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Out goes the arbitrary funding threshold: in come NICE “directives”
On Wednesday 9 January 2008, the House of Commons health select committee published the report of its second inquiry into the National Institute for Health and Clinical Excellence (NICE).1 The committee’s first inquiry into NICE was published six years ago,2 just three years after the institute’s launch. Much has happened since the initial inquiry. The institute is now well established and is a core policy driver within the National Health Service in England and Wales (its remit does not cover Scotland), and we know much more about how it operates. Moreover, the working environment of the institute has changed with, for instance, the publication of the Cooksey report on funding for health research in the United Kingdom,3 the introduction of legislation making NICE technology appraisals essentially compulsory,4 the involvement of the courts in a legal challenge to NICE,5 and most recently the Office of Fair Trading’s critical review of how brand name drugs are priced in the UK through the Pharmaceutical Price Regulation Scheme (PPRS).6
All these and more have been embraced in this new inquiry, for which members visited equivalent bodies to NICE in Canada, France, and Scotland; took oral evidence from 31 witnesses; and received 124 written submissions. The committee’s report contains 32 recommendations, many of which are far reaching and reflect the work of a particularly effective inquisitorial team.
The report highlights certain disappointments—for example, the failure of NICE to implement some of the committee’s recommendations made in 2002, such as making technology appraisals available at the time of drug launches. And the report is critical of the way ministers have tried to influence decision making by NICE. At the same time the committee recognises that NICE now plays a vital role in determining NHS health policy and that this role is going to become “more important and demanding.”
Four particularly notable themes emanate from the recommendations, and these relate primarily to the institute’s work on technology appraisals of drugs. Firstly, the committee calls for greater clarity in NICE’s decision making processes. The report recommends more communication with stakeholders, a clarification of the institute’s role as a rationing body, and a change in terminology so that compulsory advice given in technology appraisals is referred to as a NICE directive, leaving other advice from the institute to be referred to as guidance or guidelines.
Secondly, the committee questions the threshold used by NICE when determining whether or not a new drug should be made available in the NHS. As a general rule, NICE recommends only new products estimated to cost the NHS less than around £30000 (€40000; $59000) per quality adjusted life year (QALY) for use in the NHS. The committee learnt that this amount was determined by NICE, does not have any basis in hard science, has not changed since NICE’s inception, is not related to the NHS budget, is almost certainly higher than that which primary care trusts use when they consider new drugs, and does not take account of key costs such as those borne by carers and social services. The report recommends that a body independent of NICE should be established to review the threshold and set the levels and ranges that the institute uses.
The committee also recommends that NICE appraises all new drugs and that the results of appraisal are available at the time of each drug’s launch. These more rapid appraisals would, where appropriate, be followed by more detailed single or multiple appraisals—as happen now—when more research became available. Currently, NICE appraises only a proportion of drugs, and seems to concentrate on those that are new, expensive, and used in acute medicine and secondary care. Moreover, these appraisals are published months or years after a drug is marketed. The current policy delays the introduction of effective new drugs and diverts provision away from older, useful, and possibly cheaper measures that have not been appraised.
Lastly, the committee is concerned about the quality of the data available to NICE and how this quality is assessed. The data used by NICE, which by and large are generated by drug companies and relate to published information, are often weak, inadequate, or biased—and make reliable decision making difficult. The committee wants trial data made available to NICE that are more complete, more independent (of the drug industry), more relevant to clinical practice, and more amenable to the needs of economic evaluation. All the information available to the UK drug licensing authority should also be available to NICE.
The Department of Health has three months to respond to the report. All of the committee’s recommendations are challenging, but it is those relating to the timing and breadth of the technology appraisals that would have the widest implications; if adopted they would inevitably reduce the amount we spend on drugs and temper the influence the drug industry has on clinical practice.7 Such changes would also have an important bearing on the proposed reforms to the Pharmaceutical Price Regulation Scheme, in which drug prices would be negotiated at launch for each drug by an independent commission using evidence of the product’s perceived clinical value, including evidence from NICE.8
Competing interests. JC was a specialist advisor to the House of Commons health select committee during this inquiry, as he was for the committee’s inquiry into NICE in 2001-2, and its inquiry into the influence of the pharmaceutical industry in 2005. He was also an advisor to the Office of Fair Trading in its 2007 inquiry into the Pharmaceutical Price Regulation Scheme.
Provenance and peer review: Commissioned; not peer reviewed.