As anticipated, Sir Ian Kennedy's report into whether NICE values innovation appropriately (read: sufficiently broadly to satisfy the industry) has been published. This matters, remember, because NICE's methodologies, priorities and direction are and will continue to be followed by other markets.You can read it here, and we'll have more to say on it shortly (and would love to hear your views, too). Briefly, though (there are 25 recommendations): the Quality Adjusted Life Year (QALY) measure that NICE currently uses should remain, says the report, but that doesn't end the debate, far from it. NICE should commission research to determine whether--and how--social and other benefits a drug may bring could form part of its approach. (Isn't that just passing on the problem, somewhat? Ok, so we haven't had time, what with GSK's results 'n all that, to study this fully....)
Likewise, it's up to NICE to formulate a definition of 'innovation' (admittedly tough), but the report suggests incentives to promote innovation, stating (to industry's undoubted delight) that:
"....a higher price could be accepted for some patients or indications, or even across the board, taking the cost-effectiveness of the product beyond the normal threshold. There could be an agreed higher threshold, determined by NICE. The price could then be maintained for a set period of time, eg 3-5 years, after which it must be adjusted to bring the product within the normal threshold. NICE could achieve this by establishing a special protocol for innovation. Or, NICE could undertake the appraisal using one of the new schemes established through the recent revision of the Pharmaceutical Prices Regulation Scheme, the "flexible pricing" scheme, or the "patient access" scheme."
Read this to swot up on the PPRS and flexible pricing schemes, and stay tuned....
Having worked globally in the health economics field for over 20 years I can state without equivocation that the QALY is one of the most useless outcome measures I have ever seen. While it may provide guidance at the societal level of the relative "worth" of a technology, it has virtually no meaning in decision-making at the payer or provider levels. Due to a lack of standardized measurement comparisons across technologies are virtually useless and its lack of consideration of budget constraints/realities is a further limitation.
ReplyDeleteWhile the QALY is somewhat interesting from an academic perspective it should never have found its way into countries' review processes.