Select Committee on Health Second Report


 "Clear credible guidance and robust audit methodologies are essential. But in

 themselves, these will not achieve change. Information needs to reach the right

 people - health professionals, patients, carers and those commissioning services -

 and be locally owned and acted on in the right way"

 [A First Class Service, Department of Health, 1998, 2.21.]

Securing local ownership

69. Many witnesses suggested that there was an inherent contradiction in the aspiration for centrally produced national guidance to be locally owned, as national priorities might not always coincide with local needs.[88] However, most organisations who submitted evidence to us agreed that some level of national priority setting was appropriate. Inclusive processes that involve and engage appropriate stakeholders may go some way towards improving local ownership of national guidance, but as discussed in section I, there is some doubt as to whether NICE has succeeded in achieving ownership within the NHS.

Has NICE guidance been acted on in the right way and been implemented fully?

70. While it is not within NICE's remit to ensure that the guidance it issues is fully implemented by the NHS, NICE clearly has an active interest in its impact, and it cited a survey of health authorities carried out by CancerBACUP to argue that "The majority of health authorities (80%) have a written policy for assessing the clinical and financial implications of implementing NICE guidance. Sixty-five per cent have a written policy for disseminating NICE guidance locally".[89] The research suggests that NICE guidance on the use of taxanes in treating breast and ovarian cancer is well implemented, with over 90% of suitable breast cancer patients being offered taxanes and nearly 90% of suitable ovarian cancer patients.

71. However, CancerBACUP used this research to claim that NICE guidance was not being implemented uniformly throughout the NHS: "While some health authorities have set aside funds to ensure that NICE guidance is fully implemented, the majority have not. Fewer than half the health authorities in England and Wales have a policy for monitoring local compliance with NICE guidance, and most do not know whether all suitable patients are being offered treatments recommended by NICE".[90] Using their own analysis of prescribing data, the ABPI claimed that there had been wide variations in uptake of medicines that have been appraised by NICE, with actual increases in prescribing of NICE-approved drugs only totalling at most a third of NICE's projected estimates.[91]

72. In addition to claims of 'under-implementation', we also received evidence of inappropriate 'over-implementation'. Alan Maynard, Professor of Health Economics at the University of York, suggested that following the issue of a NICE recommendation, pressure from patient groups sponsored by industry led to "excessive and inefficient use of the new technology beyond the recommendations of NICE", and cited the example of rosiglitazone in the treatment of diabetes, where actual NHS expenditure has far outstripped NICE's estimates.[92] Professor Walley gave the example of the now widespread use of Cox II inhibitors, which, he claimed, clinicians justified on the basis of the NICE guidance, but "which is in reality contrary to the detail of this advice".[93]

73. Professor Rawlins did not give us a definitive answer on whether he thought NICE guidance had been properly implemented, citing amongst other factors a lack of reliable data about secondary care prescribing. Lord Hunt also told us it was "hard to come up with precise figures" for the implementation of NICE guidance due to methodological difficulties. Rather than giving blanket approval or rejection, NICE guidance often recommends drugs in very specific circumstances, making it hard to gauge implementation by looking at overall prescribing changes; another problem is that it is hard to separate the impact of NICE guidance from other factors which may influence prescribing behaviour, including the fact that a treatment or intervention has been referred to NICE.[94] The Department of Health's evidence includes primary care prescribing data showing increases in prescribing of certain drugs following a NICE recommendation, but given the difficulties outlined by Lord Hunt, it is probably inappropriate to infer the impact of NICE guidance from these figures.[95] Despite these difficulties in obtaining precise data, Lord Hunt told us that "the general feeling we have is that NICE guidance is taken very seriously by the NHS".[96] To ensure uniformity over implementation, in December 2001 the Government issued directions making it mandatory for health authorities to act on NICE recommendations.

74. There also seemed to be a lack of clarity surrounding the role of the Commission for Health Improvement (CHI) in monitoring the implementation of NICE guidance. CHI suggested that would be part of their "future work" and Lord Hunt told us the same thing.[97] However, Professor Aidan Halligan, Director of the Clinical Governance Support Team within the Department of Health, suggested that NICE guidance had already been subject to some monitoring by CHI, arguing that: "One of the most common findings by the Commission for Health Improvement in their clinical governance reviews is that guidance from NICE and elsewhere is only partially, or sometimes not at all, implemented".[98]

75. There is a clear and urgent need for a systematic and co-ordinated approach to monitoring the implementation of NICE guidance. Given the difficulties associated with monitoring implementation using relatively crude indicators such as change in prescribing rates, we feel it is important that where possible, monitoring should focus on the use of particular treatments as part of holistic patient management. The Commission for Health Improvement, and in future the Commission for Healthcare Audit and Inspection (CHAI), seems to us the appropriate body to lead monitoring of NICE guidance. However, we are concerned that under its current organisation and power CHI may not be able to conduct detailed national audits of individual pieces of NICE guidance. Under current CHI arrangements NHS organisations are reviewed every four years, and the implementation of NICE guidance constitutes only a small part of a more broadly focused review, so may not be able to provide enough detail.[99] CHI plans for its national studies to include a review of implementation of NICE guidance, but national studies are currently only being carried out in National Service Framework areas. While in the long term the NSF programme may expand to be in concert with all NICE guidelines, there remains a question about the monitoring of the implementation of guidance on individual technologies that fall outside the areas for which there are currently National Service Frameworks, including, for example, Relenza.

76. We recommend that the Government ensures the systematic monitoring of the implementation of NICE guidance. The Government should ensure that CHI (and later, CHAI) is encouraged to undertake specific national reviews of NICE guidance in priority areas, and that strategic health authorities include the implementation of NICE guidance as part of their regular monitoring of PCTs and acute trusts. Monitoring data should then be used to review and improve systems for dissemination and implementation.

Mandatory implementation of NICE's recommendations

77. The Government's recent directive announcing that implementation of NICE's recommendations on technology appraisals will be mandatory within three months of their issue can be seen as a positive step towards ensuring that NICE's guidance is acted on in the right way. Although the implementation of NICE's recommendations will not be 'mandatory' in the sense that NICE recommendations will override individual clinical judgement, health authorities and PCTs will have to ensure that the funding is available and the infrastructure in place to enable clinicians to act on NICE's recommendations. However, clinicians and commissioners of care are concerned that without specific 'extra' funding this will lead to inequities in the funding and provision of treatments and services which are not subject to NICE appraisal. The NHS Alliance argued that, because of mandatory funding, "In the pursuit of national equity ¼ there is a real danger of producing an even more sinister form of rationing than postcode prescribing - based on whether or not a patient has a 'politically correct' disease".[100]

78. As well as treatments that are not initially investigated by NICE, other fields that may be disadvantaged include less visible but equally important parts of the care package such as nursing services. Dr Crayford told us that:

"four implantable cardiac defibrillators cost £120,000 and for that same amount of money you could have funded four extra nurses ... the nurses we could put into accident and emergency very directly stack up against some of the things which NICE have funded. When NICE says yes and it is mandatory, it deprives our local residents of the chance of getting core and basic services."[101]

79. Several of our witnesses maintained that mandatory funding of NICE recommendations meant that inequities would appear not only between different conditions and areas of service provision, but even within different aspects of service provision within one treatment area. Thus, the NHS Confederation suggested:

"A very disturbing example of perverse and unintended consequences of mandated funding is beginning to be apparent in the case of atypical anti-psychotics (which is currently at final appraisal stage). To fund the implications of the NICE decisions, reductions will need to be made in the already stretched staffing of mental health trusts, which will mean poorer overall care for patients."[102]

80. Health authorities argued that a remedy to this problem would be for the implementation of NICE guidance to be given additional ring-fenced funding. Lord Hunt, however, told us he believed the additional funding currently being directed into the health service was sufficient to fund the impact of NICE guidance as well as funding and developing other service areas.[103] Our inquiry has not probed the budgetary and financial impact of NICE guidance in detail, and so we are not able to make an informed assessment of whether or not PCTs will be able to afford to implement all NICE guidance. However, it is clear that in making the implementation of NICE Health Technology Appraisals mandatory in a healthcare system which operates within fixed budgets, there is the potential to give the provision of certain, NICE-approved treatments priority over other, perhaps equally important treatments and services not considered by NICE. This is a broader issue warranting consideration by the Department of Health rather than by NICE, and is discussed in greater detail in section V.

81. Much of our evidence indicated that there may be other barriers to the successful implementation of NICE guidance. The RCGP argued that given NICE's ambitious work programme, "there is a danger of overloading clinicians, particularly generalists, with information", and recommended that "the considerable level of investment by NICE should be parallelled by local resources directed at supporting clinicians in implementing the guidance."[104] In his written submission Andrew Moore, editor of Bandolier, an evidence-based medicine journal, put forward the concept of each NHS trust and primary care trust nominating a 'NICE ambassador' to improve the level of NHS input into NICE processes, and to facilitate greater implementation of NICE guidance at a local level. We recommend that the Government should consider what practical systems and structures could be put in place to improve the NHS's capacity to implement NICE guidance, including the possibility of designated individuals within NHS trusts and strategic health authorities liaising with NICE to facilitate implementation.

88   Ev 213 (Mid Devon Doctors' Group); Ev 74 (Lambeth, Southwark and Lewisham Health Authority). Back

89   Ev 127. Back

90   Ev 52. Back

91   Ev 94-97.  Back

92   Ev 237. Back

93   Ev 25. Back

94   Q523. Back

95   Ev 174. Back

96   Q523. Back

97   Ev 200; Q523. Back

98   Ev 226-27. Back

99   How Successful has NICE been? T Dent, M Sadler, BMJ 2002; 324: 842-45. Back

100   Ev 252. Back

101   Q182. Back

102   Ev 225; see also Q175. Back

103   Q508. Back

104   Ev 230. Back

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