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.
RegLink Associates, LLC is an online publisher of two e-weekly Global Updates that provide a round-up of the previous week’s regulatory, clinical, reimbursement, commercial and health technology assessment developments worldwide. Its Global Drugs and Biologics Update and Global Medical Device Update aggregate the “What’s New” from major markets around the world by country, region and topic with links to source documents and brief translation of
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