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
