Measurement, modeling and QALYs.

Over the past 30 years, a mainstay of health technology assessment has been the creation of modeled incremental cost-per-quality adjusted life year (QALY) claims. These are intended to inform resource allocation decisions. Unfortunately, the reliance on the construction of QALYs from generic utility scales is misplaced. Those advocating QALY-based lifetime modeled claims fail to appreciate the limitations placed on these constructs by the axioms of fundamental measurement. Utility scales, such as those created by the EQ-5D-3L instrument, are nothing more than multidimensional, ordinal scales. Such scales cannot support basic arithmetic operations. Interval scales can support addition and subtraction; ratio scales the further operations of multiplication and division. Those who advocate the construction of QALYs fail to appreciate that such an operation is only possible if the utility scale is unidimensional and has ratio properties with a true zero. The utility measures available do not meet these requirements. As we cannot produce meaningful utility values, the QALY is an invalid construct. Consequently, cost-per-incremental QALY claims are impossible to sustain and the application of cost-per QALY thresholds meaningless. As utility is a latent, unidimensional variable, the best a measure of utility could achieve would be unidimensionality and interval scaling properties. Where such measures are available, they could support claims for response to therapy. Consequently, there would be no need to continue constructing imaginary lifetime value assessment frameworks. Admitting that the QALY is a fatally flawed construct means rejecting 30 years of cost-per-QALY models.