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Feng, Xiaodong_ Xie, Hong-Guang - Applying pharmacogenomics in therapeutics-CRC Press (2016)

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Pharmacoeconomics of Pharmacogenomics

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efficacy and safety, which results in substantial economic savings by decreasing

costs associated with therapy failure or drug toxicity to be avoided by genotyping,

PGx cannot be assumed to be cost-effective if any economic evaluation is not

available for a certain PGx intervention. To determine whether PGx technologies

or interventions are implemented in a cost-effective manner, all costs and benefits

resulting from a PGx intervention should be properly evaluated according to the

basic principles and practice of pharmacoeconomics. 5,7–10 In this chapter, a novel

term— pharmacoeconogenomics—is coined to better describe the marriage of pharmacoeconomics

and PGx in patient care. In other words, pharmacoeconogenomics

is the study of economic evaluation of PGx interventions. Through this chapter, the

readers can better follow the basic principles of pharmacoeconomics and some welldefined

examples in the PGx research field, and further understand how the PGx

component is incorporated into pharmacoeconomics, and why not all patients benefit

more from a cost-effective perspective, using only genotype-guided medications.

PRINCIPLES OF PHARMACOECONOGENOMICS

The term cost is defined as the value of resource input relative to “charge,” which

is the amount charged to the payer. The direct costs refer to all costs where funds

are paid out as a consequence of the intervention, whereas indirect costs refer to all

other costs not categorized as direct costs. On the other hand, healthcare outcomes or

outputs of these costs are measured in different ways in pharmacoeconomic evaluation,

such as cost per quality-adjusted life years (QALY) gained, quality of lifeadjusted

life expectancy, the number and severity of medical events, the number

of deaths averted, or the costs saved by prevention of hospitalization of a patient

with adverse drug reaction events after use of an alternative medication or another

intervention, and so on. Therefore, measurement and assessment of the outcomes

produced by the resource inputs is the key for a pharmacoeconomic study—in particular,

PGx-based strategies. 11

PGx is the study of how genetic differences affect variation in response to medication,

and thus testing of a patient’s genetic make-up has the potential to predict

intended or undesired responses to the medication in patient care. How such tests

can best be performed and applied in a cost-effective way is the key to guide an economic

evaluation of PGx testing in clinical settings. Therefore, the major principles

and methodologies of pharmacoeconomic analyses are also applied to relevant PGx

studies.

Cost-Effectiveness Analysis

Cost-effectiveness analysis (CEA) is a widely used tool to measure and assess the

value of new healthcare interventions relative to empiric or current conventional

therapy with standard dosing, and also a quantitative method to systematically

compare the costs and healthcare outcomes of competing healthcare technologies

or interventions. By definition, CEA can use various outcomes, including

clinical events or life years saved. In fact, CEA is a specific type of economic

evaluation that measures costs in relation to all types of the outcomes gained,

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