Early decision-analytic modeling - a case study on vascular closure devices.
BACKGROUND
As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account not only medical need and potential clinical effectiveness, but also cost-effectiveness. Already early in the innovation process economic evaluations can support decisions on development in specific indications or patient groups by anticipating future reimbursement and implementation decisions. One potential concept for early assessment is value-based pricing.


METHODS
The objective is to assess the feasibility of value-based pricing and product design for a hypothetical vascular closure device in the pre-clinical stage which aims at decreasing bleeding events. A deterministic decision-analytic model was developed to estimate the cost-effectiveness of established vascular closure devices from the perspective of the Statutory Health Insurance system. To identify early benchmarks for pricing and product design, three strategies of determining the product's value are explored: 1) savings from complications avoided by the new device; 2) valuation of the avoided complications based on an assumed willingness-to-pay-threshold (the efficiency frontier approach); 3) value associated with modifying the care pathways within which the device would be applied.


RESULTS
Use of established vascular closure devices is dominated by manual compression. The hypothetical vascular closure device reduces overall complication rates at higher costs than manual compression. Maximum cost savings of only about €4 per catheterization could be realized by applying the hypothetical device. Extrapolation of an efficiency frontier is only possible for one subgroup where vascular closure devices are not a dominated strategy. Modifying care in terms of same-day discharge of patients treated with vascular closure devices could result in cost savings of €400-600 per catheterization.


CONCLUSIONS
It was partially feasible to calculate value-based prices for the novel closure device which can be used to inform product design. However, modifying the care pathway may generate much more value from the payers' perspective than modifying the device per se. Manufacturers should thus explore the feasibility of combining reimbursement of their product with arrangements that make same-day discharge attractive also for hospitals. Due to the early nature of the product, the results are afflicted with substantial uncertainty.
Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Ingolstädter Landstrasse 1, 85764, Neuherberg, Germany. post@alinabrandes.de.
Alina
A
Brandes
Department of Medicine I, University Hospital Munich, Ludwig-Maximilian University, Marchioninistrasse 15, 81377, Munich, Germany. Moritz.Sinner@med.uni-muenchen.de.
Moritz F
MF
Sinner
Department of Medicine I, University Hospital Munich, Ludwig-Maximilian University, Marchioninistrasse 15, 81377, Munich, Germany. Stefan.Kaab@med.uni-muenchen.de.|Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK, German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Biedersteiner Strasse 29, 80802, Munich, Germany. Stefan.Kaab@med.uni-muenchen.de.
Stefan
S
Kääb
Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Ingolstädter Landstrasse 1, 85764, Neuherberg, Germany. rogowski@helmholtz-muenchen.de.|Ludwig-Maximilian University, Munich, Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Clinical Center, Ziemssenstrasse 1, 80336, Munich, Germany. rogowski@helmholtz-muenchen.de.
Wolf H
WH
Rogowski
D002404:Catheterization / Q000191:economics; D000066491:Clinical Decision-Making / Q000379:methods*; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003663:Decision Trees; D004867:Equipment Design; D005240:Feasibility Studies; D006470:Hemorrhage / Q000191:economics* / Q000517:prevention & control; D006801:Humans; D018803:Models, Economic; D012187:Retroperitoneal Space; D017211:Treatment Failure; D062505:Value-Based Purchasing / Q000191:economics; D065506:Vascular Closure Devices / Q000009:adverse effects / Q000191:economics* / Q000592:standards