The Spanish Ministry of Health recently rejected the use of QALYs in cost-effectiveness analyses. At issue is the subjective nature of the parameters used to develop the QALY. The Quality-Adjusted Life-Years (QALY) is a product of the change in utilities associated with a treatment multiplied by the time of treatment exposure. The QALYs gained combined with costs (cost/QALY) enable the comparison of treatment effects within and across therapeutic areas. For example, living one year in a health state of utility 0.7 is equivalent to 0.7 QALYs.
Spain joins other countries that reject the use of QALYs - Germany, Norway, and the USA. Criticism is leveled against the subjective evaluation of utilities. Life-years gained by healthy individuals are valuable more than life-years gained among chronically ill patients. Furthermore, the multiplicative model used to derive QALYs (mixing interval scales with ratio scales) generates inappropriate numbers for QALYs gained.
While the list grows of high-income countries banning the use of QALYs, governments in middle-income countries are eager to legislate the use of QALYs through mandatory pharmacoeconomic guidelines. The Brazilian guidelines prioritize the use of QALYs in cost-utility analyses, and the South African guidelines require benefits in a cost-utility analysis reported in QALYs. Some Middle East countries are also looking to include the QALY in draft pharmacoeconomic guidelines.
Are communities in middle-income countries best served by QALYs? In other words, will the use of QALYs alleviate or exacerbate resource constraints in middle-income countries? The QALY may provide decision-makers a sense of comfort facilitated by an “objective” measure to guide decision-making. However, behind this veil of objectivity is a methodologically flawed tool that either requires improvement or substitution with a better measure.