Select Committee on Health Minutes of Evidence

Annex 1



  1.1  ABPI believes that the majority of NICE guidance should take the form of best practice guidelines on the overall treatment of clinical conditions; where guidance on individual technologies is issued, this should only be given when there is mature evidence upon which to base reliable conclusions.

  1.2  ABPI recognises that the NHS needs information on new medicines at launch. The National Prescribing Centre provides high-quality, objective information on new medicines and we would recommend this as a model. Information (rather than guidance) at launch should include the licensed indications, the summary of product characteristics, a summary of the available evidence, the product's proposed position in treatment, and an estimate of budget impact based upon licensed use and clinical practice.

  1.3  New medicines (ie those that have been launched within the last two years) constitute only 0.3 per cent of the total NHS budget. The approach above does not run counter to the DH's need to manage NHS resources effectively, and offers the benefits of improved evidence and greater confidence in the quality of NICE guidance when it is ultimately given.


  2.1  Historically, the NHS has had the option to choose guidance from a wide variety of sources, and in many cases NHS organisations have developed their own guidance. There is little evidence that this situation has changed: local committees still exist at many levels, and if anything, with the advent of PCOs, the number of bodies used to filter national, or develop local, guidance has increased. NICE guidance is also being interpreted differently in different locations. There is still, therefore, considerable variation in clinical practice on the ground.

  2.2  NICE itself has "double vision" in examining technology appraisals and clinical guidelines. Completely different experts are used for each process, and guidelines groups are not allowed to comment on draft guidance issued for technology appraisals. Quoting specific examples, the scope of the clinical guideline for multiple sclerosis, which is under development, does not include reference to any disease modifying therapies, and is focused only on palliative care. Another example is the scope of the clinical guideline for falls, which does not include treatments that prevent or treat osteoporotic fractures, a major cause of disability in the elderly.

  2.3  There remains room for improvement in coordination between the creation of NICE clinical guidelines and the broader issues considered by such policy areas as National Service Frameworks (NSFs). For example, Standard 6 of the NSF for Older People covers both falls and fractures as priority areas of clinical need to reduce visits to Accident & Emergency Departments. The scope of the NICE guideline for falls excludes any consideration of fractures. Achieving cohesion is a challenging task, and illustrates the complexity and difficulty in getting the scoping right for NICE's technology appraisals and clinical guidelines projects.

  3.  Is NICE providing guidance that is locally owned and acted on in the right way?

  3.1  As stated earlier, even once NICE guidance is issued, implementation is poor. ABPI has undertaken a detailed analysis of uptake of medicines appraised by NICE, and Annex 2 to this document gives some extracts from this work. The work demonstrates that:

    —  There are still wide variations in uptake of medicines that have been appraised by NICE: postcode prescribing still persists.

    —  Increases in uptake have rarely resulted from NICE guidance.

    —  The Annex quantifies the continuing problem of low uptake by the NHS by analysing expenditure on medicines for which NICE guidance up to October 2000 had been available for a full year. NICE's own estimates of increased uptake in its guidance predicted a total annual addition of £93 million. This figure compares with an actual increased uptake of, at most, £32 million, ie only a third. There is also evidence that predicted savings accruing from NICE decisions have not been realised.

  3.2  The Government's recent announcement requiring HAs and PCOs to fund NICE recommendations is implicit confirmation that they not currently being implemented satisfactorily. While we very much welcome this move as a step in the right direction, we would contend that additional sufficient funding needs to be made available to enable such compliance.


  Annex 3 shows that many patients are still failing to benefit from faster access. Measures to promote and fund best practice through the issuing of NICE guidance are not yet sufficient to the task.


  5.1  NICE's work programme is decided by Ministers. NICE has developed its structure and processes in a concerted attempt to involve a broad range of stakeholders who can give a broad perspective on its activities. Perceptions prevail among many stakeholders that NICE is not independent of Ministerial intervention, and is not yet perceived as a genuine force for improving the quality of NHS care rather than as a tool to control costs.

  5.2  Currently, NICE is a Special Health Authority and is constituted to receive directions from Ministers on technologies subject to review. The process for appointments to NICE bodies is with the agreement of Ministers. ABPI believes that NICE has the best opportunity to achieve its objectives if it remains part of the NHS family. However, we also believe that whilst it should remain linked to the DH, it should be independent of Ministers in the conduct of its technology appraisals and its development of guidance and guidelines.

  5.3  NICE is an organisation that has the potential to have significant effects on patients, clinicians, the health of the nation, and on the industries that provide new solutions to unmet clinical need. It is important therefore that it be publicly accountable for its activities and the impact these have on the quality of NHS care and on its stakeholders.

  5.4  The objectives of NICE are not yet being met. The future status of NICE is under some discussion; currently as a Special Health Authority it is subject to quinquennial review. Our concern is that such a review process is inadequate in view of NICE's state of evolution and essential role in the setting of standards and improving NHS care, and we support a two yearly review by an independent body.

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Prepared 8 July 2002