Abstract
BackgroundAs 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.MethodsThe 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.ResultsUse 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.ConclusionsIt 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.
Highlights
As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account medical need and potential clinical effectiveness, and the cost-effectiveness of a new drug or medical device
The purpose of this study is to provide an example of using value-based pricing and product design in the early economic evaluation of an innovative Vascular closure device (VCD) for cardiac diagnosis and interventions in which methods of regenerative medicine are used to reduce the number of bleeding complications
The scenario analysis of diagnostic catheterization results in incremental costs of €77 and a reduction of 0.0084 complications per catheterization for the VCD strategy when compared to manual compression
Summary
As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account medical need and potential clinical effectiveness, and 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. As economic considerations become more important in healthcare reimbursement, decisions about the further development of medical innovations need to take into account medical need and potential clinical effectiveness, and the cost-effectiveness of a new drug or medical device. It has been proposed that already in an early phase of the innovation process, economic evaluations can support decisions on further development in specific indications or patient groups by anticipating future reimbursement and implementation decisions [1, 2]. Development activities are oriented towards attributes which are most valuable to those who decide about the innovations’ reimbursement and implementation in clinical practice
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