Experts' Perceived Patient Burden and Outcomes of Knee-ankle-foot-orthoses (Kafos) Vs. Microprocessor-stance-and-swing-phase-controlled-knee-ankle-foot Orthoses (Mp-sscos).

BACKGROUND: Patients with neuromuscular knee-instability assisted with orthotic devices experience problems including pain, falls, mobility issues and limited engagement in daily activities. OBJECTIVES: The aim of this study was to analyse current real-life burden, needs and orthotic device outcomes in patients in need for advanced orthotic knee-ankle-foot-orthoses (KAFOs). METHODOLOGY: An observer-based semi-structured telephone interview with orthotic care experts in Germany was applied. Interviews were transcribed and content-analysed. Quantitative questions were analysed descriptively. FINDINGS: Clinical experts from eight centres which delivered an average of 49.9 KAFOs per year and 13.3 microprocessor-stance-and-swing-phase-controlled-knee-ankle-foot orthoses (MP-SSCOs) since product availability participated. Reported underlying conditions comprised incomplete paraplegia (18%), peripheral nerve lesions (20%), poliomyelitis (41%), post-traumatic lesions (8%) and other disorders (13%). The leading observed patient burdens were "restriction of mobility" (n=6), followed by "emotional strain" (n=5) and "impaired gait pattern" (n=4). Corresponding results for potential patient benefits were seen in "improved quality-of-life" (n=8) as well as "improved gait pattern" (n=8) followed by "high reliability of the orthosis" (n=7). In total, experts reported falls occurring in 71.5% of patients at a combined annual frequency of 7.0 fall events per year when using KAFOs or stance control orthoses (SCOs). In contrast, falls were observed in only 7.2 % of MPSSCO users. CONCLUSION: Advanced orthotic technology might contribute to better quality of life of patients, improved gait pattern and perceived reliability of orthosis. In terms of safety a substantial decrease in frequency of falls was observed when comparing KAFO and MP-SSCO users.

Comparison of clinical outcomes of edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonists in patients with atrial fibrillation in Germany: A real-world cohort study.

BACKGROUND: The aim of the study was to compare the real-world effectiveness and safety in atrial fibrillation (AF) patients treated with edoxaban versus other oral anticoagulants (OACs) (apixaban, dabigatran, rivaroxaban, and vitamin K antagonists [VKA]) in Germany. METHODS AND RESULTS: Using a representative database of 3.5 million statutory health-insured lives in Germany, a retrospective cohort study was conducted to examine ischemic stroke (IS) or systemic embolism (SE) and major bleeding in AF patients initiating anticoagulant therapy from January 2014 through June 2017. Inverse probability of treatment weighting using propensity score was applied for baseline covariate adjustment. Cox proportional hazards models were used to estimate the adjusted risk (hazard ratio [HR]) of each outcome comparing edoxaban versus other OACs. Among 21,038 patients treated with OACs, 1236 edoxaban, 6053 apixaban, 1306 dabigatran, 7013 rivaroxaban, and 5430 VKA patients were included. The adjusted combined risks of IS or SE were lower (p < 0.05) for each edoxaban pairwise comparison with other OACs (HR: 0.83 vs. apixaban, 0.60 vs. dabigatran, 0.72 vs. rivaroxaban, 0.64 vs. VKA). Edoxaban favored lower risks of major bleeding compared with rivaroxaban (HR: 0.74) and VKA (HR: 0.47). No differences in the risk of major bleeding were found between edoxaban and apixaban (p = 0.33), and between edoxaban and dabigatran (p = 0.06). CONCLUSIONS: Edoxaban was associated with better effectiveness compared with other OACs in AF patients from Germany. Edoxaban also demonstrated a favorable safety profile.

Patient characteristics in German allergological practices - a nationwide survey.

INTRODUCTION: In Western societies a significant incidence and prevalence of allergic asthma and other allergic diseases is observable. The present study investigated epidemiological patterns of allergic diseases and the utilization of health care resources by subjects who are already under specialized allergological treatment. Furthermore the study was performed to identify factors which had a significant impact on accessibility to specific immunotherapy (SIT). METHODS: The study was based on a cross-sectional survey on patient characteristics, which was performed by participating physicians, who were specialized in the field of allergological disorders and SIT, in collaboration with their patients. The analysis of data was divided into descriptive analyses and an analytical part, in which influencing factors for accessibility to specific immunotherapy were investigated. Logistic regression models to identify several predictor variables were used. RESULTS: 495 physicians documented the data of 19,990 patients. 18,177 patients were included in the analyses. Patients had a mean age of 31.5 ± 15.5 years and 53.2% were female. The most frequent and most severe allergic disorders observable in German allergological practices were conjunctivitis and rhinitis. The seasonal symptoms occurred mainly during March to August, while seasonal disease manifestation was 2.5 times more frequent than perennial forms. The most received anti-symptomatic medications are antihistamines and corticosteroids. Patients who receive SIT were mainly treated using subcutaneous immunotherapy (SCIT) - only in lower age groups, the likelihood of receiving sublingual immunotherapy (SLIT) was increased. CONCLUSION: In Germany, conjunctivitis and rhinitis are the most severe allergic disorders in allergological practices. Compared to the German general patient population, people who were already in allergological treatment had better access to SIT.

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.