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Economic methods and Social Costs Value Analysis (SCVA)

A major objective of economic analyses is the measurement of value. At the Division of Health Economics, two major streams of activity can be distinguished in this field. The first falls into the realm of the conventional evaluation model, i.e., the "logic of cost effectiveness", while the second addresses approaches to overcome the limitations of the current standard paradigm.

1. Methods development within the conventional paradigm

Multi-attribute utility (MAU) theory-based instruments to measure health-related quality of life (HRQoL).

Contemporary methods to measure health-related quality of life (HRQoL) for economic evaluation are grounded in multi-attribute utility theory. In the Multi-Instrument Comparison (MIC) study, all relevant instruments were systematically compared, and the results revealed that the instruments measure related but different constructs and differ substantially, with far-reaching implications for the valuation and thus economic comparison of different health care services. We conducted analyses of the German branch of the MIC study (led by Michael Schlander as PI), and found broadly similar results as reported for Australia, Canada, Norway, and the United States. Findings were presented to and discussed with experts from international HTA agencies, including the German IQWiG. As per outlook, two manuscripts are in preparation for publication in the peer-reviewed literature.

Validity of health state utility values used for cost effectiveness analyses.

Health state utility values (HSUVs) refer to the weights or cardinal preferences people place on the interventions or medical technologies and their attributes. HSUVs are an essential input parameter to cost effectiveness analysis (CEA), which are used to adjust the length lived in a disease state, and the quality of life experienced, in order to produce quality-adjusted life years (QALYs). There is a need for a scientifically developed and widely accepted quality assurance (QA) tool, helping interpret (and informing systematic reviews and syntheses of) HSUV studies. To improve the methods on HSUVs, we aim to develop and validate a generic quality appraisal tool for use in SLRs of studies eliciting HSUVs. The embarking step of this endeavor was to comprehensively review and investigate how QA was done in 73 systematic literature reviews of HSUVs published between January 2015 and April 2021. As per outlook, we established an international, multidisciplinary expert panel and plan to have three semi-structured Delphi rounds during this project phase.

Value of a statistical life year.

The evaluation of medical interventions – in particular in the context of HTAs – invariably implies some kind of (explicit or implicit) cost benefit assessment. One possible anchor is the value of a statistical life year (VSLY); however, currently used benchmarks for the willingness-to-pay (WTP) per quality-adjusted life year (QALY) gained are controversial and lack robust empirical support. Our systematic literature review identified 132 studies reporting original data, yielding 145 unique estimates for the value of a statistical life (VSL). After transformation of VSL into VSLY values, we expressed the VSLY – contingent on variables including regional origin of data, valuation method, and study design – in Euro (2014) and as multiples of annual gross domestic product (GDP) per capita. The median VSLY was €164,409 (mean, €224,331) or 6.4 times annual GDP/capita. Regression results indicated that studies with North American data sources reported significantly higher VSLY estimates. We also observed differences by measurement method. Overall, our results suggest that the empirical WTP for a statistical life year might be substantially higher than currently accepted international benchmarks for cost-effectiveness within the health care context. An update of the global analysis including the most recently published literature since 2016 is underway.

 

Selected Publications:

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.

M. Schlander:
Measuring health-related quality of life.
Oral presentation at Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG).
Köln, Germany. July 9, 2018.

M. Schlander, O. Schwarz, D. Hernandez, R. Schäfer:
The search for a cost effectiveness standard: 1-3 times GDP/Capita?
Poster presentation at Health Technology Assessment international (HTAi) Conference.
Vancouver, Canada. June 1-5, 2018.

M. Schlander, O. Schwarz, D. Hernandez, R. Schaefer.
The Value of a Statistical Life Year (VSLY) – An Analysis of Empirical Economic Studies from 1995 to 2015.
Presentation to the 12th European Conference on Health Economics,
Maastricht, July 14, 2018.

2. Methods development beyond the conventional paradigm

Social preferences and their measurement.

In the European social preferences measurement (ESPM) project, a comprehensive review of the literature on social preferences with regard to the allocation of health care resources indicated empirical support for a number of characteristics or "attributes" (beyond clinical effectiveness) of interventions. In particular, these include: 1) giving priority to the worst-off patients (in terms of severity, related to the ex ante health state); 2) prioritizing urgent interventions (urgency, because of the risk of major irreversible consequences without intervention, which may be conceptualized as a component of "effectiveness"); 3) not discriminating against persons in "double-jeopardy" (or, more generally, persons with comorbid conditions); 4) prioritizing health care for younger over older patients (age or the "fair innings" argument); and wishing to share resources with patients even if their treatment costs are high, in order not to disenfranchise them from a fair chance of access to effective care. A research program was initiated to investigate how citizens value selected characteristics (or "attributes") of health care interventions, and how they weigh them against each other; to compare the valuation results obtained in the project with those based on the conventional logic of cost effectiveness. Concerning orphan indications (or "rarity", an attribute of primary interest), the studies indicated consistently that citizens are prepared to accept (sometimes much) higher cost per patient in rare and ultra-rare conditions. In terms of outlook, the ESPM project was affected similarly as the VSLY studies, and full publication of the main study is still outstanding. The critical follow-up survey to investigate the sensitivity of citizens' WTP on size had to be put on hold. At the time of writing, we are preparing to re-initiate the "sensitivity-to-size" study.

Capability and health outcomes.

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© dkfz.de

Any value assessment of medical care requires a definition of value and its components or "attributes". Constructs traditionally used in applied health economics – predominantly, individual WTP in cost benefit analysis or QALYs in cost effectiveness evaluations – either have not been broadly accepted in the evaluation of health states and health care, or have been criticized for representing a restrictive, overly narrow concept, respectively. So the choice of an outcome measure for economic evaluations is of paramount importance for their validity. Proponents of the capability approach have argued that medical interventions increase the freedom of individuals to do or be. The question remains how the measurement of this freedom (also called "capabilities") can be operationalized. In order to address the question, first a review was conducted on how researchers have operationalized the measurement of capabilities in the past. Based on insights from this review, an improved theoretical framework of capability was developed that can contribute to the conceptualization of patient-reported outcomes (PROs). Based on this framework, a PRO measure was developed that shows the benefits of using comprehensive and precise concepts in the operationalization of the capability approach. First validation studies indicate that responses to the proposed instrument are relatively unaffected by adapted preferences. As per outlook, this stream of work is planned to be merged with ongoing research into socioeconomic impact analysis.

 

Selected Publications:

M. Brougham, M. Schlander, H. Telser, S. Bakshi, O. Sola-Morales:
Use of the incremental cost effectiveness ratio for decision-making policies - what's the problem? A perspective paper.
Expert Review of Pharmacoeconomics & Outcomes Research, 2022: 22 (6) 913-918.
DOI: 10.1080/14737167.2022.2064847.

J. J. Caro, J. E. Brazier, J. Karnon, P. Kolominsky-Rabas, A. J. McGuire, E. Nord, M. Schlander:
Determining value in Health Technology Assessment: Stay the course or tack away?
PharmacoEconomics, 2019: 37 (3) 293-299.
DOI: 10.1007/s40273-018-0742-2.

J. M. Heard, C. Vrinten, M. Schlander, C. M. Bellettato, C. van Lingen, M. Scarpa; MetabERN collaboration group:
Availability, accessibility and delivery to patients of the 28 orphan medicines approved by the European Medicine Agency for hereditary metabolic diseases in the MetabERN network.
Orphanet Journal of Rare Diseases, 2020: 15 (1) 1-10.
DOI: 10.1186/s13023-019-1280-5.

M.-J. Linton, P. M. Mitchell, H. Al-Janabi, M. Schlander, J. Richardson, A. Iezzi, J. Ubels, J. Coast:
Comparing the German translation of the ICECAP-A capability wellbeing measure to the original English version: Psychometric properties across healthy samples and seven health condition groups.
Applied Research in Quality of Life, in press (2018).
DOI: 1-23. 10.1007/s11482-018-9681-5.

D. Moro, M. Schlander, H. Telser, O. Sola-Morales, M. D. Clark, A. Olaye, C. Camp, M. Jain, T. Butt, S. Bakshi:
Evaluating discrete choice experiment willingness to pay [DCE-WTP] analysis, and relative social willingness to pay [RS-WTP] analysis in a health technology assessment of a treatment for an ultra-rare childhood disease [CLN2].
Expert Review or Pharmacoeconomics & Outcomes Research, 2022: 22 (4) 581-598.
DOI: 10.1080/14737167.2022.2014324.

J. Richardson, M. Schlander:
Health Technology Assessment (HTA) and economic evaluation: Efficiency or fairness first.
Journal of Market Access & Health Policy, 2019: 7 (1) 1557981.
DOI: 10.1080/20016689.2018.1557981.

M. Schlander:
Woran bemisst sich Effizienz im Gesundheitswesen? Zur Klärung fachwissenschaftlicher Begriffe und Kriterien.
Amos International, (2017) 11(1) 22-31.

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.

M. Wagner, D. Samaha, R. Casciano, M. Brougham, P. Abrishami, C. Petrie, B. Avouac, L. Mantovani, A. Sarría-Santamera, P. Kind, M. Schlander:
Moving towards accountability for reasonableness: A systematic exploration of the features of legitimate healthcare coverage decision-making processes using rare diseases and regenerative therapies as a case study.
International Journal of Health Policy and Management, 2019: 8 (7) 424-443.
DOI: 10.15171/ijhpm.2019.24.

3. COVID-19 pandemic related research

With the outbreak of the COVID-19 crisis, we responded to a request by the Management Board by launching a broad range of exploratory and research initiatives. Since policy makers prioritized health care to treat infected patients and to prevent the spread of the infection to others, there was immediate concern that vulnerable patient groups, notably including cancer patients, would be negatively affected. This early concern has since been confirmed by a massive amount of evidence. Among other activities, we explored various data sources for their usefulness as early indicators of changes in health care utilization and outcomes, and we represented the DKFZ at the "COVID-19 & Cancer Task Force" of the Union for International Cancer Control (UICC) led by Richard Sullivan (London).

For the first study, we partnered with the DKFZ Cancer Information Service (Krebsinformationsdienst, KID) to conduct a cross-sectional online survey in Germany (July 2020 to June 2021) to assess the frequency of changes to cancer care amount cancer patients and to study the psychological and financial impact of the pandemic. We took the opportunity to also look at financial consequences of cancer per se, not merely costs attributed to the pandemic. We found 13% of the respondents reported a change to their treatment or care plan. Of those patients with changes, the majority of changes were made to follow-up care after treatment (56%, to monitoring during treatment (29% and to psychological counseling (20%). More than half of the 621 patients (55%) reported symptoms of anxiety, and 39% reported symptoms of depression; patients with a change in cancer care were more likely to report symptoms of depression. Sixty-six percent of the respondents reported out-of-pocket expenditures due to cancer, 20% had additional cost due to the COVID-10 pandemic, and 16% reported income loss attributed to the pandemic. For those with jobs or self-employment, inability to work was associated with both symptoms of anxiety and of depression.

A subsequent study, "Consequences of Corona Restrictions for Cancer Therapy and Survivorship (CroKus-1), under the leadership of Volker Arndt and his team (DKFZ and Baden-Württemberg Cancer Registry), was conducted in 2021 with a representative sample of cancer patients and cancer survivors.

Further analyses addressed the need for a fair balance between different ethical principles for health care prioritization in general, and for vaccine allocation in particular, such as maximizing population-level benefit, reciprocity, social justice, and equal respect or rights of persons. In one study, a quantitative model was used to illustrate trade-offs and their consequences, delineating a national and transparent approach to political prioritization decisions. In another article we showed how actual policies concerning resource allocation to COVID-19 preventative measures could be understood through the paradigm of the "Rule of Rescue", without claiming that the Rule of Rescue ought to be the (sole) rationale of resource allocation in the COVID-19 pandemic.

 

Selected Publications:

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.

R. Eckford, A. Gaisser, E. Kludt, S. Weg-Remers, M. Schlander:
Financial impact on cancer patients in Germany during the COVID-19 pandemic.
Oral presentation at World Cancer Congress (WCC) 2022.

A. Gaisser, R. D. Eckford, V. Arndt, D. Doege, E. Kludt, J. Ubels, M. Schlander, S. Weg-Remers:
Fast zwei Jahre Coronapandemie aus der Perspektive von Krebsbetroffenen [Nearly two years of the coronavirus pandemic from the perspective of people affected by cancer].
Der Onkologe, 2022: 28 (3) 248-252.
DOI: 10.1007/s00761-022-01096-w.

J. W. 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.

J. W. März, S. Holm, M. Schlander:
Resource allocation in the COVID-19 health crisis: are COVID-19 preventive measures consistent with the Rule of Rescue?
Medicine, Health Care and Philosophy, 2021: 24 (4) 487-492.
DOI: 10.1007/s11019-021-10045-0.

J. W. März, M. Schlander:
Not kennt kein Gebot? Die Rule of Rescue als Leitprinzip in der Covid-19-Pandemie.
AMOS International, 2021: 15 (3): 39-44.

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