Healthcare costs associated with breast cancer in Germany: a claims data analysis.

PURPOSE: This study estimates the healthcare costs associated with breast cancer (BC) for different treatment phases (initial, intermediate, terminal) in Germany from the payer's perspective. METHODS: The analysis uses claims data from the AOK Bayern covering 2011-2014 for continuously insured BC patients identified through inpatient and outpatient diagnoses. We calculate the healthcare costs attributable to BC using a control group design comparing the target population to a 1:2 matched control group adjusted for age, gender, and comorbidities. For incident and prevalent BC cases, we calculate age-standardized phase-specific incremental costs stratified by cost domain. RESULTS: The initial, intermediate, and terminal phases comprise 3841, 28,315, and 1767 BC cases, respectively. BC-related incremental costs follow a u-shaped curve, with costs highest near diagnosis and death, and lower in between. With average costs of €33,237 per incident and €28,211 per prevalent case in the remaining 11 months before death, the highest BC-related incremental healthcare costs can be found in the terminal phase. In the initial phase, there were mean incremental costs of €21,455 the first 11 months after diagnosis. In the intermediate phase, incremental costs totaled €2851 per incident and €2387 per prevalent case per year. Healthcare costs decreased with age in most phases. The cost drivers depend on the treatment phase, with cytostatic drugs and inpatient treatment showing the highest economic impact in most phases. CONCLUSION: The study concludes that BC care costs impose a relevant economic burden on statutory health insurance and vary substantially depending on the treatment phase.

Informal and formal care preferences and expected willingness of providing elderly care in Germany: protocol for a mixed-methods study.

INTRODUCTION: In Germany, the number of elderly people in need of care is expected to increase from 2.4 million in 2015 to 3.2 million in 2030. The subsequent rise in demand for long-term care facilities is unlikely to be met by the current care structures and available staff. Additionally, many Germans still prefer to be cared for at home for as long as possible. In light of recent changes, such as increasing employment rates of women and growing geographical distances of family members, informal caregiving becomes more challenging in the future. The aim of this study is to explore preferences for informal and formal care services in the German general population, as well as the expected willingness of providing elderly care. METHODS AND ANALYSIS: A mixed-methods approach will be used to explore care preferences and expected willingness of providing elderly care in the German general population. A systematic literature review will be performed to provide an overview of the current academic literature on the topic. Qualitative interviews will be conducted with informal caregivers, care consultants and people with no prior caregiving experiences. A labelled discrete choice experiment will be designed and conducted to quantitatively measure the preferences for informal and formal care in the German general population. People between 18 and 65 years of age will be recruited in cooperation with a (regional) statutory health insurance (AOK Lower Saxony). A mixed multinomial logit regression model and a latent class finite mixture model will be used to analyse the data and test for subgroup differences in care preferences. ETHICS AND DISSEMINATION: The study has been approved by the Committee for Clinical Ethics of the Medical School in Hannover. Data will be treated confidential to ensure the participants' anonymity. The results will be discussed and disseminated to relevant stakeholders in the field. TRIAL REGISTRATION NUMBER: DRKS00012266.

Which attributes of whole genome sequencing tests are most important to the general population? Results from a German preference study.

OBJECTIVE: The aim of this study was to identify the preferences for whole genome sequencing (WGS) tests without genetic counseling. METHODS: A discrete choice experiment was conducted where participants chose between two hypothetical alternatives consisting of the following attributes: test accuracy, test costs, identified diseases, probability of disease occurrence, and data access. People from the general German population aged ≥18 years were eligible to participate in the survey. We estimated generalized linear mixed effects models, latent class mixed-logit models, and the marginal willingness to pay. RESULTS: Three hundred and one participants were included in the final analysis. Overall, the most favored WGS testing attributes were 95% test accuracy, report of severe hereditary diseases and 40% probability of disease development, test costs of €1,000, and access to test results for researchers. Subgroup analysis, however, showed differences in these preferences between males and females. For example, males preferred reporting of results at a 10% probability of disease development and females preferred reporting of results at a 40% probability. The test cost, participant's educational level, and access to data influenced the willingness to participate in WGS testing in reality. CONCLUSION: The German general population was aware of the importance of genetic research and preferred to provide their own genetic data for researchers. However, among others, the reporting of results with a comparatively relatively low probability of disease development at a level of 40%, and the test accuracy of 95% had a high preference. This shows that the results and consequences of WGS testing without genetic counseling are hard to assess for individuals. Therefore, WGS testing should be supported by qualified genetic counseling, where the attributes and consequences are explained.

Health-Related Genetic Direct-to-Consumer Tests in the German Setting: The Available Offer and the Potential Implications for a Solidarily Financed Health-Care System.

BACKGROUND: The global genetic direct-to-consumer (DTC) market will reach a volume of USD 230 billion in 2018. The expenditures for this genetic analysis are borne by the customer, whereas consequential costs may arise for a solidarily financed system. In a first step, it is essential to gain an overview of the currently available offer in the German setting. METHODS: In April 2016, we conducted a systematic internet search in the Google search engine. In November 2016, we updated the information of the webpages in terms of country, language, types of health-related tests, additional offer of non-health-related DTC test, information about sensitivity and specificity, certification and accreditation, costs as well as reference to German Act on Genetic Testing. RESULTS: Thirty-five webpages were included in the final overview. A plurality of different predictive analysis options was identified. Price information was not available for all offered genetic analyses. Costs for predictive analysis in one disease vary between EUR 90 and 990, for predictive package analysis between EUR 232.18 and 375, and for genetic lifestyle analysis between EUR 84.55 and 570.20. CONCLUSIONS: Genetic results may lead to uncertainty and anxiety; therefore, subsequent costs for a solidarily financed system may arise. Genetic DTC tests may have an influence on different players on the micro-, meso- and macro-levels, which may have a cost-cutting or cost-increasing effect on health-care expenditures. The increased interest in genetic analysis as well as the possibility of worldwide internet-based access to genetic tests requires population-wide education.

Cost analysis of whole genome sequencing in German clinical practice.

OBJECTIVES: Whole genome sequencing (WGS) is an emerging tool in clinical diagnostics. However, little has been said about its procedure costs, owing to a dearth of related cost studies. This study helps fill this research gap by analyzing the execution costs of WGS within the setting of German clinical practice. METHODOLOGY: First, to estimate costs, a sequencing process related to clinical practice was undertaken. Once relevant resources were identified, a quantification and monetary evaluation was conducted using data and information from expert interviews with clinical geneticists, and personnel at private enterprises and hospitals. This study focuses on identifying the costs associated with the standard sequencing process, and the procedure costs for a single WGS were analyzed on the basis of two sequencing platforms-namely, HiSeq 2500 and HiSeq Xten, both by Illumina, Inc. In addition, sensitivity analyses were performed to assess the influence of various uses of sequencing platforms and various coverage values on a fixed-cost degression. RESULTS: In the base case scenario-which features 80 % utilization and 30-times coverage-the cost of a single WGS analysis with the HiSeq 2500 was estimated at €3858.06. The cost of sequencing materials was estimated at €2848.08; related personnel costs of €396.94 and acquisition/maintenance costs (€607.39) were also found. In comparison, the cost of sequencing that uses the latest technology (i.e., HiSeq Xten) was approximately 63 % cheaper, at €1411.20. CONCLUSIONS: The estimated costs of WGS currently exceed the prediction of a 'US$1000 per genome', by more than a factor of 3.8. In particular, the material costs in themselves exceed this predicted cost.

[Whole-genome sequencing in German clinical practice : Economic impacts of its use in selected areas of application]. / Ganzgenomsequenzierung in der deutschen Versorgung : Ökonomische Auswirkungen eines Einsatzes in ausgewählten Anwendungsgebieten.

BACKGROUND: The diagnostic use of whole-genome sequencing (WGS) is a growing issue in medical care. Due to limited resources in public health service, budget-impact analyses are necessary prior to implementation. OBJECTIVE: A budget-impact analysis for WGS of all newborns and diagnostic investigation of tumor patients in different oncologic indications were evaluated. METHODS: A cost analysis of WGS based on a quality-assured process chart for WGS at the German Cancer Research Center (DKFZ), Heidelberg, constitutes the basis for this evaluation. Data from the National Association of Statutory Health Insurance Funds and the Robert-Koch-Institute, Berlin, were used for calculations of specific clinical applications. RESULTS AND DISCUSSION: WGS in newborn screening leads to costs of € 2.85 bn and to an increase of total expenditure by 1.41%. Sequencing of all tumor patients would cost approximately € 0.84 bn, which corresponds to 0.42% of total expenditures. In all scenarios, the sole consideration of procedure costs results in increasing costs. However, in cost discussions potential savings (reduction of disease-related follow-up-costs, improved cost-effectiveness of medical measures etc.) should be considered. Such considerations are the subject of economic indication-specific evaluations. WGS has the potential to generate a large number of deterministic findings for which treatment options are limited. Hence, it is necessary to limit indications, in which WGS has proven medical evidence.

Cost-Effectiveness of Pharmacogenomic and Pharmacogenetic Test-Guided Personalized Therapies: A Systematic Review of the Approved Active Substances for Personalized Medicine in Germany.

BACKGROUND: The use of targeted therapies has recently increased. Pharmacogenetic tests are a useful tool to guide patient treatment and to test a response before administering medicines. Pharmacogenetic tests can predict potential drug resistance and may be used for determining genotype-based drug dosage. However, their cost-effectiveness as a diagnostic tool is often debatable. In Germany, 47 active ingredients are currently approved. A prior predictive test is required for 39 of these and is recommended for eight. The objective of this study was to review the cost-effectiveness (CE) of pharmacogenetic test-guided drug therapy and compare the application of drugs with and without prior genetic testing. METHODS: A systematic literature review was conducted to identify the CE and cost-utility of genetic tests. Studies from January 2000 until November 2015 were searched in 16 databases including Medline, Embase, and Cochrane. A quality assessment of the full-text publications was performed using the validated Quality of Health Economic Studies (QHES) instrument. RESULTS: In the majority of the included studies, the pharmacogenetic test-guided therapy represents a cost-effective/cost-saving treatment option. Only seven studies lacked a clear statement of CE or cost-savings, because of uncertainty, restriction to specific patient populations, or assumptions for comparative therapy. Moreover, the high quality of the available evidence was evaluated. CONCLUSION: Pharmacogenetic testing constitutes an opportunity to improve the CE of pharmacotherapy. The CE of targeted therapies depends on various factors including costs, prevalence of biomarkers, and test sensitivity and specificity. To guarantee the CE comparability of stratified drug therapies, national and international standards for evaluation studies should be defined.