House of Commons - Health

Select Committee on Health Second Report

II. HAS NICE ENDED CONFUSION BY PROVIDING A SINGLE NATIONAL FOCUS?

"There is currently no coherent approach to the appraisal of research evidence and

the subsequent production of guidance for clinical practice. Guidance is issued by

numerous bodies at national, regional and local levels, each of which have different

ways of appraising the evidence and developing recommendations. The status

and implications of the products are not always clear, nor what actions are expected

to follow as a result of them. This is confusing for clinicians wanting to know what

care they should be expected to give, and for patients knowing what care to expect.

NICE will reduce duplication of this activity". "It will provide a single national focus

for appraisal of significant new and existing interventions, with subsequent guidance"

[A First Class Service, Department of Health, 1998, 2.11.]

Confusion between NICE guidance and guidance issued by other bodies

50. Our evidence revealed widespread support for NICE's aim of providing a single focus for guidance.[57] However, as noted by the Royal College of Paediatrics, "other groups such as SIGN and the Drug and Therapeutics Bulletin have continued to provide alternative guidance which does not always agree with NICE guidance",[58] with the potential to cause confusion and to damage NICE's credibility. The NHS Centre for Reviews and Dissemination argued that despite NICE's aim to provide a single national focus, decision-makers in the NHS would still "need to sift and weigh evidence, from a range of sources, to provide best practice", and that in this context collaborative working with "independent and well-respected sources, such as the Drug and Therapeutics Bulletin, the Effective Health Care publications, and the Cochrane Library" remained essential for NICE.[59]

Confusion about NICE's own guidance

51. As well as the confusion that can be generated by conflicting guidance from different organisations, some memoranda complained of a lack of co-ordination between different types of guidance issued by NICE. A First Class Service gives an example of the sort of 'Conflicting clinical advice' NICE was aiming to clarify:

"Current guidelines from the British Hypertensive Society are ambivalent about the role of ACE inhibitors as a first line treatment for uncomplicated hypertension. Some clinicians hold that there is now sufficient evidence to justify using these medicines as the preferred treatment ... However, there is still no unequivocal guidance available for clinicians. In such cases, NICE will look at the evidence and make a clear recommendation, issue appropriate guidance and advise on what further research is needed."[60]

52. In its written submission, the British Cardiac Patients' Association used the same example to argue that such confusion still persists, claiming that hypertension has "to date been covered in four separate NICE clinical guidelines and one technology appraisal, in addition to other guidelines and recommendations that remain relevant from other professional and advisory bodies".[61] The Association pointed out that as well as creating confusion this placed a significant burden on clinicians in terms of duplication in reading and implementation.

53. NICE and National Service Frameworks (NSFs) were conceived as a dual initiative to set quality standards in the NHS, and it was assumed that the two initiatives would work in close concert. However, uncertainty about the relationship between government-issued NSFs and NICE guidance was a common theme in the evidence we received from both clinicians[62] and from patient organisations such as the British Cardiac Patients' Association, who argued that "Poor integration between technology appraisals, clinical guidelines and other initiatives such as National Service Frameworks has in some ways neglected an opportunity to end confusion".[63]

54. The ABPI felt that there remained "room for improvement in coordination between the creation of NICE clinical guidelines and the broader issues considered by such policy areas as NSFs. For example, Standard 6 of the NSF for Older People covers both falls and fractures as priority areas of clinical need to reduce visits to A&E Departments. The scope of the NICE guideline for falls excludes any consideration of fractures".[64] We recommend that NICE should strive to improve clarity and co-ordination within and between its own workstreams, and should work closely with the Government to ensure clarity about the relationship between its own work, NSFs and other policy initiatives in the NHS.

Confusion between technology appraisals and clinical guidelines

55. The ABPI argued that in separating its programmes of technology appraisal and clinical guidelines, NICE was suffering from "double vision": "Completely different experts are used for each process, and guidelines groups are not allowed to comment on draft guidance issued for technology appraisals. Quoting specific examples, the scope of the clinical guideline for multiple sclerosis, which is under development, does not include reference to any disease-modifying therapies and is focused only on palliative care".[65] This concern was echoed by the NHS Alliance: "NICE have not connected their production of technology assessments (both drugs and non-drug interventions) with the issue of treatment guidelines and referral guidance. Such a disjointed approach runs the risk of, at best, damaging the credibility of NICE, and at worst, producing confusion".[66]

56. Several witnesses felt that the development of technology appraisals outside the context of a disease management framework made them less useful and potentially confusing. Dr Duerden used the example of technology appraisals issued by NICE on two anti-obesity drugs, orlistat and sibutramine: "These clearly should be used within a carefully constructed and agreed obesity management guideline. Taken in isolation it is difficult to know how best to use these; for example, which should be used in preference, and in what circumstances".[67] This was supported by oral evidence from Professor Tom Walley, a clinical pharmacologist with recognised expertise in guideline issues: "We have two appraisals on two separate technologies rather than the consideration of how we should manage obesity in the whole of the NHS. It is being driven by the existence of the technology, not the priority of the NHS in managing the condition".[68]

57. Guidelines produced by SIGN were frequently cited as an example of good practice[69] and we also received suggestions that NICE might improve its usefulness by following SIGN's example and devoting a significantly larger proportion (or even all) of its resources to guideline development.[70] GlaxoSmithKline added that the subsequent reduction in distinct pieces of work could ease NICE's workload, although clearly producing comprehensive clinical guidelines takes significantly longer than completing a technology appraisal.[71]

58. The report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary chaired by Professor Sir Ian Kennedy (The Kennedy Report), proposed that NICE's programme of clinical guidelines should be extended to cover the treatment and management of all major areas of morbidity and mortality in the UK, a task which NICE told us it would welcome.[72] In evidence to us, Lord Hunt was also supportive of this idea: "we do not want to ¼ just target drugs in isolation from the clinical priorities of the NHS or the guidelines. That would not be sensible ... I think we have learned through experience that you can move away from very narrow remits in terms of asking to appraise one drug to get a more balanced view by making comparisons with a class of drugs".[73]

59. We recommend that the Government should fundamentally shift the emphasis of NICE's work away from appraisals of specific treatments or interventions in isolation from the wider condition-management framework, towards producing guidance relating to classes of drugs or relevant groups of drugs, and/or on the treatment of particular conditions. In addition, we endorse the recommendation of the Kennedy Report that NICE's guideline development programme should be extended to cover all major causes of mortality and morbidity. This may necessitate an increase in NICE's capacity and/or a change in its organisational structure.

The timing of NICE guidance, 'NICE blight', and confusion and duplication within local health economies

60. One of the reasons for NICE's establishment was to reduce the need for duplication of effort within local health economies.[74] Our evidence suggested that this aim was welcomed by the NHS, in that, as Croydon Health Authority argued, "the centralised sifting through the evidence offers the NHS as a whole an economy of scale".[75] However, Hammersmith Hospitals NHS Trust commented that within its local health economy there were still a number of other bodies who independently reviewed the use of new drugs, including the New Drugs Panel within the hospital, the Health Authority Priority Setting Sub-Committee, and the relevant sub-committee of the Regional Specialist Commissioning Group. The consequence of this was that "there appears still to be considerable confusion as to the roles of these different bodies in the light of NICE guidance".[76]

61. Several memoranda suggested that NICE's aim of ending confusion was hampered by the lengthy duration of the technology appraisal process, which could give rise to the phenomenon of 'NICE blight', whereby some health authorities issued blanket bans on the use of all treatments while they were going through the NICE process. CancerBACUP, a national charity providing information and support to people affected by cancer, said that this had occurred with the drugs trastuzumab for breast cancer and irinotecan for colorectal cancer, and argued that "In the case of cancer, this means that patients are being denied treatments that their doctors want to prescribe and that may offer them extra survival time and improved quality of life".[77] The ABPI argued that 'NICE blight' operated at two different levels: firstly, health authorities and primary care organizations withhold funding of a product on the NICE work programme pending the NICE verdict; secondly, the same organizations also withhold funding in areas not listed when they assume that NICE is likely to look at them in the future.[78] A graph of prescribing data for the obesity drug orlistat, submitted to us by the Department of Health, shows a surge in prescriptions following the issue of NICE guidance, perhaps suggesting that 'NICE blight' had limited the use of the treatment prior to guidance being issued.[79]

62. The Department of Health has now issued guidance prohibiting health authorities from issuing blanket bans on treatments awaiting NICE appraisal. While we welcome this, the persisting time lapse between launch of new treatments and publication of NICE guidance means that health authorities and primary care trusts must continue to conduct their own interim appraisals of treatments or interventions in the same way as they did prior to NICE's formation. As Ealing, Hammersmith and Hounslow Health Authority put it, "Despite the creation of NICE ... a need to assess technologies and set priorities locally has remained because of the inherent delays in the NICE appraisal process".[80] This leads to duplication of effort and variation of outcome, the potential scale of which will be substantially increased when health authority budgets are fully subdelegated to primary care trusts (PCTs). Problems may also arise when a local decision is contradicted by subsequent NICE guidance.

63. NICE accepted that the issue of timing was causing considerable problems:

"We have been playing a lot of catch-up at NICE. We have been looking at anti-cancer drugs that were first launched in 1994. This is not a tolerable situation. What we do need to do ... is to be proactive. We need to be starting the appraisal process a year before a drug is licensed. It is perfectly feasible to do it."[81]

64. Mr Dillon cited the technology appraisal of glitazones for the treatment of diabetes as an example of guidance which had been issued shortly after launch and had worked well as a result. In its submission to us, NICE specifically suggested that it should be commissioned to "undertake reviews of technologies at an early stage in their development to enable guidance to be issued to the NHS at or shortly after they become available for use in the NHS".[82]

65. We agree with Dr Duerden that "the expectations on NICE have been tremendous".[83] Over the past two years the sheer scale of work has become apparent, and with this has come an increased recognition of the cost of such processes. With the benefit of hindsight,

it could be argued more consideration should have been given to this prior to NICE's establishment. Dr Duerden also suggested that "it might have been better to clearly separate the catch up role, where central guidance was required for drugs already on the market, being used subject to local vagaries (for example beta interferon for multiple sclerosis) from the need to horizon-scan and have guidance available for drugs at point of licence".[84]

66. Lord Hunt told us that over the next five to ten years it was his expectation that "any significant new technology where there was likely to be any doubt or controversy over cost-effectiveness and clinical effectiveness would be reviewed by NICE after launch or within a short period of time after launch".[85] We welcome this aim, but remain concerned that without further investment in capacity and detailed consideration of the process it may not be possible for NICE to deliver this. We also feel that the five to ten year timescale proposed by Lord Hunt is too long given the significant problems this is causing the NHS.

67. We recommend that for all new technologies, NICE's work programme is arranged to facilitate publication of guidance at the time of launch. When this is not possible, NICE should conduct rapid 'interim' appraisals of clinical and cost-effectiveness to be published at the time of a treatment's launch, as was the case with zanamivir. The funding of these interim appraisals should not be mandatory. Although the amount and type of information available at time of launch may be less than ideal, an 'interim' appraisal will provide useful guidance until a more detailed appraisal of the treatment is conducted as part of NICE's expanded main function of developing clinical guidelines. While issuing revised guidance does have the potential to cause confusion, we trust that NICE will learn from the experience of its zanamivir appraisal and be very explicit about the reasons for any changes in the new guidance. Appraisals on existing treatments or interventions should also be conducted as part of NICE's clinical guidelines programme.

Status of NICE guidance

68. Our evidence revealed persisting confusion regarding the status and authority of NICE guidance. This came both from clinicians and from academics in the medico-legal field, who found it difficult to reconcile the conflicting messages given by the legal Directions made on 11 December 2001 and the duties of healthcare commissioners to respond to the needs of the local communities they serve.[86] In addition to this, clinicians have a legal duty of care to their patients, and PCTs have a duty to remain within their budgets. As pointed out by Dr Crayford: "It is very expensive seeking medico-legal advice and usually the same firms of lawyers are giving the same advice to all of our different authorities".[87] We recommend that the Government and NICE should clarify the legal status of NICE guidance in relation to the other legal duties incumbent upon clinicians and commissioners of health care.

57 For example, Ev 77 (Newcastle and North Tyneside Health Authority); Ev 71 (Croydon Health Authority); Ev 73 (Lambeth, Southwark and Lewisham Health Authority). Back

58 Ev 232. Back

59 Ev 223. Back

60 A First Class Service, Ch2. Back

61 Ev 242. Back

62 For example Ev 213 (Mid Devon Doctors' Group). Back

63 Ev 242. Back

64 Ev 93. Back

65 Ev 93. Back

66 Ev 252. Back