The use of pharmacogenetic testing in clinical practice is limited thus far. A potential barrier to the widespread implementation of pharmacogenetic testing is the lack of evidence on whether testing provides good value for money. The objective of this review was to provide a systematic and critical review of economic evaluations of pharmacogenetic testing. A literature search using publically available databases was performed for articles published up to October 2009. To be included, studies had to meet the definition of being a pharmacogenomic study (defined as use of information on human genetic variation to target drug therapy) and an economic evaluation (defined as an evaluation of both costs and clinical outcomes). Articles that met these criteria were subsequently reviewed and graded using the Quality of Health Economic Studies (QHES) instrument. Lastly, the evidence for biomarker validity and utility were qualitatively assessed using expert opinion. A total of 34 articles were identified using our defined criteria. The most common disease category was thromboembolic-related diseases (26%), while the most common biomarkers were thiopurine methyltransferase and cytochrome P450 2C9 (18% each). Almost all studies were published after 2004 (91%). Two types of studies were identified: cost-effectiveness studies and cost-utility studies, with roughly half of the overall studies being cost-utility studies (53%) and a majority of these published within the last 3 years. The average quality score was 77 (range 29-99). Of the biomarkers reviewed, it was estimated that most had demonstrated clinical validity, but only two had demonstrated clinical utility. Despite a recent increase in the number of economic evaluations of pharmacogenetic applications, further studies examining the clinical validity and utility of these biomarkers are needed to support cost-effectiveness assessments.
Objective The objective of this study was to evaluate the feasibility and outcomes of incorporating value of information (VOI) analysis into a stakeholder-driven research prioritization process in a US-based setting. Methods Within a program to prioritize comparative effectiveness research areas in cancer genomics, over a period of 7 months, we developed decision-analytic models and calculated upper-bound VOI estimates for three previously selected genomic tests. Thirteen stakeholders representing patient advocates, payers, test developers, regulators, policy-makers, and community-based oncologists ranked the tests before and after receiving VOI results. The stakeholders were surveyed about the usefulness and impact of the VOI findings. Results The estimated upper-bound VOI ranged from $33M to $2.8 billion for the three research areas. Seven stakeholders indicated the results modified their rankings, nine stated VOI data was useful, and all indicated they would support its use in future prioritization processes. Some stakeholders indicated expected value of sampled information might be the preferred choice when evaluating specific study designs. Limitations Our study was limited by the size and the potential for selection bias in the composition of the external stakeholder group, lack of a randomized design to assess effect of VOI data on rankings, and the use of expected value of perfect information versus expected value of sample information methods. Conclusions Value of information analyses may have a meaningful role in research topic prioritization for comparative effectiveness research in the US, particularly when large differences in VOI across topic areas are identified. Additional research is needed to facilitate the use of more complex value of information analyses in this setting.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.