[Costs of a guideline-based treatment of patients with chronic hepatitis C in the era of interferon-free treatment]. / Kosten einer leitliniengerechten Versorgung von Hepatitis-C-Patienten im Zeitalter Interferon-freier Therapien.

The treatment of chronic hepatitis C has considerably changed with the introduction of recent direct acting antivirals. These antivirals have sustained virologic response (SVR) rates above 90 % as well as reduced toxicity and treatment duration. Therefore, current German guidelines recommend these interferon-free regimens as first-choice treatment. Nevertheless, recent developments were accompanied by a significant increase in treatment costs, which led to extensive discussions on reasonable pharmaceutical prices. The aim of the current study was to analyze the average treatment costs and costs per patient cured for guideline treatment recommendations. Analyses were stratified according to genotype, treatment status (naive/experienced), and presence/absence of cirrhosis. Costs were separated in (1.) basic diagnostic procedures, (2.) monitoring, and (3.) pharmaceuticals. The calculation is based on a remuneration scheme in the statutory health insurance system. In treatment-naïve non-cirrhotic patients, the average cost is 41 766 €/SVR for the treatment with SOF/LDV calculated (PTV/r/OMV+DSV: 53 129 €/SVR). In treatment-naive cirrhotic patients, costs were 60 323 €/SVR (SOF/LDV+RBV) and 80 604 €/SVR (PTV/r/OMV+DSV+RBV). Treatment-experienced genotype 1 patients had average costs of 60 366 €/SVR for SOF/LDV treatment as well as 53 134 €/SVR for PTV/r/OMV+DSV±RBV treatment (cirrhotic patients: 62 208 €/SVR for SOF/LDV+RBV; 80 824 €/SVR for PTV/r/OMV+DSV+RBV). The average treatment costs per SVR in treatment-naive genotype 1 patients are comparable to previous standard of care treatments and lower in treatment-experienced patients. In other genotypes, treatment costs and costs per cure are significantly higher compared to previous standard of care. However, long-term modelling studies show that new regimens are cost-effective.

Costs and outcomes of treating chronic hepatitis C patients in routine care - results from a nationwide multicenter trial.

Viral hepatitis is a major public health problem affecting millions of people worldwide. Long-term consequences are the development of liver cirrhosis and hepatocellular carcinoma. The aim of the study was to assess outcomes and costs of treating patients with chronic hepatitis C in clinical practice in Germany. We carried out a prospective noninterventional study. Information on treatment outcomes, resource utilization and quality of life was provided by 281 physicians throughout Germany. Data of 3708 monoinfected HCV-patients treated between 2008 and 2011 were analysed. Therapy consisted of peginterferon/ribavirin. Mean age of patients was 43.7 years, 60.3% were male and estimated duration of infection was 13.6 years. Predominantly genotype 1 (61.3%) or 3 (28.5%) infections were observed. Sustained viral response (SVR)-rates in most frequently observed genotypes were 49.2% in GT-1 and 61.9% in GT-3 treatment-naive patients (Relapser: GT-1: 35.3% and GT-3: 57.3%; Nonresponder: GT-1: 25.0% and GT-3: 33.3%). Average treatment costs were lowest in treatment-naive patients (€18 965) and higher in patients who failed previous treatments (relapsers: €24 753; nonresponders: €19 511). Differences according to genotype were observed. Average costs per SVR in treatment-naive patients were €44 744 for GT-1 and €22 218 for GT-3. Treatment was associated with a decrease in quality of life; post-treatment quality of life was higher in patients achieving SVR. Our insight on real-life treatment outcomes and costs can serve as a reference for a comparison with other treatments. There is high need for short-term and long-term cost-effectiveness analysis in real-life settings as newly introduced treatment strategies with direct acting antivirals result in high SVR-rates but are more costly.

[Health and Prevention Behaviour of Persons with and without Migration Background]. / Gesundheits- und Präventionsverhalten von Personen mit und ohne Migrationshintergrund.

Based on a sample of the Hannover registration office this project analyses the health and prevention behaviour of Russian- and Turkish-language migrants compared to natives. The project analysis revealed considerable differences, particularly concerning addiction behaviour and physical activities.

[Effectiveness and Cost-Effectiveness of Daily School Sport in the Primary School--Project: "fit for pisa"]. / Effektivität und Kosteneffektivität täglichen Schulsports in der Grundschule--das Projekt "fit für pisa".

The "fit for pisa" intervention implemented daily physical education at five primary schools in Göttingen. The results of the evaluation show an increase in physical activity among the students participating in the programme. At the same time sedentary behaviour, like watching television, decreased remarkably. In the long run the promotion of an active lifestyle had improved the body mass index. The study emphasises the need for government funding to implement the programme across the country.

[The Preventive Home Visit as a Preventive Intervention to Reach the Elderly--Effectiveness and Cost-Effectiveness of Different Ways of Approach]. / Der präventive Hausbesuch als zugehende Präventionsmaßnahme im Alter--Effektivität und Kosteneffektivität von Zugangswegen.

The aim of the study was a systematical further development of targeted approaches. Research questions were how elderly women and men could be motivated to participate in a preventive intervention and by which approaches elderly with different health risks could be reached. In several stages a specific motivational material was developed. Afterwards two different approaches to the elderly (general practice, health insurance) were tested and evaluated considering its (cost) effectiveness.

[Costs of a guideline-based treatment of patients with chronic hepatitis C in Germany]. / Kosten einer leitliniengerechten Versorgung von Hepatitis-C-Patienten in Deutschland.

The costs of a guideline-based treatment in chronic hepatitis C infected people are unknown. The goal of HCV therapy is to achieve a sustained viral response and thereby to reduce morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma. This study analyses the costs of a guideline-based treatment based on the German guideline on the management of HCV infection. In addition, costs of newly introduced protease inhibitors were calculated. Costs for baseline diagnostics, monitoring and medical treatment were calculated according to the stage of the disease, the HCV genotype and viral response. Costs for baseline diagnostics account for €â€Š302.75 and monitoring accounts for €â€Š596 to €â€Š1173. Dual therapy with pegylated interferon and ribavirin results in average costs of €â€Š7709 to €â€Š34 692. Total costs of a guideline-based treatment range between €â€Š8,608 and €â€Š36 167 depending on HCV genotype and length of therapy. With the introduction of protease inhibitors for HCV genotype 1 patients, costs of pharmaceuticals have increased further. Triple-therapy with telaprevir accounts for €â€Š43 280 respectively €â€Š54 844. Costs for Boceprevir treatment range from €â€Š34 143 to €â€Š60 990. Due to increasing costs, health-economic evaluations gain significant relevance and should be considered when implementing new treatment strategies.

[Health economic evaluation of health promotion - the example "fit for pisa"]. / Gesundheitsökonomische Evaluation der Gesundheitsförderung - am Beispiel "fit für pisa"

The increasing prevalence of risk factors associated with physical inactivity lead to an economic burden on society. The article uses the example of the prevention measure "fit for pisa" to investigate to what extent a full economic evaluation can provide a basis for decision-makers. The intervention integrated the daily physical education at 5 primary schools in Göttingen for the entire school term. The study is intended to provide information on short- and long-term potential savings. A process analysis identified the prevention performance from a societal perspective. Resource consumption was recorded in (partly) standardisedform and evaluated and also revealed the need for investment in sports halls with capacity to expand the programme to all primary schools in Göttingen. In the routine the implementation costs of half-day schools are 619 € per student year; for all-day schools 236 € per student year. The consideration of the short-term outcomes shows that TV viewing has decreased and physical activity has been strongly encouraged. The active life style promotion has shown an improvement on BMI in the medium-term. On the basis of a decision analytical model, a cost-benefit analysis of the program over the life course will be undertaken.

[Memorandum prevention research - research areas and methods]. / Memorandum zur Präventionsforschung - Themenfelder und Methoden (Langfassung).

From 2004 to 2012, the German Ministry of Education and Research (BMBF) established its first funding programme for the promotion of prevention research. 60 projects on primary prevention and health promotion and the meta-project entitled "Cooperation for Sustainable Prevention Research" (KNP) received BMBF grants under this programme during this period. The experience and knowledge gained and recommendations arising from the research funded under this programme are compiled in memorandum format. The "Memorandum on Prevention Research - Research Areas and Methods" highlights 5 research areas that are considered to be especially relevant from the perspective of the involved scientists and practice partners.The promotion of structural development and sustainability enhancement in disease prevention and health promotion are central areas that should branch out from existing nuclei of crystallization. Improving the health competence of the population and of specific subpopulations is another major area. Research in these areas should contribute to the development of theoretical concepts and to the empirical testing of these concepts. The transfer of knowledge for effective use of developed disease prevention and health promotion programmes and measures is still a scarcely researched area. Among other things, studies of the transfer of programmes from one context to another, analyses of the coop-eration between politics and science, and the continued theoretical and conceptual development of transfer research are needed. Long-term data on the effects of intervention studies are also needed for proper evaluation of sustainability. The latter dem-onstrates the importance of method development in disease prevention and health promotion research as an area that should receive separate funding and support. This research should include, in particular, studies of the efficacy of complex interventions, health economic analyses, and participative health research.

[Costs of guideline-based treatment of hepatitis B patients in Germany]. / Kosten einer leitliniengerechten Versorgung von Hepatitis-B-Patienten in Deutschland.

The costs of guideline-based treatment are unknown for most diseases. This also applies for economically significant infectious diseases like viral hepatitis and HIV. On the basis of the "German Guidelines for the Management of HBV Infection" from 2011 patients were grouped into HBsAg-positive, immuntolerant and chronic hepatitis patients with and without cirrhosis. Costs were divided in baseline diagnostics, monitoring and medical treatment according to the guideline. The calculation was modelled for a period of five years. Costs for virological diagnostics and imaging account for a large proportion of diagnostic costs. The main cost factors are expenses for pharmaceutical treatment with interferon or HBV polymerase inhibitors. On the assumption that only 25 % of the infected patients are diagnosed, 5-year total costs in Germany account for more than 2.5 billion Euros. Therefore, chronic hepatitis B is a disease with a very high economic burden. The aim of a guideline treatment is to prevent the development of cirrhosis with all its complications as well as the development of liver-cell carcinoma. Prophylactic vaccination against hepatitis B should be advised also considering the potential economic impact.

[Methods of health economic evaluation for health services research]. / Methoden der gesundheitsökonomischen Evaluation in der Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. The present paper focuses on methodological issues of economic evaluation of health care technologies. It complements the Memorandum III "Methods for Health Services Research", part 2. First, general methodological principles of the economic evaluations of health care technologies are outlined. In order to adequately reflect costs and outcomes of health care interventions in the routine health care, data from different sources are required (e. g., comparative efficacy or effectiveness studies, registers, administrative data, etc.). Therefore, various data sources, which might be used for economic evaluations, are presented, and their strengths and limitations are stated. Finally, the need for methodological advancement with regard to data collection and analysis and issues pertaining to communication and dissemination of results of health economic evaluations are discussed.

[Hospitalisations for acute myocardial infarction--comparing data from three different sources]. / Stationäre Behandlung des Akuten Myokardinfarktes--ein Vergleich unterschiedlicher Datenquellen.

OBJECTIVES: The aim of this study is to compare information on hospitalisations for acute myocardial infarction (AMI) from three different sources. METHODS: (A) The national hospital discharge statistics, covering all hospitalisations in Germany, is representative for this population. However, the information is limited, as data are collected case-related containing only few characteristics. (B) In contrast, claims data of sickness funds can be analysed longitudinally and contain more characteristics. The data have to be collected from single sickness funds. As for the data from registries (C) these data cannot be assumed to be representative. RESULTS: Data from the included sickness fund showed good consistency when compared to data from the national hospital discharge statistics regarding most, but not all, results. Comparisons with the register in Augsburg lead to divergent results regarding case fatality rates and rates of utilisation of technologies. CONCLUSIONS: None of the three sources can be considered ideal. Part of the differences could be explained by methodological and regional effects. More insight could be gained by comparing data at the individual level. According to recent legislation, data from all statutory sickness funds are supposed to be merged. This would simplify such comparisons and most likely would allow for more valid information regarding the incidence and treatment of AMI and many other diseases.

[Comments by the Working Group for Methods of Economic Evaluation in Health Care (AG MEG) to IQWiG's Draft Guidelines "Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System"]. / Stellungnahme der AG Methoden der gesundheitsökonomischen Evaluation (AG MEG) zu dem Methodenpapier "Methodik für die Bewertung von Verhältnissen zwischen Nutzen und Kosten im System der deutschen gesetzlichen Krankenversicherung" des Instituts für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG).

Since the coming into force of the GKV-Wettbewerbsstärkungsgesetz ("Act to strengthen competition in the statutory health insurance system") in April 2007, the Gemeinsame Bundesausschuss (G-BA "Federal Joint Committee") can commission the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG--Institute for Quality and Efficiency in Health Care") with the assessment of costs and benefits of drugs. In January 2008, IQWiG published a working document for consultation describing the proposed methods for carrying out those evaluations. This commentary by the AG Methoden der Gesundheitsökonomischen Evaluation (AG MEG--"Working Group for methods of economic evaluation in health care") provides a critical appraisal and recommendations for the further development of IQWIG's draft guidelines. The core statements of the commentary are as follows: (1) The draft guidelines are unbalanced. Instead of providing comprehensive methodological guidance for health technology assessment, which is the actual task of IQWiG, they deal predominantly with the methods of technology appraisal which is in the responsibility of the decision-making bodies, i.e. of the G-BA and the Spitzenverband Bund der Krankenkassen ("Central Federal Association of Health Insurance Funds"). (2) IQWiG intends to compare the cost-effectiveness of alternative treatment options only within a given therapeutic area. The rationale for this restriction is not clear, as the decision-makers have to determine ceiling prices across therapeutic areas and diseases and effectively the overall volume of health care expenditure, as well. (3) IQWiG aims at carrying out an economic evaluation only if in a preceding benefit assessment a drug has been judged to be superior. Therefore, it has to be assured that the benefit assessment is performed in such a way that its results may be used for the economic assessment. This requires the application of summary scores for the joint measurement of multidimensional endpoints (as, e.g., QALYs), to evaluate community effectiveness instead of efficacy, and to choose a time horizon that is sufficiently long to reflect any differences in the health benefits between the technologies being compared. Furthermore, the comment hints at some additional problems embodied in the draft guidelines and a number of key methodological issues which are not discussed at all in the working document. In summary, the methods currently proposed by IQWiG are not up to the task of conducting economic evaluations. It is strongly recommended to perform a public consultation process for the revised draft guidelines anew.

[Quality of care and health economics in occupationally acquired hepatitis C in German health care workers between 1993 and 2004]. / Versorgungsqualität und Gesundheitskosten bei berufsgenossenschaftlich anerkannter Hepatitis C. Untersuchung in der Modellregion West zwischen 1993 und 2004.

BACKGROUND AND OBJECTIVE: Data for quality of care and health economics in patients with occupationally acquired hepatitis C are lacking in Germany. The aim of this study was to analyse quality and economics of health care in occupationally acquired hepatitis C recognized by the Employees Compensation Boards between 1993 and 2000 in the area of Cologne and Bochum, Germany. METHODS: Results for 192 patients (146 women and 46 men, mean age 42 +/- 10 years) were analysed, using a standardized evaluation form. In addition to direct medical costs and diagnostic and therapeutic performance, disability days and benefit payments were also analysed. The observational period was from 01.01.1993 to 31.07.2004. Disability benefits were considered from 1983 onwards. RESULTS: HCV genotype 1 accounted for 79 % of infections. 112 patients (58 %) received antiviral treatment at least once. There were no differences in treatment rates between patients with prognostically favorable genotypes (2/3) and those with unfavorable HCV types (1/4) (59 % v. 60 %) or patients with low and those with advanced fibrosis (61 % v. 64 %). A sustained virological response was achieved in 53 % of treated patients. Disability days were more frequent in patients receiving antiviral treatment (214 v. 67 days). The cost of medication made up a major part of health care expenditure (mean of i 13,279 per patient). In addition, total disability benefits of i 6,933,789 were paid out between 1983 and 2004. CONCLUSION: Occupationally acquired hepatitis C is a major health-economic burden in Germany. Quality of health care corresponded to guidelines at any one time and sustained virological response was in the range of large controlled trials. However, 69 % of the patients remain chronically infected and are at risk for disease progression and transmission.

[Empirical standard costs for health economic evaluation in Germany -- a proposal by the working group methods in health economic evaluation]. / Empirische Bewertungssätze in der gesundheitsökonomischen Evaluation -- ein Vorschlag der AG Methoden der gesundheitsökonomischen Evaluation (AG MEG).

Measurement of health care costs is a crucial task in health economic evaluation. Various guidelines with different amount of details have been set up for costing methods in economic evaluation which, however, do not precisely stipulate how to value resource consumption. In this article we present a proposal for the standardisation of the monetary valuation of health care utilisation occurring in the follow up period after the actual intervention to be evaluated. From a societal perspective the primary direct and indirect cost components are considered, such as outpatient medical care, pharmaceuticals, non-physician health services, inpatient care, days of sick leave and early retirement due to sickness. The standard costs are based on administrative charges and rates or on official statistics. They are based on the most current data sources which are mainly from 2002 and 2003. This system of standard costs aims at an average valuation of resource consumption. This makes for the comparability of different health economic studies. Most standard costs are not based on market prices but on administratively specified charges and rates. This implies that institutional changes which are quite common in the health care system, may also affect the valuation rates, for example the introduction of DRGs. This should be taken into account when updating the system of standard costs.

[Health economic evaluation of rehabilitation programmes in the "rehabilitation sciences" research funding programme in Germany]. / Gesundheitsökonomische Evaluation von Rehabilitationsprogrammen im Förderschwerpunkt Rehabilitationswissenschaften.

A main problem of the German rehabilitation sector is to meet the increasing demand for rehabilitation treatment while available resources are scarce. Thus, health economic evaluation is gaining more importance for decision making in the rehab system. In the "Rehabilitation Sciences" research funding programme the relevance of health economic analyses was recognised from the outset. In nearly all regional networks health economic analyses were conducted - though with different scope. In the first funding period the main focus of health economic evaluation was on (1) patient education programmes and (2) the comparison of inpatient versus outpatient rehabilitation. The projects of the research funding programme have initialised health economic evaluation of rehabilitation in Germany. It was shown that health economics can contribute relevant results for designing rehabilitation concepts. The article concludes with an outlook on the main future questions of rehab economic evaluation.

[Performance and costs of outpatient clinics of university hospitals for medical care, teaching, research activities]. / Leistungen und Kosten der Hochschulambulanzen in Forschung, Lehre und Versorgung -- Ergebnisse der Hochschulambulanzenstudie.

BACKGROUND: Outpatient clinics of university hospitals (Hochschulambulanzen) play a significant role in the German health care system. Universities have in contrast to other hospitals the right to implement an outpatient clinic, but the health care services they can render are restricted to clinical research and teaching activities. The university outpatient clinic study evaluates the intensity of medical care, teaching, research activities, and the related costs. METHOD AND DATABASE: 6 university hospitals with 51 outpatient departments in Germany were included. The prospective documentation of consultations was restricted to 800 visits per department. A total of 26,312 consultations with approximately 40,000 diagnoses and 150,000 services were documented. Furthermore, data concerning costs, teaching activities and research facilities were documented. RESULTS: Clinical treatment without any correlation to research or teaching activities amounted to about 81 % of the working time in the outpatient department (research 11 %; teaching 8 %). The primary task of the university outpatient clinics takes up less than 20 % of the working time. The physicians documented that the disease of every fourth visit was in accordance with their main field of research. 6.9 % of the visits were asked to take part in clinical trials, of these 1.25 % were included for the first time, 3.7 % were already included. 6.5 % of the visits were addressed to participate in specific teaching activities. The average total costs per case added up to 149 Euro. No outpatient clinic could cover the total per case costs with the lump sum payments. On the average 31 % of these costs were covered by lump sum payments (without cases concerning research and teaching). CONCLUSION: Treatment in outpatient departments of university clinics is far beyond research and teaching activities required by law. However, the ability of outpatient departments of universities to provide excellent outpatient services should have a more dominant role in the health care system. Therefore access to care should be deregulated for the patients and reimbursement schemes should be adjusted to adjust for the present losses.

[Costs and benefits of an education program for patients with ankylosing spondylitis as part of an inpatient rehabilitation programs-study design and first results]. / Kosten und Nutzen eines Schulungsprogramms für Patienten mit Spondylitis ankylosans in der stationären RehabilitationUntersuchungsdesign und erste Ergebnisse.

The economic evaluation of a patient education program "ankylosing spondylitis"-based on a randomised controlled prospective multi-center study design-compares program costs and savings in direct and indirect follow-up costs. The collection of health services and cost data was conducted by questioning staff (education programme costs) and patients (follow-up costs). The present study results are: program costs per patient range between 117 euro (10 participants per course) and 186 euro (6 participants per course). Savings in indirect costs (unfitness to work) amount to 2500 euro and thus overcompensate program costs. Currently patient data are verified by sickness fund data and direct follow-up costs and qualitiy of life data are analysed.

[Model project of hearing screening in new-born in Hanover (preliminary results)]. / Modellprojekt Neugeborenen-Hörscreening in Hannover (Zwischenergebnisse).

In Germany, congenital hearing disorders are usually detected too late resulting in insufficient therapy of the disorder. To investigate these problems, the Federal Ministry of Health and the principal associations of statutory health insurance commissioned a pre-operative study. The study's aim is to verify whether introduction of a universal new-born hearing screening results in earlier diagnosis of hearing disorders and thus improves medical care for children with impaired hearing. Feasibility, effectiveness and economic tenability of this hearing screening programme will be investigated. The study is realised in the Hanover region and aims at carrying out a hearing test in all new-born during the first days of life. The tests will be performed in all 10 birth clinics and 2 paediatric clinics in the relevant region and in 24 otolaryngological practices. Hearing ability is controlled via an automated screening device measuring otoacoustic emissions. Sensitivity and specificity of the test is more than 95%. Economical feasibility is investigated by cost-effectiveness analyses. During a 6-month period the screening has been implemented in all clinics in every day routine. The mean coverage rate in the clinics has been stabilised to 97% of the total number. 4.7% of the children were presumed to suffer from unilateral hearing disorders and 2.3% from bilateral. In 13 cases the diagnosis of hearing disorder was confirmed. The mean age of diagnosis in these children was 3.7 months. The average age of therapy onset was 4.4 months. According to the present experience, area-wide implementation of hearing screening seems feasible in existing health care structures. The intention to advance the time of diagnosis and the therapy onset can be achieved by this method. Systematic training, introduction and quality assurance measures of screening are mandatory. Tracking of suspicious cases is necessary, even if it challenges data privacy regulations.

How high are the costs of eating disorders - anorexia nervosa and bulimia nervosa - for German society?

Anorexia and bulimia are relatively rare psychogenic illnesses, which nevertheless are of great concern for society since they affect a mostly very young population and are accompanied by a significantly raised mortality risk. This cost-of-illness analysis for eating disorders in Germany considers hospitalization, rehabilitation services, and indirect costs through inability to work and premature death. The cost estimates are based on projections derived from benefit data as listed by health insurance schemes and pension insurance schemes and from epidemiological studies on the prevalence of eating disorders and mortality rates. For anorexia the cost of illness amounts to approximately 195 million euros (73 direct costs and 122 mortality costs, for bulimia it comes to around 124 million euros (12 direct costs and 112 mortality costs). The annual cost per anorexia and bulimia patient is approximately 5,300 and 1,300 euros, respectively. This cost-of-illness analysis underlines the significance of indirect costs due to premature death, but also highlights the extremely cost-intensive treatment. The hospitalization cost of 12,800 euros per anorexia patient is markedly higher than the average hospitalization cost of 3,600 euros.