(a)  It is clear that expectations of NICE have been high, and in addition to the challenges of its remit, NICE has also faced the same logistical and operational challenges as all nascent organisations. In this context, we welcome the support we have seen for the establishment of NICE, and we recognise that this represents an improvement on the previous situation (paragraph 6).

Credibility

(b)  To neglect the input of respected bodies such as the Drug and Therapeutics Bulletin and the British National Formulary is to miss a key opportunity for quality assuring NICE's work, and risks serious damage to the credibility of its guidance. We recommend that NICE puts in place robust mechanisms to ensure closer and more constructive collaborative working with BNF, DTB, and other similar bodies. Although we recognise that such bodies may not have the capacity to contribute to every piece of guidance that NICE issues, they should be allowed a formal opportunity to contribute to work where they have relevant expertise, and there should be an established mechanism for discussing and resolving technical differences (paragraph 26).

(c)  Involving such a broad sweep of stakeholders is a complex and time-consuming task, and we welcome NICE's efforts in this area to date. We recommend that NICE should take steps to improve its stakeholder identification methods, to ensure that relevant bodies and individuals are systematically identified for inclusion. If NICE is to gain the full respect of the medical profession, it is essential that it involves clinicians with relevant clinical experience, alongside those capable of taking a broad overview. NICE should consider the possibility of inviting stakeholders in the technology appraisal process to 'self nominate' in the same way as they are permitted to in the clinical guidelines process (paragraph 31).

Inclusiveness  

(d)  We recommend that NICE takes steps to improve current methods of involving the NHS in the development of technology appraisals and clinical guidelines, including arrangements for the NHS to be involved in a timely appeal process. Measures to achieve this might include the extension of membership of the Appraisal Committee to more than two NHS representatives; and the establishment of a network of designated individuals within NHS Trusts and strategic health authorities, through whom NICE can maintain open dialogue with working clinicians and commissioners of care throughout the guidance development process. These individuals would be able to act as intermediary facilitators between NICE and the wider NHS, acting as a local source of reference about NICE's processes and promoting the implementation of its guidance, as well as ensuring the systematic inclusion of NHS representatives in NICE decision-making (paragraph 36).

(e)  We welcome NICE's attempts to achieve better relationships and open channels of communication with stakeholders - particularly the NHS and patient groups. The future credibility of NICE rests on it being responsive to criticisms, and to it being willing to study them, and if necessary, learn from them. Wherever possible, any resulting press statements about the resolution of disagreements should be agreed with the other parties involved before release (paragraph 38).

Improved transparency

(f)  We recommend that all information which NICE uses in its decision-making process is made available for public scrutiny. If industry or others have previously unpublished data which they want to use to support their case then this should no longer be presented to NICE subject to confidentiality (paragraph 40).

(g)  We recommend that NICE should improve the transparency of its processes by striving to make information on how and why its decisions are taken, and on members' declarations of interests as readily and clearly available to lay stakeholders as possible. For the sake of clarity, members should declare all interests at the beginning of each appraisal. The decision-making audit trail could be improved if the NICE website supplemented its sections on individual technology appraisals with links to the minutes of all relevant meetings. It would also be helpful if, instead of listing the full membership of the Appraisal Committee, each guidance document listed those specific members who had taken part in decision-making on that particular treatment, and those who had withdrawn due to competing interests (paragraph 43).

The appeals system

(h)  Improvements in the inclusiveness and transparency of NICE's processes are needed to ensure that the appeals process is not the only means for stakeholders to enter into constructive dialogue with NICE (paragraph 45).

(i)  The current role of the Chair in the appeals system seems to us to be flawed. We recommend that the Government gives careful consideration to reforming the appeals system, as it has at least the appearance of lacking impartiality. We are also concerned that the distance that this creates between the Chair and the everyday business of NICE may be to the detriment of the organisation as a whole (paragraph 49).

Improved clarity

(j)  We recommend that NICE should strive to improve clarity and co-ordination within and between its own workstreams, and should work closely with the Government to ensure clarity about the relationship between its own work, NSFs and other policy initiatives in the NHS (paragraph 54).

A shift in focus from technology appraisals to clinical guidelines

(k)  We recommend that the Government should fundamentally shift the emphasis of NICE's work away from appraisals of specific treatments or interventions in isolation from the wider condition-management framework, towards producing guidance relating to classes of drugs or relevant groups of drugs, and/or on the treatment of particular conditions. In addition, we endorse the recommendation of the Kennedy Report that NICE's guideline development programme should be extended to cover all major causes of mortality and morbidity. This may necessitate an increase in NICE's capacity and/or a change in its organisational structure (paragraph 59).

The timing of NICE guidance

(l)  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 programme (paragraph 67).

The legal status of NICE guidance

(m)  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 (paragraph 68).

Implementation and monitoring of NICE guidance

(n)  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 (paragraph 76).

(o)  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 (paragraph 80).

(p)   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 (paragraph 81).

Improvements on information and evidence

(q)  We recommend that the Government should take steps to ensure the submission of all relevant clinical information to NICE. The definition of what types of information are deemed 'relevant' to NICE will obviously require careful consideration, and to this end we suggest that NICE should work with the ABPI to establish guidelines on which types of information must be routinely supplied to NICE, and which types must be made available on request. If the ABPI is prepared to require companies' compliance with these guidelines as a condition of continued membership, it may be possible to avoid the alternative of legislation in order to ensure that no important information is withheld from NICE (paragraph 85).

(r)  Improved regulation of submission of information to NICE should be supplemented by closer working relationships between the MCA and NICE, including the sharing of appropriate summary information prepared for the CSM, in order to prevent duplication and strengthen the quality of NICE's outputs (paragraph 86).

(s)  We accept that there are limitations on the information that can be gained prior to the launch of a treatment, and that there is a tension between the difficulties in assessing clinical effectiveness at an early stage, and the NHS's evident need for guidance at the time of launch to help it manage the introduction (or restriction) of new treatments in the NHS. The system of appraisals at the time of launch that we have recommended does not preclude the possibility of conducting fuller appraisals of a treatment's effectiveness when more information has been collected. Indeed, we recommend this should take place, but within the broader context of NICE's main work on clinical guidelines (paragraph 91).

(t)  We recommend that NICE should consider options for improving its evidence base in respect of patient experience and quality of life, including the possibility of working with governments, at national and E.U. level, and with the pharmaceutical industry to promote the routine inclusion of condition-specific quality of life measures into controlled clinical trials carried out prior to licensing by the pharmaceutical industry. NICE may find it profitable to draw on the expertise of the new Commission for Patient and Public Involvement in Healthcare when this body is established. The Government should consider extending the remit of this body to include explicitly the securing of appropriate patient input into NICE processes (paragraph 94).

Quality assurance of NICE's work

(u)  We recommend that NICE should ensure that the academic centres to which it contracts its assessment work are adequately resourced to enable them to conduct Health Technology Assessments to the highest possible standard. Increasing the resources NICE directs at this area of its activity may enable it to improve the quality of its work and recruit more scientists of the highest calibre and experience. In addition to this, we are concerned that with the considerable expansion in NICE's coverage we have suggested, there may be workforce as well as funding issues. There are at present only a limited pool of skilled academics available within the UK, especially in the field of health economics, and the pharmaceutical industry is competing to recruit from the same pool. NICE and the Government must work together to address this problem (paragraph 98).

(v)  We recommend that the Government institutes independent detailed peer review of a random selection of guidance prepared by NICE. This could be carried out by CHI/CHAI on a three-yearly basis (paragraph 99).

Greater clarity over criteria for evaluating clinical and cost-effectiveness

(w)  Whether or not Quality Adjusted Life Years are used, we recommend that NICE should consider the wider societal costs and advantages of particular treatments and in particular the wider costs and benefits to the public purse of reduced benefit dependency and improved ability to work both for patients and their carers (paragraph 102).

(x)  We note NICE's plans to establish a Citizens Council composed of "ordinary men and women around the country" to advise on these value judgements. [188] We agree with the many witnesses who argued for a review of NICE's appraisal methodology, and the publication of clear criteria.[189] We therefore recommend that NICE, aided by the Department of Health, should conduct a review of its methodologies for assessing clinical and cost-effectiveness, which should result in the publication of a set of clear and consistent criteria for the assessment of both aspects. This should include a description of the weighting given to different types of evidence, a detailed argument for its use of Quality Adjusted Life Years, and the impact of both cost and clinical effectiveness on the final determination, including any cost-effectiveness 'thresholds'. In tandem with this, NICE should work to strengthen its cost-effectiveness evidence base by encouraging pharmaceutical companies to collect this type of data routinely (paragraph 104).

Affordability of NICE's recommendations

(y)  Decisions about the affordability of NICE's recommendations are, we believe, properly a matter for government. We also believe that there is a need for decisions about the affordability of NICE's recommendations to be seen to be made entirely separately from NICE's decisions about clinical and cost-effectiveness. While we have received no compelling evidence that these decisions are not being taken independently, the widespread perception that the three elements are linked urgently needs to be dispelled. We therefore recommend that the Government should take steps to clarify its own role in taking decisions about whether or not individual pieces of NICE guidance will be funded. One solution would be for the Department of Health to issue a separate document alongside each piece of NICE guidance, stating the costs (both financial and staffing) of implementation of the guidance, and on the basis of this indicating whether or not, and in what circumstances, the guidance was to be implemented (paragraph 107).

Selection of topics for NICE's work programme

(z)  Some witnesses (including, for example, the BMA) argued that NICE should be able to determine its own work programme, suggesting that this would facilitate a more neutral, rational appraisal of the costs and total health benefits of various treatments, drawing on public and professional concerns, and that it would significantly improve NICE's credibility.[190] However, NICE itself does not ask for this additional responsibility. We feel that this very high-level prioritisation is rightly the job of Government, rather than that of a body which is not publicly or politically accountable for such a function (paragraph 116).

(aa)  We welcome in principle the idea of a web-based topic proposal system suggested in the Government's consultation, but this needs to be supported by a clear and transparent selection process for the assessment of proposed topics. We feel that current government proposals for widening the membership of the Technology Advisory Group (TAG) still leave the NHS, and in particular patients, under-represented.[191] We therefore recommend that the skills mix of the TAG is further weighted towards these groups, and that the deliberations and decisions of TAG meetings are put into the public domain (paragraph 118).

(bb)  We welcome the amendments to the selection criteria proposed by the Government in its consultation document, as we feel they offer a clearer, more consistent and more rational framework for the selection of topics. However, we recommend that these criteria are explicitly underpinned by the principle of maximising total health benefit to all patients. The process by which topics are assessed against these criteria must also be inclusive and transparent, and should be backed up by a clear and public explanation of why particular topics have been prioritised for assessment by NICE (paragraph 126).

(cc)  We welcome the fact that the need to evaluate treatments and interventions where the evidence suggests that it may be appropriate for the NHS to reduce rather than expand use is reflected in the Government's proposed selection criteria, and recommend that the Department of Health gives explicit consideration to devoting a larger proportion of NICE's clinical guidelines programme to work in this area (paragraph 128).

Policy on beta interferon

(dd)  We recommend that the Government, working together with NICE, should ensure that any subsequent decisions which could appear to run contrary to NICE recommendations are issued in a way that is sensitive to the potential risk such decisions may pose to NICE's credibility. Such decisions should be clearly communicated to stakeholders, and could be issued in collaboration with NICE (paragraph 129).

Prioritisation within the NHS

(ee)  Prioritisation of healthcare spending is an issue of overwhelming importance, and during the course of this inquiry it has become clear to us that a more open debate on healthcare prioritisation needs to take place. Our inquiry has persuaded us that, with so many competing interests vying for attention and funding in an area where resources are finite, it is not sufficient to have implicit healthcare prioritisation. We feel that NICE has been laid open to unfair criticism in respect of the 'rationing' debate, as a consequence of the lack of clarity in policy here (paragraph 134).

(ff)  We wish to record our view that the Government must work to achieve a comprehensive framework for healthcare prioritisation, underpinned by an explicit set of ethical and rational values to allow the relative costs and benefits of different areas of NHS spending to be comparatively assessed in an informed way. Such a framework would need to secure the input of the wider population as well as NHS patients and staff, policy makers and academics. Although we are not seeking a detailed response on this point, we would welcome an acknowledgement on the part of the Government that this is a key issue, and we would not be convinced if the Government were to argue that prioritisation were already subject to such a framework (paragraph 135).

189   Ev 2 (Consumers' Association); Ev 246 (Aventis). Back

190   Ev 197-98. Back

191   Proposed membership includes 12 representatives from the Department of Health/ National Assembly for Wales, 3 representatives from NICE, 4 from the NHS and 2 from patient organisations (Clinical Guidance from the National Institute for Clinical Excellence - Timing and Selection of Topics for Appraisal, Department of Health/ National Assembly for Wales, March 2002, Annex B). Back