Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. / Health-Technology-Assessments in der Radiologie in Deutschland: Fehlende Nachfrage, fehlendes Angebot.

BACKGROUND: Health technology assessments (HTAs) are an interdisciplinary method to support sustainable, evidence-based healthcare decisions. They systematically assess medical products, procedures, and technologies with respect to medical, economic, legal, social, and ethical aspects. METHOD: This review analyzes the current use of HTAs in radiology in Germany and discusses challenges associated with HTAs. In particular, incentive structures of various players in the healthcare field involved in HTA implementation are considered for both the inpatient and outpatient sectors. Taking into account that the Joint Federal Committee (G-BA) has different authority between sectors ("ban reservation" for inpatients and "authorization right" for outpatients), we focus on the repercussions on reimbursement for new diagnosis or treatment methods by statutory health insurance companies. RESULTS: The G-BA's authority implicitly creates a paradox in terms of incentives to implement and finance HTAs: in the outpatient sector HTAs are considered necessary to evaluate new medical services while players may not have sufficient incentive to implement and finance HTAs in the inpatient sector. CONCLUSION: Characteristics of HTAs differ widely with respect to the items to be assessed. Therefore, an HTA for drug effectiveness is not easily transferable to radiological procedures. Within radiology, each method must be assessed individually (e. g. according to tumor stage). Despite these challenges, systematic compilation and critical assessment (regarding both cost and medical effectiveness) of available evidence should be a basic component of evidence-based radiology. As companies in healthcare fail to invest in studies that advance evidence-based radiology and considering the lack of incentive for such investments, public funding institutions need to accept the challenge to support studies that assess the benefit of radiological procedures. KEY POINTS: · HTAs should be a basic component of evidence-based radiology.. · G-BA's authority implicitly creates a paradox in terms of inventives to implement and finance HTAs.. · University hospitals and public funding institutions need to support studies that assess the benefit of radiological procedures.. CITATION FORMAT: · Winkelmann C, Neumann T, Zeidler J et al. Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. Fortschr Röntgenstr 2019; 191: 635 - 642.

[Checklist for the Development and Assessment of Cost-of-Illness Studies]. / Checkliste zur Erstellung und Bewertung von Krankheitskostenstudien.

BACKGROUND: Cost-of-illness (CoI) studies are important instruments for estimating the socioeconomic burden of specified diseases. CoI studies provide important information about the cost structure of a disease, the resulting research need, approaches to improve aspects of care and, monetary consequences from different perspectives. This information can be useful for healthcare research and health policy. Due to heterogeneity of available Cost-of-Illness studies, the working group 'Health Economics' of the German Network for Healthcare Research (DNVF) in accordance with the German Society for Health Economics (DGGÖ) developed an instrument for the planning, conduct and assessment of CoI studies. METHODS: The checklist was developed based on a systematic literature search of published national and international checklists as well as guidelines and recommendations for development and assessment of CoI studies and health economic evaluations. Structure and subject matter of the generic checklist was designed, approved and, finally, examined in a pretest by the working group. RESULTS: Based on the results of the literature search (n=2 454), 58 articles were used for the identification of relevant criteria for the checklist. With respect to the results of the pretest, 6 dimensions were included in the checklist: (i) general aspects, (ii) identification of resources, (iii) description and quantification of resource consumption, (iv) valuation of resources (v) analysis and presentation of results and (vi) discussion and conclusion. In total, the 6 dimensions were operationalized through 37 items. CONCLUSION: This checklist is an initial approach to improve transparency and understanding of CoI studies in terms of the extent, structure and development of the socioeconomic burden of diseases. The checklist supports the comparability of different studies and facilitates study conception.

Who prefers the 'cost-effectiveness ratio' prioritization approach in health-care decisions? Results of an empirical analysis.

BACKGROUND: The problem of resource scarcity has led to an on-going debate about priority setting in the health-care system. Prioritization via the economic-based cost-effectiveness ratio (CER), for example, is controversial and has many advocates as well as opponents. Hence, the aim of our research is to analyse the fairness consideration of the CER approach in comparison with other prioritization approaches and to investigate whether these preferences depend on the field of study. METHODS: We developed and tested a unique questionnaire. Between October 2011 and January 2012, freshmen and advanced university students of medicine, law, economics, philosophy and religion in Germany were asked to choose among four prioritization approaches (CER, minimum health, random selection and age) using a dichotomous choice technique. The data were analysed by descriptive and microeconometric regression techniques. RESULTS: Data on 913 students were included in the study. A majority of the students prioritized cost-effectiveness second after minimum health. Advanced economics students preferred the CER approach significantly more than did incoming economics students. The attitudes of the advanced philosophy/religion students towards the CER were significantly more negative compared with the respective freshmen. Further, gender had a strong, significant impact on attitudes: women chose the CER less often than men did (P < 0.01). CONCLUSION: The results of this study indicate that attitudes presented by opinion leaders in the investigated fields of study seem to be in line with the perceptions of the respective fields' advanced students. Because of these differences, the debate on how to deal with scarce resources may remain complicated.

A systematic review of the cost-effectiveness of targeted therapies for metastatic non-small cell lung cancer (NSCLC).

BACKGROUND: Non-small cell lung cancer (NSCLC) imposes a substantial burden on patients, health care systems and society due to increasing incidence and poor survival rates. In recent years, advances in the treatment of metastatic NSCLC have resulted from the introduction of targeted therapies. However, the application of these new agents increases treatment costs considerably. The objective of this article is to review the economic evidence of targeted therapies in metastatic NSCLC. METHODS: A systematic literature review was conducted to identify cost-effectiveness (CE) as well as cost-utility studies. Medline, Embase, SciSearch, Cochrane, and 9 other databases were searched from 2000 through April 2013 (including update) for full-text publications. The quality of the studies was assessed via the validated Quality of Health Economic Studies (QHES) instrument. RESULTS: Nineteen studies (including update) involving the MoAb bevacizumab and the Tyrosine-kinase inhibitors erlotinib and gefitinib met all inclusion criteria. The majority of studies analyzed the CE of first-line maintenance and second-line treatment with erlotinib. Five studies dealt with bevacizumab in first-line regimes. Gefitinib and pharmacogenomic profiling were each covered by only two studies. Furthermore, the available evidence was of only fair quality. CONCLUSION: First-line maintenance treatment with erlotinib compared to Best Supportive Care (BSC) can be considered cost-effective. In comparison to docetaxel, erlotinib is likely to be cost-effective in subsequent treatment regimens as well. The insights for bevacizumab are miscellaneous. There are findings that gefitinib is cost-effective in first- and second-line treatment, however, based on only two studies. The role of pharmacogenomic testing needs to be evaluated. Therefore, future research should improve the available evidence and consider pharmacogenomic profiling as specified by the European Medicines Agency. Upcoming agents like crizotinib and afatinib need to be analyzed as well.

Targeted therapies in metastatic colorectal cancer: a systematic review and assessment of currently available data.

BACKGROUND: Survival of patients with metastatic colorectal cancer (mCRC) has been significantly improved with the introduction of the monoclonal antibodies targeting the vascular endothelial growth factor (VEGF) and the epidermal growth factor receptor (EGFR). Novel molecular-targeted agents such as aflibercept and regorafenib have recently been approved. The aim of this review is to summarize and assess the effects of molecular agents in mCRC based on the available phase II and III trials, pooled analyses, and meta-analyses/systematic reviews. METHODS: A systematic literature search was conducted using the meta-database of the German Institute of Medical Documentation and Information. Criteria of the Scottish Intercollegiate Guidelines Network were used to assess the quality of the controlled trials and systematic reviews/meta-analyses. RESULTS: Of the 806 retrieved records, 40 publications were included. For bevacizumab, efficacy in combination with fluoropyrimidine-based chemotherapy in first- and subsequent-line settings has been shown. The benefit of continued VEGF targeting has also been demonstrated with aflibercept and regorafenib. Cetuximab is effective with fluoropyrimidine, leucovorin, and irinotecan (FOLFIRI) in first-line settings and as a single agent in last-line settings. Efficacy for panitumumab has been shown with oxaliplatin with fluoropyrimidine in first-line settings, with FOLFIRI in second-line settings, and as monotherapy in last-line settings. Treatment of anti-EGFR antibodies is restricted to patients with tumors that do not harbor mutations in Kirsten rat sarcoma and in neuroblastoma RAS. CONCLUSION: Among various therapeutic options, the future challenge will be a better selection of the population that will benefit the most from specific anti-VEGF or anti- EGFR treatment and a careful consideration of therapy sequence.

Does the perception of fairness and standard of care in the health system depend on the field of study? Results of an empirical analysis.

BACKGROUND: The main challenge in the context of health care reforms and priority setting is the establishment and/or maintenance of fairness and standard of care. For the political process and interdisciplinary discussion, the subjective perception of the health care system might even be as important as potential objective criteria. Of special interest are the perceptions of academic disciplines, whose representatives act as decision makers in the health care sector. The aim of this study is to explore and compare the subjective perception of fairness and standard of care in the German health care system among students of medicine, law, economics, philosophy, and religion. METHODS: Between October 2011 and January 2012, we asked freshmen and advanced students of the fields mentioned above to participate in a paper and pencil survey. Prior to this, we formulated hypotheses. The data were analysed by micro econometric regression techniques. RESULTS: Data from 1,088 students were included in the study. Medical students, freshmen, and advanced students perceive the standard of care significantly as being better than non-medical students. Differences in the perception of fairness are not significant between the freshmen of the academic disciplines; however, they increase with the number of study terms. Besides the field of study, further variables such as gender and health status have a significant impact on perceptions. CONCLUSIONS: Our results show that there are differences in the perception of fairness and standard of care between academic disciplines, which might influence the interdisciplinary discussion on health care reforms and priority setting.

Genome sequencing: a systematic review of health economic evidence.

Recently the sequencing of the human genome has become a major biological and clinical research field. However, the public health impact of this new technology with focus on the financial effect is not yet to be foreseen. To provide an overview of the current health economic evidence for genome sequencing, we conducted a thorough systematic review of the literature from 17 databases. In addition, we conducted a hand search. Starting with 5 520 records we ultimately included five full-text publications and one internet source, all focused on cost calculations. The results were very heterogeneous and, therefore, difficult to compare. Furthermore, because the methodology of the publications was quite poor, the reliability and validity of the results were questionable. The real costs for the whole sequencing workflow, including data management and analysis, remain unknown. Overall, our review indicates that the current health economic evidence for genome sequencing is quite poor. Therefore, we listed aspects that needed to be considered when conducting health economic analyses of genome sequencing. Thereby, specifics regarding the overall aim, technology, population, indication, comparator, alternatives after sequencing, outcomes, probabilities, and costs with respect to genome sequencing are discussed. For further research, at the outset, a comprehensive cost calculation of genome sequencing is needed, because all further health economic studies rely on valid cost data. The results will serve as an input parameter for budget-impact analyses or cost-effectiveness analyses.

Impact of radiofrequency ablation for patients with varicose veins on the budget of the German statutory health insurance system.

OBJECTIVES: In contrast to other countries, surgery still represents the common invasive treatment for varicose veins in Germany. However, radiofrequency ablation, e.g. ClosureFast, becomes more and more popular in other countries due to potential better results and reduced side effects. This treatment option may cause less follow-up costs and is a more convenient procedure for patients, which could justify an introduction in the statutory benefits catalogue. Therefore, we aim at calculating the budget impact of a general reimbursement of ClosureFast in Germany. METHODS: To assess the budget impact of including ClosureFast in the German statutory benefits catalogue, we developed a multi-cohort Markov model and compared the costs of a "World with ClosureFast" with a "World without ClosureFast" over a time horizon of five years. To address the uncertainty of input parameters, we conducted three different types of sensitivity analysis (one-way, scenario, probabilistic). RESULTS: In the Base Case scenario, the introduction of the ClosureFast system for the treatment of varicose veins saves costs of about 19.1 Mio. € over a time horizon of five years in Germany. However, the results scatter in the sensitivity analyses due to limited evidence of some key input parameters. CONCLUSIONS: Results of the budget impact analysis indicate that a general reimbursement of ClosureFast has the potential to be cost-saving in the German Statutory Health Insurance.

How do insured perceive their financial security in the event of illness?--a panel data analysis for Germany.

OBJECTIVE: There is a lack of research regarding the subjective perception of financial security in the event of illness of insured persons. Therefore, the aim of our study was to analyze the subjective perception of financial security in the event of illness in the German setting over time and to identify major determinants of that perception. METHODS: We applied a probit-adapted ordinary least squares estimation procedure including fixed effects to a balanced data set from the German Socio-Economic Panel. After correcting our data set, we included approximately 23,500 observations in our analyses. RESULTS: We show that higher income and the existence of private health insurance have a positive and significant impact on the perception of financial security. Furthermore, private supplementary health insurance has a positive and significant effect on this perception; however, this is solely true for policies that cover special features during hospital stays. Experience with the health care system is also positively related to the individual's perception. Finally, our regression results illustrate that the overall perception is declining over time. CONCLUSIONS: The results indicate that political decision makers are facing challenges regarding the declining subjective perception in the German health care system. Because of the positive correlation between experience and subjective perception, it can be assumed that the health care system and especially statutory health insurance are better than their presentation in the media. Hence, there is a problem of communication and information, and political decision makers face challenges in presenting the system objectively and handling the media in a proper way.

Cost effectiveness of ulcerative colitis treatment in Germany: a comparison of two oral formulations of mesalazine.

BACKGROUND: The treatment of ulcerative colitis (UC) can place a substantial financial burden on healthcare systems. The anti-inflammatory compound 5-aminosalicylic acid (5-ASA; mesalazine) is the recommended first-line treatment for patients with UC. In this analysis, the incremental cost effectiveness ratio (ICER) of two oral formulations of 5-ASA (Mezavant® and Asacol®) is examined in the treatment of patients with mild-to-moderate, active UC in Germany. METHODS: A Markov cohort model was developed to assess the cost effectiveness of Mezavant compared with Asacol over a 5-year period in the German Statutory Health Insurance (SHI). Drug pricing details for 2009 were applied throughout the model, and overall resource use was determined and also fitted to 2009 from published results of a large cross sectional study of German SHI patients. Cost per quality adjusted life year (QALY) was the primary endpoint for this study. Remission rates were obtained using data from a randomised, phase III trial of Mezavant with an active Asacol reference arm and a long-term, open label, safety and tolerability trial of Mezavant. Uncertainty in the study model was assessed using one-way and probabilistic sensitivity analyses applying a Monte Carlo simulation. RESULTS: Over a 5-year period, healthcare costs for patients receiving Mezavant were 624 Euro lower than for patients receiving Asacol. Additionally, patients receiving Mezavant gained 0.011 QALYs or 18 more days in remission compared with Asacol. One-way sensitivity analyses suggest that these results are driven by both differences in the acquisition cost between mesalazine formulations and differences in treatment efficacy. Furthermore, sensitivity analyses suggest a probability of 76% for cost savings and higher QALYs with Mezavant compared with Asacol. If adherence and its influence on the remission rates and the risk of developing colorectal cancer were included in the model, the results might have even been more favorable to Mezavant due to its once daily dosing regimen. CONCLUSIONS: This model suggests that patients treated with Mezavant may achieve increased time in remission and higher QALYs, with lower direct costs to the SHI when compared with Asacol. Mezavant may therefore be a suitable first-line option for the induction and maintenance of remission in UC.

Health care costs and their predictors of inflammatory bowel diseases in Germany.

OBJECTIVES: Detailed cost studies of inflammatory bowel diseases (IBD) for Germany are limited. Aim of this study was to collect resource-use data related to IBD via a cross-sectional study, to quantify these from the perspective of the Statutory Health Insurance (SHI) and to identify cost-driving factors. METHODS: Patients with Crohn's disease (CD) or ulcerative colitis (UC) from 24 gastroenterological specialists' practices and two hospitals were enrolled in an internet-based database between March 2006 and July 2007. Outpatient services, inpatient visits as well as medication usage were recorded and evaluated from the perspective of the SHI for 2007. Disease severity was measured by the Crohn's Disease Activity Index (CDAI) and the Colitis Activity Index (CAI), respectively. Extensive statistical analyses including generalized linear modeling (gamma model with the log link) to identify cost-driving factors were performed. RESULTS: Data from 1,030 patients with IBD (CD: 511; UC: 519) were collected. On average a patient with CD incurs annual costs of EUR 3,767 (± 5,895 (SD)) (among those 68.5% medication; 20.5% inpatient) and an average patient with UC incurs EUR 2,478 (± 4,591) (74% medication; 10% inpatient), whereas 10% of the patient with IBD account for 49% (CD: 50%; UC: 46%) of the costs. The regression analysis showed that especially the use of TNF-alpha-inhibitors, inpatient stays, gender as well as the severity status has a significant influence on costs. Further disease-specific impact factors were identified. CONCLUSIONS: This is the first study to calculate costs due to CD and UC from the perspective of the SHI in Germany and to identify cost-driving factors. It confirms a high economic burden of IBD to payers and society.

Considerations about the effectiveness and cost effectiveness of therapies in the treatment of hyperphosphataemia.

Because of an elevated serum phosphate level, patients who suffer from chronic kidney failure frequently tend to have cardiovascular calcification and are therefore exposed to a higher probability of a fatal event. Phosphate binders are able to reduce these negative effects. Currently, there are primarily two groups of phosphate binders (calcium-containing and calcium-free phosphate binders) which are considered to be almost equally effective in terms of binding of free phosphate. There are, however, a few disadvantages of the two groups. While the calcium-containing binders are associated with an increased risk of hypercalcemia, which is dose dependent, calcium-free binders have been criticized as being too expensive. As the expenditure for patients suffering from chronic kidney failure increases from year to year, as a result of increasing prevalence, there is a growing need for an alternative to existing phosphate binders. The study presented here therefore summarizes available information for the novel combination preparation OsvaRen® (calcium acetate/magnesium carbonate) as an alternative therapy to the calcium-free phosphate binder Renagel® (sevelamer-hydrochloride) and to calcium-containing preparations.The results of this systematic review showed that OsvaRen® is at least equally effective in the regulation of serum phosphate level as Renagel®. In particular, OsvaRen® shows no clinically relevant difference in terms of the control of the serum calcium levels compared to Renagel® and thereby does not increase the risk of a hypercalcaemia, in contrast to pure calcium-based phosphate binders. On the other hand, Renagel® therapy is much more frequently associated with gastrointestinal side-effects, a tendency to result in higher tablet burden for patients and high medication costs. The CALMAG study showed that OsvaRen® was at least as effective and safe in terms of controlling serum phosphate and serum calcium levels as Renagel® while, at the same time, resulting in about 80% lower costs. In addition, OsvaRen® offers a lower risk of hypercalcaemia and associated subsequent costs and is thereby also superior to pure calcium-containing phosphate binders.Because of the effectiveness and tolerability of calcium acetate/magnesium carbonate, OsvaRen® offers a clinically suitable and, at the same time, cost-effective therapeutic option in the therapy of hyperphosphataemia.

[Aspects of outpatient palliative care and assessment of the nursing workload. Survey among care givers in Germany]. / Versorgungssituation von Palliativpatienten und Einschätzung der Arbeitsbelastung der Pflegenden. Befragung unter ambulant tätigen Pflegenden in Deutschland.

INTRODUCTION: The aim of this study is to explore aspects of the health care situation of outpatient palliative patients in Germany as well as effort and workload of care from the viewpoint of involved care givers. Additionally the future development with regard to the cooperation with other health care providers is assessed. METHODS: A detailed questionnaire was developed and sent to 188 outpatient care givers, all members of the German Association for Palliative Medicine, in January 2009. All data was analyzed via SPSS version 16. RESULTS: 69 questionnaires were included into statistical analyses. Care givers estimate the effort of care of palliative patients as very high. 28 per cent of working time is spent on administration. Responders consider general and quantitative workload to be the highest. Most care givers assess the SAPV-directive of the Federal Joint Committee as well as the future health care situation of palliative patients and cooperation with other health care providers as good. DISCUSSION: Further studies should focus on the collection of longitudinal patient data for a more comprehensive insight.

Cancer management and reimbursement aspects in Germany: an overview demonstrated by the case of colorectal cancer.

This paper provides an overview of cancer management, particularly with respect to colorectal cancer (CRC), in Germany. The information presented reflects findings from the peer-review literature and government documentation, as well as interviews with cancer and CRC specialists. Topics such as epidemiology, expenditure, CRC screening, pharmaceutical and non-pharmaceutical treatment are discussed in this paper. Furthermore, insights into the German reimbursement system with regard to cancer management as well as regulatory aspects are presented.