The Early Bird Catches the Worm: Early Cost-Effectiveness Analysis of New Medical Tests

Buisman, Leander R.; Mölken, Maureen P.M.H. Rutten-van; Postmus, Douwe; Luime, Jolanda J.; Groot, Carin A. Uyl–de; Redekop, William K.

doi:10.1017/s0266462316000064

Cited by 33 publications

(45 citation statements)

References 36 publications

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“…Further, a higher price for TEHV than bioprostheses is possible. Second, it provides patients and clinicians the first estimates of potential improvements in clinical outcomes of TEHV, which may result in faster adoption of TEHV in clinical practice [40]. We showed that, although benefits of TEHV may be relatively low in elderly patients due to their limited remaining life expectancy, TEHV may result in improvements in (quality-adjusted) life expectancy and reduced costs.…”

Section: Discussionmentioning

confidence: 84%

“…We showed that, although benefits of TEHV may be relatively low in elderly patients due to their limited remaining life expectancy, TEHV may result in improvements in (quality-adjusted) life expectancy and reduced costs. Finally, this study informs Dutch healthcare payers about the possible entrance of TEHV to the market and its associated national cost savings, which may result in more timely decisions about reimbursement [40].…”

Section: Discussionmentioning

confidence: 97%

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Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients

et al. 2020

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Objectives Aortic valve disease is the most frequent indication for heart valve replacement with the highest prevalence in elderly. Tissue-engineered heart valves (TEHV) are foreseen to have important advantages over currently used bioprosthetic heart valve substitutes, most importantly reducing valve degeneration with subsequent reduction of re-intervention. We performed early Health Technology Assessment of hypothetical TEHV in elderly patients (≥ 70 years) requiring surgical (SAVR) or transcatheter aortic valve implantation (TAVI) to assess the potential of TEHV and to inform future development decisions. Methods Using a patient-level simulation model, the potential cost-effectiveness of TEHV compared with bioprostheses was predicted from a societal perspective. Anticipated, but currently hypothetical improvements in performance of TEHV, divided in durability, thrombogenicity, and infection resistance, were explored in scenario analyses to estimate qualityadjusted life-year (QALY) gain, cost reduction, headroom, and budget impact. Results Durability of TEHV had the highest impact on QALY gain and costs, followed by infection resistance. Improved TEHV performance (− 50% prosthetic valve-related events) resulted in lifetime QALY gains of 0.131 and 0.043, lifetime cost reductions of €639 and €368, translating to headrooms of €3255 and €2498 per hypothetical TEHV compared to SAVR and TAVI, respectively. National savings in the first decade after implementation varied between €2.8 and €11.2 million (SAVR) and €3.2-€12.8 million (TAVI) for TEHV substitution rates of 25-100%. Conclusions Despite the relatively short life expectancy of elderly patients undergoing SAVR/TAVI, hypothetical TEHV are predicted to be cost-effective compared to bioprostheses, commercially viable and result in national cost savings when biomedical engineers succeed in realising improved durability and/or infection resistance of TEHV.

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Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 97%

Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients

et al. 2020

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“…2016 Jan;32(1-2):46–53. [33]13*Miquel-Cases A, Retèl VP, van Harten WH, Steuten LMG. Decisions on Further Research for Predictive Biomarkers of High-Dose Alkylating Chemotherapy in Triple-Negative Breast Cancer: A Value of Information Analysis.…”

Section: Appendixmentioning

confidence: 99%

Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature

et al. 2017

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Early health technology assessment is increasingly being used to support health economic evidence development during early stages of clinical research. Such early models can be used to inform research and development about the design and management of new medical technologies to mitigate the risks, perceived by industry and the public sector, associated with market access and reimbursement. Over the past 25 years it has been suggested that health economic evaluation in the early stages may benefit the development and diffusion of medical products. Early health technology assessment has been suggested in the context of iterative economic evaluation alongside phase I and II clinical research to inform clinical trial design, market access, and pricing. In addition, performing early health technology assessment was also proposed at an even earlier stage for managing technology portfolios. This scoping review suggests a generally accepted definition of early health technology assessment to be “all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty”. The present review also aimed to identify recent published empirical studies employing an early-stage assessment of a medical product. With most included studies carried out to support a market launch, the dominant methodology was early health economic modeling. Further methodological development is required, in particular, by combining systems engineering and health economics to manage uncertainty in medical product portfolios.

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“…The expected net benefit of sampling (ENBS) may estimate the value of specific study designs, for example, to inform the sample size of a trial, by accounting for the cost of research itself [91]. The ability of these methods to inform the design of future research may facilitate iterative economic evaluation [92], such that a de novo decision-analytic model may be built during the early development phase of a health technology, and subsequently refined, repopulated, and re-analyzed as more evidence is generated over the life cycle of the health technology [93–95]. …”

Section: Generating Evidence To Support the Economic Case For Precisimentioning

confidence: 99%

The economic case for precision medicine

Gavan

Thompson

Payne

2018

Expert Review of Precision Medicine and Drug Development

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Introduction: The advancement of precision medicine into routine clinical practice has been highlighted as an agenda for national and international health care policy. A principle barrier to this advancement is in meeting requirements of the payer or reimbursement agency for health care. This special report aims to explain the economic case for precision medicine, by accounting for the explicit objectives defined by decision-makers responsible for the allocation of limited health care resources. Areas covered: The framework of cost-effectiveness analysis, a method of economic evaluation, is used to describe how precision medicine can, in theory, exploit identifiable patient-level heterogeneity to improve population health outcomes and the relative cost-effectiveness of health care. Four case studies are used to illustrate potential challenges when demonstrating the economic case for a precision medicine in practice. Expert commentary: The economic case for a precision medicine should be considered at an early stage during its research and development phase. Clinical and economic evidence can be generated iteratively and should be in alignment with the objectives and requirements of decision-makers. Programmes of further research, to demonstrate the economic case of a precision medicine, can be prioritized by the extent that they reduce the uncertainty expressed by decision-makers.

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The Early Bird Catches the Worm: Early Cost-Effectiveness Analysis of New Medical Tests

Abstract: A well-designed early-CEA methodology can improve the ability to develop (cost-)effective medical tests in an efficient manner. Early-CEAs should continuously integrate insights and evidence that arise through feedback, which may convince developers to return to earlier steps.

Cited by 33 publications

References 36 publications

Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients

Early cost-utility analysis of tissue-engineered heart valves compared to bioprostheses in the aortic position in elderly patients

Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature

The economic case for precision medicine

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