Is it time for NICE to revise its threshold?

“There just isn’t, and never will be, enough money to provide every possible service” – a reminder to participants of the NICE Citizens Council (November 27–29, 2008) as they were asked to consider in what circumstances should NICE recommend interventions where the cost per QALY (quality-adjusted life-year) is above the threshold range of £20–30,000. The Council’s conclusions drew criticism from Alan Maynard, OBE, a professor of health economics.

Professor Peter Littlejohns, clinical and public health director of NICE, offered the reminder as part of the meeting’s introduction. As he noted, NICE was created by the Government in the United Kingdom (UK) in 1999, but was left to develop its own criteria for recommending technologies to the National Health Service (NHS) as well as its own threshold. The £20–30,000 range was set in 2004 and, according to the Council’s report, is divided as follows: “ £20,000 per QALY as the sum below which an effective treatment would normally be accepted; and £30,000 per QALY as the sum above which very good reasons would be needed to gain acceptance. The acceptance of interventions costing between these two figures would be subject to debate.”

During the 3-day meeting, participants considered the myriad factors affecting the decision of whether to maintain the threshold and to recommend a technology, including the certainty of the evidence under consideration, disease severity, avoiding immediate loss of life, averting a public health threat, fostering potentially valuable medical research, treatment of rare diseases, to address need and/or equity, unmet clinical need, the existence of other therapies, whether the technology is a bridge to future therapies, ease of obtaining patient compliance, and whether a technology creates extra costs or benefits outside the health arena, to carers or the wider community (e.g., a reduction in crime due to drug misuse). Overall, the committee voted on 15 circumstances that might prompt a departure from the threshold; the results are shown below.

*An initial vote revealed that two of the 29 Council members felt there were no circumstances in which NICE should depart from the established threshold. These two members took no further part in the voting.

Also according to the report, NICE authorised medicines that lie above the £30,000 threshold on “only four or five occasions”. Deviations from the threshold have received criticism from Prof Maynard, Professor of Health Economics and Director of the York Health Policy Group in the Department of Health Sciences at the University of York, UK (He also noted that he was “involved in establishing NICE” in 1997). Prof Maynard argues that “this decision to ignore the efficiency rule and apply an arbitrary equity value judgment is inherently unfair for those not in the last two years of life.” This unfairness also applies to higher and more generous thresholds for those with rarer conditions. Moreover, he notes the problem of definition – “What is end-of-life? What is a rare disease? Both of these categories are rather ambiguous.”

Despite inflation and increased NHS funding, the NICE threshold has never been changed, according to report. Moreover, not every technology is appraised by NICE and “much decision-making in the NHS, including which treatments to pay for, is still local.” Prof Maynard agrees: “Essentially, we’ve got two rationing mechanisms.”

The Council report will be presented to the NICE Board in May 2009. It is available on-line and is open for comments.