The UK's National Institute for Health and Clinical Excellence's ("NICE") methodology for evaluating new drugs and making recommendations for or against their adoption is flawed, says the European Consortium in Healthcare Outcomes and Cost Benefit Research ("ECHOUTCOME"), a project of the European Commission.
ECHOUTCOME was established as an interdisciplinary European research platform, with 7 participants (4 from France and 1 each from Belgium, Switzerland and Italy) funded by the European Commission, with the principal objective of producing new European Guidelines for assessing Health Outcomes and conducting Cost-Effectiveness assessments. The objectives specifically reference NICE and its guidelines and the intention behind the establishment of ECHOUTCOME is to assess whether to provide an alternative to, or replacement for, the NICE approach.
NICE's methodology takes into account the value of health effects expressed in Quality-Adjusted Life Years (QALY). ECHOUTCOME project leader Ariel Beresniak, speaking at a conference in Brussels on 25th January 2013, said: "The research provides robust scientific evidence that QALYs produce hugely inconsistent, wrong results, on which important decisions are being made. Agencies such as NICE should abandon QALY in favour of other approaches. European Health Technology Assessment agencies currently looking to adopt the NICE model must seriously reconsider." Gerard Duru, emeritus research director in mathematics at the French National Centre of Scientific Research, added: "The underlying assumptions of the QALY outcome are very theoretical and are not verified in a real population. The QALY indicator is not a valid scientific scale. It is impossible to know what we are measuring, and therefore impossible to base a formula on it."
ECHOUTCOME struck a chord with the Association of the British Pharmaceutical Industry (ABPI), with ABPI Chief Executive Stephen Whitehead saying that ABPI had long argued that a broader and more sensitive approach to measuring value was required and that the current system was not fit for purpose.
NICE denied ECHOUTCOME's criticisms, a spokeswoman saying: "The [ECHOUTCOME] study is rather limited…The QALY is the best measure anyone has come up with…[Our approach] is developing and improving all the time and the criticisms in this, rather limited, study haven't shaken our confidence in its value to NICE."
The technology appraisals programme makes NICE a highly influential actor, not only in the English healthcare market but in the rest of Europe and beyond. Similar methodologies are used in Canada, Australia, Belgium, Portugal and the Nordic countries. Therefore, the consequences of any change in the NICE approach could be profound for both the pharmaceutical and wider healthcare industries. Final ECHOUTCOME recommendations (which are expected later this year) and the reactions from national and other authorities should be studied carefully.