Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: A Societal Perspective: The ISPOR Drug Cost Task Force Report—Part II

Garrison, Louis P.; Mansley, Edward C.; Abbott, Thomas A.; Bresnahan, Brian W.; Hay, Joel W.; Smeeding, James E.

doi:10.1111/j.1524-4733.2009.00660.x

Cited by 137 publications

(95 citation statements)

References 12 publications

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“…Additionally, stratification by cost or budget impact raises questions of which costs to consider and which analytic perspective to assume (e.g. payer perspective vs. societal perspective) [20]. For these reasons, evaluation of genetic tests with a stratified risk-benefit matrix may lead to unintended policy consequences and prove to be an additional roadblock in building stakeholder consensus about risk-benefit modeling in genetic test evaluation.…”

Section: Discussionmentioning

confidence: 99%

Stakeholder Perspectives on a Risk-Benefit Framework for Genetic Testing

Roth¹,

Garrison²,

Burke

et al. 2010

Public Health Genomics

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A key to accelerating the appropriate integration of genomic applications into healthcare in the coming decades will be the ability to assess the tradeoffs between clinical benefits and clinical risks of genetic tests in a timely manner. Several factors limit the ability of stakeholders to achieve this objective, including the lack of direct evidence, the lack of a framework to quantitatively assess risk and benefit, and the lack of a formal analytic approach to assess uncertainty. We propose that a formal, quantitative risk-benefit framework may be particularly useful for assessing genetic tests intended to influence health outcomes, and communicating the potential clinical benefits, harms, and uncertainty to stakeholders. As part of the development process for such a framework, a stakeholder meeting was held in Seattle (Wash., USA) in December of 2008, with the objective of discussing a risk-benefit framework, using warfarin pharmacogenomics as a case study. Participants engaged in focused discussion to elucidate the potential role of genetic test risk-benefit analysis in informing decision-making, categorizing genetic tests and directing research prioritization. This research investigation focuses on qualitative analysis of responses elicited from workshop participants during the proceedings of the workshop session. The major findings of the workshop were: (1) stakeholder support for risk-benefit modeling as a tool to structure discussion of the clinical utility of genetic tests; (2) desire for the modeling process to be iterative, transparent, and parsimonious in its presentation to stakeholders, and (3) some concern with the use of quality-adjusted life-years in the evaluation process. The meeting’s findings emphasize the potential utility of risk-benefit analysis in genetic test evaluation, and highlight key areas for future research and stakeholder consensus-building.

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Section: Discussionmentioning

confidence: 99%

Stakeholder Perspectives on a Risk-Benefit Framework for Genetic Testing

Roth¹,

Garrison²,

Burke

et al. 2010

Public Health Genomics

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show abstract

“…Of course, what constitutes the societal perspective has engendered considerable debate. An ISPOR Task Force [11] recommended three key elements: 1) indirect or time costs should be included in addition to direct medical costs, 2) the prices of medical resources should reflect their true social opportunity cost, and 3) the preferences of the general population should be considered. Health economists pointed out that few CEAs meet these three elements, and it is understood that no single actor in the health care system will take this societal perspective.…”

Section: Issues and Challenges In Using Cea In Developing Clinical Gumentioning

confidence: 99%

Cost-Effectiveness and Clinical Practice Guidelines: Have We Reached a Tipping Point?—An Overview

Garrison

2016

Value in Health

Self Cite

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Given recent developments in the United States, where professional clinical societies have attempted to define "value" and consider it in their deliberations about appropriate care, this thematic article describes those recent specialty society efforts in the United States in cardiology and oncology and the multispecialty efforts in the United Kingdom for over 10 years. Despite our high levels of health spending, and our field's long and consistent approach to the basic tools of cost-effectiveness analysis (CEA), US private and public payers are not routinely or explicitly using CEAs in their reimbursement decisions. This is a puzzle that raises the following question: Why does the United States have so many skilled pharmacoeconomic practitioners and produce so many CEAs given this apparent lack of interest and trust? There are multiple reasons, but the lack of incentives to use the information certainly matters. This article identifies and discusses a number of key issues and challenges for incorporating CEA into US clinical guidelines development: potential bias in manufacturer-sponsored CEAs, the role of societal perspective, payer-subscriber and physician-patient agency relationships, the need for disease area CEA studies and modeling, patient heterogeneity, investigators' conflicts of interest, assessing the quality of economic studies, and aggregation of information using multicriteria decision analysis. These developments suggest that the application of CEA in health care decision making in the United States is evolving and may be approaching a tipping point. With increasing pressures on drug prices, perhaps reflecting challenges to industry sustainability, payers, providers, and patients are looking for value for money. CEA should be an important part of this process.

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“…Opportunitätskosten innovativer Arzneimittel zu bestimmen ist aufwendig, da ein enormer Informationsbedarf entsteht. Zunächst sollte festgelegt werden, ob auf die langfristigen oder die kurzfristigen Opportunitätskosten abgestellt werden soll [12,31]. Gesundheitsökonomische Evaluation unterstützt grundsätzlich die Entscheidungsfindung bei Investitionsentscheidungen, was bedeutet, dass die langfristigen Grenzkosten bevorzugt werden.…”

Section: Bewertung Von Medikamentenunclassified

“…Gesundheitsökonomische Evaluation unterstützt grundsätzlich die Entscheidungsfindung bei Investitionsentscheidungen, was bedeutet, dass die langfristigen Grenzkosten bevorzugt werden. Dennoch diskutiert die Literatur zu den Opportunitätskosten von Arzneimitteln beide Ansätze, kurzfristige und langfristige Grenzkosten [12,31] [32,33]. Vollkommener Wettbewerb impliziert Vollbeschäftigung auf dem Arbeitsmarkt (was der empirischen Erfahrung von substanzieller Arbeitslosigkeit in vielen Ländern widerspricht).…”

Section: Bewertung Von Medikamentenunclassified

Methoden der Kostenbestimmung in der gesundheitsökonomischen Evaluation

Krauth¹

2010

Gesundh ökon Qual manag

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Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: A Societal Perspective: The ISPOR Drug Cost Task Force Report—Part II

Cited by 137 publications

References 12 publications

Stakeholder Perspectives on a Risk-Benefit Framework for Genetic Testing

Stakeholder Perspectives on a Risk-Benefit Framework for Genetic Testing

Cost-Effectiveness and Clinical Practice Guidelines: Have We Reached a Tipping Point?—An Overview

Methoden der Kostenbestimmung in der gesundheitsökonomischen Evaluation

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