Select Committee on Health Minutes of Evidence


Memorandum by the Medical Technology Group (MT 44)

INTRODUCTION

  The Medical Technology Group (MTG) appreciates the opportunity to submit evidence to the Health Select Committee, addressing the critical issue of patient access to medical technology in the United Kingdom. Representing 25 health care organisations, the MTG is a coalition of patient groups, clinicians and industry representatives committed to increasing patient access to medical technologies within the NHS (see Appendix A). As such the MTG welcomes the announcement of the Committee's inquiry.

  The MTG has long been concerned that the UK lags behind other industrialised nations in its use of critical, life-saving and enhancing medical technologies. The reasons behind the barriers to patient access of medical technology are numerous and the MTG's submission attempts to outline the nature of these barriers plus make recommendations for reform.

MTG VIEWS ON THE INQUIRY'S TERMS OF REFERENCE

1.   The effectiveness and cost benefit of new technologies

  1.1  Medical device technologies span a very broad range of therapeutic, palliative and preventive modalities, serving patients in innumerable ways. From tissue based implants for reconstructive surgery to neurostimulators for severe movement disorders, to computer-driven drug delivery systems, medical technology plays a role in every facet of health care.

  1.2  The uses of medical technology bring enormous benefits to patients, from critical and acute care to rehabilitation, patients depend on medical technologies to continue every day activities and to give new hope for productive, healthier lives. In addition to clinical and other patient benefits, medical technologies also bring significant economic benefits to the NHS and to our society.

  1.3  But traditional tools for measuring the benefits of medical technologies often have failed to reach beyond the clinical setting. This broad range of life enhancing products can bring economic and human returns in terms of enhanced quality of life and renewed patient and health care provider productivity.

  1.4  Models for assessing the benefit of technology should consider wider benefits to society as a whole. A patient who's quality of life is improved by more effective treatment methods, reduced hospitalisation and fewer return visits to hospital is likely to have a quicker return to pre illness activity. That might be a return to work and income generation, to a vital caring role within the family or just to live independently. All reduce the burden on other community services and/or State support.

  1.5  The MTG believes that adequate patient access to medical technology will enable the Government to achieve many targets including those set out in the National Service Frameworks (NSFs) and other Department of Health guidelines.

Improved quality of life for patients

  1.6  In addition to providing cost benefits and effective clinical solutions, medical technology has an enormous role to play in raising the quality of life of patients who suffer from a wide range of chronic and acute medical conditions. This manifests itself in a number of different ways:

    —    Increased life expectancy.

    —    Reducing further complications for patients.

    —    Improved standards of living.

    —    Improved productivity, both for patients and their caregivers.

  1.7  In contrast to this, there are significant costs if adequate provision of medical technology is not made. For example, the continued dominance of coronary heart disease patients in UK hospitals is a problem that can be addressed through new technologies for prevention and treatment.

  1.8  A questionnaire by SADS UK to families with a member suffering from a cardiac condition that had been addressed by an implantable cardio-defibrillator (ICD), showed that there was not only increased quality of life, but peace of mind for parents and carers:

    "The positive response from those living with an ICD or as a parent of a child with an ICD was quite staggering compared to the more negative response of those purely taking anti-arrhythmic medication".[15]

  Personal statements from this survey included:

    —    "I feel it's a life saver."

    —    "It gives me freedom from the anxiety of suffering cardiac arrest."

    —    "It's like having a portable hospital inside me."

    —    "I can live as normal a life as possible without the worry of dropping dead at any moment."

    —    "It's a life-saver after losing my other child to the same condition."

  1.9  There is evidence that suggests once a condition is detected, and the necessary treatment is given, patients can experience improvements in psychological well-being. In a study of 38 patients (6-18 years) with recurrent arrhythmias who underwent radio frequency catheter ablation of ectopic myocardial foci, psychological functioning was assessed and the patients resembled a normal population without elevations in anxiety or depression. After they had had the ablation, the patients showed reductions in the "fear of their heart problem" and increases in "the things that they enjoy". The findings showed that the patients who underwent a curative ablation had better functioning and that children appear to have the opportunity for an improved quality of life after ablation[16].

Increased Safety

  1.10  Improved safety and reduced complications often result from the adoption of new medical technologies. This lessens the anxiety for patients and their families, that results from uncertainty and repeated hospital visits. For example, innovations in phacoemulsification for cataract removal mean that fewer complications will occur, meaning less post-operative visits and increased patient throughput.

  1.11  Case Study 1 (below)—Reduction of injuries using safer needle devices, demonstrates clearly that all the stakeholders have worked together to massively reduce the risk from sharps to both healthcare worker and patients (see case study 1 and Figure 1, below). Reducing these complications has led to service improvements:

    Case Study 1—Reduction of injuries using safer needle devices

    —  It is estimated that over 100,000 sharps injuriesi occur in the NHS every year, and these could cost NHS trusts as much as £500,000 per yearii.

    —  But sharps modified with safety devices are now readily available to the NHS (see Fig 1).

    —  The Department of Health's "Blue Book" on preventing sharps injuries is expected soon, and will require NHS trusts to take measures to improve data collection, identify training needs and identify where safety technology could be introduced to reduce risksi.

    —  MTG supports the Government in this drive and notes that additional funding may be required, in the first instance, for safer technologies to be introduced.

i  www.saferneedlesnow.net

ii  National Audit Office, "A Safer Place to Work: Improving the Health and Safety Risk to Staff in NHS Trusts", p 30, 2004.

Figure 1

REDUCTION OF INJURIES USING "SAFETY" CATHETERS AND WINGED STEEL "SAFETY" NEEDLES[17]


Economic benefits

  1.12 The use of medical technology plays a large role in helping transform the NHS and increasing patient productivity—a vital element in an economy facing the prospect of an ageing society. According to Government figures, the number of people aged over 65 has doubled in the last 70 years and the number of people over 90 will double in the next 25 years[18]. New technology can increase the throughput of patients, address problems of bed blocking, reduce patient waiting times and improve overall patient access to the NHS (see Case Study 2, overleaf).

—  Hospital productivity

  1.13 The use of medical technologies can bring long-term economic gains by shifting the site of care to less intensive settings, for instance from inpatient hospital to day-surgeries or home care. By reducing hospitalisation, waiting times are often reduced and hospital capacity is freed. For example, women suffering from menorrhagia (heavy menstrual bleeding) can be treated by free fluid thermal endometrial ablation in a day case setting and consequently avoid the need to undergo surgical hysterectomy, which has an average hospital stay of over five days and many weeks recuperation period.

—  Improved patient productivity

  1.14 Increased investment in medical technology leads to an increase in societal productivity. In today's ageing society, this is vital if people are to lead active lives unencumbered by the health and mobility problems associated with old age. For instance, technologies like hip and knee implants are improving the quality of health care and reducing costs by enabling people to return more quickly to active, productive lifestyles. These effects therefore have the potential to assist the UK economy in its drive to maintain a competitive edge—and by reducing dependency on social security and disability benefits.

  1.15 Use of technology to improve public health has widespread consequences for the economy. For example, in the US, the societal value of a 1% reduction in heart disease has been found to be worth some $500 billion—twice the size of the public Medicare insurance annual budget[19]. According to David Canning, a health economist whose work is cited in the 2002 Wanless Report, a similar per-ratio figure for the UK is not inconceivable. A new study investigating Patent Foramen Ovale closure for migraine could begin to address the £750 million and 18 million work days lost to the UK economy each year due to migraines[20].

    Case study 2—Thyroidectomy by Harmonic Scalpel

    —  In the UK currently around 9,000 thyroidectomies are performed annuallyi; the procedure takes between one and three hours to perform. The current technique involves careful dissection and tying of the vessels with sutures, which results in blood loss.

    —  Alternatively, thyroidectomy can be performed using the harmonic scalpel. This reduces blood loss, clinical risk and procedure time by 30 minutesii.

    —  Based on sample resource costs from 11 NHS hospitals, it is estimated that the net saving would be around £740,000 across the UK after taking into account additional capital and consumable costs. This should also free up NHS capacity to treat more than 3,000 additional patients waiting for major surgery. iii.

    —  Adoption rates for this technology are limited by annual capital budget constraints at the hospital level and poor financial flexibility on capital finance options.

i  Hospital Episode Statistic 2003-04 and industry estimates of private activity.

ii  P Voutilainen et al. "Ultrasonically Activated Shears in thyroidectomies", Helsinki University, Finland.

iii  Estimate by Johnson and Johnson, based on average resource costs of the 11 Trusts taken from reference cost databases.


2.   The Speed of and Barriers to, the Introduction of New Technologies

  2.1  Although the UK is a world leader in inventing and developing technologies, [21]this is in stark contrast to its continued failure to exploit this strength in innovation, and utilise the vast investment in research and development. The UK lags far behind other countries in its spending on medical technology, as illustrated in Figure 2:

Figure 2

EXPENDITURE ON MEDICAL TECHNOLOGIES BY SELECTED COUNTRIES, AS A PROPORTION OF TOTAL HEALTHCARE EXPENDITURE AND GROSS dOMESTIC PRODUCT[22]


Country% of healthcare spent on medical technologies % of GDP spent on medical technologies
France6.50.62
Germany8.60.92
Italy5.80.5
Slovenia7.10.57
Spain6.10.46
UK4.8 0.36
European average6.4 0.55
USA5.10.71

  2.2  Because of these low rates of utilisation, patients in the UK fail to reap the benefits of technologies available to other nations, through shorter recovery times, reduced hospitalisations, and increased quality of life and productivity. Illustrated overleaf is just one example of the UK's technology access gap: modern cancer screening techniques that are used more widely in other countries.

Figure 3



  2.3  Not surprisingly, the same countries listed above with higher screening rates also enjoy higher survival rates for these two types of cancers. [23]Nationwide, the NHS would stand to benefit from increased utilisation rates for many technologies, as capacity and waiting times would improve, as more patients could be treated more effectively with fewer hospital beds, and nurse and physician time.

  2.4  Where the Government has attempted to improve particular areas of healthcare, through focussing on recommended solutions in the National Service Frameworks accompanied by significant and sustained investment, technology uptake has been higher and Government targets reached. For example, the National Service Framework on Coronary Heart Disease set a goal of 750 interventions per million population each, for coronary artery bypass grafting and coronary angioplasty; these targets were exceeded in 2003. [24]

  2.5  However, where this investment and focus has been less concentrated, so uptake has been less rapid. For example, a low-cost patient monitoring device that assists GPs in the early diagnosis of atrial fibrillation (AF) for stroke prevention and other life-threatening heart rhythm disturbances has been taken up by less than 1% of all GPs since its introduction over four years ago, even though estimates by the current users suggest that over 150 patients' lives have been saved since then. [25]

Barriers to Introduction of New Technologies

  2.6  The MTG has identified three potential barriers that we believe will threaten patient access to new technologies. These are outlined below.

(i)  Inadequate Tariffs Under Payment by Results.

  2.7  The MTG applauds the enormous efforts of the Department of Health (DOH) to design and implement a system of "Payment by Results" to facilitate choice and patient centred care. While Payment By Results promises to bring new efficiency and improved performance over time, the current transition to Heathcare Resource Groups (HRGs) for English hospitals as the central method of achieving payment by results risks the use of tariffs that do not reflect the true costs of patient care for a number of critical technologies.

  2.8  HRG tariffs are calculated based on prior two year data submitted by hospitals. Inaccuracy for certain tariffs may reflect routine errors on the part of hospitals in submitting costing data, as many hospitals are challenged in adapting to this complex system. For newer technologies, inadequate tariffs simply reflect the absence of an appropriate code available to collect data two years' previously—so related costs become "lost" in the hospital costing data.

  2.9  To address potential shortfalls, the DOH established a "pass-through" payment that allows for primary care trusts (PCTs) to pay for the additional costs of new technologies in a supplemental fashion, for a period of up to two years. The DOH also recently expanded the pass through definition to include certain low volume, existing therapies that may face underpayment.

  2.10  The MTG fully supports these measures but remains concerned that PCTs actually have the staff and financial resources to establish pass-throughs for critical technologies. MTG also is concerned that a diverse, local approach to providing pass-through payment will present new challenges once the two-year period has expired for a technology and a tariff amount must be calculated. Finally, MTG wishes to bring attention to a number of existing technologies that likely do not fit the pass through criteria, but are nonetheless facing extremely low payment under the 2005 tariffs (please see Appendix B).



Figure 4

CARDIAC PACEMAKERS CONSTITUTE A HIGH VOLUME, EXISTING TECHNOLOGY FACING TARIFF UNDERPAYMENT IN 2005[26]





  MTG has written a policy paper on the HRG issues, with recommendations for Government action; this paper is attached as Appendix C.

(ii)  Audit Mechanisms in Support of NICE Determinations

  2.11  MTG has long supported a fair and transparent product review process by the National Institute for Clinical Excellence (NICE) and has worked to support the adoption and enforcement of NICE recommendations. However, the adoption of technologies covered by NICE recommendations has failed to improve substantially and patients continue to face barriers to access.

  2.12  One hindrance to improving adoption of NICE recommendations is the current absence of reliable national measures for technology utilisation, that could be used to gauge progress towards NICE targets for uptake. A recent study by York University published in the British Medical Journal[27] shows that following guidance from NICE, there was no apparent increase in the uptake of several critical device technologies: hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair and laparoscopic colorectal cancer surgery. The study also found that NICE guidance has been "less influential in surgical procedures and use of medical devices" than for pharmaceuticals.

  2.13  MTG calls on the Government to ensure that NHS bodies—such as the Healthcare Commission—understand the difficulties of auditing devices and recognise the need to do so. The Group is also working to ensure that the Healthcare Commission and its counterparts in the devolved nations have in place appropriate systems to monitor uptake of all NICE-approved technologies. Through monitoring uptake, NHS bodies will be able to commission effectively and plan the provision of healthcare to achieve targets and respond to the needs of local communities. Monitoring uptake will also help NICE to assess its own effectiveness as a reviewing body and its relevance to frontline care providers.

  2.14  Ensuring compliance with NICE guidance can be achieved by relating the commissioning arrangements within PCTs to the NICE recommendations. Recent Government activity to this end is a positive sign. For example, the Department of Health's Standards for Better Health[28] include the need for healthcare organisations to "ensure they conform to NICE technology appraisals and, where it is available, take into account nationally agreed guidance when planning and delivering treatment and care."

  2.15  However, there is certainly more work to do. With inadequate assessment tools, the economic benefits of NICE-approved technologies are often not taken into account, and Trusts could be forced to choose between following NICE recommendations or going over budget. There is also evidence of "seasonal prescribing", whereby patients are denied access to certain technologies at times of the year or month when budgets are likely to over-run. In the future, budget constraints will be increasingly problematic for technologies facing HRG tariffs that are too low to cover the basic costs of care. Thus, further mechanisms must be put in place to reinforce guidance and ensure and encourage its implementation.

(iii)  Procurement mechanisms and their impact on quality of patient care

  2.16  The MTG is worried that the methods of purchasing medical technology products are shifting away from the interests of the patients and physicians who depend on them. Procurement systems must ensure the availability of the best treatment options for the full diversity of clinical needs of our population, while still supporting innovation. In 2004, the Commercial Directorate embarked on an ambitious scheme to consolidate suppliers, create rapid financial savings, and apply generic, price-focused purchasing tactics to a broad range of items such as office supplies, food products, office furniture and, in equal measure, to medical technologies.

  2.17  This is implemented by PASA whose primary focus has been the use of reverse auctions and internet-based purchasing that disproportionately favour price as a purchasing criterion. PASA has maintained that quality will be addressed through its purchasing process, but the MTG is very concerned that this is simply unachievable under the purchasing methods in use. Unlike office furniture, which is purchased by a diversity of consumers in the UK, health care products are purchased almost exclusively by the NHS—and will easily vanish from the marketplace under adverse purchasing conditions that do not recognise clinical value.

  2.18  The MTG remains concerned that the approach of PASA is inappropriate for most medical products and threatens to severely limit the treatment options available to clinicians and patients in the UK. In short, we believe that whilst the NHS is seeking to promote innovation and the use of the latest therapies which are wanted by patients and needed by doctors this approach by the Commercial Directorate is creating barriers to access.

  2.19  To illustrate the patient impact of this current PASA activity, a recent PASA procurement action excludes a silver alloy and hydrogel urinary catheter that has been identified by the Health Protection Agency's Rapid Review Panel as having potential value in preventing pervasive MRSA bacterial infections—a leading concern in English hospitals. MRSA infections are resistant to antibiotics and have been linked to numerous excess patient deaths. Some hospitals have been obliged to close because of persistent MRSA patient infections. Silver alloy and hydrogel-coated catheters have been demonstrated with extensive clinical evidence to reduce infections, yet they will be unavailable to English patients because of a PASA process that is focused disproportionately on price.

  2.20  While the Rapid Review Panel finding serves as a positive model of Government action to address an urgent healthcare need—PASA's actions for this product example shows that it is out of step with the views of other important public bodies such as NICE and the Rapid Review Panels. MTG proposes that nationally-agreed guidance, guidelines and recommendations from public bodies, such as NICE and Rapid Review Panels, should be given more authority, and that a clear division of responsibility is made, so that where action is recommended by such bodies, it is supported and implemented by other bodies.

3.   Key outputs of the Healthcare Industries Task Force (HITF) Report

  3.1  The MTG is hugely encouraged by the key outputs of the Healthcare Industry Task Force (HITF) and is anxious to see its policies implemented quickly and comprehensively. A coordinated approach by Government Departments was taken on the researching and drafting of HITF and a similar coordinated approach by the Departments for Health, Trade and Industry and HM Treasury is needed for the successful implementation of its agreed policies. Amongst the key outputs of HITF, there are a number of particular interest to MTG, as they will have direct impact on patient access to technology.

  3.2  Device Evaluation: The MTG supports measures that ensure patient safety, but within a framework that speeds patient access to important new therapies. A barrier to uptake of new technologies is the duplication of evaluations prior to procurement, causing needless delays in patient access and wasted NHS resources. A principle of "once-only" evaluation should be adopted, and an expanded Device Evaluation Service should be the vehicle for accelerating new technology adoption. To achieve this, the DES will require governance to ensure impartiality and independence from short-term cost-saving initiatives that might be drivers of PASA behaviour.

  3.3  Procurement: The MTG strongly supports HITF recommendations for a regional procurement focus and joint commissioning between PCTs and SHAs. MTG recommends that mechanisms be established for discussions between policy-makers, industry and commissioners about how to adopt new technologies, across PCT and SHA borders where necessary. HITF also rightly recognises the pivotal role of clinicians in progressive and effective procurement. The early and active involvement of clinicians with procurement representatives should be built in to the commissioning structure to allow for informed, value-driven commissioning and procurement decisions.

  3.4  Communication with patients and the public: The MTG strongly supports the recommendation to improve public understanding of medical devices, their benefits and risks and the nature of the regulatory system. We applaud the proposal that MHRA should lead a project to achieve this, as part of their efforts to increase communication with the public. We believe that this patient education effort fits squarely within the Government's support of patient choice. MTG would recommend a single source repository of patient information (NHS website or NHS Direct) that contains links to approved sources of information for patients and carers. MTG also recommends the establishment of multiple media channels for the dissemination of this information as Internet penetration has been shown to influence only parts of the patient population, whilst being largely ineffective with hard-to-reach patient populations.

  3.5  Training and education: Using technology almost always requires taking on new skills; therefore where training is under-provided, incorrect usage can lead to unsafe practices. Therefore, the MTG welcomes the recommendation on training in the use of devices, and notes that substantial training already undertaken by manufacturers is a valuable part of the use of medical technology products. It is also important to ensure that clinicians are kept updated with developments in diagnosis and recognition of symptoms.

4.   The utilisation of Telemedicine (including Telecare) and its future potential for improving services

  4.1  Telemedicine and other remote care innovations are technology applications that can truly recast the paradigm of health care in the UK. Cutting edge technologies in this area include remote transmitting pacemakers that allow for continuous observation of patient heart functions, to remote monitoring tools that survey patient heart rate and blood glucose levels, and other key indicators from the patient's home. Technologies such as these not only displace the need for in-person care, they provide insight to clinicians that in some instances is far more robust that what can be assessed in a clinical setting.

  4.2  Remote technologies, including the broad range of telemedicine applications also provide essential economic benefits by reducing the need for hospital observation and testing, shortening waiting times and leveraging more fully hospital based diagnostic assets.

  4.3  The challenges facing telemedicine are potentially greater than those faced by conventional therapies, since the provision of diagnostic and monitoring services and their reimbursement has traditionally been linked to in-person clinical visits. In telemedicine, the site of investment is often disconnected from the site where cost savings occur. Additionally, and because investment and cost benefit are rarely linked and the benefits are accrued in other parts of the system, new, comprehensive ways of measuring total cost effectiveness are needed to truly appraise the value of these important new technologies.

  4.4  The inequities across different regions in adoption of related technologies is also a challenge, and many of these technologies require capital investments that are beyond the reach of smaller institutions and physician practices. In addition, there is currently a lack of infrastructure to deal with information that is collected, a problem that may be addressable through the new national framework for IT. MTG recommends investigation into the potential for joint commissioning of telemedicine and across PCTs.

5.   Summary of recommendations to the Committee

  MTG recommends to the Committee the following points for action by the Government:

    —    Put patient care and access to effective treatment as the guiding factor in all commissioning and purchasing arrangements for Medical Technology.

    —    Ensure that tariffs under Payment by Results reflect the true cost of patient care for new technologies, and do not prevent the introduction of technologies through inaccurate data.

    —    Equip Primary Care Trusts with the resources to establish pass-through payments, and to ensure there are payment mechanisms for all new technologies.

    —    Introduce further mechanisms to reinforce guidance from NICE and other public bodies and ensure and encourage its implementation.

    —    Review the procurement methods utilised by PASA and the NHS Commercial Directorate, with the objective of identifying if and how they limit the introduction of new technologies.

    —    Implement the key outputs of HITF quickly and comprehensively.

    —    Investigate the potential for joint commissioning of telemedicine across PCTs and identify mechanisms to link incentives to provision of patient care.

    —    Nationally-agreed guidance, guidelines and recommendations from public bodies, such as NICE and Rapid Review Panels, should be given more authority, and a clear division of responsibility made, so that where action is recommended by such bodies, it is supported and implemented by other bodies.











15   Anne Jolly, SADS UK Chair, speech to the Parliamentary launch of the "Making the Case for Economic Technology", June 2004. Back

16   DeMaso et al, "Psychological Functioning in Children and Adolescents Undergoing Radiofrequency Catheter Ablation", Psychosomatics 41: 134-139, 2000; research by Cardiac Risk in the Young. Back

17   Chen et al, "Prevention of needlestick injuries in healthcare workers: 27 month experience with a resheathable `safety' winged steel needle"; Mendelson et al, "Evaluation of a safety IV catheter"; both Mount Sinai Med Center, New York, NY, 2000. Back

18   Department of Health, National Service Framework on Older People's Care, 2001. Back

19   University of Chicago research by economists Robert Topel and Kevin Murphy. Back

20   Migraine Intervention with STARflex technology trial, 2004; see www.migraine-mist.org Back

21   Technology in Orthopaedics, Professor John Kenwright, Research Director, Wishbone Trust; Science in Parliament, Vol 60, No 1, Spring 2003. Back

22   Eucomed Medical Technology Brief 2004. Back

23   Source: Health Affairs, 23:3, May/June 2004, p 92, Exhibit 1. Back

24   BCIS audit return, adult interventional procedures, 2003. Back

25   British Journal of Cardiology: (2001: Vol 8-6). "Changes in referral patterns to cardiac out-patient clinics with AECG monitoring in general practice". Back

26   Reflects Tariff payment estimates for applicable HRGs, with adjustments for specialised services. Cost of care estimate reflects an average industry-collected data from typical hospital purchasers of pacemakers. Back

27   Sheldon et al, "What's the evidence that NICE guidance has been implemented, BMJ 329:999, October 2004. Back

28   Department of Health, "Standards for Better Health" July 2004.@PARA@@PARA@ @PARA@ Back


 
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