QALYs, pseudoscience, credibility, imaginary worlds, scientific method
One of the more puzzling features of published claims for cost-effectiveness is the popularity of claims presented in terms of quality adjusted life years (QALYs). Despite the popularity of QALYs as the ‘gold standard’ outcome measures among academic audiences, professional groups and a number of single payer health care systems, there is no evidence to suggest that cost-per-QALY based claims have ever been assessed, either through experimentation or observation, to support formulary decisions. In part this stems from the fact that cost-per-QALY claims are typically not expressed in evaluable terms; it also stems from the fact that, despite the plethora of QALY publications, QALYs are not collected on a regular basis by any health care system as part of administrative claims or electronic medical records. In the US QALYs have typically been ignored by health care decision makers. Given this, the continuing popularity of utility-based measures for studies published in the leading pharmacoeconomics journals is difficult to understand. One possible explanation is that those promoting QALY claims are locked into a relativist position that defends the publication of nontestable product claims. A position that is reinforced by recommendations from ‘peer organizations’ such as the Academy of Managed Care Pharmacy (AMCP) in their promotion of their Format for Formulary Submission standards which support the role of lifetime cost-per-QALY modeled imaginary worlds or thought experiments. Another explanation is that QALYs have been taken at face value with little though given to how they might be implemented to support both initial formulary decisions as well as ongoing disease area therapeutic class reviews. The purpose of this review is to put the case that the continued emphasis on cost-per-QALY claims has no practical benefit in formulary decision making.
Conflict of Interest
Langley PC. Great Expectations: Cost-Utility Models as Decision Criteria. Inov Pharm. 2016;7(2): Article 14. https://pubs.lib.umn.edu/innovations/vol7/iss2/14.