Overview of the socio-economic consequences of heart failure.

Heart failure (HF) is a frequent cause of morbidity and mortality worldwide. The prevalence of HF increases, and in high-income countries, 1-2% of total healthcare expenditure is spent on HF. This article gives an overview on the impact of HF on health-related quality of life (HRQoL) and the economic burden of HF. Those suffering from HF are associated with a substantial decrease of HRQoL compared to individuals with most other chronic diseases and to individuals without HF. Therapeutic approaches, which decrease risk factors and lead to an improvement of the clinical status of patients, have a positive effect on HRQoL of the patients. Hospitalization rates have been shown to be correlated with disease severity, mortality, and HRQoL. Inpatient treatments of HF patients are cost intensive and the most important component for the economic burden of HF, responsible for at least half of direct cost. Prevention strategies, diagnostic and therapeutic approaches should focus on avoiding need for hospitalizations, and in particular, readmissions. Outpatient care including medication represents the second largest cost component. The cost of HF varies from less than 1,000 USD per patient in low-income countries to between 5,000 and 15,000 EUR in Europe, and between 17,000 and 30,000 USD in the US. There is a lack of study results on indirect costs. All study results on the socio-economic burden of HF clearly underscore the public health relevance of HF, showing a large economic burden for healthcare systems all over the world and a considerable impact on patients' HRQoL. The results on HRQoL are relatively homogeneous, but there are large differences across countries in respect of the economic burden they have to bear. Despite the large number of studies on the socio-economic consequences of HF further research is necessary, especially on indirect cost and for low- and middle-income countries. Future studies would benefit from a greater standardization of methods and presentation of results.

Cost-effectiveness of the artificial liver support system MARS in patients with acute-on-chronic liver failure.

BACKGROUND: For patients with an acute exacerbation of chronic liver failure (ACLF), the molecular adsorbent recirculating system (MARS) can result in a prolongation of life, but data on costs and cost-effectiveness are lacking. METHODS: A health economic evaluation of a prospective controlled cohort trial in patients with ACLF not eligible for liver transplantation with 3 years follow-up and consecutive modelling of long-term costs, outcomes and cost-effectiveness was conducted. Costs were calculated from the perspective of the German health-care system. RESULTS: One hundred and forty-nine patients with ACLF were included of which 67 (44.9%) were treated with MARS and 82 (55.1%) assigned to the control group. Mean survival was 692 days in MARS-treated patients (33% survival after 3 years) and 453 days in control patients (15% after 3 years, logrank P = 0.022). MARS patients gained 0.66 [95% confidence interval (CI): -0.12 to 1.46] life years (LYs), determined by the bootstrap method. The mean cost difference was 19.835 euro (95% CI: 13.308-25.429) with 35639 euro for MARS-treated patients and 15804 euro for controls. Incremental costs per LY gained were 29.985 euro (95% CI: 9.441-321.761) and 43.040 euro (95% CI: 13.551-461.856) per quality-adjusted LY gained. CONCLUSION: There is an acceptable cost-effectiveness of MARS, compared with other medical technologies presently reimbursed. Randomized controlled trials with sufficient sample size are necessary before a final recommendation for MARS can be given.

Economic evaluation of the artificial liver support system MARS in patients with acute-on-chronic liver failure.

BACKGROUND: Acute-on-chronic liver failure (ACLF) is a life threatening acute decompensation of a pre-existing chronic liver disease. The artificial liver support system MARS is a new emerging therapeutic option possible to be implemented in routine care of these patients. The medical efficacy of MARS has been demonstrated in first clinical studies, but economic aspects have so far not been investigated. Objective of this study was to estimate the cost-effectiveness of MARS. METHODS: In a clinical cohort trial with a prospective follow-up of 3 years 33 ACLF-patients treated with MARS were compared to 46 controls. Survival, health-related quality of life as well as direct medical costs for in- and outpatient treatment from a health care system perspective were determined. Based on the differences in outcome and indirect costs the cost-effectiveness of MARS expressed as incremental costs per life year gained and incremental costs per QALY gained was estimated. RESULTS: The average initial intervention costs for MARS were 14600 EUR per patient treated. Direct medical costs over 3 years follow up were overall 40000 EUR per patient treated with MARS respectively 12700 EUR in controls. The 3 year survival rate after MARS was 52% compared to 17% in controls. Kaplan-Meier analysis of cumulated survival probability showed a highly significant difference in favour of MARS. Incremental costs per life-year gained were 31400 EUR; incremental costs per QALY gained were 47200 EUR. CONCLUSION: The results after 3 years follow-up of the first economic evaluation study of MARS based on empirical patient data are presented. Although high initial treatment costs for MARS occur the significantly better survival seen in this study led to reasonable costs per live year gained. Further randomized controlled trials investigating the medical efficacy and the cost-effectiveness are recommended.

Economic evaluation and survival analysis of immunoglobulin adsorption in patients with idiopathic dilated cardiomyopathy.

Idiopathic dilated cardiomyopathy (DCM) is a life-threatening heart disease and a major reason for heart transplantations. The medical efficacy of immunoadsorption (IA) for DCM patients has been demonstrated in initial clinical studies. This prospective matched-case control study examined 5-year survival rates, direct medical costs, and cost-effectiveness in Germany (n=34) from a health-care system perspective. In a cost-effectiveness analysis costs per life year gained were calculated. Patients treated with IA showed a greater survival rate: 5-year survival rate in the intervention group was 82% vs. 41% in controls. Log rank statistics after Kaplan-Meier analysis of cumulated survival probability were highly significant. Initial intervention costs for IA were found to be 28,400 euro per patient treated. Direct medical costs for a 5-year follow-up were 128,600 euro per patient treated with IA and 75,500 euro in controls. Considering only the actual survival time we calculated annual treatment costs of 24,900 euro in the IA group and 28,900 euro in controls. The cost-effectiveness ratio expressed in costs per life year gained was 34,400 euro. This is the first controlled study to perform 5-year survival analysis and economic evaluation of this new emerging technology for patients with DCM. Although high initial treatment costs for IA are incurred, the significantly better survival rates lead to reasonable costs per live year gained.

Economic evaluation and 1-year survival analysis of MARS in patients with alcoholic liver disease.

Objective of this study was to determine 1-year survival, costs and cost-effectiveness of the artificial liver support system Molecular Adsorbent Recirculating System (MARS) in patients with acute-on-chronic liver failure (ACLF) and an underlying alcoholic liver disease. In a case-control study, 13 patients treated with MARS were compared to 23 controls of similar age, sex and severity of disease. Inpatient hospital costs data were extracted from patients' files and hospital's internal costing. Patients and treating GPs were contacted, thus determining resource use and survival 1-year after treatment. Mean 1-year survival time in MARS group was 261 days and 148 days in controls. Kaplan-Meier analysis shows advantages of MARS patients (Logrank: P=0.057). Direct medical costs per patient for initial hospital stay and 1-year follow-up from a payer's perspective were Euro 18,792 for MARS patients and Euro 9638 for controls. The costs per life-year gained are Euro 29,719 (time horizon 1 year). From a societal perspective, the numbers are higher (costs per life-year gained: Euro 79,075), mainly because of the fact that there is no regular reimbursement of MARS and therefore intervention costs were not calculated from payer's perspective. A trade-off between medical benefit and higher costs has to be made, but 1-year results suggest an acceptable cost-effectiveness of MARS. Prolonging the time horizon and including indirect costs, which will be done in future research, would probably improve cost-effectiveness.

Economic evaluation of MARS--preliminary results on survival and quality of life.

OBJECTIVES: The short-term medical benefit of the liver dialysis system MARS in patients with severe acute liver disease has clearly been demonstrated. An economic analysis of MARS has not been presented previously. Objective of the study is to calculate the costs per life saved and life year gained and to measure health related quality of life in patients who survived acute liver failure. First results on survival and HRQL are presented here. STUDY DESIGN: Cost effectiveness and cost utility analysis of MARS are performed. All patients since 1993 with chronic liver failure (Bilirubin > 300 micro mol/l) of the university hospital Rostock are included in the original sample (n = 141). Survival data are calculated. Surviving patients were contacted personally, thus quality of life data (EQ 5D and SF12) determined. Patients were compared in case control study design. In a later stage inpatient hospital costs, direct and indirect outpatients costs are included in the analysis. PRELIMINARY RESULTS: MARS-Patients show a higher survival: Kaplan-Meier cumulative survival after 100 days: 0.59 after MARS, 0.39 without (P <0.05). There was no significant difference in health related quality of life (SF12 and EQ-D). Calculations of quality adjusted life years (QALYs) result in 0.116 QALYs gained by treatment of one patient with MARS in one year. DISCUSSION: First preliminary results suggest that 1 year after therapy MARS seems to have a positive effect concerning survival rate, survival time and QALYs gained. Final results of cost-effectiveness and cost-utility analysis will soon be presented.