[Cost-Effectiveness of Pharmacological Smoking Cessation Therapies - A Systematic Literature Review]. / Kosteneffektivität von pharmakologischen Raucherentwöhnungsmaßnahmen ­ ein systematisches Literaturreview.

Aim of the Study: Through the promotion of smoking cessation premature mortality can be prevented. Therefore it is necessary to provide effective and cost-effective smoking cessation interventions. In Germany the cost of pharmacological smoking cessation measures are not yet reimbursed by the statutory health insurance. The aim of this study is to present the evidence on the cost-effectiveness of already approved pharmacological smoking cessation therapies and to evaluate their quality. Method: A systematic literature research was conducted in the databases by DIMDI (Medline, Embase, etc.) in April 2013 (update April 2014). The study research was focused on studies for cost effectiveness of nicotine replacement therapy (NRT), varenicline and bupropion. The assessment of study quality was performed using the "Quality of Health Economic Studies" (QHES) instrument. Results: 33 Of the original 10 340 identified studies were finally included. The majority of the studies show that an additional prescription of NRT or bupropion to a medical consultation is a cost-effective strategy. In addition, in most studies varenicline is a dominant strategy compared to bupropion. Overall, the study quality was found to be very heterogeneous between 45 and 80 points (Ø 63.7 points). Conclusion: The studies show that treatment with varenicline is the most cost effective strategy followed by bupropion and the NRT. However, the studies can only be compared inadequately due to different levels of age and country-specific intervention costs.

[Measures to improve the health situation of patients with rare diseases in Germany. A comparison with the National Action Plan]. / Maßnahmen zur Verbesserung der gesundheitlichen Situation von Menschen mit seltenen Erkrankungen in Deutschland. Ein Vergleich mit dem Nationalen Aktionsplan.

BACKGROUND: Approximately 4 million patients with a rare disease live in Germany. The medical care of these patients is problematic because of the rarity and heterogeneity of different clinical pictures. The Federal Ministry of Health has therefore published a research report on "Measures to improve the health situation of people with rare diseases in Germany" in 2009. OBJECTIVE: The aim of this paper is to present the main recommendations of this research report and relate it to current developments in the field of medical care for people with rare diseases. METHODOLOGY: The care situation of patients with rare diseases was determined using questionnaires, expert interviews and focus group discussions with representatives of patients, service providers and stakeholders from the health institutions. RESULTS: The main range of actions that have been identified in the research report were centre and network formation, specialized forms of medical care, diagnosis and treatment, information and experience exchange, performance fees and reimbursement of the costs, guidelines and patient pathways, the research, the implementation of a National Action Alliance and the development of a National Action Plan. DISCUSSION: In March 2010 a National Action League for People with Rare Diseases (NAMSE) was founded. The NAMSE created a national plan of action for people with rare diseases for improving medical care in the field of rare diseases which was approved by the Federal Government in August 2013. Thus, two important areas of the research report have already been implemented. In a comparison of the areas of activity of the research report with those of the National Action Plan it becomes clear that priorities will be in the context of health services research in rare diseases, for example the introduction of centres of reference for rare diseases, measures to accelerate the diagnostic process and the promotion of research and information management in the future.

[Calculation of disease-related costs in claims data analyses with the example of attention-deficit hyperactivity disorder. Comparison of methods]. / Die Berechnung indikationsspezifischer Kosten bei GKV-Routinedatenanalysen am Beispiel von ADHS. Ein Methodenvergleich.

Claims data have proven useful for carrying out cost-of-illness studies. To avoid overestimating disease-related costs, only those costs that are related to a specific disease should be considered. The present study demonstrates two basic approaches for identifying disease-related costs. Using the example of attention-deficit hyperactivity disorder (ADHD), the advantages and drawbacks of expert-based approaches and those based on control groups are compared. Anonymized data from the "Techniker Krankenkasse" for 2008 were available for the study. The study population encompassed all ADHD patients and a control group that was five times bigger. Additionally, a systematic literature review was carried out on 65 relevant studies. Compared with the control group, disease-related costs were EUR 2,902 per ADHD patient on average. However, using the expert-based approach, costs were established to be EUR 923 lower. This is mainly because a comparison with an appropriate control group incorporates all costs for possible comorbidities and concomitant diseases. Both approaches have specific advantages and drawbacks, and when planning studies the respective limitations need to be considered.

[Therapy of rheumatoid arthritis with methotrexate. Claims data analysis of treatment patterns]. / Therapie der rheumatoiden Arthritis mit Methotrexat. Analyse von Versorgungsaspekten anhand von GKV-Routinedaten.

Methotrexate (MTX) is the most important disease-modifying antirheumatic drug (DMARD) and is recommended by national and international guidelines as the first choice for treatment of rheumatoid arthritis (RA). Recent studies reporting prescription data of MTX captured only patients who were treated by rheumatologists. Therefore, the aim of the present study was to analyse several aspects of the prescription of MTX based on claims data. Outpatient and inpatient diagnoses as well as prescription data was available for 9579 RA patients for the years 2005-2008. Of the patients 45% were treated exclusively with parenteral MTX, 8% were treated exclusively with oral MTX and 48% switched between both forms of application. The average weekly dosage presribed in 70% of the patients was between 10 and 25 mg. The most common DMARD combination was MTX plus leflunomide with 16%. In 16% RA patients were treated with a combination of MTX and TNF-α inhibitors. Glucocorticoids were prescribed temporarily in 81% together with MTX and supplementation with folic acid was given only in 65%. The results of this study provide important insights into the drug supply of MTX to RA patients in the German statutory health care sector. In particular, the high frequency of prescriptions of parenteral MTX and the inadequate prescription of folic acid are different from the recently published multinational recommendations of the 3E initiative for the use of MTX.

[Decision support through economic evaluation from the perspective of science in Germany]. / Entscheidungsunterstützung durch gesundheitsökonomische Evaluation in Deutschland aus Perspektive der Wissenschaft.

For decades, economic evaluation studies, or cost-benefit analyses (CBA), have been a tool for decision support in the use of public funds. Despite this, in the last few years, debates on the inclusion of CBAs in the German health care system have paid little attention to the findings and practical experiences of scientific research. CBAs - especially the QALY - were instead represented a priori as "unfair" and "discriminatory." Today they have virtually no meaning when it comes to allocation and pricing decisions about publicly funded health services. Of course, CBAs are based on value judgments, which have to be communicated. They can lead to allocations that violate the minimum standards of justice. Here, distributive requirements and criteria are needed and must be developed in an interdisciplinary discourse. However, a general waiver of CBA does not make decisions about the allocation of resources easier, especially since its involvement can contribute to more openness and transparency in the system. Accordingly, for Germany a dual approach is recommended: an interdisciplinary exploration of the methodological foundations of economic evaluation and a consistent application of these in healthcare decision-making.

[Implementation of the new German job role code and its application in claims data analysis. Possibilities and limitations]. / Einführung des neuen Tätigkeitsschlüssels und seine Anwendung in GKV-Routinedatenauswertungen. Möglichkeiten und Limitationen.

In recent years, claims data analyses have become of increasing importance in several scientific disciplines in Germany. In specific research projects, it can be necessary to refine and to standardize the results by socioeconomic data. Information about graduation, social status, and occupation are provided by the German job role code for all people insured by statutory health insurance. During recent years, the working scheme has changed and new professions have appeared. Therefore, there has been a discussion about actualization and modification of the job role code. Since December 2011, an actualized job role code with an extensive set of new information is available. In addition, a new classification of professions is available in Germany which was considered in the design of the new job role code. The aim of this overview is to describe the structure of the new job role code as well as to discuss possible uses and limitations.

[Economic valuation of physician contacts in German outpatient care of COPD. Results from a survey of general practitioners and respiratory specialists]. / Ökonomische Bewertung ambulanter Arztkontakte von COPD-Patienten in Deutschland. Ergebnisse einer Befragung von Allgemeinmedizinern und Pneumologen.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is associated with considerable morbidity and mortality and features a substantial economic burden. METHODS: This article analyses the frequency of physician contacts and commonly provided services in the outpatient care of patients with COPD in Germany. Information on characteristic health care delivery in case of patients with COPD has been further used to construct basic scenarios of outpatient resource use. RESULTS: Altogether, 34 out of 150 respiratory specialists and 55 out of 350 general practitioners participated in the survey (response rates of 22.7 and 15.7%, respectively). Results point out, that the number of commonly provided services (a) is limited to a very basic set, (b) does not differ substantially according to severity of COPD, and (c) does not substantially vary between the stable phase of the disease and the presence of exacerbations. CONCLUSIONS: Despite its low level of evidence, the use of expert opinion can serve as a valuable and legitimate tool; especially when the literature does not provide any or only outdated information.

[Costs of illness and health-related quality of life for community-acquired pneumonia--a systematic review]. / Krankheitskosten sowie gesundheitsbezogene Lebensqualität (hrQoL) bei ambulant erworbener Pneumonie (CAP)--ein systematisches Review.

AIM: There are only very limited data available on the costs and health-related quality of life (hrQoL) of patients with community-acquired pneumonia (CAP) in Germany. The aim of this review was to identify studies in the international literature regarding the costs and hrQoL of CAP. METHOD: In March 2010, a systematic literature search was performed. The acquired literature was evaluated separately for costs of illness and/or hrQoL analyses followed by a structured discussion of the findings. RESULTS: A total of 172 references was identified. Sixteen publications on the cost of illness for CAP and five publications on hrQoL met the selection criteria and were included in the present review. CONCLUSION: There are only very limited and, furthermore, outdated data available on the costs and quality of life impacts of CAP. Hence, further research is urgently needed to fill this lack of evidence.

Current issues in German healthcare.

Germany has developed a model of social health insurance for financing healthcare. The basic characteristics of this model are compulsory membership, income-dependent contributions paid by employers and employees, a comprehensive package of healthcare entitlements, stringent government regulation and implementation by not-for-profit health insurers--the sickness funds--which operate under public law. Since the mid-1970s, when health care cost containment gradually evolved as a new issue in German healthcare policy-making, a long series of reform programmes have been initiated. Two recent development can be noted: the introduction of market competition in health insurance and the introduction of fixed budgets. Market competition in health insurance is now an explicit policy tool in Germany. This article analyses the German healthcare system, the history of healthcare reforms and the current healthcare acts. Special emphasis is given to the German drug market and its regulation. The paper describes the present cost-containment policy for pharmaceutical products, especially the global budget concept which was introduced for medicines and patients' copayments.

Economic evaluation of medical technologies: from theory to practice--the German perspective.

This paper briefly describes the German health care system and the role of economic studies in medical technologies and drugs in a decentralized health care system like Germany's. It also provides a number of examples of studies which have been conducted recently in Germany and shows the variation of sponsors, study types, study perspectives and objectives of those studies. It concludes with an outlook on the future role of pharmaco-economic studies in Germany and the recently published German recommendations for conducting those studies.

Forming and reforming the market for third-party purchasing of health care: a German perspective.

Germany is known for its comprehensive health care coverage by sickness funds and private health insurers and its successful cost containment policy. The stabilization of health care expenditures as a percentage of GNP was enforced by five cost containment laws since 1977. The last one became effective in 1993 and the next ones are planned for 1996 and 2000. The 1993 law has initiated drastic changes of the system. Office based physicians will be paid by a mixture of capitation, fee-for-service and fees for combined service packages. The hospital financing will be transformed from the current per diem remuneration to a payment system where per diems are combined with payments based on diagnostic related groups and patient management categories. Up till now many restrictions exist for insurees to switch sickness funds. These limitations were removed by the 1993 law. To allow unbiased competition between sickness funds, a risk compensation pool, some kind of statutory reinsurance, will transfer financial resources from sickness funds with good risk structure to those with many bad risks. In many respects health policy has imposed what health economists have recommended for a long time. However, there is some doubt whether increased competition will really increase efficiency of providing medical care because it takes place in a highly regulated market.

Unintended effects of a cost-containment policy: results of a natural experiment in Germany.

In this paper empirical evidence for substitution processes caused by the budget for drugs prescribed by office-based physicians is provided. Due to substitution processes in a natural experiment the number of referrals and hospital admissions increased significantly after the introduction of a drug budget in Germany. This leads to additional direct and indirect cost for the health care system.

Direct costs for the treatment of HIV-infection in a German cohort after the introduction of HAART.

BACKGROUND: Highly active antiretroviral combination therapy (HAART) has become the standard of care for HIV infection. The reduction of morbidity by HAART has been proven to be cost-effective despite high expenditures for regular use of antiretrovirals. We examined direct costs in a German monocentric cohort of HIV-infected patients after introduction of HAART. SUBJECTS/METHODS: In 1997 recruitment started and 201 patients gave informed consent. They underwent structurized interviews. Additional data were taken from the patients records. Later on follow-ups were performed for the same cohort in the years 2000 and 2001 respectively. Direct costs have been calculated per patient and year for each period. RESULTS: The proportion of HAART treated patients rised in the cohort from 86% to 93%. The mean of antiretrovirals used per case increased from 2.4 to 3.4. Nevertheless mean direct costs for HAART decreased significantly from Euro 17,746 to Euro 16,007. Reduction of expenditures for additional drugs, hospitalisation and diagnostics led to about one third decrease of mean total direct cost from Euro 35,865 in 1997 to Euro 24,482 in 2001. For surviving patients expenditures remained higher in advanced stage of disease for HAART, hospitalisation, diagnostics and total costs. CONCLUSION: Expenditures for HAART remained on a high level. Despite rising drug prices and increased use of antiretrovirals a decrease of mean costs of HAART by about 10% resulted from more frequent use of less expensive drug combinations. The continuous decrease of expenditures for non-HAART drugs, diagnostics and hospitalisation predominated and therefore HAART caused about a half of total direct costs in 1997 and two third in 2001 respectively. Higher expenditures in advanced stages of disease continued over the follow up period and raise the question of an economic impact of earlier initiation of treatment. More extensive use of standardized evaluation of direct costs could be an important tool towards a more rational allocation of resources in health care.

The influence of economic evaluation studies on decision making. A European survey. The EUROMET group.

Despite the growing activity in the field of health economics very little is known about the influence of economic evaluation studies on health care decision making in the EU member states. Several investigations about the impact of health economic studies on decision making have been performed, but most of them did not involve decision makers themselves. In this paper the results of the EUROMET survey are reported and discussed. Different types of decision makers in nine European countries were surveyed by postal questionnaires, semi-structured interviews and focus group discussions. Questions include issues about the extent of knowledge about economic evaluation, the actual and potential use of study results as well as barriers and incentives in the use of studies. It is concluded that despite the general positive attitude knowledge about the formal methodology is rather limited. Accordingly, results of economic evaluation studies are not widely used in decision making. The results show that institutional dimensions, such as difficulties in transferring budgets, are viewed as important barriers. Also, the lack of credibility of studies is assigned a high relevance. Moreover, decision makers wish for a better explanation of the practical relevance of studies and feel that there is a need for more training in health economics. Considering these requirements a number of recommendations for enhancing the value of health economic studies are given.

Measuring the unmeasurable: the role and importance of quality of life measurement in economic evaluations of sleep disorder treatment.

Sleep disorder is a widespread chronic disease. Its treatment and the disease itself causes losses to society, eg treatment cost and cost of sick leaves. On the other hand an appropriate treatment increases patients' quality of life and work productivity. The basic methods for evaluating the costs and benefits of treating sleep disorders are described.

[Using the excimer laser in refractive eye surgery. Results of a survey of German ophthalmologists]. / Verwendung des Excimer-Lasers in der refraktiven Augenchirurgie. Ergebnisse einer Umfrage unter deutschen Augenärzten.

BACKGROUND: Little information about the cost-effectiveness of excimer laser operations is available. As the number and structure of providers of these services in Germany are relatively unknown, only rough estimations can be made about the number of operations. PURPOSE: In this study the market for excimer laser operations is defined, structured from an economic view and examined according to medium-term demand and supply trends. The aim of the study is an applicable estimation of the current level of dissemination and of existing economic conditions for providers of excimer laser operations. METHODS: In a postal survey 219 ophthalmologists in Germany were asked to provide the number of excimer laser operations they had carried out and the organizational and financial details of these services. The questionnaire was answered anonymously. RESULTS: One can conclude that the annual number of interventions is increasing, although less significantly than in the United States. In most cases, providers of German health insurance have rejected inclusion of this service in their reimbursement catalogue. CONCLUSIONS: As of yet, excimer-laser-related turnover has frequently not met expectations. However, because of modifications of technological, health-economic and demand conditions an increase in the number of operations within this area is expected in the future.

[Evaluation of cost effectiveness in primary health care]. / Evaluation von Kosteneffektivität in der Gesundheitsversorgung.

Evaluation of Cost-Effectiveness in Health Care considers the background, methodology and potential political influence of economic evaluation (EE) in health care, the following conclusions can be drawn: EE is not just about cost cutting--it considers both costs and outcomes. EE needs to be integrated with decision-making procedures at different levels, namely the macro (policy) level, the meso (management) level, and the micro (clinical) level. EE needs to be seen as a part of a broader effort in health technology assessment and in relation to parallel efforts, e.g. guidelines development, quality assurance, evidence-based medicine. EE needs to be methodologically sound, but is not always possible to undertake the perfect study due to constraints of resources, time, information availability. Ways of setting priorities for EE need to be developed; this means selecting relevant topics and researchable questions. EE needs to be locally relevant; this means taking into account the variations of setting--within and between countries--and differences between trials (efficacy) and regular practice (community effectiveness). Factors that either encourage or inhibit the adoption of study results, i.e. adequate dissemination, professional support, financial incentives or political will, have to be considered.

[Economic aspects in treatment of cystic fibrosis with chronic pulmonary pseudomonas infection. Ambulatory intravenous therapy in comparison with inpatient treatment]. / Okonomische Aspekte der Behandlung zystischer Fibrose mit chronischer pulmonaler Pseudomonasinfektion. Ambulante intravenöse Therapie im Vergleich zur stationären Behandlung.

BACKGROUND: Due to limited resources within the health service and the continuous discussion on cost containment, economic criteria should also be considered when assessing therapy concepts. Particular results in terms of economic efficiency reserves are to be expected from a transfer of care from the in-patient to the out-patient sector. METHODS: In a prospective, direct cost recording of all relevant uses of resources, the direct and indirect costs of the treatment of 14 patients with cystic fibrosis (CF) were included in the cross-over-design. The quality of life was recorded at least once for each patient using the EuroQol. In-patient intravenous antibiotic therapy carried out during the block of out-patient care served as one of the disqualification criteria when selecting patients. RESULT: Over an observation period of nine months, the average direct cost recorded were DM 35,706 for out-patient and DM 40,143 for in-patient treatment (+15%). As far as indirect costs are concerned, the losses of production in the national economy recorded for in-patient treatment were 80% higher. CONCLUSION: The direct and indirect costs for in-patient CF-therapy are in total higher than for out-patient care. Whether these cost advantages have to be "bought" with lower medical effectiveness needs to be demonstrated by further clinical studies. In the sense of the disease management approach, the results of this study should be used to help rationally weigh up the costs of out-patient care against alternative treatment concepts.

[Cost of asthma therapy in relation to severity. An empirical study]. / Kosten der Asthmatherapie nach Schweregrad. Eine empirische Untersuchung.

BACKGROUND: The aim of asthma therapy, i.e. the permanent elimination of the patient's symptoms, is as a rule, achievable over the long-term only with the aid of anti-inflammatory drugs. As well as medical, this approach also has considerable economic implications. The comparatively low compliance among asthmatics makes treatment in this context all the more difficult. An alternative that presents itself is the use of combination preparations, a mixture of a long-term prophylactic and a therapeutic agent. PATIENTS AND METHODS: With the aid of standardised questionnaires, data were acquired from 216 patients and assigned to subgroups in accordance with the degree of severity of the asthma. The patients were treated in the offices of a total of 23 GPs and internists selected at random from a complete list of all relevant practices in Germany. The use of resources, i.e. all diagnostic and therapeutic measures, was recorded retrospectively for a period of 1 year. In this way, all those resources of relevance to the health insurance carriers used during the observation period were identified. In addition to direct costs, so-called indirect costs were also estimated, i.e. in the present study the productivity loss to the economy due to illness-related absence from work. RESULTS: The annual cost of treating adult asthmatics was calculated to be DM 3,339 for level 1 severity, DM 5,260 for level 2 severity and DM 12,016 for level 3 severity. As the illness progresses in particular the direct cost of inpatient care and the indirect costs rise disproportionately. The yearly expenditure for women sufferers is about DM 800 more than for male sufferers. The direct cost of asthma treatment in children amounts to DM 2,950 for level 1, DM 3,225 for level 2, and DM 4,811 for level 3, severity. Here, drug-related costs in particular, rise significantly as the disease progresses. CONCLUSION: One of the results of the present study is the fact that for asthma sufferers in general, there is a positive correlation between average total costs and degree of severity. It may thus be postulated that preventive medical treatment of asthma that slows the progression of the illness, together with appropriate patient instruction, would have a positive effect on the total expenditure per patient. If, for example, the appropriate use of drugs in combination with patient instruction improved the compliance of asthmatics, lower treatment costs and a better quality of life for the patient could be expected.

[Common effect measures in medical and health economics studies? Results of an exploratory survey of physicians]. / Gemeinsame Effektmasse in medizinischen und gesundheitsökonomischen Studien? Ergebnisse einer explorativen Arztebefragung.

BACKGROUND: In economic evaluation studies quality-adjusted life years (QALYs) are often used as measure of effects. QALYs are calculated by weighting survival time with a valuation of health-related quality of life (HRQoL). The results may support clinical decisions for patient groups provided that physicians consider QALYs acceptable and clinically relevant. This study investigates whether physicians accept the various methodological steps of the calculation of QALYs and whether effect measures that result from these steps are useful in clinical studies, too. METHODS: In summer 1998, 41 physicians (21 principal investigators of clinical studies in oncology, 12 surgeons, 8 primary care physicians) completed a questionnaire. RESULTS: 90% of the physicians considered HRQoL a relevant measure of clinical effectiveness but only 54% were familiar with the concept of HRQoL. 80% accepted the creation of an index of HRQoL, 68% accepted the integration of HRQoL and survival time into a single effect measure, but only 44% accepted the multiplicative way of calculating QALYs. According to most physicians, HRQoL should be valued either by study patients or health care professionals rather than general population samples. 92% of the physicians considered identical effect measures in clinical and economic studies necessary or desirable. CONCLUSIONS: QALYs are not generally rejected by the responding physicians. The integration of HRQoL is largely accepted. The multiplicative way of combining survival time and HRQoL values is rejected by many physicians. The findings can be used to define a starting point for the development of common effect measures in medicine and health economics.