Washington, D.C. (PRWEB) January 31, 2013
RegLink News, in its monitoring of developments at regulatory and health technology assessment (HTA) agencies around the world, is accustomed to reporting on decisions as to coverage or not of new drugs and medical devices. This week’s HTA news has significance well beyond a particular product: 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 co
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