Cancer Core Europe and DART
DKFZ Division of Health Economics is involved in the international Cancer Core Europe (CCE) consortium to collaborate on the DART project. The project has received funding from the European Union´s Horizon 2020 research and innovation programme under grant agreement No 965397.
For further information please visit the CCE-DART website: https://cce-dart.com/
Building Data Rich Clinical Trials (CCE- DART): Cancer research is rapidly evolving with the proliferation of molecular targeted therapies. New clinical trial designs including adaptive, basket, and umbrella trials, have been developed to assess innovative treatments tied to the existence of selected biomarkers rather than histological site. Clinical trials are the best source of clinical evidence but current studies still are too rigid and have too many limitations that do not allow them to adapt to the speed of the discoveries in oncology. The project aims to improve the design and implementation of clinical trials, and the use of newer, more effective methods. The Division of Health Economics contributes to the research project by investigating how clinical data from new trial designs can be incorporated in health economic evaluations to ensure validity of outcomes. The project is ideal to implement state-of-the-art health economic methods for cost-effectiveness analyses to assess the health care impact of molecular targeted therapies.
Recent Publications
Health Technology Assessment–Informed Decision Making by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care in Germany and the National Institute for Health and Care Excellence in England: The Role of Budget Impact
Empirical studies usually focus on the effect of evaluation criteria on recommendations by health technology assessment (HTA) agencies or compare assessment outcomes and underlying regulations. This study aimed to extend upon the existing HTA literature regarding (official) assessment criteria, explore variations in evaluation outcomes, and provide insights on the potential role of the budget impact in decision making for both the Federal Joint Committee (Gemeinsamer Bundesausschuss, GBA) and Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) in Germany and the National Institute for Health and Care Excellence (NICE) in England.
Ramon Schaefer et al. found that GBA/IQWiG and NICE follow their (official) evaluation criteria consistently. Results indicated that NICE recommendations are largely driven by the incremental cost-effectiveness ratio (or cost per quality-adjusted life year gained) and, if applicable, by end-of-life criteria. GBA resolutions and IQWiG recommendations strictly focus on the principles of evidence-based medicine. While IQWiG assessments are significantly affected by the availability of randomized controlled trials and patient-relevant endpoints, GBA appraisals are primarily associated with endpoints.
Interestingly, after controlling for all significant variables, the budget impact seems to have an effect on HTA outcomes both in Germany and in England. Therefore, budget impact analyses might be of relevance in HTA decision making procedures followed by GBA/IQWiG and NICE, although their (unofficial) role remains ambiguous.
R. Schaefer, D. Hernandez, T. Baernighausen, P. Kolominsky-Rabas, M. Schlander:
The HTA-informed Decision-Making by GBA/IQWiG in Germany and NICE in England: The Role of Budget Impact.
Value Health, 2023: published 13 Mar 2023.
DOI: 10.1016/j.jval.2023.02.018.
Modeling the Natural History and Screening Effects of Colorectal Cancer Using Both Adenoma and Serrated Neoplasia Pathways: The Development, Calibration, and Validation of a Discrete Event Simulation Model
The problem with current screening models for colorectal cancer (CRC) is that they only focus on the adenoma pathway which is thought to result in overly optimistic screening predictions. The objective of this research was to create a CRC screening model that considers both adenoma and serrated neoplasia pathways, calibrate it using approximate Bayesian computation methods, and validate it with data from large CRC screening trials.
Chih-Yuan Cheng and his co-authors developed the first discrete model for CRC screening which accounts for both the adenoma-carcinoma and the serrated neoplasia CRC tumorigenesis pathways. This model is flexible for evaluating various screening modalities as well as differentiating the screening effects in different parts of the colon. It successfully reproduced the CRC epidemiological data as well as the CRC screening benefits from sigmoidoscopy and colonoscopy. Being the first of its kind designed for the German setting, DECAS will be further developed to evaluate the effectiveness and cost-effectiveness of various CRC screening strategies in Germany.
C.-Y. Cheng, S. Calderazzo, C. Schramm, M. Schlander
Modeling the natural history and screening effects for colorectal cancer using both adenoma and serrated neoplasia pathways: the development, calibration, and validation of a discrete event simulation model.
MDM Policy & Practice, 2023: 8(1), published 21 Jan 2023.
DOI: 10.1177/23814683221145701.
Out‑of‑pocket payments and loss of income among long‑term breast cancer survivors in Germany: a multi‑regional population‑based study.
The main objective of this study was to examine the magnitude of out-of-pocket (OOP) payments and income loss among long-term breast cancer survivors in Germany and identify socioeconomic and clinical factors associated with these financial burdens.
The authors found that certain socioeconomic and clinical factors were associated with higher out-of-pocket payments and income loss. These factors included age at time of diagnosis, education, retirement, stage of diagnosis, time from diagnosis, comorbidities, and use of rehabilitation services. Furthermore, the results highlight that for some survivors in Germany, financial burden can be considerably high despite comprehensive healthcare and support from social security. In particular, OOP payments related to domestic help and nursing staff, as well as to outpatient care, were most frequent. The results highlight the need for better financial support and resources for long-term breast cancer survivors in Germany to help alleviate the financial burden of cancer treatment.
J. Schneider, D. Hernandez, CAESAR study group, M. Schlander, V. Arndt:
Out-of-pocket payments and loss of income among long-term breast cancer survivors in Germany: A multi-regional population-based study.
Journal of Cancer Survivorship, 2022: 1-21.
DOI: 10.1007/s11764-022-01293-x.
Quality appraisal for systematic literature reviews of health state utility values: a descriptive analysis
Within the context of cost-utility analysis, the objective of this study was to comprehensively describe the nature of quality appraisal (QA) in published systematic literature reviews (SLRs) of primary studies eliciting Health state utility values (HSUVs). The study conducted a comprehensive literature search of papers published from January 2015 to May 2021. Furthermore, the team extracted descriptive data, which included QA tools checklists or good practice recommendations used or cited, items used, and the methods of incorporating QA results into study findings.
The results of the study showed that the prevalence of QA in SLRs of HSUVs is 55% (40 out of 73) and that the most commonly used QA items in SLRs were response rates, statistical analysis, sample size, and loss of follow-up. Most commonly featured items in QA tools and good practice recommendations were statistical analysis, confounding or baseline equivalency, and blinding.
Muchandifunga (Trust) Muchadeyi et al. concluded that there is a low prevalence of QA in SLRs of HSUVs and a wide variation in the QA dimensions and items included in both SLRs and extracted tools. This underscores the need for a scientifically developed QA tool for multi-variable primary studies of HSUVs.
M. T. Muchadeyi, K. Hernandez-Villafuerte, M. Schlander:
Quality appraisal for systematic literature reviews of health state utility values: a descriptive analysis.
BMC Medical Research Methodology, 2022: 22 (1), 303.
DOI: 10.1186/s12874-022-01784-6.
Loss of income after cancer - results from Germany
General cancer care costs such as medication and treatments, are covered by the publically funded healthcare system in Germany. Despite this comprehensive healthcare system, this publication draws attention to the problem of financial burdens faced by cancer survivors in Germany. Volker Arndt et al. reviewed an extensive repertoire of research that focused on income changes that occurred after a cancer diagnosis.
Their work highlights that young adults who are of working age in particular can be at risk for facing financial challenges such as income loss after cancer. Their review included evaluations on income loss after cancer by collaborators Diego Hernandez and Michael Schlander published in 2021. More information on their results can be found below.
Income loss after a cancer diagnosis in Germany: An analysis based on the socio-economic panel survey
In this study Hernandez and Schlander used data from the German Socio-Economic Panel survey of 20,000 individuals traced annually from 2009-2015 to analyze the impact of cancer diagnosis on job income, work status, working hours, and pension. The analysis employed ordinary least squares and multinomial logistic estimators and included sample consistency checks to limit measurement of error biases.
The study found that job incomes dropped by 26-28% in the year of a cancer diagnosis and persisted for two years. This was linked to increased unemployment and reduced working hours by 24% while pension levels were not affected. These results suggest cancer patients face financial hardship in Germany, particularly during working age and before pensions can be obtained. Further research is needed to identify vulnerable patient groups.
V. Arndt, D. Hernandez, M. Schlander:
Einkommenseinbußen nach Krebs – Ergebnisse aus Deutschland.
Onkologie, 2022: 28 951-956.
DOI: 10.1007/s00761-022-01243-3.
D. Hernandez, M. Schlander:
Income loss after a cancer diagnosis in Germany: An analysis based upon the socio-economic panel survey.
Cancer Medicine, 2021: 10 (11) 3726-3740.
DOI: 10.1002/cam4.3913.
Economic Burden of Pancreatic Cancer in Europe: a Literature Review
Despite its low incidence, pancreatic cancer has a substantial cost on society, mainly as the result of its high mortality. Knowing that, the objective of this paper was to provide an overview of the economic burden of pancreatic cancer in Europe specifically by conducting an extensive literature review using search engines EconLit, Google Scholar, PubMed and Web of Science, from articles published after 1992 and before 2020.
A total of 26 studies on the economic burden attributable to pancreatic cancer in Europe were found and Cost per patient and cost per patient per month (PPM) was calculated. Drivers of estimate heterogeneity were analyzed as well. Their results showed that cancer patients in Germany are facing significant financial struggles, particularly those who are diagnosed while still working and before they can receive pension benefits.
Diego Hernandez and his co-authors found that although direct costs PPM are in the upper bound relative to other cancer types, direct per patient costs are likely to be lower because of shorter survival. This research suggests that more investigation is needed to determine which patient groups are particularly vulnerable.
D. Hernandez, F. Wagner, K. Hernandez-Villafuerte, M. Schlander:
Economic burden of pancreatic cancer in Europe: a literature review.
Journal of Gastrointestinal Cancer, published online ahead of print 2022 Apr 26.
DOI: 10.1007/s12029-022-00821-3.
The Value of Freedom: A Review of the Current Developments and Conceptual Issues in the Measurement of Capability
According to the capability approach, health improvements should be evaluated as broad domains which reflect the capabilities of individuals. The objective of this publication was to review various instruments that operationalize the capability approach and analyze it in different stages.
Jasper Ubels et al. found that despite using a shared definition of capability, the unclear conceptualization by existing frameworks can be problematic. For instance, the different ways of instrument measurement may lead to overlooking content which reflect the true burden experienced by people trying to achieve their capabilities in certain contexts.
Their results suggest that developing capability instruments based on a less ambiguous definition of capability, such as the concept of "option freedom" by Petitt may lead to a more comprehensive assessment of wellbeing. Furthermore, the inclusion of a variety of questions to assess wellbeing in terms of capabilities, functioning and other concepts may lead to a broader assessment of wellbeing.
J. Ubels, K. Hernandez-Villafuerte, M. Schlander:
The value of freedom: a review of the current developments and conceptual issues in the measurement of capability.
Journal of Human Development and Capabilities, 2022: 23 (3) 327-353.
DOI: 10.1080/19452829.2022.2053506.
The Ethics of COVID-19 Vaccine Allocation: Don't Forget the Trade-Offs!
Vaccinations have been one of the most effective measures to prevent hospitalizations and premature deaths from COVID-19. The objective of this paper was to illustrate trade –offs by using a quantitative analysis that evaluates opportunity costs in terms of loss of lives and loss of life years incurred by six (idealized) real-world vaccination strategies.
Julian März and coauthors highlight that developing COVID-19 vaccination prioritization schemes is a highly complex task, with decision-makers having to strike a fair balance between different ethical principles of COVID-19 vaccine allocation and different groups in society. Among other findings, this paper emphasizes important trade-offs to consider in allocating COVID-19 vaccines, and further demonstrates how quantitative analysis can help illustrate trade-offs and inform political decisions on COVID-19 vaccine allocation.
J. März, A. Molnar, S. Holm, M. Schlander:
The ethics of COVID-19 vaccine allocation: Don't forget the trade-offs!
Public Health Ethics, 2022: 15 (1) 41-50.
DOI: 10.1093/phe/phac001.
The COVID-19 Pandemic and Cancer Patients in Germany: Impact on Treatment, Follow-Up Care and Psychological Burden
During the COVID-19 pandemic, measures were put in place by governments to decrease the spread of the disease, and healthcare resources were allocated specifically for COVID-19 patients. This study conducted in Germany, aimed to specifically assess the frequency of changes to cancer care among patients and to explore the psychological impact during the pandemic.
Cancer patients were invited to complete an online questionnaire capturing demographics, cancer specifics, and any changes to their medical, follow-up, psycho-oncological or nursing care. The survey also measured psychological distress using the Hospital Anxiety and Depression Scale. The results showed that 13% of 621 cancer patients reported a change to their treatment or care plan due to the pandemic. Changes were primarily made to follow-up care after treatment (56%), monitoring during treatment (29%), and psychological counseling (20%). Additionally, the study found that over half of patients (55%) reported symptoms of anxiety and 39% reported symptoms of depression. These findings highlight the need for healthcare services and policy makers to not only attend to cancer patients' medical needs, but also their psychological and social well-being. This is particularly important in situations where the healthcare system is strained, and prioritization is necessary.
R. D. Eckford, A. Gaisser, V. Arndt, M. Baumann, E. Kludt, K. Mehlis, J. Ubels, E. C. Winkler, S. Weg-Remers, M. Schlander:
The COVID-19 pandemic and cancer patients in Germany: impact on treatment, follow-up and psychological burden.
Frontiers in Public Health, published online 2022 Feb 9: Article 788598.
DOI: 10.3389/fpubh.2021.788598.
Recent Presentations
The ISPOR Europe 2022 conference, which took place November 6-9, 2022 in Vienna provided an opportunity for members of our team to present some of their ongoing work. Below is a full listing with links to the poster presentations.
A. Molnar, M. Störzel, M. Muchadeyi, R. Baird, I. Imaz-Igelsia, B. Nagy, J. M. Postma, G. de Pouvourville, V. Retel, M. Schlander:
Health economic evaluations alongside new clinical trial designs – Results of an international expert panel workshop.
M. Muchadeyi, K. Hernandez-Villafuerte, M. Schlander:
The nature of quality appraisal in systematic literature reviews of health state utility values (HSUVS). A rapid evidence review.
P. D. Pham, J. Ubels, K. Hernandez-Villafuerte, R. Eckford, M. Schlander:
Developing a conceptual framework for socioeconomic impact research in European cancer patients: A best-fit framework synthesis.
J. Schneider, D. Hernandez, CAESAR study group, M. Schlander, V. Arndt:
To what extent are long-term breast cancer survivors subjected to financial burden in Germany? Results from a patient survey-based study.
M. Störzel, A. Molnar, M. Schlander:
Challenges of health economic evaluations alongside innovative clinical trial designs in precision oncology – Results of a literature review.
How to work with us
If any of our areas of research are of interest (see: What we do) and you would like to pursue a PhD or master's degree in our department, please contact Katrin Eike-Verfürth at k.eike-verfuerth@dkfz-heidelberg.de