Have a NICE Day: Look out for Report on Value-Assessment

Keep your eyes peeled for item number 6 on the agenda for NICE’s AGM, which kicks off today at 2pm BST. It’s “to receive Sir Ian Kennedy’s report: ‘Appraising the value of innovation & other benefits—a short study for NICE.’

A short study for NICE—that makes it sound rather friendly, doesn’t it, as if Sir Ian Kennedy (professor of health law, ethics and policy of University College London) was doing the agency a favor. Maybe he is. After all, it was NICE which commissioned this ‘independent study’ into the red-hot question of how it assesses value, and whether its methodologies take into account a sufficiently broad definition thereof, back in January.

But it did so mostly because it had to—in response to an industry report calling for an enquiry to assess the long-term impact of NICE on drug cost and uptake in the UK. Behind that: plenty of drug firms frustrated at the narrowness of NICE’s current parameter for measuring cost-effectiveness, the QALY (quality-adjusted life year). This represents the estimated additional cost of one year of healthy life, for one person, when comparing a new drug with current standard practice.

Industry argues that the QALY is overly quantitative and fails to take into account wider benefits to society that a product may offer, such as making life easier for caregivers and employers, and further, to the industry's contribution to the UK economy and to innovation. "Too much calculation, and not enough judgment," was how David Fisher, commercial director of UK industry association the ABPI, put it earlier this year. (See this IN VIVO feature for the full NICE treatment.)

We’ll soon find out whether Sir Kennedy agrees—the NICE press office promises that the report will go up onto its website at 2pm.

Meantime, though, NICE isn’t apparently planning to change the current £20-30k cost-effectiveness threshold that it uses to make its go/no-go decisions, according to agenda item 8. The report of an April 2009 workshop to discuss the issue (triggered as a response to concerns expressed by the Health Select Committee) concludes that “on the basis of the current information it would be inappropriate for the Institute to change its current threshold range.”

Ok then. But there are instances where that threshold is ignored or, shall we say, stretched anyway. Like under the end-of-life guidance, issued late last year, which relaxes the cost-effectiveness criteria for drugs licensed for terminal illnesses affecting fewer than 7,000 patients per year. Several drugs, including Celgene’s Revlimid, have apparently already benefited from this loophole (as critics on the NHS/ payor side would call it). And yes, an update report on the application of this guidance is agenda item number 7 at today’s AGM.

Even after just four months of implementation, this supplementary guidance has raised several significant questions. Does the size of the population a drug treats refer to that across all indications, or only that under review? What happens to existing guidance if a drug receives subsequent additional marketing approval? What if two similar drugs are reviewed using this guidance a short time apart—would the first go through and the second be rejected, based on a an ‘alternative treatment’ being available? How should we measure a treatment’s survival gain, using mean or median survival? Should we take into account quality-of-life benefits during that time?

It’ll be a busy day for NICE’s board, after what CEO Andrew Dillon calls in his report “one of the most challenging years the Institute has experienced.”

The action’s likely to continue given NICE’s growing influence on pricing, its role in implementing the new ‘Innovation Pass’ announced earlier this month, the various additional consulting and advisory services it has set up, and ongoing pledges to increase transparency and accountability.