"Reports of the institution's death have been greatly exaggerated," declared NICE chief executive Andrew Dillon at the FT Pharmaceutical and Biotechnology Conference in London today. Of course, it's clear from the cost-watchdog's latest spate of assessments that NICE is still going strong today.
Dillon's invocation of Twain refers to the fate of NICE post-2013, when a new value-based pricing system in the UK will necessarily change the institute's role. Lord Howe, Parliamentary Under Secretary of State in the Department of Health, recently declared that NICE's decisions on whether a new medicine should be reimbursed by the National Health Service will be "somewhat redundant". That's what prompted the death reports.
Ok, so they weren't really death reports, they were "NICE will soon have significantly less sharp teeth" reports.
And we stand by them (ours, anyway). No-one (not even Dillon) knows precisely what NICE's role will be in the UK's new value-based vision of health care provision, since the government's consultation report isn't out yet. (It's due before year-end, though, so watch this space).
Still, "what I do know is that NICE will continue to assess clinical and cost-effectiveness of new pharmaceuticals," Dillon explained. "But it seems we won't be asked to formally recommend, in the terms we have used to date, how a new drug should be used" (in other words, whether it is reimbursed or not).
So NICE's cost-effectiveness assessments of individual drugs, while still likely to happen, won't lead to stark 'yes' or 'no' recommendations. Instead, "we will articulate the outcome of our assessment in a way that makes clear the optimal use of the product," Dillon explained.
NICE will still express the output of its assessment in terms of cost-per-QALY (quality-adjusted life year), or in terms of a cost-per-QALY range, Dillon clarified to your blogger later. "But we will not be asked to say whether this cost-per-QALY is acceptable or not, as we do now."
Bye-bye the controversial £30,000 cost-per-QALY threshold for determining whether a drug will get reimbursement, in other words (although NICE tends to deny that such a cut-off exists anyway). That's the crux of it. That's the trigger for the death reports.
Instead, Dillon continued, "someone else" will decide whether that cost-per-QALY is acceptable or not, "since the drug price will be driven by someone else in the system," he continues, pointing to the UK's forthcoming value-based pricing set-up. Details of who or what that someone else is, and how they decide whether and how a new drug should be used, remain to be agreed. Formal discussions between industry and the department of health are due to begin next year.
ABPI director general Richard Barker is confident that these talks "won't be too protracted", and speaks positively about a "collaborative approach" where industry has a real say.
It seems unlikely, though, that it will be NICE which takes into account in its assessments the broader factors – including societal impact, treatment support & carer costs – which are to be included in the UK government's vision of value-based pricing and a health care system defined by "value-based pathways", as the catch-phrase appears to be.
Instead NICE will probably do broadly what it did before – and will do so in an equally transparently and consultative fashion, emphasized Dillon – but that this will be just one ingredient that's put into a bigger, as-yet-to-be-defined 'value-based' machine that will determine product usage. "I don't know for sure, though," qualified Dillon (although he did add that there are few if any concrete measures used, to date, to quantify the broader societal benefits of a particular drug…).
More important to Dillon right now is ensuring that his empire does remain a key influence on health care provision. "I want NICE to provide a point of reference on how an intervention should be used," he says."This is very important, and I expect will be expressed in the government's consultation document."
Being a 'point of reference' is somewhat different to being a key decider, as NICE is now.
So from industry's perspective, things probably look good, as far as NICE is concerned. Barker says he doesn't really care at what point these broader, less easily quantifiable elements are blended into decisions on drug usage – whether it happens within the NICE process or afterward. "We're not hung up on what institution does it." As long as it's in there, making it less likely that his members' innovative drugs are tripped up at the starting line.
OK then, NICE isn't dying. In fact it's taking on a broader remit; from 2012 NICE will look at social care, too, as well as maintaining and developing role in promoting optimal public health via general treatment guidelines. "This is a real opportunity for NICE to re-invent itself," and to make sure health care provision is value-focused and outcomes-focused, and to ensure it adequately encompasses social care, too, insists Dillon.
A NICE with a broader remit is a NICE that's spread thinner, though, with less weight in specific areas – like single drug reimbursement assessments.
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