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The Great I-QALY Disaster.

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The Quality-Adjusted Life Year (QALY) is fundamentally flawed and should be abandoned. Decades of QALY-based assessments for pharmaceuticals are conceptually and technically incorrect, impacting healthcare decisions.

Keywords:
I-QALYQALY disasterimpossible QALY

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Area of Science:

  • Health Economics
  • Measurement Theory
  • Pharmaceutical Policy

Background:

  • The Quality-Adjusted Life Year (QALY) is a widely used metric for health economic evaluations.
  • QALYs aim to measure the value for money of health interventions.
  • Concerns exist regarding the theoretical underpinnings and practical application of QALYs.

Purpose of the Study:

  • To critically evaluate the conceptual and technical validity of the QALY.
  • To assess the impact of QALY-based decision-making in pharmaceutical product and device value assessment.
  • To advocate for the development of alternative value assessment frameworks.

Main Methods:

  • Theoretical analysis of the QALY construct based on fundamental measurement axioms.
  • Critique of the use of utility scales in QALY calculations.
  • Review of historical application and impact of QALYs in pharmaceutical policy.

Main Results:

  • The QALY construct is shown to be impossible and defies common sense.
  • Utilities, as ordinal scales, are inappropriate for creating QALYs.
  • Thirty years of QALY-based assessments are conceptually and technically flawed, leading to erroneous formulary decisions.

Conclusions:

  • The QALY paradigm is fundamentally unsound and should be abandoned.
  • Past QALY-based assessments represent a significant failure in value assessment.
  • A new framework for value assessment is urgently needed to replace the flawed QALY model.