NICE and the Definition of Innovation

What 'innovation' means to NICE--or at least, how it takes innovation into account in its cost-effectiveness assessments--may yet become a little clearer. Tomorrow the National Institute of Clinical Excellence will hold one of its regular public board meetings and item 7 on the agenda is the agency's response to the Ian Kennedy report.

In case you'd forgotten (it was before the summer holidays, after all): Sir Ian Kennedy published a report in July proposing, among other things, how NICE should take into account the 'innovative' nature of medicines. We summarized it here, noting that industry was particularly peeved about Kennedy's support for the controversial QALY measure which NICE uses to judge cost-effectiveness.

Innovation is a tricky one. Kennedy had a shot at defining it, including criteria such as that a drug should 'substantially and significantly improve the way that a current need is met'. NICE argues that it already 'has flexibility in supporting the use of technologies' whose cost-per-QALY exceeds the £30,000 threshold (the cut-off point as to whether a drug will be reimbursed or not), including 'where the intervention is an innovation that adds substantial, distinct and demonstrable benefits that may not have been adequately captured in the measurement of health gain'. The agency also points to recently-introduced guidance which allows it to raise the threshold for treatments which extend life at the end of life (from which several drugs have already benefited) and the even-newer "Innovation Pass" notion foisted upon it by the UK government in its bid to kick-start the sector.

Still, recognizing its role in supporting innovation (and in particular the UK government's fresh call for it to do so), NICE is proposing two measures that, if not exactly radically change the way the agency values and assesses innovation, certainly try to make the process clearer and thus make the agency more accountable.

Firstly, if a company claims its product is 'innovative' and that this confers specific benefits upon it, scoping workshop meetings (prior to assessment) will be used to explore those 'unique characteristics [of the drug or technology] which support this proposition, and the data sources through which the Appraisal Committee will be able to validate it'. In other words, NICE is saying, we'll explicitly lay out, up-front, the company's claim to innovation and how we can validate it.

But clearly, NICE must establish whether a supposedly 'innovative' product in fact has a substantial impact on health-related benefits and improves the way a current need is met (above and beyond best supportive care). Innovation for its own sake isn't much help.

Thus in its second measure, the agency states that where the Appraisal Committee is satisfied that a product represents a 'step change'--noting that it's up to the Committee to decide what 'step change' means--it will have to demonstrate that these innovative characteristics have been taken into account (and, one presumes, how they've been taken into account) in the QALY calculation of health-related quality of life. If they haven't directly been factored into that calculation, the Committee will have to describe how it has evaluated their impact (if at all) on its overall judgment of the drug's cost-effectiveness.

Basically, then, NICE's committees are going to have to better explain themselves and their evaluation processes, and pinpoint how and where they factor in innovative value, rather than just claiming that they do. "We're going to be more systematic in cataloging those [innovative] features and in tracking our assessments of those features through the appraisal process, all the way through to the final guidance," explains NICE's CEO Andrew Dillon.

At the end of the day, though, the exercise isn't going to get any easier. "We have to convert a proposition that a drug or technology is innovative into a measurable assessment of patient benefit," Dillon continues. "We have to unpick the proposition and find out in what way a product's innovativeness can benefit patients. Then we factor that into the value of a drug."

Drug companies, are you paying attention? Don't just go in and say your drug is 'innovative'.

(NICE's proposals, if agreed at the meeting tomorrow, will be open for consultation.)