Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by the British Cardiac Patients Association (NC 116)


  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.


  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.


  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.


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.


  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.


  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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