The task of establishing the cost-effectiveness threshold which decides whether a medicine or treatment should be made available on the UK National Health Service needs to be taken away from the National Institute for Health and Clinical Excellence (NICE) and given to an independent review panel similar to the Bank of England’s monetary review committee, Members of Parliament have been told by two leading health economists.
Operating at arm’s length from NICE, this Threshold Review Committee would allow the Institute to focus on the task of assessing evidence and effectiveness and implementing the threshold through its judgments, Nancy Devlin and John Appleby, both of the City University and the King’s Fund, told the House of Commons Health Select Committee last week.
Professors Devlin and Appleby pointed out that NICE is still using the cost-effectiveness threshold range of £20,000-£30,000 per quality of life-adjusted years (QALYs) which was established back in 1999. Changes since then include an almost 90% increase in the real NHS budget, they said, and to keep up with the increase in health sector inflation in the last eight years, the range should now be £28,000-£42,000. However, they also stressed that they were not calling for the threshold to be raised, but rather pointing to the “utter implausibility” that the range now can be the same as it was in 1999.
In any case, the threshold has no basis in underlying evidence, they told MPs; there are no grounds for asserting that it is consistent with the NHS budget, resources allocation decisions being made in the health system or the value which society places on increases in length or quality of life.
The Threshold Review Committee proposed by Professors Devlin and Appleby could consider the evidence base relevant to the threshold, issue clear statements about it and be responsible for annually reviewing it for relevant changes in inflation, budgets, societal values, etc, they suggested.
Moreover, this issue cannot be resolved once and for all, but will necessarily be a matter for ongoing review into the future, they emphasised.
Neverthless, Profs Devlin and Appleby told the panel that, while there are still areas where its processes might be strengthened, NICE’s achievements mean the NHS is now a world leader in public decision-making about new health care technologies. Its appraisal process is rigorous and its decision-making processes are considerably more transparent and “public” than most similar bodies internationally, they noted.
However, the MPs also heard claims from industry and patient group representatives that NICE is over-reliant on QALYs, and that it underestimates the importance of quality of life to both patients and their carers. Without a doubt, there is a bias at the Institute towards quantity rather than quality of life, said Steve Winyard, director of campaigns at the Royal National Institute of Blind People (RNIB).
He pointed to the “enormous public outcry” which greeted NICE’s preliminary proposal for the use of anti-VEGF therapies in the treatment of wet age-related macular generation (AMD) in August, which called for these drugs - Pfizer/Eyetech’s Macugen (pegaptanib) and Novartis/Genentech’s Lucentis (ranibizumab) - to be made available to patients only after they have gone blind in one eye. NICE got it “disastrously wrong,” he said and, while the agency has since announced that it will examine the issues again, “the only thing the [NICE] Appraisal Committee is interested in is cost per QALY,” Mr Winyard told the panel.
There is no acceptance by NICE that QALYs are not scientific, but they are just an estimate, he said, and also condemned the NICE appraisal process as being “phenomenally” slow. There is no sense of urgency,” he said.
Rafiq Hasan, director of market access at Novartis, was also highly critical of the Institute’s “apparent over-reliance” on cost/QALYs. They are useful but should not be the sole basis for decision-making with regard to patients’ access to medicines, said Dr Hasan, and he called on other factors such as clinical need and availability of other effective treatments to be given relevant weight in the decision-making process.
He also suggested that the perspective taken by NICE in assessing value might be “incompatible” with that of the public, and added that some patient groups, particularly those who derive quality rather than quantity of life benefits from treatment, are being disadvantaged by the methods used by NICE. This is contrary to the government’s increasing attention on management of long-term conditions and the focus on care and dignity for the elderly, and on equality of access to care, Dr Hasan reminded the MPs, and he called for a broader debate on exactly how the value of medicines should be assessed. By Lynne Taylor