Cost-effectiveness analysis at the development phase of a potential health technology: examples based on tissue engineering of bladder and urethra

McAteer, Helen; Cosh, Emma; Freeman, G. H.; Pandit, Anand; Wood, Paul; Lilford, Richard

doi:10.1002/term.36

Cited by 63 publications

(61 citation statements)

References 45 publications

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“…Not surprisingly, the new bioreactor-based approach also carries certain weaknesses and invokes threats that need to be addressed as part of a well developed clinical, regulatory and reimbursement plan. In order to derive more quantitative indications, the use of a Headroom Method has been proposed as a simple but rigorous way to make preliminary conclusions as to the cost-effectiveness of a new tissue engineering treatment [22].…”

Section: Commercial Aspectsmentioning

confidence: 99%

Bioreactor-based roadmap for the translation of tissue engineering strategies into clinical products

Martin

Smith

Wendt

2009

Trends in Biotechnology

134

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Section: Commercial Aspectsmentioning

confidence: 99%

Bioreactor-based roadmap for the translation of tissue engineering strategies into clinical products

Martin

Smith

Wendt

2009

Trends in Biotechnology

134

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“…Several studies identified early models as useful tools to inform device development programmes, including early market assessment, research and development (R&D) portfolio management, and first estimations of pricing and reimbursement scenarios [83][84][85][86]. Two studies provided applied examples of using modelling to inform value [37,84].…”

Section: Early Modelsmentioning

confidence: 98%

“…Two studies provided applied examples of using modelling to inform value [37,84]. Two studies recommended using a Bayesian approach to incorporate all available evidence to help companies manage uncertainties and identify major risks and hence make better informed choices at each decision point [76,87].…”

Section: Early Modelsmentioning

confidence: 98%

A Review of the Economic Tools for Assessing New Medical Devices

Craig

Carr

Hutton

et al. 2014

Appl Health Econ Health Policy

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Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices.

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“…More detailed accounts of this work can be found in McAteer et al . 4 It can be seen from these examples that health gain in Box 1: Regenerative medicine for urethral stricture A substitute for urethral tissue is needed in operations on lengthy strictures, and sometimes for epispadias and hypospadias (congenital defects resulting in the urethral opening on the top or bottom surface of the penis). Buccal mucosa, tissue making up the lining of the cheek, is becoming the gold standard substitute, 14 although it does have disadvantages, relating to morbidity at the donor site.…”

Section: Estimating Qalymentioning

confidence: 98%

“…For example, it curtailed. 4 Return on investment may be affected by the rarity of a condition or because it occurs only in economies unable to support high-cost remedies. For example, a tissue-engineered solution to small contracted bladders could not rely on treating Bilharziasis patients, since this parasitic disease occurs mostly in the world ' s poorest countries.…”

Section: Refi Ning the Clinical Problemmentioning

confidence: 99%

Investing in new medical technologies: A decision framework

Cosh¹,

Girling²,

Lilford³

et al. 2007

J Commer Biotechnol

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Purchasing and reimbursement decisions in healthcare systems with fi nite resources are increasingly infl uenced by formal health economic analysis. It is therefore sensible for a company considering the development of a new medical technology to assess its potential cost effectiveness as early as possible in the development cycle. This document describes a process by which an organisation can add rigour to decisions about which technologies to pursue, as well as creating a persuasive argument for outside investment. The process consists of a series of analyses that should be conducted before substantial investments are made. The stages of the algorithm are: strategic considerations, clinical problem defi nition, headroom analysis, return on investment analysis and further economic analysis. This paper concentrates on the clinical problem defi nition and headroom analysis aspects of the process. Two worked examples of calculating headroom for theoretical products in tissue engineering of urogenital tissue are given. The health gain in urethral tissue is unlikely to be suffi cient to justify the cost of a regenerative medicine solution, whereas bladder substitution after tumour resection has the potential to be cost effective providing marginal costs do not exceed £ 16,000. The framework discussed here provides a structure for investment decisions that can illuminate a situation, which may otherwise appear hard to fathom. A headroom analysis is primarily useful as a barrier to misguidedly investing in those devices, which can never be cost effective.

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Cost-effectiveness analysis at the development phase of a potential health technology: examples based on tissue engineering of bladder and urethra

Abstract: The Headroom Method can help inform instrumental decisions concerning new treatments without having to build a complex model with very wide parameter uncertainty.

Cited by 63 publications

References 45 publications

Bioreactor-based roadmap for the translation of tissue engineering strategies into clinical products

Bioreactor-based roadmap for the translation of tissue engineering strategies into clinical products

A Review of the Economic Tools for Assessing New Medical Devices

Investing in new medical technologies: A decision framework

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