The timing of NICE guidance,
'NICE blight', and confusion and duplication within local health
60. One of the reasons for NICE's establishment was
to reduce the need for duplication of effort within local health
economies. 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".
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".
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".
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.
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
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".
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
"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."
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".
65. We agree with Dr Duerden that "the expectations
on NICE have been tremendous".
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".
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".
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
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. 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".
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
Ev 232. Back
Ev 223. Back
A First Class Service, Ch2. Back
Ev 242. Back
For example Ev 213 (Mid Devon Doctors' Group). Back
Ev 242. Back
Ev 93. Back
Ev 93. Back
Ev 252. Back
Ev 18. Back
Ev 70. Back
For example, Ev 209 (Health Technology Board for Scotland); Ev
90 (ABPI). Back
Learning from Bristol: The Report of the Public Inquiry into
children's heart surgery at the Bristol Royal Infirmary, 1984-1995,
Recommendation 127, p.453; Ev 126. Back
Q488; Q524. Back
A First Class Service, 2.11. Back
Ev 71; see also Ev 73 (Lambeth, Southwark and Lewisham Health
Ev 234. Back
Ev 52. Back
Ev 90. Back
Ev 174. Back
Ev 204 (Ealing, Hammersmith and Hounslow Health Authority). Back
Ev 129. Back
Ev 17. Back
Ev 17. Back
"Before the Directions were published, it was understood
that PCTs would be duty-bound to implement all NICE guidance.
The press release which announced the policy said health authorities
and PCTs would be expected to manage their budgets 'so that patients
can be guaranteed that if a treatment recommended by NICE is ...
the appropriate treatment for them, they will receive it'. But
the wording of the Direction itself is much less clear. The Direction
A Health Authority shall ... apply such
amounts paid to it ... as may be required so as to ensure that
a [treatment] recommended by the Institute ... is normally available
What does this mean? A 'guarantee' of
access to care would direct that treatment recommended by NICE
is always available. Why use the phrase 'normally available'?
Crucially, in what abnormal circumstances can PCTs decide not
to implement NICE guidance? Would scarce resources be a good reason?
If so, how different is the duty of PCTs now by comparison to
the position before 2002?" [Christopher Newdick] (Ev. 19;
see also Q197). Back