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APHA Scientific Session and Event Listing

Julie N. Harris, MPH¹, David L. Veenstra, PhD, PharmD², Grace Wang, MPH¹, and Carolyn Watts, PhD³. (1) Institute for Public Health Genetics, University of Washington, Box 357236, Seattle, WA 98195, 1 206 667-6339, harrisjn@u.washington.edu, (2) Department of Pharmacy, University of Washington, Box 357630, Seattle, WA 98195, (3) Department of Health Services, University of Washington, Box 357660, Seattle, WA 98195

Cystic Fibrosis (CF) is one of the most common genetic disorders among people of European descent. An estimated 1 in 25 European-Americans is a carrier of the disease. CF affects 1 in 3500 live births in the US, and 1000 individuals are newly diagnosed each year. Among the principle manifestations of this disease are severe and recurrent pulmonary infections. In the 1960's, childhood mortality from CF was extremely high. Currently, the median life expectancy of individuals with CF is approximately 33 years, in large measure the result of the development of effective drugs (primarily aminoglycosides) to treat these infections. Aminoglycoside use, however, has been associated with a risk of hearing loss. Recently, a genetic marker has been evaluated that may identify patients at higher risk of aminoglycoside-induced hearing loss. While there is some disagreement regarding the severity of the hearing loss, it appears that even a low level of drug exposure can cause hearing loss in those with the genetic marker. Athena™ has developed a pharmocogenomic test designed to identify individuals with this susceptibility, allowing the consideration of alternative therapy. We previously reported the results of a cost-effectiveness analysis (CEA) of this test. The current study examines a variety of policy issues that arise when the results of the CEA are considered in policy decision making. The CEA indicates, based on the best available evidence, a cost of quality adjusted life year (QALY) saved at the margin of what is generally considered reasonable ($50,000). However, the available evidence is both sparse and of modest robustness. Sensitivity analyses on key parameters indicate high sensitivity to varying assumptions and parameter values that generally increase the cost of a QALY. The marginal results of this CEA provide fertile ground for exploring a number of key policy questions. What threshold of evidence should there be for clinical use of such a test? The cost of the test is moderate ($250); what should the threshold for cost-effectiveness evidence be for reimbursement? Should the threshold vary according to whether public or private dollars are used to pay for the test? How will various stakeholder groups view and/or use the results of the CEA? Is the model useful in determining the appropriate policy response to direct to provider or direct to consumer advertising of the test? We will briefly describe the CEA model and its results, and then discuss these questions in the context of our findings.

Learning Objectives: At the conclusion of this session, participants will be able to

• articulate the choices created by the genetic test
• discuss the relevant costs and benefits of these choices
• apply the principles presented in the policy discussion to other emerging technologies

Keywords: Genetics, Policy/Policy Development

Related Web page: depts.washington.edu/genpol

Presenting author's disclosure statement:

Not Answered