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the use of mapping methods to estimate health state utility values

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Whe<strong>the</strong>r <strong>the</strong> <strong>mapping</strong> approach will <strong>of</strong>fer an advantage over simply using mean <strong>values</strong> from<br />

an external dataset will, in part, depend on <strong>the</strong> structure <strong>of</strong> <strong>the</strong> economic model being <strong>use</strong>d <strong>to</strong><br />

reflect <strong>the</strong> decision problem. If <strong>the</strong> model has a simple structure with few <strong>health</strong> <strong>state</strong>s, <strong>the</strong>n<br />

reliable <strong>estimate</strong>s <strong>of</strong> <strong>the</strong> mean (and variance) <strong>of</strong> <strong>the</strong> EQ-5D <strong>values</strong> associated with those<br />

<strong>health</strong> <strong>state</strong>s may suffice. However where <strong>the</strong>re are multiple predic<strong>to</strong>rs <strong>of</strong> <strong>health</strong> status that<br />

can be measured and reflected in <strong>the</strong> decision-model, <strong>the</strong>n <strong>the</strong> <strong>mapping</strong> approach can predict<br />

<strong>the</strong> <strong>health</strong>-related <strong>utility</strong> value more accurately. For example, if <strong>the</strong> <strong>health</strong> <strong>state</strong>s in a model<br />

are defined according <strong>to</strong> a 20-point measure <strong>of</strong> disease severity, it may not be possible <strong>to</strong><br />

obtain EQ-5D <strong>values</strong> for each <strong>of</strong> those 20 levels <strong>of</strong> severity from a sufficient number <strong>of</strong><br />

patients. However – providing <strong>the</strong>re is a predictable relationship between <strong>the</strong> EQ-5D and <strong>the</strong><br />

severity measure – <strong>the</strong> relationship between <strong>the</strong> measures can be <strong>estimate</strong>d based on all <strong>the</strong><br />

data in order <strong>to</strong> provide EQ-5D <strong>estimate</strong>s for each <strong>of</strong> <strong>the</strong> 20 <strong>health</strong> <strong>state</strong>s. Mapping also<br />

enables <strong>the</strong> <strong>health</strong>-related <strong>utility</strong> data <strong>to</strong> be linked directly back <strong>to</strong> data collected within <strong>the</strong><br />

clinical trial(s) <strong>use</strong>d <strong>to</strong> inform <strong>the</strong> <strong>estimate</strong>s <strong>of</strong> cost effectiveness.<br />

Mapping is most commonly <strong>use</strong>d in NICE submissions where <strong>utility</strong> data have not been<br />

directly collected within <strong>the</strong> clinical trials <strong>of</strong> <strong>the</strong> treatments under consideration. However,<br />

<strong>mapping</strong> techniques can also be <strong>use</strong>d <strong>to</strong> incorporate <strong>utility</strong> data collected directly within <strong>the</strong><br />

main clinical trial <strong>of</strong> interest in<strong>to</strong> economic models, where <strong>the</strong> structure <strong>of</strong> <strong>the</strong> model is driven<br />

by o<strong>the</strong>r outcome measures. An economic model may have been constructed <strong>to</strong> define <strong>health</strong><br />

<strong>state</strong>s using a clinical measure <strong>of</strong> disease severity. In this case, <strong>mapping</strong> techniques can be<br />

<strong>use</strong>d <strong>to</strong> explain <strong>the</strong> relationship between <strong>the</strong> two measures and <strong>to</strong> <strong>estimate</strong> <strong>the</strong> <strong>utility</strong> value (or<br />

distribution <strong>of</strong> <strong>values</strong>) associated with a <strong>health</strong> <strong>state</strong> defined by <strong>the</strong> clinical measure. An<br />

alternative approach would be <strong>to</strong> simply <strong>estimate</strong> <strong>the</strong> mean and variance for each <strong>of</strong> <strong>the</strong><br />

<strong>health</strong> <strong>state</strong>s described by <strong>the</strong> model from <strong>the</strong> data collected. For example, in <strong>the</strong> case <strong>of</strong><br />

treatment for rheuma<strong>to</strong>id arthritis, <strong>the</strong> Health Assessment Questionnaire (HAQ) 6 is a<br />

commonly <strong>use</strong>d measure <strong>of</strong> clinical outcomes. Several studies have sought <strong>to</strong> explain <strong>the</strong><br />

relationship between <strong>health</strong>-related <strong>utility</strong> and HAQ scores using <strong>mapping</strong> type <strong>methods</strong> (see<br />

7 for a recent overview). It is possible <strong>to</strong> <strong>use</strong> this approach even when <strong>utility</strong> data have been<br />

collected directly within <strong>the</strong> primary source/s for clinical effectiveness, as a means <strong>of</strong><br />

incorporating <strong>the</strong> data within <strong>the</strong> economic model. However, concerns have been expressed<br />

when EQ-5D data have been <strong>use</strong>d in this manner in one NICE Technology Appraisal. In this<br />

appraisal concerns were expressed by <strong>the</strong> independent reviewers and Advisory Committee<br />

10

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