Subcutaneous specific immunotherapy: Economic implications from the perspective of statutory health insurance - a population based cost-effectiveness estimation.

BACKGROUND: Specific immunotherapy is the only potentially curative therapy in patients with allergic rhinitis (AR) and allergic asthma (AA). The present study examined the effects of subcutaneous immunotherapy (SCIT) on the financial situation of the German statutory health insurance systems and measures the impact on AR/AA prevalence during the next decades. A further objective was to identify possible SCIT-treatment strategies in order to reach an efficient SCIT-use. METHODS: Taking population projections of the German Statistical Federal Office, the number of expected new cases (AR, AA) was calculated until 2050. Based on assumptions about the proportion of patients who received SCIT in the future, age cohorts run through a model-calculation based on Markov chains. Data on effectiveness were extracted from published literature. For determining the cost situation of SCIT pharmacies we used selling prices for Allergovit®. All future costs are discounted at a mean rate of 2%. The model calculation was supplemented by a Delphi panel. RESULTS: Based on the current situation, a total annual economic burden of 540 million Euros is to be expected for care of about yearly 6 million patients with AR and AA in Germany between 2011 and 2050. Several scenarios have shown that the use of SCIT seems to be associated with cost savings from the perspective of statutory health insurances, when SCIT is offered to a larger amount of patients with moderate to severe symptoms. That would result in reduced number of expensive patients who suffer from AA. The best effects on the future number of diseased patients could be achieved, however, if SCIT additionally would be applied to patients in earlier stages of disease. Due to the large number of patients receiving SCIT in such a scenario, the initial costs would not completely compensated by cost savings. Nevertheless, the additional costs of 300 to 350 Euros per additionally healed patient seem to be justifiable. CONCLUSION: From the perspective of the SHI, SCIT is a useful strategic option for preventing the progression of allergic diseases. Particularly with increased use in early disease stages, the number of healed patients is high. Potential cost savings may result from increased treatment rates in patients with advanced disease stages.

Cost impact of a non-invasive, portable device for patient self-administration of chronic migraine in a UK National Health Service setting.

BACKGROUND: Chronic migraine (CM) is a neurological disorder associated with substantial disability. Botulinum toxin type A (Botox) is an approved and effective preventive treatment option for adult patients with CM. Transcranial magnetic stimulation (TMS) is an alternative treatment device delivering a brief pre-set magnetic pulse used for self-administration by the patient at home. Despite being available in a risk share scheme TMS is perceived to be more costly in the UK. The objective of this study was to analyse the incremental costs of TMS compared to Botox in refractory CM patients both for a UK individual funding request setting as well as for an average UK specialist center setting. METHODS: Cost impact results were derived from a decision-tree model simulating treatment pathways over 1 year. Costs were applied from the most recently available UK data sources. Sensitivity analysis was performed for all variables. RESULTS: Based on published utilisation data 45.5 % of CM patients would continuously receive Botox over 1 year, whereas 53.7 % of TMS patients would be still on treatment at the end of year one. Total costs of Botox treatment accrue to £2923 in an individual funding request NHS cost setting, whereas TMS treatment results in £1466 in the first year. Applying a time-based NHS cost setting expenditures accrue to £1747 for the Botox treatment and to £1361 for the TMS treatment. In both cost settings variation of cost assumptions did have a minor impact on the cost increment from Botox to TMS. CONCLUSION: The current risk share based remuneration model of TMS allows the UK NHS to reimburse only the cost of those patients experiencing reduction in migraine days resulting in lower costs for treating migraine attacks. Treatment of chronic refractory migraine using TMS implies a substantial cost reduction potential for the management of chronic treatment of refractory migraine patients compared to conventional Botox treatment.

[Cardiovascular diseases in the focus of health economics. The example of drug-eluting vascular stents in coronary heart disease]. / Herz-Kreislauf-Erkrankungen im Fokus der Gesundheitsökonomie. Das Beispiel medikamentenfreisetzender Gefäßstents bei koronarer Herzerkrankung.

Coronary heart disease is an important disorder in Western industrialized societies, with regard to both the epidemiologic and economic burden of illness. A modern therapeutic strategy consists of coronary interventions and the implantation of drug-eluting vascular stents. The cost-effectiveness of such drug-eluting stents has been an important subject of health-economic evaluation research in recent years. This article presents two examples of such studies and deals with the question whether existing study projects are able to provide sufficient evidence for allocation decisions in health care. On this basis we discuss important challenges for future health economic analysis. A key conclusion is the need for long-term and cross-sectoral evaluation strategies that could be based on routinely collected health care data. Supplemented by health economic results from clinical trials, the use of such data would lead to a broader data basis for allocation decisions in health care.

[Clinical and health economic challenges of personalized medicine]. / Herausforderungen an die klinische Evaluation und Gesundheitsökonomie auf dem Weg zur personalisierten Medizin.

Healthcare systems across the globe are currently challenged by aging populations, increases in chronic diseases and the difficult task of managing a healthcare budget. In this health economic climate, personalized medicine promises not only an improvement in healthcare delivery but also the possibility of more cost-effective therapies. It is important to remember, however, that personalized medicine has the potential to both increase and decrease costs. Each targeted therapy must be evaluated individually. However, standard clinical trial design is not suitable for personalized therapies. Therefore, both scientists and regulatory authorities will need to accept innovative study designs in order to validate personalized therapies. Hence correct economic evaluations are difficult to carry out due to lack of clear clinical evidence, longitudinal accounting and experience with patient/clinician behavior in the context of personalized medicine. In terms of reimbursement, payers, pharmaceutical companies and companion diagnostic manufacturers will also need to explore creative risk-sharing concepts. Germany is no exception to the challenges that face personalized medicine and for personalized medicine to really become the future of medicine many health economic challenges first need to be overcome. The health economic implications of personalized medicine remain unclear but it is certain that the expansion of targeted therapies in current healthcare systems will create a host of challenges.

[Patients suffering from atrial fibrillation in Germany. Characteristics, resource consumption and costs]. / Patienten mit Vorhofflimmern in Deutschland. Charakteristika, Ressourcenverbrauch und Kosten.

INTRODUCTION: Atrial fibrillation (Afib) is considered to be the most frequent form of cardiac dysrhythmia and is well known as a key risk factor for arterial thromboembolism. The incidence of Afib will increase in the future due to demographic changes as well as improved treatment options for acute and chronic heart diseases. OBJECTIVE: The primary objectives of this analysis were to describe patient characteristics, to assess the resource consumption associated with Afib and to measure costs of direct treatment as well as consequential costs. A secondary objective was to identify factors that influence the costs or the type of Afib. METHODS: The analysis is based on the representative ATRIUM register (Ambulantes Register zur Morbidität des Vorhofflimmerns, Ambulatory register on morbidity of atrial fibrillation), a prospective, multicenter cohort study in which general practitioners and family doctors documented the characteristics and resource utilization of consecutively enrolled patients. The documented resource consumption use was subsequently valued with unit costs. The presented results are focused on the baseline documentation and refer to the period 12 months before enrollment. RESULTS: A total of 3,667 patients (mean age 72.1±9.2 years, 58% men) fulfilled all inclusion criteria and were included by a total of 730 doctors. The patients had an average of 2.4±1.0 risk factors and the most common was hypertension (84% of patients). The most commonly observed comorbidities were heart failure (43%) and coronary heart disease (CHD, 35%). Medicines for oral anticoagulation (86%) and beta blockers (75%) were the most frequently prescribed drugs. A total of 1/3 of all patients received a specific kind of Afib therapy (e. g. drug conversion, cardioversion) during the past 12 months. The disease-specific mean costs of the patients were 3,274±5,134 Euro, while the acute (inpatient) treatment represented the largest proportion of these total costs (1,639±3,623 Euro). Patients with high treatment costs were significantly younger and suffered from more concomitant diseases. CONCLUSION: Atrial fibrillation is associated with significant patient-related attributable costs that are caused particularly by expenditures of inpatient stay. New, innovative treatment strategies seem to offer particular potential savings if they are able to reduce the number of hospitalizations due to Afib itself or subsequent cardiac events.

Health economic evaluation of the use of drug-eluting stents : First results from the Drug-Eluting Stent Registry (DES.de).

OBJECTIVE: The purpose of the economic evaluation of the German Drug-Eluting Stent (DES) registry includes the investigation of the economic impact and cost-effectiveness of DES compared to bare-metal stents (BMS) and between paclitaxel-eluting (PES) and sirolimus-eluting stents (SES). Here, methodology and initial results are presented. METHODS: Patients were recruited in 2005 and 2006 in 87 centres across Germany. Selection of PES, SES, or BMS was made at the discretion of the cardiologists in charge. Clinical, economic, and quality of life (QoL) data were collected at baseline and up to 12 months. Group comparisons were conducted using Fisher's exact and t test. RESULTS: Overall, 3,930 patients were enrolled: 3,471 (75% male, 65 ± 11 years) received DES and 458 (74% male, 67 ± 11 years) BMS. Among the DES patients, 1,821 received PES (75% male, 65 ± 10 years) and 1,600 SES (76% male, 65 ± 11 years). There were baseline differences in clinical and procedural characteristics but not in QoL. During the hospital stay, major adverse cardiac and cerebrovascular events occurred in 1.6% of DES (PES 1.9%, SES 1.1%) and 2.2% of BMS patients (BMS vs. DES, PES, and SES p = 0.327, 0.706, and 0.098, respectively). Hospital treatment costs were 4,989 ± 1,284  and 3,609 ± 924 , respectively, in DES and BMS patients (p < 0.001) with no significant difference between PES and SES. CONCLUSION: The economic evaluation of the large DES registry demonstrates increased initial hospitalisation costs associated with DES compared to BMS. Further analysis of the economic impact and cost-effectiveness of DES will provide estimates on large "real world" patient populations for decision makers and aid in reimbursement decisions of DES within the German and other health care systems.

[On general practitioners' care of patients with asthma]. / HausärztlicheVersorgung von Patienten mit Asthma.

UNLABELLED: This review offers readers new aspects for the guideline-compliant care of asthma patients. Here, attention is focused on illustrating the bottlenecks in the administration of good and practicable therapeutic care and listing these as "major challenges for GPs". The interdisciplinary team of authors - consisting of three hospital-based pulmonologists, one pulmonologist in private practice, one internist in general practice, one pharmacist and one health economist discussed aspects of asthma therapy relevant in clinical practice. RESULTS AND CONCLUSIONS: Practicable results for the reader included an asthma pentagram, a graphic depicting the links and interactions between diagnosis, symptom management, communication, application and costs. From this emerged a consensus on four recommendations that can help GPs improve their care of their patients: (1) Whenever possible, have a specialist verifythe diagnosis. (2) Practice inhalation techniques with the patient and check up on their technique at regular intervals. (3) Monitor and fine-tune the therapeutic goals set down together with the patient. (4) Clearly define the (patient's) responsibilities and who is organizing care (communication between GP-specialist-patient-pharmacist-family members).

Two-year vascular hospitalisation rates and associated costs in patients at risk of atherothrombosis in France and Germany: highest burden for peripheral arterial disease.

OBJECTIVES: To obtain Western European perspectives on the economic burden of atherothrombosis in patients with multiple risk factors only (MRF), cerebrovascular disease (CVD), coronary artery disease (CAD), and in the under-evaluated group of patients with peripheral arterial disease (PAD), we examined vascular-related hospitalisation rates and associated costs in France and Germany. DESIGN: The prospective REACH Registry enrolled 4693 patients in France, and 5594 patients in Germany (from December 2003 until June 2004). METHODS: For each country, 2-year rates and costs associated with cardiovascular events and vascular-related hospitalisations were examined for patients with MRF, CVD, CAD, and PAD. RESULTS: Two-year hospitalisation costs were highest for patients with PAD (3182.1€ for France; 2724.4€ for Germany) and lowest for the MRF group (749.1€ for France; 503.3€ for Germany). Peripheral revascularizations and amputations were the greatest contributors to costs for all risk groups. Across all PAD subgroups, peripheral procedures constituted approximately half of the 2-year costs. CONCLUSION: Hospitalisation rates and costs associated with atherothrombotic disease in France and Germany are high, especially so for patients with PAD.

[Aspects of health economic evaluations as a contribution to the priority-setting debate in Germany]. / Aspekte gesundheitsökonomischer Evaluationen als Beitrag zur Priorisierungsdebatte.

Decision-making in healthcare is a priority-setting process. Tools used in health economic evaluation support decision-making by outlining complex interdependences, simulating short- and long-term consequences, and quantifying formal comparisons of health technologies. Key elements in health economic evaluations are patient-relevant outcomes and cost parameters. Costing of healthcare services is demanding and reflects only an approximation to reality, particularly in Germany, as the reimbursement schemes neither fully provide all details nor the different costing perspectives. Hence, in order to obtain uniform and cross-indication applicable cost parameters, a German standard cost dataset is necessary. In addition, patient-relevant and indication-specific sets of outcomes parameters should be agreed upon in order to also enable a reliable clinical product development. Economic aspects could be applied in a two-step decision-making approach, where initially the anticipated indication-specific technical efficiency level in terms of cost per adjusted life years would be assessed from a health system perspective. The second step would employ prioritization based on indication-relevant outcomes and ranking criteria in the individual patient decision situation. Health economic evaluations are relevant tools to support prioritization of health technologies, both on an individual as well as public health level.

[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.

[Atrial fibrillation--epidemiologic, economic and individual burden of disease]. / Vorhofflimmern--epidemiologische, ökonomische und individuelle Krankheitsbelastung.

Atrial fibrillation (AF) is the most frequent cardiac arrhythmia. AF affects especially the elderly. The incidence rises with increasing age to over 15% for those over 90 years old. AF is a risk factor for systemic embolism and ischemic stroke. Stroke with AF is more severe with regard to neurologic impairment. In the management of AF an anticoagulation is essential. However, only half of the patients benefit from anticoagulation in therapeutic target ranges. Costs associated with AF accrue to 660 to 924 Mio Euro in Germany with hospitalization being the major cost contributor. Management of stroke patients with AF is at 3000 Euro higher compared to those patients without AF. AF has an impact on patients' wellbeing and impairs patients' quality of life, particularly the symptomatic form. With an increasing ageing of the society it is suggested to ensure that care management for patients with AF will be optimized.

Economic evaluation of BDP/formoterol fixed vs two single inhalers in asthma treatment.

BACKGROUND: Asthma treatment costs are substantial, the largest proportion being incurred by medications. Combination therapy with inhaled corticosteroids (ICS) and long-acting beta(2)-agonists (LABA) is recommended in patients not adequately controlled by ICS alone. Aim of this study was to compare costs and health outcomes of a fixed ICS-LABA combination of beclomethasone dipropionate (BDP) and formoterol fumarate (FF) vs the same drugs delivered via separate inhalers in Germany. METHODS: A cost-minimization analysis, a cost-effectiveness analysis, as well as a threshold analysis were undertaken. Efficacy results were obtained from a recent clinical trial. Cost inputs include medical costs, physician costs, and hospital admission costs. Medical costs, health outcomes, and treatment costs were also varied to assess their impact on results. RESULTS: Beclomethasone dipropionate/FF fixed combination was less costly compared to BDP + FF delivered as separate inhalers, costs totaling euro 525 and euro 637, respectively, over a 24-week treatment period. The incremental cost-effectiveness ratio was euro-9.77 per additional day free of asthma symptoms. Equal cost-effectiveness ratios would still be obtained at a price of the fixed combination increased by 3.4-fold. CONCLUSION: A cost-minimization analysis as well as a cost-effectiveness analysis for Germany based on different product price calculations show that BDP/FF fixed combination is superior to BDP + FF delivered via separate inhalers.

[An economic organisation analysis of the need for the exchange of information between the European health systems]. / Eine ökonomische Organisationsanalyse des Informationsbedarfs zwischen europäischen Gesundheitssystemen.

BACKGROUND AND GOAL: Demographic development and technological progress are rapidly changing the existing health systems in Europe. As a result, increasingly more complex and heterogeneous structures are emerging, which clearly differ in each of the European member state. From a company's point of view these continuously changing frameworks are leading to an increasing non-transparency regarding the structures and processes within the healthcare systems themselves. The goal is to design a suitable solution to overcome the obstacles within the information exchange process between the individual European health systems. METHODS: Theoretic-deductive analysis was used for the design of an organisational structure that enables information transparency between the individual European health systems. Incorporation of an economic perspective was implemented under consideration of the theory for the building of the new institutional economics. RESULTS: The operational organisation analysis proves that the matrix project organisation with a function- and project-related decision system is the theoretically optimal organisational form. DISCUSSION AND CONCLUSION: The organisation model derived from the theoretical analysis offers an organisation variant that guarantees an optimal processing of tasks pertaining to European health systems. This could result in the closing of an existing supply gap in the knowledge market for health systems. The evaluation of enterprise practice and the comparison with existing departments in enterprises can be explored in further research work.

[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.

[Utilisation of medical resources of patients with pain undergoing an outpatient opioid therapy]. / Inanspruchnahme von medizinischen Leistungen bei Schmerzpatienten unter Opioid-Therapie in der ambulanten Versorgung.

In Germany, opioid therapy of patients with chronic musculoskeletal pain has not been sufficiently scrutinised. Furthermore, no observational resource utilisation study for these patients concerning the treatment with opioids is available. For the analysis of outpatient costs 6 months before and after the first prescription of different opioids (oxycodone HCI, fentanyl TD, morphine retard), data from the IMS disease analyser (mediplus) database were employed. Costs of the opioids differed significantly. Highest costs could be observed for the therapy with fentanyl (601.36 euro), followed by oxycodone (355.80 euro) and morphine (229.47 euro). Patients under treatment with oxycodene showed lower costs for other drugs compared with those under treatment with fentanyl and morphine during the opioid therapy, although there were no differences in the period before the first prescription of opioids. The number of consultations rose significantly after the first prescription of opioids. Patients with chronic pain, who are treated with long-lasting opioids for the first time, initially use considerably more healthcare resources. The type of opioid influences the amount of resource utilisation.

Follow-up costs up to 5 years after conventional treatments in patients with cartilage lesions of the knee.

In this retrospective cross-sectional study, we contacted patients who had been diagnosed with (and, if necessary, treated for) knee cartilage defects by arthroscopy at one of seven treatment centres in Germany between 1997 and 2001. In early 2003, patients completed a questionnaire on the health care resources they had used since the time of the arthroscopy. Based on this information, we determined follow-up costs. Data from a total of 1,708 patients were included in the final analysis. Of these, 1,070 were assigned to the initial operation (IO) group (61% men, 49+/-15 years; 39% women, 52+/-14 years) and 638 were assigned to the re-operation (RO) group (64% men, 44+/-13 years; 36% women, 47+/-14 years). The cumulative direct medical costs caused by knee complaints for the first 5 years following the arthroscopy were 1,984 Euro for the IO population and 4,203 Euro for the RO population. The cumulative indirect costs (i.e. costs associated with loss of productivity), however, amounted to 7,669 Euro and 15,265 Euro, respectively, and were thus almost four times as high as the cumulative direct costs. This is the first study that quantifies the considerable follow-up costs in patients who have undergone surgery for knee cartilage defects. As such, it may provide a yardstick for future treatments.

Long-term cost-effectiveness of clopidogrel in patients with acute coronary syndrome without ST-segment elevation in Germany.

Patients with acute coronary syndrome without ST-segment elevation receiving clopidogrel in addition to acetylsalicylic acid (ASA) showed a 20% risk reduction in comparison to patients receiving ASA monotherapy (CURE trial). Economic models for assessing the impact on costs exist for several countries but not for Germany on a long-term basis. The objective of this model adaptation is to assess the long-term economic impact of clopidogrel taken in addition to ASA in Germany. A Markov model with six states [at risk, first year with stroke, following years with stroke, first year with new myocardial infarction (MI), following years with MI, and death] was adapted for Germany. Model outcome was life-years saved. Effects of 1-year treatment were calculated based on the CURE trial. Resource use for the different health states was based on published data, which included costs for drugs, outpatient care, hospitalization, rehabilitation and nursing. Risk data for MI and stroke were based on Swedish data and validated for the German adaptation. The model calculates lifetime costs and survival length. Costs were estimated from the payers' perspective. A series of one-way sensitivity analyses was conducted (follow-up costs, discount rates). The Markov analysis predicts a survival of 8.89years in the placebo treatment group and 9.02 years in the clopidogrel treatment group. The cumulated costs were euro 8,548 and euro 8,953, respectively. The incremental cost-effectiveness ratio (ICER) was euro 3,113 for each life-year saved. The model was robust regarding variations in key parameters in the sensitivity analysis, resulting in a range of ICER from euro 1,338 to euro 9,322. Our results are in line with the results for other healthcare systems. Adding clopidogrel to ASA for patients with acute coronary syndrome without ST-segment elevation generated an additional life-year saved at a comparably low value of euro 3,113. One-year treatment with clopidogrel is a cost-effective treatment option in patients with acute coronary syndrome from the perspective of a third-party payer in Germany.