition. The total amount of each resource or component used was aggregated and multiplied by the unitary cost, and thus individual cost for each patient was obtained. RESULTS:: The total expenditure of the 482 patients was US$ 6,064,986.51. Outpatient and impatient costs correspond to 32.4% of total cost (US$ 1,965,045.52) and 67.6% (US$ 4,099,940.99) respectively. Main cost drivers in outpatient were: medicines (44.31%), laboratorial tests and image exams (31.68%). Main cost drivers regarding hospitalizations were: medicines (35.20%), bed use in ward and ICU (26.38%) and laboratorial tests (13.72%). Patients with MELD score between 25-30 were the most expensive on the waiting list (US$ 16,686.74 ± 16,105.02) and the less expensive were those with MELD below 17 (US$ 5,703.22 ± 9,318.68). CONCLUSION:: Total costs on the waiting list for liver transplantation increased according to the patient's severity. Individually, hospitalizations, hemocomponents reposition and hepatocellular carcinoma treatment were the main cost drivers to the patient on the waiting list. The longer the waiting time, the higher the total cost on list, causing greater impact on health systems.

Higher MELD score increases the overall cost on the waiting list for liver transplantation: a micro-costing analysis based study / Altos valores de MELD aumentam o custo total em lista de espera para o transplante hepático. Um estudo de microcusteio

ABSTRACT BACKGROUND: The pre-transplant period is complex and includes lots of procedures. The severity of liver disease predisposes to a high number of hospitalizations and high costs procedures. Economic evaluation studies are important tools to handle costs on the waiting list for liver transplantation. OBJECTIVE: The objective of the present study was to evaluate the total cost of the patient on the waiting list for liver transplantation and the main resources related to higher costs. METHODS: A cost study in a cohort of 482 patients registered on waiting list for liver transplantation was carried out. In 24 months follow-up, we evaluated all costs of materials, medicines, consultations, procedures, hospital admissions, laboratorial tests and image exams, hemocomponents replacements, and nutrition. The total amount of each resource or component used was aggregated and multiplied by the unitary cost, and thus individual cost for each patient was obtained. RESULTS: The total expenditure of the 482 patients was US$ 6,064,986.51. Outpatient and impatient costs correspond to 32.4% of total cost (US$ 1,965,045.52) and 67.6% (US$ 4,099,940.99) respectively. Main cost drivers in outpatient were: medicines (44.31%), laboratorial tests and image exams (31.68%). Main cost drivers regarding hospitalizations were: medicines (35.20%), bed use in ward and ICU (26.38%) and laboratorial tests (13.72%). Patients with MELD score between 25-30 were the most expensive on the waiting list (US$ 16,686.74 ± 16,105.02) and the less expensive were those with MELD below 17 (US$ 5,703.22 ± 9,318.68). CONCLUSION: Total costs on the waiting list for liver transplantation increased according to the patient's severity. Individually, hospitalizations, hemocomponents reposition and hepatocellular carcinoma treatment were the main cost drivers to the patient on the waiting list. The longer the waiting time, the higher the total cost on list, causing greater impact on health systems.

RESUMO CONTEXTO: O período pré-transplante é complexo e inclui grande quantidade de procedimentos. A gravidade da doença hepática predispõe a um alto número de internações e procedimentos de alto custo. Estudos em avaliação econômica são uma importante ferramenta para o manejo dos custos em lista de espera para o transplante hepático. OBJETIVO: O objetivo do presente estudo foi avaliar o custo total do paciente em lista de espera para o transplante hepático e os principais recursos relacionados ao alto custo. MÉTODOS: Foi realizado um estudo de coorte em 482 pacientes registrados em lista de espera para o transplante hepático. Os pacientes foram acompanhados por um período de 24 meses, no qual foram avaliados todos os custos de materiais, medicamentos, consultas, procedimentos internações, exames laboratoriais e de imagem, reposição de hemocomponentes e nutrição recebida. A quantidade total de cada recurso e componente utilizado foi obtida e multiplicada pelo seu valor unitário e, desta maneira, o custo individual de cada paciente foi obtido. RESULTADOS: O total gasto pelos 482 pacientes foi de US$ 6.064.986,51. Os custos ambulatoriais corresponderam a 32,4% do total (US$ 1.965.045,52) e os custos em internação corresponderam a 67,6% do total (US$ 4.099.940,99). Os principais determinantes do custo em ambulatório foram: medicamentos (44,31%) e exames laboratoriais e de imagem (31,68%). Os principais determinantes de custo em internações foram: medicamentos (35,20%), utilização do leito em enfermaria e em UTI (26,38%) e exames laboratoriais (13,72%) Pacientes com valores de MELD entre 25-30 foram os de maiores custos em lista de espera (US$ 16.686,74 ± 16,105.02) e os de menor custo foram os pacientes com MELD abaixo de 17 (US$ 5.703,22 ± 9.318,68). CONCLUSÃO: O custo total em lista de espera para o transplante hepático aumenta de acordo com a gravidade do paciente. Individualmente, internações, reposição de hemocomponentes e o tratamento do paciente com carcinoma hepatocelular são os principais determinantes de custo para os pacientes em lista de espera para o transplante hepático. Quanto maior o tempo de espera, maiores serão os custos em lista, causando maior impacto nos sistemas de saúde.

Before or After Transplantation? A Review of the Cost Effectiveness of Treating Waitlisted Patients With Hepatitis C.

All patients with chronic hepatitis C virus (HCV) infections can and should be treated. Though highly effective direct-acting antiviral therapies are costly, the price of a cure is a 1-time investment that is outweighed by future benefits. For clinicians caring for patients requiring liver transplant, the key question relates to the timing of treatment: before or after liver transplantation? On 1 hand, treating HCV often improves our patients' model for end-stage liver disease (MELD) score, decreasing costs, and potentially improving longevity by reducing our patients' risk of death and transplantation. On the other hand, there is a concern that the cured patient with decompensated cirrhosis will find themselves in "MELD purgatory" with nonprogressive liver disease but a poor quality of life. At the same time, some patients, such as those with hepatocellular carcinoma, will require liver transplant irrespective of their MELD meaning that pretransplant therapy cannot reduce costs in such settings. These important tradeoffs are often difficult reconcile for clinicians who care for patients awaiting liver transplant. Fortunately, guidance for navigating these competing concerns can be obtained from cost-effectiveness analyses. Herein, we review the available data on this approach to HCV therapy before or after liver transplant.

Clinical epidemiology and disease burden of nonalcoholic fatty liver disease.

Nonalcoholic fatty liver disease (NAFLD) is defined as the presence of hepatic fat accumulation after the exclusion of other causes of hepatic steatosis, including other causes of liver disease, excessive alcohol consumption, and other conditions that may lead to hepatic steatosis. NAFLD encompasses a broad clinical spectrum ranging from nonalcoholic fatty liver to nonalcoholic steatohepatitis (NASH), advanced fibrosis, cirrhosis, and finally hepatocellular carcinoma (HCC). NAFLD is the most common liver disease in the world and NASH may soon become the most common indication for liver transplantation. Ongoing persistence of obesity with increasing rate of diabetes will increase the prevalence of NAFLD, and as this population ages, many will develop cirrhosis and end-stage liver disease. There has been a general increase in the prevalence of NAFLD, with Asia leading the rise, yet the United States is following closely behind with a rising prevalence from 15% in 2005 to 25% within 5 years. NAFLD is commonly associated with metabolic comorbidities, including obesity, type II diabetes, dyslipidemia, and metabolic syndrome. Our understanding of the pathophysiology of NAFLD is constantly evolving. Based on NAFLD subtypes, it has the potential to progress into advanced fibrosis, end-stage liver disease and HCC. The increasing prevalence of NAFLD with advanced fibrosis, is concerning because patients appear to experience higher liver-related and non-liver-related mortality than the general population. The increased morbidity and mortality, healthcare costs and declining health related quality of life associated with NAFLD makes it a formidable disease, and one that requires more in-depth analysis.

Future Economics of Liver Transplantation: A 20-Year Cost Modeling Forecast and the Prospect of Bioengineering Autologous Liver Grafts.

During the past 20 years liver transplantation has become the definitive treatment for most severe types of liver failure and hepatocellular carcinoma, in both children and adults. In the U.S., roughly 16,000 individuals are on the liver transplant waiting list. Only 38% of them will receive a transplant due to the organ shortage. This paper explores another option: bioengineering an autologous liver graft. We developed a 20-year model projecting future demand for liver transplants, along with costs based on current technology. We compared these cost projections against projected costs to bioengineer autologous liver grafts. The model was divided into: 1) the epidemiology model forecasting the number of wait-listed patients, operated patients and postoperative patients; and 2) the treatment model forecasting costs (pre-transplant-related costs; transplant (admission)-related costs; and 10-year post-transplant-related costs) during the simulation period. The patient population was categorized using the Model for End-Stage Liver Disease score. The number of patients on the waiting list was projected to increase 23% over 20 years while the weighted average treatment costs in the pre-liver transplantation phase were forecast to increase 83% in Year 20. Projected demand for livers will increase 10% in 10 years and 23% in 20 years. Total costs of liver transplantation are forecast to increase 33% in 10 years and 81% in 20 years. By comparison, the projected cost to bioengineer autologous liver grafts is $9.7M based on current catalog prices for iPS-derived liver cells. The model projects a persistent increase in need and cost of donor livers over the next 20 years that's constrained by a limited supply of donor livers. The number of patients who die while on the waiting list will reflect this ever-growing disparity. Currently, bioengineering autologous liver grafts is cost prohibitive. However, costs will decline rapidly with the introduction of new manufacturing strategies and economies of scale.

Hepatitis B and liver transplantation: molecular and clinical features that influence recurrence and outcome.

Hepatitis B virus (HBV) continues to be a major cause of morbidity and mortality worldwide. It is estimated that about 350 million people throughout the world are chronically infected with HBV. Some of these people will develop hepatic cirrhosis with decompensation and/or hepatocellular carcinoma. For such patients, liver transplantation may be the only hope for cure or real improvement in quality and quantity of life. Formerly, due to rapidity of recurrence of HBV infection after liver transplantation, usually rapidly progressive, liver transplantation was considered to be contraindicated. This changed dramatically following the demonstration that hepatitis B immune globulin (HBIG), could prevent recurrent HBV infection. HBIG has been the standard of care for the past two decades or so. Recently, with the advent of highly active inhibitors of the ribose nucleic acid polymerase of HBV (entecavir, tenofovir), there has been growing evidence that HBIG needs to be given for shorter lengths of time; indeed, it may no longer be necessary at all. In this review, we describe genetic variants of HBV and past, present, and future prophylaxis of HBV infection during and after liver transplantation. We have reviewed the extant medical literature on the subject of infection with the HBV, placing particular emphasis upon the prevention and treatment of recurrent HBV during and after liver transplantation. For the review, we searched PubMed for all papers on the subject of "hepatitis B virus AND liver transplantation". We describe some of the more clinically relevant and important genetic variations in the HBV. We also describe current practices at our medical centers, provide a summary and analysis of comparative costs for alternative strategies for prevention of recurrent HBV, and pose important still unanswered questions that are in need of answers during the next decade or two. We conclude that it is now rational and cost-effective to decrease and, perhaps, cease altogether, the routine use of HBIG during and following liver transplantation for HBV infection. Here we propose an individualized prophylaxis regimen, based on an integrated approach and risk-assessment.

Increased uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease in England: modelling the predicted impact of treatment under different scenarios.

BACKGROUND & AIMS: Hepatitis C (HCV) related disease in England is predicted to rise, and it is unclear whether treatment at current levels will be able to avert this. The aim of this study was to estimate the number of people with chronic HCV infection in England that are treated and assess the impact and costs of increasing treatment uptake. METHODS: Numbers treated were estimated using national data sources for pegylated interferon supplied, dispensed, or purchased from 2006 to 2011. A back-calculation approach was used to project disease burden over the next 30 years and determine outcomes under various scenarios of treatment uptake. RESULTS: 5000 patients were estimated to have been treated in 2011 and 28,000 in total from 2006 to 2011; approximately 3.1% and 17% respectively of estimated chronic infections. Without treatment, incident cases of decompensated cirrhosis and hepatocellular carcinoma were predicted to increase until 2035 and reach 2290 cases per year. Treatment at current levels should reduce incidence by 600 cases per year, with a peak around 2030. Large increases in treatment are needed to halt the rise; and with more effective treatment the best case scenario predicts incidence of around 500 cases in 2030, although treatment uptake must still be increased considerably to achieve this. CONCLUSIONS: If the infected population is left untreated, the number of patients with severe HCV-related disease will continue to increase and represent a substantial future burden on healthcare resources. This can be mitigated by increasing treatment uptake, which will have the greatest impact if implemented quickly.

Assessing variation in the costs of care among patients awaiting liver transplantation.

Previous economic analyses of liver transplantation have focused on the cost of the transplant and subsequent care. Accurate characterization of the pretransplant costs, indexed to severity of illness, is needed to assess the economic burden of liver disease. A novel data set linking Medicare claims with transplant registry data for 15,710 liver transplant recipients was used to determine average monthly waitlist spending (N = 249,434 waitlist months) using multivariable linear regression models to adjust for recipient characteristics including Model for End-Stage Liver Disease (MELD) score. Characteristics associated with higher spending included older age, female gender, hepatocellular carcinoma, diabetes, hypertension and increasing MELD score (p < 0.05 for all). Spending increased exponentially with severity of illness: expected monthly spending at a MELD score of 30 was 10 times higher than at MELD of 20 ($22,685 vs. $2030). Monthly spending within MELD strata also varied geographically. For candidates with a MELD score of 35, spending varied from $19,548 (region 10) to $36,099 (region 7). Regional variation in waitlist costs may reflect the impact of longer waiting times on greater pretransplant hospitalization rates among high MELD score patients. Reducing the number of high MELD waitlist patients through improved medical management and novel organ allocation systems could decrease total spending for end-stage liver care.