Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project

  title={Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project},
  author={Ariel Beresniak and Antonieta Medina-Lara and J. P. Auray and Alain De Wever and J C Praet and Rosanna Tarricone and Aleksandra Torbica and Danielle Dupont and Michel P. Lamure and G{\'e}rard Duru},
BackgroundQuality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as ‘cost-effectiveness analyses’. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about… 

Is there an alternative to quality-adjusted life years for supporting healthcare decision making?

  • A. BeresniakD. Dupont
  • Political Science, Medicine
    Expert review of pharmacoeconomics & outcomes research
  • 2016
This review presents a selection of robust alternative methodologies that could be used to support HTA decisions more accurately and more fairly than using the QALYs, including for determining the level of patient access and reimbursement coverage to healthcare interventions.

Great Expectations: Cost-Utility Models as Decision Criteria

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.

An overview of the time trade-off method: concept, foundation, and the evaluation of distorting factors in putting a value on health

It is concluded that the TTO may be a pragmatic method of eliciting health state values, but the limitations in regard to measurement theory and practical elicitation problems makes it prone to inconsistencies and arbitrariness.

Health-state utility estimates for health technology assessment: a review of the manufacturers’ submissions to the French National Authority for Health

Conclusions: Numerous concerns are identified in the selection, valuation and use of HSU, as well as a frequent lack of clarity in the methods used.

Measurement, modeling and QALYs

Admitting that the QALY is a fatally flawed construct means rejecting 30 years of cost-per-QALY models and there would be no need to continue constructing imaginary lifetime value assessment frameworks.

Measurement , modeling and QALYs [ version 1 ; peer review : 1 approved ]

Admitting that the QALY is a fatally flawed construct means rejecting 30 years of cost-per-QALY models and there would be no need to continue constructing imaginary lifetime value assessment frameworks.

Imaginary Worlds and Efficiency Frontiers: Should We Abandon the IQWiG Health Technology Assessment Model?

The commentary concludes that the efficiency frontier framework for health technology assessment, in supporting the creation of non-evaluable claims from models or simulations, fails of to meet the standards of normal science: it fails to support claims that are credible, evaluable and replicable.

Determining Value in Health Technology Assessment: Stay the Course or Tack Away?

Alternative courses involving expansion of the measure of benefit or adjusting the threshold have been proposed and some have advocated tacking away from the cost per QALY entirely to implement therapeutic area-specific efficiency frontiers, multicriteria decision analysis or other approaches that keep the dimensions of benefit distinct and value them separately.

HAS Should Not Be NICE: Rejecting Imaginary Worlds in the French Technology Assessment Guidelines

The recommendation is that HAS should put to one side mandating lifetime cost-per-quality adjusted life year (QALY) or life years saved claims in favor of short-term claims that can be evaluated and reported to health system decision makers as part of a provisional assessment of new products as well as supporting ongoing disease area and therapeutic class reviews.

[Controversies around QALYs].

The paper summarizes the criticisms of the QALY concept utilization in health-economic evaluations that has been growing stronger in the last years and investigates whether the critical arguments summarized will lead to a development of alternative tools that have a potential of eliminating imperfections in QALys, and consequently provide more complex data for the decision process.



What next for QALYs?

The QALY provides a convenient yardstick for measuring and comparing health effects of varied interventions across diverse diseases and conditions and serves as a rough benchmark for health gains and as one of several inputs into decisions.

Limitations of the Methods Used for Calculating Quality-Adjusted Life-Year Values

The techniques used as a basis from which to calculate quality-adjusted life-year values are flawed and the underlying assumptions of the multiattribute utility model do not correspond to behaviour patterns observed in a real population, suggesting use of the QALY technique should be questioned in healthcare decision-making settings.

Retaining, and enhancing, the QALY.

The enthusiasm with which analysts fromacademia and contract research organizations embrace the QALY in economic evaluations is evident from a quick review of the leading health policy evaluation journals or the roster of presen-tations at any recent ISPOR Annual International Meeting.

Advantages and limitations of utility assessment methods in rheumatoid arthritis.

Real cost-effectiveness analyses based on observed clinical outcomes appear to be more robust and reliable to assist decision-making, particularly in the context of RA.

QALYs: are they helpful to decision makers?

The QALY is not sufficiently accurate or reliable to be used by decision makers as a basis for comparison of the costs of different technologies, and it is necessary to estimate the cost effectiveness of health interventions by relating their cost to their primary health outcomes.

Preference-based measures in economic evaluation in health care.

Although cost-utility analyses have become more popular recently, many challenges remain for the field and widespread acceptance of the methodology likely awaits more consensus on measurement techniques, as well as educational efforts in the public health and medical communities on the usefulness of the approach.

Variation in the Estimation of Quality‐adjusted Life‐years by Different Preference‐based Instruments

Although results moderately support the idea that the three tools are measuring a similar underlying construct, the tools are not interchangeable because they are scaled differently and produce varying results.

Multiple criteria decision analysis for health technology assessment.

  • P. ThokalaA. Duenas
  • Medicine, Political Science
    Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
  • 2012

A note on the nature of utility in time and health and implications for cost utility analysis.

The Ranking Properties of Healthy-Years Equivalents and Quality-Adjusted Life-Years Under Certainty and Uncertainty

  • M. Johannesson
  • Medicine, Political Science
    International Journal of Technology Assessment in Health Care
  • 1995
This paper investigates the theoretical properties of healthy-years equivalents (HYEs) and quality-adjusted life-years (QALYs) and finds that in the case of certainty, HYEs always rank health profiles according to individual preferences, whereas QALys only rank health profile according to Individual preferences if constant proportional trade-off holds for all health states and if additive independence of quality in different periods holds.