Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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Reduced mortality with low-dose computed tomography (LDCT) lung cancer screening was demonstrated in a large randomized controlled study of high-risk individuals. Cost-effectiveness must be assessed before routine LDCT screening is considered. We aimed to evaluate the cost-effectiveness of LDCT lung cancer screening in Israel. ⋯ Our analysis suggests that baseline LDCT lung cancer screening in Israel presents a good value for the money and should be considered for inclusion in the National List of Health Services financed publicly.
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There is a need for methodological scrutiny in the economic assessment of personalized medicine. In this article, we present a list of 10 specific issues that we argue pose specific methodological challenges that require careful consideration when designing and conducting robust model-based economic evaluations in the context of personalized medicine. Key issues are related to the correct framing of the research question, interpretation of test results, data collection of medical management options after obtaining test results, and expressing the value of tests. ⋯ Finally, it is important to understand that a test strategy does not necessarily lead to more quality-adjusted life-years (QALYs). It is possible that the test will lead to not only fewer QALYs but also fewer costs, which can be defined as "decremental" cost per QALYs. Different decision criteria are needed to interpret such results.
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The decade since the completion of the sequencing of the human genome has witnessed significant advances in the incorporation of genomic information in diagnostic, treatment, and reimbursement practices. Indeed, as case in point, there are now several dozen commercially available genomic tests routinely applied across a wide range of disease states in predictive or prognostic applications. Moreover, many involved in the advancement of personalized medicine would view emerging approaches to stratify patients in meaningful ways beyond genomic information as a signal of the progress made. ⋯ Starting with a framework with which to characterize personalized medicine, this Special Issue proceeds to illuminate issues related to the intersection of personalized medicine and comparative effectiveness; use of personalized medicine approaches in drug development; methodological challenges; and payer approaches to evaluation and reimbursement of pharmacodiagnostics in the United States and Europe. It concludes with a look ahead, underscoring current controversies yet to be resolved along with their implications for further research and policy. It is hoped that these articles will help inform the daily challenges faced by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) community as it collectively addresses what promises to be a new era in drug development and health care delivery.
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The preceding articles in this volume have identified and discussed a wide range of methodological and practical issues in the development of personalized medicine. This concluding article uses the resulting insights to identify implications for the economic incentives for evidence generation. It argues that promoting an efficient path to personalized medicine is going to require appropriate incentives for evidence generation including: 1) a greater willingness on the part of payers to accept prices that reflect value; 2) consideration of some form of intellectual property protection (e.g., data exclusivity) for diagnostics to incentivize generation of evidence of clinical utility; 3) realistic expectations around the standards for evidence; and 4) public investment in evidence collection to complement the efforts of payers and manufacturers. It concludes that such incentives could build and maintain a balance among: 1) realistic thresholds for evidence and the need for payers to have confidence in the clinical utility of the drugs and tests they use; 2) payment for value, with prices that ensure cost-effectiveness for health systems; and 3) levels of intellectual property protection for evidence generation that provide a return for those financing research and development, while encouraging competition to produce both better and more efficient tests.
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There is undisputed evidence that personalized medicine, that is, a more precise assessment of which medical intervention might best serve an individual patient on the basis of novel technology, such as molecular profiling, can have a significant impact on clinical outcomes. The field, however, is still new, and the demonstration of improved effectiveness compared with standard of care comes at a cost. How can we be sure that personalized medicine indeed provides a measurable clinical benefit, that we will be able to afford it, and that we can provide adequate access? The risk-benefit evaluation that accompanies each medical decision requires not only good clinical data but also an assessment of cost and infrastructure needed to provide access to technology. ⋯ Health economics and outcomes research (HEOR) emerges as an approach that can satisfy both needs. Although HEOR represents a well-established approach to demonstrate the effectiveness of interventions in many areas of medical practice, few HEOR studies exist in the field of personalized medicine today. It is reasonable to expect that this will change over the next few years.