“Decision-making that saves lives” – a new article published by the ZILLION INTERNATIONAL about the flawed QALY approach revealed through the ECHOUTCOME Project
xx edition 2014
Ariel Beresniak, CEO of Data Mining International SA, warns of the perils of bad calculations in standards used in the health sector. One example is the Quality Adjusted Life Years index (QALY) used in the UK by the National Institute for Health and Care Excellence (NICE) which, according to a study they conducted, is flawed and should be discontinued. The company -with its broad experience in the health sector- helps companies assess their risks, prioritise and make better use of data.
Imagine your life was threatened by a disease. Now imagine that there’s a drug that can save your life but, because of a miscalculation, isn’t approved and you cannot receive it. This frightening reality was exposed by Data Mining International, the independent Swiss company that –through a European Commission research grant– came to the conclusion that the QALY index is a flawedelementintheNationalInstitute for Health and Care Excellence’s decision making process.
During the research project –won by a European research consortium lead by Data Mining International over several highly competitive projects–, they debunked the presumption that health could be expressed with a simple multiplication. Through many robust methods of analysis, the company concluded that the QALY approach did not meet the basic requirements to be considered serious scientific criteria. “The QALY approach is flawed,” says Mr. Beresniak. “We definitely, from a scientific standpoint, should not use QALY in any kind of decision making, much less in one that’s related to human life. We need to propose alternatives,” he warns.
What comes next? Mr. Beresniak warns that the first step after having confirmed the flaw in the calculation is to not use the approach outside the UK and find a better way to express the cost-effectiveness of the drug. “It is not fair for the citizen’s social security to not have access to a drug just because of this flawed approach,” says Mr. Beresniak.
Data Mining International was established in 2004. During its ten year tenure it has garnered experience in offering risk assessment programs to companies so that they may compare different strategies and objectives according to multiple criteria and can rank and assess the risk factor in their operations. Additionally, they offer services in cost-effectiveness evaluation and portfolio prioritisation. “Big companies often undertake many projects at once that require attention and resources. We have developed a unique way to prioritise them using advanced mathematical multi-criteria methods which we adapt, customise and program according to tailor-made solutions,” Mr. Beresniak states.
The full publication revealing the results of the ECHOUTCOME project has been published in September 2014:
Beresniak A, Medina-Lara A, Auray JP, De Wever A, Praet JC, Tarricone R, Torbica A, Dupont D, Lamure M, Duru G. Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project. Pharmacoeconomics. 2014 Sep 18.
Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project.
BACKGROUND: Quality-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 equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity.
OBJECTIVES: The main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making.
METHODS: An experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula.
RESULTS: Observed and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions.
CONCLUSIONS: This European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.