Personalized Medicine: Pricing and Reimbursement Policies as a Potential Barrier to Development and Adoption, Economics of

Garrison, LP; Towse, Adrian

doi:10.1016/b978-0-12-375678-7.01210-4

Cited by 16 publications

(24 citation statements)

References 9 publications

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“…There is an additional challenge in allocating value between the two complements-the test and treatment. This issue has been discussed in the literature, but different health systems have handled this reimbursement split in different ways [23,24].…”

Section: Value Of Reducing Uncertainty Due To a New Diagnosticmentioning

confidence: 99%

Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3]

et al. 2018

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The third section of our Special Task Force report identifies and defines a series of elements that warrant consideration in value assessments of medical technologies. We aim to broaden the view of what constitutes value in health care and to spur new research on incorporating additional elements of value into cost-effectiveness analysis (CEA). Twelve potential elements of value are considered. Four of them-quality-adjusted life-years, net costs, productivity, and adherence-improving factors-are conventionally included or considered in value assessments. Eight others, which would be more novel in economic assessments, are defined and discussed: reduction in uncertainty, fear of contagion, insurance value, severity of disease, value of hope, real option value, equity, and scientific spillovers. Most of these are theoretically well understood and available for inclusion in value assessments. The two exceptions are equity and scientific spillover effects, which require more theoretical development and consensus. A number of regulatory authorities around the globe have shown interest in some of these novel elements. Augmenting CEA to consider these additional elements would result in a more comprehensive CEA in line with the "impact inventory" of the Second Panel on Cost-Effectiveness in Health and Medicine. Possible approaches for valuation and inclusion of these elements include integrating them as part of a net monetary benefit calculation, including elements as attributes in health state descriptions, or using them as criteria in a multicriteria decision analysis. Further research is needed on how best to measure and include them in decision making.

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Section: Value Of Reducing Uncertainty Due To a New Diagnosticmentioning

confidence: 99%

Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3]

et al. 2018

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“…Therefore, it is possible to argue that the development of advanced therapy pharmaceuticals and personalized medicine are slower than expected. The reasons for this slow progress are three-fold: scientific -the development processes of advanced therapy pharmaceuticals are complex and R&D is intensive; regulatory -there are significant imperfections in the regulation of advanced therapy pharmaceuticals; and economic -there are issues regarding cost-effectiveness analyses, pricing and reimbursement [1]. In addition, it's possible to argue that, due to these imperfections, the incentives for personalized medicine and the innovation of advanced therapy drugs are not aligned [5].…”

Section: Recent Developments In Advanced Therapiesmentioning

confidence: 99%

The Challenges and Future of Advanced Therapies

Öztürk¹

2018

Pharmaceutical Market Access in Developed Markets2018

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Globally, we observe that diagnostic and treatment methods are rapidly changing and evolving, due to epidemiologic and demographic transitions. In this context, personalized medicine is increasingly emerging, because of the recent technological advances in health care service provision. Several definitions have been proposed to define "personalized medicine" (Box 1). A formal definition can be as follows: "Providing the right treatment, to the right patient, at the right time, with the help of new biomarker-based diagnostic tests". Such tests help identify patients at high risk, or patients for whom conventional therapies are less effective, or ineffective-i.e. "stratification" [1]. Patients with the same diagnosis respond differently to the same therapy, due to their different genetic and biological endowments. Personalized medicine evaluates these differences on a molecular basis, and develops advanced therapies which depend on the patient's specific needs. This new field, which is arising from advanced pharmacology and genomics, is defined as pharmacogenomics [2]. Pharmacogenomics focuses on patients for whom pharmaceuticals are ineffective (Box 2). Personalized medicine and advanced therapies are more utilized in genetic and metabolic illnesses, such as cancer or rare genetic diseases. The most recent studies proved the existence of a significant relationship

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“…The terms “precision” or “stratified” medicine have emerged in recent years as a refinement of this concept [1,2]. This newer concept was formally defined by President Obama’s 2015 Precision Medicine Initiative as “an approach to disease treatment and prevention that seeks to maximize effectiveness by taking into account individual variability in genes, environment, and lifestyle” [3].…”

Section: Introductionmentioning

confidence: 99%

Precision Health Economics and Outcomes Research to Support Precision Medicine: Big Data Meets Patient Heterogeneity on the Road to Value

Chen

Guzauskas

et al. 2016

JPM

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The “big data” era represents an exciting opportunity to utilize powerful new sources of information to reduce clinical and health economic uncertainty on an individual patient level. In turn, health economic outcomes research (HEOR) practices will need to evolve to accommodate individual patient–level HEOR analyses. We propose the concept of “precision HEOR”, which utilizes a combination of costs and outcomes derived from big data to inform healthcare decision-making that is tailored to highly specific patient clusters or individuals. To explore this concept, we discuss the current and future roles of HEOR in health sector decision-making, big data and predictive analytics, and several key HEOR contexts in which big data and predictive analytics might transform traditional HEOR into precision HEOR. The guidance document addresses issues related to the transition from traditional to precision HEOR practices, the evaluation of patient similarity analysis and its appropriateness for precision HEOR analysis, and future challenges to precision HEOR adoption. Precision HEOR should make precision medicine more realizable by aiding and adapting healthcare resource allocation. The combined hopes for precision medicine and precision HEOR are that individual patients receive the best possible medical care while overall healthcare costs remain manageable or become more cost-efficient.

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Personalized Medicine: Pricing and Reimbursement Policies as a Potential Barrier to Development and Adoption, Economics of

Cited by 16 publications

References 9 publications

Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3]

Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3]

The Challenges and Future of Advanced Therapies

Precision Health Economics and Outcomes Research to Support Precision Medicine: Big Data Meets Patient Heterogeneity on the Road to Value

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