1.  EXECUTIVE SUMMARY

  1.1  The Medical Technology Group (MTG), launched in 2000, is an active coalition of patient groups, medical professionals and industry, committed to promoting patient access to technologies, such as diagnostic equipment and surgically implanted devices, as well as ensuring the introduction of new innovations. Now in our seventh year, we are making a big difference in widening patient access to medical technology, including the latest treatments for heart conditions, diabetes, stroke, orthopaedics and continence. We want to see a modern and effective NHS responsive to the needs of the patient.

  1.2  The Medical Technology Group welcomes the opportunity to be able to comment on the work of the National Institute for Health and Clinical Excellence through the Health Select Committee inquiry. Medical technologies are in a unique situation in that they can be subject for inclusion in technology appraisals, clinical guidelines, and the interventional procedures programme. Therefore the Medical Technology Group is extremely well placed to comment on the work of the Institute.

  1.3  Recommendations:

—  NICE guidance should take in to consideration long-term—across the board—saving gains that can be produced by medical technologies.

—  An independent mechanism should be put in place to determine initial topic selection.

—  NICE guidance for medical devices should be produced more quickly so as to not stifle innovation and ensure patients can get access to the latest medical technologies.

—  Implementation of NICE guidance should be monitored more closely.

—  There should be a joined up strategy between NICE and procurement systems to ensure that medical devices which have positive NICE guidance are made available to patients in a timely fashion.

MTG RESPONSE TO THE COMMITTEE'S REMIT

2.  WHY NICE'S DECISIONS ARE INCREASINGLY BEING CHALLENGED

  2.1  The National Institute for Health and Clinical Excellence is renowned the world over as the gold standard for assessing the clinical and cost effectiveness of treatments, including medical devices, via technology appraisals, clinical guidelines and its interventional procedures programme. As NICE guidance is increasingly becoming the determining factor by which Trusts allocate their limited resources, the importance of receiving a positive determination from NICE is more important than ever.

  2.2  Therefore industry, patients and clinicians are all more likely to appeal against a negative decision for a treatment that they consider to be clinically important to ensure that it remains available for those who require it. This is particularly the case if the reason for the negative determination has been made primarily on cost effectiveness rather than clinical effectiveness. Long term vision is lacking and long term savings that medical technologies can achieve are ignored in the NICE process, with its narrow focus on institutional budgets.

3.  WHETHER PUBLIC CONFIDENCE IN THE INSTITUTE IS WANING, AND IF SO WHY?

  3.1  In September 2006 the Department of Health announced that NICE will play a bigger role the topic selection process. NICE's new extended role means that it will be the principal point of contact for individuals and organisations which want to suggest topics. It is now also responsible for the initial "sifting" of suggestions. This allows the Institute to be open to questions of impartiality—and therefore confidence—as this system may be perceived by the public and the health service as biased. The Medical Technology Group believes that NICE should not have control over initial topic selection. A body independent of NICE should be given a mandate to determine which topics are to be taken forward—and at what time—in the NICE process. Without an independent and transparent topic selection process the Institute could be subject to criticism that high profile treatments and conditions are given precedence over equally essential but less well known treatments and conditions. By ensuring that the topic selection process is entirely independent and transparent, NICE will not be open to criticism in this way.

  3.2  Public confidence in the Institute is also waning due to inconsistent implementation of NICE guidance. The MTG view on implementation is included in section six of this document.

4.  NICE'S EVALUATION PROCESS, AND WHETHER ANY PARTICULAR GROUPS ARE DISADVANTAGED BY THE PROCESS

  4.1  NICE makes recommendations on a case-by-case basis taking into account both clinical and cost effectiveness, and rejects the use of an absolute cost threshold. Many medical technologies have an initial high cost but create long term savings within the National Health Service. The NICE process should take this into account when producing guidance. For example medical technologies—such as a stent or hip replacement, where specialist techniques and instruments are used—facilitate faster recovery times, lower morbidity and reduce beds days. These techniques have the potential to offer significant benefits both to individual patients and the NHS.

  4.2  As recovery times are significantly reduced, patients are able to get back to normal life more quickly. Using medical technologies means that patients can be back at work, contributing to the economy much quicker and the length of inpatient stay can be greatly reduced. The Medical Technology Group believes that NICE does not give enough weight to wider societal implications when constructing guidance. At a time when financial resources are becoming scarce, considering the long term cost-saving benefits of medical technologies should be considered in the production of NICE guidance.

5.  THE SPEED OF PUBLISHING GUIDANCE

  5.1  NICE guidance can be viewed as one of many barriers which is stifling innovation in the UK. The UK market for medical devices is extremely small. If companies are not able to innovate and gain timely NICE guidance for new products then there is the possibility that medical device manufacturers will move overseas to more favourable markets which support innovation. This would be the worst possible outcome for patients in the UK as they will not be able to get access to the latest innovations in the medical technology market through the National Health Service and will either have to pay a premium for these things in private practice, go overseas for the most innovative treatments, or miss out on the best treatments completely.

  5.2  Sufferers in some areas have been faced with "treatment blight"—the reluctance of doctors to prescribe devices because no decision has been made by NICE, ie a product either hasn't been through the NICE process at all, or it is in the process of being appraised prior to a final determination being made.

  5.3  The MTG considers that implementation of the Single Technology Appraisal process needs to ensure that manufacturers and patient groups are given a right to reply to the "Evidence Review Group" Report before submission to the Appraisal Committee. This ensures the same degree of consultation is afforded as in the existing Multiple Technology Assessment process.

6.  THE IMPLEMENTATION OF NICE GUIDANCE, BOTH TECHNOLOGY APPRAISALS AND CLINICAL GUIDELINES (WHICH GUIDANCE IS ACTED ON, WHICH IS NOT AND THE REASONS FOR THIS)

  6.1  NICE guidance has no impact on patient care unless it is implemented. The Medical Technology Group is concerned that there is variation in the uptake of some NICE technology appraisals relating to devices and surgical procedures and recommends that NICE institutes a compliance mechanism which demonstrates mandatory rapid—within three months—adoption of guidance.

  6.2  Implementation of national policies and guidance relating to the use of technologies is often lost in a plethora of other priorities. Guidance issued by the technology appraisal advisory committee of NICE supposedly carries a mandate under the Health Services Act, yet its implementation is haphazard. Guidance on Insulin Pumps was issued in 2003, clearly defined a population who might benefit, but patient groups, who support pump wearers and their families, still commit enormous resources to fighting local battles where PCTs will not act on the guidance. NICE itself has an implementation systems directorate which supports, rather than monitors, implementation and the issue does not appear to be a sufficiently high priority for the Healthcare Commission. Given the resources committed to NICE, failure to rigorously enforce its guidance represents a significant loss of opportunity for patients to benefit from clinically and cost effective treatments.

  6.3  The financial costs of insulin pump therapy are often mentioned as a barrier to its wider application across the diabetic population. A pump, covered by the manufacturer's warranty for four years, costs on average £2,400, plus £800 pa for consumables (infusion sets, insulin cartridges, batteries, etc). If a pump is replaced every four years, the average yearly cost of the therapy is £1,400. One overnight stay in hospital following admission to A&E for a diabetic emergency costs £350. One procedure of dialysis treatment for diabetic kidney disease costs £504. One course of laser treatment for diabetic retinopathy costs £847, plus incalculable weeks off of work. In light of these costs for treating poorly controlled diabetes, insulin pump therapy as preventative medicine seems extremely cost effective.

  6.4  The Medical Technology Group is concerned that new product procurement processes put in place by NHS Supply Chain will not be rapidly responsive to reflect positive NICE guidance. NHS Supply Chain was created to facilitate centralised procurement for Trusts. Trusts can opt in and out of this process, however the 40% market share NHS Supply Chain has is likely to encourage NHS Trusts to procure through it. This may mean that a device which has received positive NICE guidance will not be used widely by Trusts until it is included on the preferred supplier lists which may be created by NHS Supply Chain and closed for a number of years. The Medical Technology Group would like to see a mechanism put in place which allows devices which have been given positive NICE guidance to gain easy and timely access to patients.

  6.5  The Medical Technology Group believes that the implementation of NICE guidance should be actively monitored by the Healthcare Commission. The Healthcare Commission Annual Health Check provides the basis for NICE's implementation monitoring. However, at present, NICE does not receive specific feedback from the Healthcare Commission about the implementation of individual pieces of guidance, even on a broad scale. The Medical Technology Group believes that it is essential that NICE receives information about the implementation of its guidance and a feedback mechanism is put in place to ensure that Trusts which do not implement guidance within the required timescale are made to do so.

7.  RECOMMENDATIONS FOR ACTION

  7.1  NICE guidance should take in to consideration long term—across the board—saving gains that can be produced by medical technologies.

  7.2  An independent mechanism should be put in place to determine initial topic selection.

  7.3  NICE guidance for medical devices should be produced more quickly so as to not stifle innovation and ensure patients can get access to the latest medical technologies.

  7.4  Implementation of NICE guidance should be monitored more closely.

  7.5  There should be a joined up strategy between NICE and procurement systems to ensure that medical devices which have positive NICE guidance are made available to patients in a timely fashion.

The Medical Technology Group

March 2007