January 31, 2013 -- A study funded by the European Commission has just concluded that the formula used by the UK’s healthcare cost containment watchdog, the National Institute for Health and Clinical Excellence (NICE), doesn’t work – and in so doing has sparked off a debate on the subject of determining patient access to new therapies.
The study, conducted by the European Consortium on Healthcare Outcomes and Cost-Benefit research (ECHOUTCOME), examined the scientific validity NICE’s formula – Quality Adjusted Life Years (QALY) – and found that it doesn’t reflect real world needs and preferences of patients.
QALY weighs the number of life years and the improvement to quality of life, and is the basis for reimbursement decisions delivered by many health technology assessment (HTA) agencies around the world, including – in addition to NICE – those in Canada and Australia. The metric has, however, been rejected by some HTA bodies, including notably Germany’s IQWiG.
The ECHOUTCOME group’s report on NICE’s methodology comes right out and says that the use of QALY “produce[s] hugely inconsistent, wrong results, on which important [reimbursement] decisions are based.” The report concludes that all four of the assumptions which allegedly support the use of QALY are invalid: (1) that time and quality of life can be measured in consistent intervals; (2) that life years and quality of life are linked; (3) that people are neutral about risk and (4) that willingness to sacrifice life years is constant over time. The head of the ECHOUTCOME study group is quoted by the UK’s Independent as saying that “agencies such as NICE should abandon QALY in favor of other approaches,” and that “European health technology assessment agencies currently looking to adopt the NICE model must seriously reconsider.”
Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, said the study “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.”
RegLink partner Ansis Helmanis points out that “the European debate is timely and should be taken up on this side of the Atlantic as well,” and that “reimbursement gatekeepers here, both public and private, are gearing up for health care reform and are refining the criteria they use – or will be using – to make the same kind of decisions that are being made by European gatekeepers such as NICE. Something flawed yet determinative as to whether patients will or will not get access to a new and possibly life extending therapy should not be used.”
The ECHOUTCOME consortium’s eight entities recommend replacing QALY with a more flexible case by case approach, such as a cost-benefit analysis of how effective a drug is in achieving disease remission or preventing relapse.
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