APPENDIX 25
Memorandum by the British Cardiac Patients
Association (NC 116)
1. THE BRITISH
CARDIAC PATIENTS
ASSOCIATION (BCPA)
The BCPA is a national voluntary organisation
offering help, support advice and reassurance to all cardiac patients,
their families and carers. It also offers advice on how to prevent
heart disease and stay healthy. The BCPA has members and groups
around the country, which meet regularly for events and support.
The BCPA represents the patient and carer on many national bodies
including the National Service Framework for Coronary Heart Disease
(CHD), The National Health Service Modernisation Board, The National
Coronary Heart Disease Task Force and many more and tries to ensure
that the patient and carer's perspective is accurately represented.
2. THE BCPA'S
EXPERIENCE WITH
NICE
The BCPA welcomes this inquiry of the Health
Select Committee to assess NICE's progress, nearly three years
after its establishment. The BCPA has been involved in several
technology appraisals to date and is participating in the development
of clinical guidelines in the CHD field, including:
— Technology appraisals of Glycoprotein
IIb/IIIa Inhibitors for the treatment of acute coronary syndromes;
— Coronary Artery Stents in Ischaemic
Heart Disease;
— Implantable cardioverter defibrillators
(ICDs) for cardiac arrhythmias;
— The development of clinical guidelines
into the management of hypertension, lipids and hypertension in
diabetics, management of post-MIs, and heart failure;
— The technology appraisal of Ramipril
and other ACE inhibitors, taking place under the new process.
The BCPA values the opportunity to participate
in the development of guidance and to represent the patient and
carer's perspective in this process. We would like to note, however,
that the weight of NICE work programme in the CHD field, combined
with participation in other initiatives such as those detailed
above, places a heavy burden on us in terms of financial resource
and staff commitment. Given that many groups who would be able
to provide a valuable insight into patient and carer perspective
work on a voluntary basis it may well be necessary, in order to
consult widely particularly with smaller patient groups, to offer
some form of administrative or financial support.
3. "CLEAR
AND CREDIBLE
GUIDANCE"
The Committee has invited evidence covering
the extent to which NICE is providing clear and credible guidance
and we highlight here the lack of attention to the patient voice,
which undermines the credibility of guidance from the patient
and carer's perspective:
Attention given to "patient voice"
The BCPA believe that it is important that the
patient's perspective is fully considered in the appraisal of
interventions and preparation of clinical guidelines. It is not
possible to assess the "value" of an intervention, without
information on the extent to which it is valued by patients and
their carers. Patients have a unique perspective on their treatment,
particularly in areas such as the tolerability of risk or side-effects;
quality of life and pain; and the overall impact personally, on
their carers and families. This is in addition to the expertise
patients and their representatives bring in areas such as living
with the condition, the appropriate use of interventions and their
needs.
However, to date it has proved difficult to
ensure evidence from patient groups is treated on an equal footing
to that of other stakeholders and experts, such as clinicians,
health economists and the industry, and given adequate consideration.
In particular, patient evidence has not been considered by the
health technology assessment bodies and so may not be covered
in their conclusions in the assessment report, which informs the
initial assessment.
There is evidence in some appraisals, for example,
that of a treatment for Motor Neurone Disease, that the value
placed on treatments has been considered. The Institute gave this
treatment a positive appraisal despite the high cost per QALY
(the highest to date), after the Committee heard of the value
placed on the limited benefits by patients. However, NICE has
not taken a consistent approach, and in other appraisals, there
is little evidence that the patient's perspective has been taken
into account. Of particular concern is the emphasis on cost-effectiveness
assessments, and the impression that the perspectives of health
economists is the key influence. We are particularly concerned
about the potential to fix a price tag of an "acceptable"
cost of treatment, at £30,000 per QALY. The quality of life
issues that are obtained by having a patient perspective are very
difficult to put a price on but are an essential part of any appraisal
and recommendation of treatment.
We recognise and welcome NICE's commitment to
engage with patient groups. We would like to highlight however,
that more work is needed, particularly in the appraisal process,
to ensure that patient evidence is actively sought, fully considered
and given due weight. It is also essential that patient groups
are given as much time as possible to consult with their members,
where necessary, so as to give a balanced viewpoint.
Openness and Transparency
In several cases, the credibility of guidance
has been undermined where it is unclear how the Institute reached
its decision. This has been the subject of successful appeals
on technology appraisals, where it was accepted that the guidance
did not include sufficient reasoning to explain the threshold
NICE had used in making its assessments. Until the sixth wave
of appraisals, there was no opportunity for dialogue on the scope
of the appraisal and stakeholders selected; and opportunity to
comment on the Evaluation Report, covering evidence submitted
and conclusions on this. We hope that the revised appraisal process
will provide a higher level of openness and transparency, which
will enable patient groups to contribute more effectively and
respond to assumptions and evidence submitted.
4. HAS NICE ENDED
CONFUSION WITH
A SINGLE
NATIONAL FOCUS
AND GUIDANCE
THAT IS
LOCALLY OWNED?
Balance of central vs. local control
NICE has faced a difficult task in meeting the
policy objectives of a national focus, whilst creating local ownership
and implementation. Local ownership is important to ensure that
facilitate appropriate implementation. However, the key question
is whether NICE has improved equity of access for patients across
the country. In our experience, take-up of one piece of positive
guidance in the CHD area, the ICDs has remained patchy. There
are undoubtedly some local differences in incidence and other
clinical reasons, however, these are not sufficient to explain
the differences in access that persist and undermine equity.
Integration
NICE has the potential to end confusion by bringing
together research and initiatives into one piece of guidance for
professionals, patients and the service. However, poor integration
between technology appraisals, clinical guidelines and other initiatives
such as the National Service Frameworks has in some ways neglected
an opportunity to end confusion. Where guidance inter-relates
(such as the guidance for stents and glycoprotein IIb/IIIas) it
would be helpful for this to be made clear to clinicians, with
good cross-referencing and updates of other sources of guidance.
Without cross-referencing and clarity, there is a danger that
one set of guidelines could be viewed in isolation, or be seen
to supplant previous guidance.
There has also been overlap and repetition in
some areas, wasting the resources of both NICE, the NHS and indeed
other stakeholders, contributing to these. This can be seen in
the coverage of certain problems such as hypertension, which to
date has been covered in four clinical guidelines and one technology
appraisal, in addition to other guidelines and recommendations
that remain relevant from professional and advisory bodies. Clinicians
may be left unsure which piece of guidance covers all the relevant
areas, which has priority if there is a conflict, and face the
burden of duplication in reading and implementation. If subjects
are not addressed holistically and in an integrated way, there
is a risk some important clinical issues could be neglected entirely.
5. HAS NICE ACTIVELY
PROMOTED EFFECTIVE
INTERVENTIONS? HAS
THERE BEEN
FASTER ACCESS?
This is perhaps the most important question,
what has the impact of NICE been for patients? However, with such
a number of important policy initiatives in the CHD field, including
the National Service Framework, benefiting the funding of the
disease area, overall infrastructure and access to treatment,
it is impossible to identify the impact of NICE guidance in isolation.
In relation to the clinical guidelines programme, where progress
has been slow and the first relevant guideline only recently issued,
there has been no discernible impact to date. We would like to
comment, however, on the expected impact of NICE and recent developments.
"NICE Blight"
The phenomenon of NICE blight is of considerable
concern. Health authorities, Primary Care Trusts and individual
health professionals may view the decision to refer an intervention
to NICE as evidence that there is some doubt as to its clinical
or cost-effectiveness; or that decisions on whether to fund such
interventions can legitimately be postponed until after NICE guidance
has been published. It also creates uncertainty and doubt amongst
patients as to whether they should be receiving a treatment ahead
of guidance. Many calls are received by our helpline from patients,
who had been given the impression by their clinician, that certain
drugs were not yet proven for use because they were at present
part of a NICE appraisal. This was particularly true for those
patients with unstable angina in the case of Glycoprotein IIb/IIIa
inhibitors.
The appraisal process has recently been lengthened,
and we welcome the additional periods of consultation it allows
for. However, patients with life threatening conditions in many
cases cannot wait until guidance is published before having access
to the most appropriate treatment, and there is usually adequate
evidence of efficacy, if not effectiveness well ahead of the NICE
appraisal. It is ironic that the NICE appraisal itself creates
a mechanism to delay access to treatment, rather than facilitating
faster access. We call for urgent consideration as to how NICE
blight can be tackled.
Funding for implementation
The Government recently announced that health
authorities and primary care trusts will be obliged to find funding
for treatments found clinically and cost-effective by NICE. We
welcome the commitment to tackling implementation, one of the
most significant problems in the credibility of NICE and its benefit
to patients. This may be useful in tackling the problem some patients
have experienced in accessing "NICEd" treatments, due
to funding constraints. We would like to highlight, however, that
funding for a treatment, such as a pharmaceutical or device, is
often a small element in the cost of care. Limitations in infrastructure,
such as other equipment, suitably qualified staff and supportive
care, could still restrict implementation of NICE guidance.
Is guidance acted on in the right way? Are there
perverse decisions?
Whilst we welcome commitment to implement positive
NICE guidance, we are concerned that this could lead to perverse
decisions. In particular, it is possible that funding could be
diverted away from "non-NICEd" treatments and interventions.
Lord Hunt has said it would be "a pity" if this was
the end result. We call for monitoring of the impact of recent
decision to require funding of NICE guidance, to ensure that it
does not result in such action which could damage the quality
of patient care. In particular, we are concerned that patients'
and clinicians' confidence in current best practice and interventions
could be undermined if they do not receive the "NICE stamp
of approval".
January 2002
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