29 January 2013

Experts Dismiss Claims NHS Drug Decisions are "Flawed"

Leading experts have dismissed claims that the formula used by NICE to recommend which drugs are funded on the NHS is “flawed” and say that it is still the best available method for assessing drugs.

A European Commission-funded study says that the method used by NICE called quality-adjusted life years (QALY) for assessing the value of new drug treatments does not reflect variations in views on illness and disability.

QALYs look at the cost of using a drug for a year and weighs it against how much someone's life can be extended and improved. Generally, if a treatment costs more than £20,000-30,000 per QALY, it would not be recommended as cost-effective by NICE.

The findings of the study - which involved surveying 1,300 respondents in Belgium, France, Italy and the UK about the QALY - are being presented today at a conference in Brussels on health outcomes in Europe.

Lead researcher Dr Ariel Beresniak, of Data Mining International, an independent research agency specialised in advanced statistics and modelling in the field of health,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 HTAs currently looking to adopt the NICE model must seriously reconsider.”

But Sir Andrew Dillon, Chief Executive of NICE, said: “When we want to find out whether a new treatment provides more for patients than current practice and whether any improvement, in quality or length of life justifies the price the NHS is asked to pay for it, we need to use a measure that can be applied fairly across all diseases and conditions. The QALY is the best measure anyone has yet devised to enable us to do this.

“Economist will argue about the precision of the QALY methods and it's not perfect. But it's based on solid research and a uses a way of measuring how quality of life changes when using different treatments which is the best we have available.

“It's developing and improving all the time and the criticisms in this, rather limited study haven't shaken our confidence in its value to NICE is helping make decisions on the best way to use new and sometimes very expensive drugs and other health technologies.

“QALYs only help to inform decisions about what the NHS should provide. The final decisions are taken by people who work in the NHS, informed by the views of patients, manufacturers and academics.”

Professor Sheila Bird, Programme Leader at the Medical Research Council Biostatistics Unit, University of Cambridge, said: “The UK's decisions on cost-effectiveness, for example by NICE, are indeed informed by valuations on quality and length of life. These valuations were drawn up through a carefully-designed survey in 1993 of 3,395 interviewees from representatively sampled 5,324 UK addresses.

“This was a major undertaking by health economists at York University, and is relied upon still. Other nations, such as Canada, have copied the UK's methodology to develop their own national valuations.

“However, the contrast is stark between how well these valuations were originally obtained and the description of how eccentrically 1,300 respondents - across several nations - were approached: not to elicit valuations, except for mobility, but to inquire about how risk averse they are.”

Professor David Spiegelhalter, Winton Professor of The Public Understanding of Risk, University of Cambridge, said: “These type of criticisms are not new and do not invalidate what is done by NICE. Of course the QALY approach is not perfect, but some mechanism is needed to provide consistent comparisons across different medical interventions, based on aggregate benefit and cost. Otherwise the money could go to those with the most appealing emotional argument."

Professor John Cairns, Professor of Health Economics, London School of Hygiene and Tropical Medicine, and a member of the NICE Appraisal Committee for ten years, added: “Given limited budgets we do need to compare different treatments for different diseases because agreeing to spend more on a particular treatment for a particular disease implies that there will be less available to spend on other diseases.

“We need to be able to compare what we gain by spending in one area with what we lose by not spending in another area. This new project's suggested approach of using measures of outcome specific to particular diseases will not allow us to do that.

“QALYs are certainly not perfect and we should be looking for better ways of informing decision making but getting rid of an imperfect system without replacing it with a better one is not the way forward.”