The quality-adjusted life year (QALY) is over 50 years old.1 Debate about the ethical basis for the QALY and its use in cost-effectiveness analysis (CEA) and policy decision making are almost as old(for example, see Harris,2 Rawles,3 and responses from Mooney,4 and Williams5). These (and other) early articles are worth rereading. Few of the arguments for or against the use of QALYs are new, although the rhetoric and policy discourse have evolved. Ongoing debates around the QALY run the gamut from technical methods issues, such as how best to establish health-related quality of life (HRQoL) values, to policy implications, such as how the cost/QALY threshold should be determined. At the center of the debate the fundamental question about whether the QALY itself is a valid measure persists.
Criticisms of QALYs and their use in CEA have gained momentum again, particularly in the United States, where anti-QALY lobbying by the pharmaceutical industry and opposition to the use of QALYs by patient groups has placed political pressure on legislators. Therefore, the use of QALYs, or similar measures, in decisions concerning Medicare coverage and reimbursement is legislatively forbidden.6 Proposed legislation would expand this to place a ban on QALYs “and other similar discriminatory measures” in all federal programs.7