The way the UK decides what medical treatments are available on the NHS is “dangerously flawed and should be abandoned”, a European Commission-funded report says.

The 1 million euro, three-year project, which has been published today, highlights what it sees as “huge failings” in the way bodies such as NICE recommend which treatments are made available on health services.

Specifically the report, which was created by a consortium of six European universities and research agencies and Bristol-Myers Squibb, warns against the use of QALY – or quality adjusted life years formula - which mathematically weighs the number of life years and the improvement to quality of life provided by different treatments.

It says that QALY is flawed in a number of ways and warns against this system being adopted across Europe.

These flaws include the fact that quality of life is personal and different people rank different conditions as having a greater or worse impact, something not taken into consideration by QALY.

The researchers also say that life years and quality of life are linked. This assumes that someone who prefers ten years of healthy life to five years, will also prefer ten years in a wheelchair to five years, but the results showed that this does not reflect how real people feel.

The consortium used a questionnaire designed by medical and economics experts and carried out by trained interviewers to test the assumptions.

The responses varied enormously across the population showing that the way people rate different medical outcomes is personal, and cannot be summed up by a neat formula, according to the authors. The project concludes that QALY is “an invalid way to make medical decisions” and should be replaced by a more flexible, case by case approach.

Instead of QALY, they offer a more pragmatic method, and suggest using a cost-per-remission approach for drugs targeting rheumatoid arthritis as an example, which could then be issued along with guidance as to when a patient can be granted the drug.

The authors say that this is “a clear, scientifically robust assessment as remission rate can be defined and cost calculated simply and quickly”.

In fact the authors, which include BMS, point to the firm’s arthritis drug Orencia, as a drug which could benefit under their suggested system. NICE gave a limited recommendation for the medicine last year, and is currently consulting on whether this should be extended.

Gerard Duru, emeritus research director in mathematics at the French National Centre of Scientific Research said: “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 upon it. To be able to trust this formula, all four of these assumptions must be validated. If they aren’t we don’t have the right to use it.”

Ariel Beresniak, chief executive of Data Mining International and project leader for the report, said: “Agencies such as NICE should abandon QALY in favour of other approaches. European HTAs currently looking to adopt the NICE model must seriously reconsider.”

QALY defence

QALY is a well-respected formula around the world and among health economists, and has been used successfully in the UK since NICE’s inception in 1999.

A spokesperson for NICE told PharmaTimes UK news: “Economists will argue about the precision of the QALY methods and it’s not perfect. But it’s based on solid research and 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 in 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.”

This project also comes at a time when the UK Government is discussing possibly dropping QALY as a method of assessing drugs’ cost effectiveness, and instead replacing this with a new definition of value, under a value-based pricing scheme.

The UK pharma industry is against this and are hoping for QALY and NICE to remain, but would like additional weighting given to QALY, such as allowing some more expensive drugs through if they can prove wider societal benefits, or help in ways not currently valued under QALY.

In a statement to PharmaTimes UK news, the ABPI’s chief executive, Stephen Whitehead, said: “This research shows why NICE so often delivers conclusions that are out of step with other bodies and can undermine clinical work in the UK and most importantly deny UK patients in need, access to new and proven treatments. This is clearly a flawed approach that can produce damaging decisions. We are working closely and urgently with NICE to look at these problems to ensure guidance that is issued truly values patient centric innovation.

“The research also demonstrates why it is so important that we get on with the job of developing value based pricing within a framework which provides stability and predictability for the NHS and industry as well as – most importantly – access to the most effective medicines for patients.”