EXECUTIVE SUMMARY

  Issues relating to topic selection and methodology are undermining public confidence in NICE.

  Recent changes to the way the Institute operates have not helped in this regard.

  Medical device technologies face peculiar and additional barriers to their uptake following guidance compared with pharmaceuticals.

  Medtronic welcomes the opportunity to submit evidence to the Health Select Committee, addressing the important issue of the National Institute for Health and Clinical Excellence (NICE). Medtronic provides advanced medical devices for patients in the United Kingdom. Since the inception of NICE in 1999 we have been an active stakeholder in over 50 work programmes of the Institute. As well as working with the Institute during the production of its guidance we are also closely engaged with other organisations who are interested in ensuring that such guidance is acted upon.

  We would like to offer the following evidence, appropriate to the Committee's terms of reference. The evidence reflects our experience described above.

Whether Public Confidence in the Institute is Waning, and if so Why

  1.  We believe that this is the case, and would cite issues around topic selection, conflict of interest within the health technology community and concerns over methodologies employed.

  2.  The topic selection process to decide which technologies and conditions are looked at by the Institute has recently been overhauled. The new system give the Institute far more say in which topics are considered than was previously the case. We have concerns that this will see the Institute support the selection of technologies that are easy to appraise at the expense of those that might be more problematic, but have wider societal benefit. We believe the topic selection process should be independent of the Institute.

  3.  We are concerned that conflict of interest is rife amongst the institutions involved in the production of the independent health technology assessments considered by the Institute. As academic institutions they are keen to publish research and lead thought in methodology and policy in the area. They also derive revenue from their work undertaking assessment reports and economic modelling for NICE, and many are also employed by industry to do the same on behalf of manufacturers during a technology appraisal. All of these individual elements are perfectly legitimate in their own right, however there is a problem when institutions attempt to combine all four elements at the same time. For example, during the current review of coronary artery stents, the review group conducting the independent assessment report published an article in a peer reviewed journal concluding that the technology could not be considered cost effective. In such situations it seems to us that stakeholders arrive at the table knowing that other key parties have already made up their mind about the likely outcome. This, we believe, brings the appraisal process into disrepute.

  4.  NICE's decisions during a technology appraisal are very heavily determined by the estimates of incremental cost effectiveness ratios. We accept that a key role of the Institute is to decide on what represents value for money for the NHS, however are not convinced that the methodologies employed are robust enough to make such decisions consistently and accurately. Quality Adjusted Life Years (QALYs) derived using one methodology in one population, probably measure something fundamentally different from QALYs derived using another methodology in a different population, yet comparisons between the two are regularly made. Health economics does not appear to be a mature enough discipline to answer the questions that are being asked of it, and we believe that the assessment groups and appraisal committee are sometimes disingenuous about the uncertainty inherent in the economic models they favour. Whilst it is fair to say the models used often represent the best available estimation of cost effectiveness, sometimes those estimates are not robust enough on which to base important decisions for patients and the NHS.

  5.  We are concerned also that the cost effectiveness thresholds that NICE indicates as acceptable are arbitrary.

The Speed of Publishing Guidance

  6.  We accept that there is need for the Institute to ensure that its quality standards and consultation processes are robust, and that this means that it will take some time to produce final guidance. We do feel, however, that the current process could be achieved more quickly by a simple reduction in the time allocated to the production of independent assessment reports.

  7.  We believe that the current attempt to shorten the process by the use of single technology appraisals (STA) is misguided. One of the strengths of NICE's existing process is that the assessment is seen as independent and there is inclusive and meaningful consultation, with the views of stakeholders demonstrably being taken into account. The problem with relying only on a manufacturer's submission, as is the case with STA, is that a consultative process is turned into an adversarial one. We feel that the instinct of the Committee, understandably, will be to be more suspicious of a manufacturer's submission than they would of one produced by an independent assessment group.

The Implementation of NICE Guidance, Both Technology Appraisals and Clinical Guidelines (Which Guidance is Acted on, Which is Not and the Reasons for This)

  8.  Our experience is that the deciding factor on the successful implementation of guidance is the presence of a local champion. Our work with Cardiac Networks Device Survey Group illustrated that for pacemakers and implantable defibrillators, there was no correlation between implant rates and deprivation, number of cardiologists or type of cardiology centre. Rather it was apparent that a single, strong local advocate could have a very significant impact on the provision of local services.

  9.  Medical devices, such as implantable cardioverter defibrillators (ICDs), have an additional challenge to their uptake because of the way they are commissioned. Pharmaceutical technologies approved by NICE often have no other barrier to their increased utilisation than changing the prescribing behaviour of doctors, whereas many technologies require infrastructure alterations, increased provision of specialised services or bespoke training and education programmes.

  10.  Furthermore, the cost of decisions relating to such technologies is often more visible at an individual patient level than that of changes in prescribing, even if the overall impact is much less. For example when guidance on the use of ICDs was first issued, it was described as the single biggest risk to PCT budgets from a NICE decision, yet last year the NHS spent £60 million on the devices and some £1 billion on statins to reduce cholesterol. Faced with the choice of approving a drug which might cost £10,000 over five years or a device that costs £10,000 today, we believe PCTs will discriminate against the device, even if the cost was a one off payment that effectively represented five years treatment. Primary care organisations need greater support to implement guidance when it relates to specialist services or requires the explicit and rapid reallocation of resources.

  11.  We believe that the implementation of NICE guidance is not a significant enough priority for NHS organisations, and implementation could be improved by a greater emphasis being placed on it by the Healthcare Commission.

RECOMMENDATIONS

—  The topic selection process should be independent of NICE.

—  No part of the Institute's work should rely solely on submissions from manufacturers.

—  Primary care organisations should be given bespoke support for guidance issued relating to specialised technologies and/or those requiring a significant up front investment.

—  Monitoring the implementation of NICE guidance should be an absolute priority for the Healthcare Commission.

Richard Devereaux-Phillips

Medtronic Ltd

March 2007

 [Mr Devereaux-Phillips serves as a member of the Health Technology Assessment Advisory Committee of NICE]