Memorandum by Dr Tim Crayford, Deputy
Director of Public Health and Chairman Prescribing Committee,
Croydon Health Authority (NC 32)
1. BACKGROUND
1.1 Croydon Health Authority covers a population
of about 330,000 people in South West London. It is co-terminus
with the Local Authority and will become a large Primary Care
Trust, when it merges with the local Community Trust in April
2002.
1.2 Croydon is a mixed affluent-deprived
area, whose demographic cross-section is quite similar to that
of England as a whole. It has one major acute provider, Mayday
Hospital, and around 75 General Practices.
1.3 Dr. Crayford is a Consultant in Public
Health Medicine, employed by Croydon Health Authority. He chairs
Croydon's Area Prescribing Committee (APC), which develops local
prescribing policy, and supports local implementation of NICE
guidance. Part of the remit of the APC in Croydon is to advise
on the relative priority of new drugs, and take an overview of
the implementation of NICE guidance relating to medicines. Dr.
Crayford is also a member of the Health Authority executive group
that decides on purchasing priorities for the health authority.
2. SUMMARY AND
RECOMMENDATIONS
2.1 NICE offers a number of helpful functions
to those who are responsible for prioritising NHS resources. The
centralised sifting through the evidence offers the NHS as a whole
an economy of scale. When NICE makes a recommendation not
to implement a technology, this has helped where we might have
otherwise struggled with a blanket ban. NICE has appointed high-calibre
people who have in turn ensured that the membership of the NICE
committees is heavyweight and unbiased.
2.2 Whilst providing detailed clinical guidance
that affects whether particular doctors offer treatment to certain
patients, NICE's main effect on Health Authorities has been to
alter how they prioritise expenditure. Health authorities can
only prioritise fairly if all competing demands are considered
at once. Because of the way in which it has been set up, NICE
does not do this, as it considers new treatments at the margin
of healthcare. In contributing to the prioritisation debate in
the NHS as a whole, it is therefore flawed. Until NICE has evaluated
things like the benefit of funding new nurses for our local A&E
department at Mayday Hospital, then its recommendations to fund
certain treatments, which are by default at the expense of this
sort of development, cannot be rational for local health economies.
The full implications of this point suggest that significant reform
is required to make NICE fit with overall prioritisation in the
NHS.
2.3 Not all areas of the country have the
same priorities. Whilst reducing the postcode lottery for a very
few high profile treatments, NICE's judgements can be at the expense
of locally supported and needed developments.
2.4 The proposal to make NICE guidance mandatory
will make local prioritisation more difficult than it already
is. If all of NICE's guidance is to be mandatory, then NICE should
have a top-sliced budget within which it should prioritise its
own advice. NICE must assume some financial accountability for
its decisions.
2.5 The one situation where NICE's guidance
should be mandatory is for drugs or technologies that are not
recommended for use in the NHS. This would still permit the government
to say that it is contributing towards the elimination of postcode
rationing and would strengthen Health Authorities' or PCTs' hand
in limiting access to ineffective treatments. There is an infinite
number of things in which we could invest. What we need help with
is in excluding things from this list, not lengthening it.
2.6 There are widespread concerns about
NICE's impartiality and bias towards evidence it receives from
the pharmaceutical and health technology sector.
2.7.There is a large legal industry that has
grown up to provide the same advice to the many different NHS
organisations affected by NICE guidance. This is usually to clarify
our liability in being unable to fund NICE guidance fully. It
would be sensible that NICE also provided a single legal service
to health authorities to help them in circumstances where they
are able only to partly-fund treatment.
3. IS NICE PROVIDING
CLEAR AND
CREDIBLE GUIDANCE?
3.1 Most commentators agree that the evidence
provided is clear and digestible. NICE has occasionally reversed
or delayed decisions, and this has made it seem indecisive in
some cases.
3.2 Some opinion considers that NICE guidance
lacks credibility. Particular concerns have been that its guidance
is not timely and that it listens to biased sources of information.
3.3 A good example would be that of Implantable
Cardiac Defibrillators (ICDs).
ICDs are relatively new devices that can detect
potentially fatal electrical disturbances in the heart and fire
a counter electric current to correct them. There is no question
that they can sometimes save lives. There is also no question
that, at £30,000 per patient, they are expensive.
There is an alternative medical treatment, using
a drug called Amiodarone, which is not quite as effective as these
devices. If cost were not an issue, one would almost certainly
choose an ICD over medical treatment. The question for the NHS
as a whole is whether this additional cost is worth the benefit.
NICE interviewed nine industry-sponsored groups
or companies, and one Professor of Cardiology whose department
has been involved with industry-sponsored research in this area.
NICE commissioned one systematic (impartial) review of evidence.
We spoke to the author of this review. Unlike the many industry
representatives, the author had not been interviewed by NICE about
their submission prior to publication of NICE's judegment. Furthermore,
they reported that their estimates of the cost per year of life
saved were "much higher" than those presented by the
industry, which they said were used in the report.
With ICDs "One death in the first three
years was averted per 10 patients treated". This seems
like a high cost for this sort of intervention. Four of these
devices were used in Croydon last year at a cost of around £120,000.
At its recent inspection of Mayday, the commission for heath improvement,
CHI, identified improvement of A&E services as a major area
for improvement. Each of these devices could have fully funded
an extra nurse in A&E next year, who would potentially benefit
many hundreds of our residents.
There is little doubt that Croydon Health Authority
would not have prioritised funding of ICDs over the provision
of basic core services.
4. HAS NICE ENDED
CONFUSION BY
PROVIDING A
SINGLE, NATIONAL
FOCUS?
4.1 NICE has unquestionably provided a single,
national focus. On the rare occasions that NICE has said "No",
it has decreased confusion. On the other occasions, it has still
left health authorities with the problem of how to fund the guidance.
This has mostly involved partial funding of the guidance, through
devices such as clinical budget-setting - i.e. agreeing to fund
a certain number of treatments for local residents per year, rather
than agreeing to fund all patients who meet certain clinical criteria,
which would be the usual way NICE guidance is expressed.
4.2 What is unfortunate is that in some
circumstances, it has paradoxically increased confusion. The delay
in resolving the use of Beta Interferon in Multiple Sclerosis
has caused us particular problems. Although Croydon would like
to issue a blanket ban on the use of this drug for our residents,
our legal advice is that because of the "planning blight"
caused by the delay, we would be open to legal challenge if we
were to do so. So even though the currently available evidence
would not support the use of NHS funds for this drug, the delay
in reaching a judgement at a national level, has meant that we
still have to pay for new patients to receive it.
5. IS NICE ACTIVELY
PROVIDING GUIDANCE
THAT IS
LOCALLY OWNED
AND ACTED
ON IN
THE RIGHT
WAY?
5.1 NICE is about national standards for
access and by definition is not contributing to local ownership.
This is not necessarily a problem. However locally sensitive one
would wish services to be, some blatant irrationalities of postcode
prescribing should be ironed out, and NICE seems like a sensible
vehicle to do this.
5.2 It is not possible for health authorities
to fully implement NICE's guidance without failing to invest in
other more needy areas.
5.3 Most Health Authorities have had to
allocate a sum to NICE guidance, which has not been enough to
cover the full cost of the guidance itself. Croydon Health Authority
for example, allocated £550,000 last year to cover the introduction
of new drugs, including those evaluated by NICE. From this, we
had to undertake a prioritisation process to decide which drugs
were to be funded, which necessarily meant not fully funding some
NICE guidance.
5.4 Where NICE could provide useful guidance
to health authorities is by specifying a "due process"
that we could follow in prioritising NICE's recommendations for
funding.
6. IS NICE ACTIVELY
PROMOTING INTERVENTIONS
WITH GOOD
EVIDENCE OF
CLINICAL AND
COST-EFFECTIVENESS
SO THAT
PATIENTS HAVE
FASTER ACCESS
TO TREATMENTS
THAT ARE
KNOWN TO
WORK?
6.1 Yes. But the issue for health authorities
is not whether the treatments work, it's how much they cost, and
specifically the trade-off between the two, usually measured in
the cost per quality adjusted life-year (QALY). As the recent
review by Raftery has shown, NICE has only considered adequate
QALY data in about ½ of the reviews conducted so far. The
paucity of adequate data on cost-utility has blighted NICEs ability
to provide credible guidance. For all the confusion this has created,
it would almost be better that NICE stopped considering cost and
simply concentrated on whether or not interventions worked.
7. CONCLUSIONS
7.1 NICE is about prioritisation in the
NHS as a whole. Because NICE has thus far considered just a very
few new technologies it has distorted health authorities' purchasing
priorities to the detriment of patients.
7.2 Significant reform of NICE is required
to make it fit with prioritisation in the NHS as a whole. What
is essential is a frank debate about what the patients of the
NHS is for, not just treatments at its margins - similar to the
"Oregon" process from the USA. NICE would seem to be
a suitable organisation to lead this.
7.3 NICE should be made financially accountable
for its decisions.
7.4 NICE should be more circumspect about
collecting evidence from the industry, from clinicians who have
conducted research funded by the industry and from lobby groups.
7.5 NICE is at its most helpful to health
authorities when it says "no". It clearly needs to raise
its thresholds for recommending expensive treatments to the NHS.
7.6 NICE should provide a service to Health
Authorities and PCTs about the legal implications of its advice.
January 2002
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