Written evidence submitted on behalf of Roche Diagnostics UK (LTC 73)

Summary

1.                 Long-term conditions, defined by the Department of Health as ‘conditions that cannot, at present, be cured but can be controlled by medication and other therapies’ have a major impact on quality of life, disability and are the main cause of premature death in England; they also account for a significant proportion of NHS expenditure.

2.                 The NHS has been largely successful at tackling Beveridge’s ‘giant’ of disease, therefore long-term conditions will assume greater absolute and relative importance. The challenge now is to support the nearly 1 in 3 people – over 20 million in England – who have at least one long-term condition: whether diabetes, coronary heart disease, etc. or as a survivor of cancer treatment.

3.                 This challenge highlights two major concerns: whether the NHS in its current form (largely funded through general taxation with access free at the point of use) is affordable – people with long-term conditions account for 70 per cent of expenditure on health and care; and whether the current model with its emphasis on the investment in the provision of treatment by medical practitioners in acute care settings is appropriate for people with long-term conditions.

4.                 This submission, whilst recognising the need for a paradigm shift, such as those advocated by Wagner[1] (1998) and Kane et al[2] (2005) to a Chronic Care Model; and emphasis on evidence-based preventative interventions such as nutrition and physical activity, advocates that the use of technology facilitating self-management by people with long-term conditions in an integrated health and social care system is an integral part of the solution.

Introduction

5.                 People with long-term conditions are often the most important primary care provider, where long-term conditions are a major burden of disease (Sobel[3], 1995). Given that most care has always been self-care, any reduction in self-management will result in a potentially insupportable burden on health and care services. The Expert Patient Programme in England demonstrated the benefits of self-management support (Kennedy et al 2007)[4].

6.                 Over the past ten or so years, government policy has sought to shift emphasis towards a primary care led NHS as part of a move towards an integrated health and care system, with emphasis being placed on fostering a more person-centred approach to care, taking a holistic view of an individual’s needs to help them live as independently as possible.

7.                 The Quality and Outcomes Framework (QOF) introduced in 2004 provides a financial incentive for GPs (10–15 per cent of the remuneration) based on achieving a range of nationally set quality-based targets focused on ill-health prevention through the effective management of people with, or at risk of, developing a range of long-term conditions. QOF incentive payments have already been shown to have a positive impact on the nature and quality of care (Campbell et al 2007)[5].

8.                 Consideration should be given to extending or looking at similar incentives to achieve the ‘paradigm shift’, recognising that this will require disinvestment elsewhere in the system. At a policy level, we have seen the integrated care pilots established as part of the NHS Next Stage Review, and more recently, the Health and Social Care Act 2012 places a duty on providers to work more closely together to address these issues.

9.                 Ham identifies ten characteristics of a ‘high-performing chronic care system (Ham, 2010)[6]. These include: ‘priority is given to patients to self-manage their conditions with support from carers and families’, ‘priority is given to primary health care’ and, ‘the need to exploit the potential benefits of information technology in improving chronic care’.

10.             Below are three examples of patient groups who take a leading role in the day-to-day management of their condition; where self-monitoring is helping them stay healthy, reducing complications and generating savings for the NHS.

Warfarin monitoring

11.             Warfarin is the main oral anticoagulant used in the UK. Anticoagulant medicines are most commonly prescribed for people who have had a condition caused by a blood clot (thrombosis) or are at risk of developing one. These conditions include:

• deep vein thrombosis (DVT)
• pulmonary embolism
• atrial fibrillation (AF)

12.             Warfarin may also be prescribed for people with a replacement or mechanical heart valve.

13.             There are more than 1.2 million people in the UK on warfarin (Gardiner[7] et al, 2004, ONS[8] 2008). Connock[9] et al (2007) estimated that numbers continue to increase by about 10% each year, primarily driven by its use for patients with atrial fibrillation. The future impact of this expansion is indicated by estimates that currently more than half of those with atrial fibrillation may remain unidentified and less than half of those identified may be receiving treatment. These estimates considered together with an ageing population mean that future service load could increase substantially.

14.             However, it is estimated that fewer than two per cent of them benefit from self-monitoring (Roche data). Self-monitoring has been shown to reduce the risk of stroke by over 50 per cent and reduce mortality rates by nearly two fifths (Henegan C[10] et al, 2006). Better access to self-monitoring of international normalized ratio (INR) levels, which measures how long it takes blood to form a clot, could also reduce the number of complications. Current estimates show that oral anticoagulation therapy (OAT) management of stable patients costs the NHS around £409 million (Fitzmaurice DA[11] et al, 2005, NICE[12] 2006). Studies also show that if only one in four patients took up self-monitoring (Connock et al, 2007) this would save the NHS approximately £62 million per year (Roche data)[13].

15.             The CoaguChek XS is a Point of Care (POC) device used by competent patients to monitor and manage their INR levels, thereby reducing the burden on NHS resources. The device uses blood sample from a finger prick applied to a testing strip. The result is displayed within a minute of applying the blood sample, and if needed, adjustments to warfarin dosage made. This gives the patient more freedom to travel and avoids disruption to work and home life that potentially frequent visits to anticoagulation clinics can cause. Patient self-management can – and where appropriate should – empower the patient to determine the dose adjustment with the support of resources, such as dosing charts and access to advice if required.

Deep Vein Thrombosis

16.             Deep vein thrombosis (DVT) is a cause of 25,000 deaths in the UK each year and can lead to the development of post thrombotic syndrome (PTS) with chronic swelling and ulceration of the legs (Health Committee 2004/5)[14]. DVT can be clinically very difficult to diagnose but early recognition and appropriate treatment can improve clinical outcomes.

17.             In response to the National Guidance on Care Close to Home (NHS Local 2010)[15] in May 2010 a DVT service was initiated at Solihull Healthcare and Walk-in Centre which enables uncomplicated DVT identification and management using D-dimer testing, hastening patient care and avoiding referrals to hospital. In the first 11 months of the service, 355 patients were tested for DVT, saving in excess of £220,000 from reduced hospital admissions, with feedback showing an improved patient experience. The Cobas® H232 D-Dimer diagnostic test is a point of care (POC) blood test that can be carried out in primary care and can be used to rule out VTE. The sample required is from a finger prick and a result is given within 8 minutes.

18.             Similarly, in 2009 South West Essex community services, now part of North East London Foundation Trust, established a DVT service based at Brentwood Community Hospital aimed at improving DVT diagnostic services for nine GP practices in the Brentwood area, serving a population of 74,000. The DVT service sees on average 250 patients per year. With each acute DVT presentation costing approximately £500 per patient if referred to secondary care. However, all patients can now be assessed and managed in primary care with an approximate annual saving of £60,000. Savings are also made in time, as well as in costs. Following a suspected DVT referral to the Community Hospital it takes approximately 30 - 60 minutes for a patient to be seen and assessed, including carrying out the D-dimer test - patients report that being able to have their condition assessed more rapidly and in a primary care setting is much less stressful for them.

Diabetes Care

19.             Diabetes is a long-term chronic condition caused by too much glucose (sugar) in the blood. There are two types of Diabetes: Type 1 occurs when your immune system destroys the beta cells in the pancreas that create insulin. As a result, the body makes very little or no insulin of its own. People with Type 1 diabetes must take insulin daily. In Type 2, not enough insulin is produced or the insulin that is made by the body doesn't work properly. Type 2 diabetes can affect people at any age.

20.             According to Diabetes UK, between 2006 and 2011, the number of people diagnosed with diabetes in England increased by 25 per cent, from 1.9 million to 2.5 million. There has also been a huge growth in complication rates during this time. Diabetes is now the biggest single cause of amputation, stroke, blindness, and end-stage kidney failure. The reality of any of those devastating outcomes for patients demonstrates the NHS is not able to plan for or manage the realities of long-term diabetes outcomes, including the multiple conditions a person with diabetes is likely to develop in the later stages of having the condition.

21.             While there have been some demonstrable improvements in diabetes care since the National Service Framework for Diabetes was first introduced in 2001, annual National Diabetes Audits indicate there remains is a great deal of work to do, including tackling poor provision of structured education and increased delivery of personalised diabetes care[16].

22.             Considering current diabetes spend accounts for around 10 per cent of the NHS budget, we need to ensure that everything is being done to encourage patients to maintain good diabetes control.

Self-monitoring of blood glucose (SMBG)

23.             Monitoring blood glucose is a very important part of managing diabetes. Regularly testing blood glucose helps measure the effectiveness of a patient’s dietary planning, exercise and medication, with good control helping reduce longer-term complications. In order to self-test blood glucose, a patient needs a blood glucose meter, a test strip and a finger pricker.

24.             In England, the blood glucose meter and finger pricker is provided free through the NHS via a healthcare professional. Test strips are then provided on prescription, with the number of tests allocated based on the frequency of testing required e.g. depending on the type of diabetes you have, your level of physical activity and how frequently you drive.

25.             Unfortunately, short-term financial savings by CCGs are, in an increasing number of incidences, threatening self-management, for example, restrictions around access to blood glucose test strips or inconsistent formulary processes/decisions surrounding the type of blood glucose meter made available to patients.

26.             There are 250,000 people with Type 1 diabetes in England. Their lives depend on insulin injection or pump treatment, which requires them to regularly carry out self-blood glucose measurements (SBGM), normally several tests a day e.g. upon waking, before/after eating and before bed.

27.             However, people with Type 1 diabetes are increasingly being restricted access to test strips. In a letter circulated to General Practitioners, Hospital Doctors, Community Pharmacists and PCT Chief Executives in February 2013, the National Clinical Director for Diabetes reaffirmed the importance of testing, stating it is ‘essential that people with Type 1 diabetes are prescribed sufficient SBGM testing strips for their clinical needs (as outlined in NICE guidance CG15, TA 60). This enables people with diabetes to self-manage, recognising the symptoms of Diabetic ketoacidosis, encouraging them to take early action and seek help, especially if it involves driving.

28.             The letter also clarified that “While testing strips dispensed in primary care may appear to have a premium cost, the wider costs to the patient’s quality of life, their safety and ability to work and to the NHS of complications of uncontrolled diabetes far outweigh these costs, including the cost of repeated unplanned A&E admissions. Further costs for the strips in most cases also include provision of educational material, meters, and helplines for patients by the manufacturer.”[17]

Access to innovative blood glucose meters

29.             Recent advances in technology have made insulin bolus advisors available to patients on multiple daily injections (MDI). Bolus advisors support patients on MDI, using a long acting basal insulin analogue to achieve optimal diabetes control. Individually programmed, patients can just test their blood glucose levels with the system, enter the carbs they are about to eat and receive bolus advise.

30.             An online user survey of patients showed that the majority of respondents felt using the bolus advisor improved confidence in the accuracy of the mealtime bolus insulin dose and reduced their fear of hypos. Patients found the system easy and motivating to use with 72% respondents reporting overall wellbeing/life with diabetes had improved or significantly improved since using their bolus advisor, with greater confidence and control in their diabetes management.[18]

Access to insulin pump therapy

31.             The role of insulin pumps for Type 1 diabetics is recognised worldwide and has been endorsed in the UK by NICE. The use of insulin pumps in the UK remains low compared to other developed nations, however, in the last 4 to 5 years we have seen a significant rise in the numbers of pumps being used.

32.             Working in partnership to improve pump uptake, Roche has made a significant contribution to this growth through a complete service offering for our NHS partners from patient/healthcare professional education through to a 24 hour careline for our patients. Our educational pump courses have helped to train over 250 DSNs on the practicalities and benefits of pump therapy helping to expand the number of centres offering pump therapy. We believe our work has helped many 100s of patients gain access to pump therapy who wouldn’t otherwise have done so.

Commissioning support

33.             Practical assistance for commissioners to support the design of local diabetes services have in past been provided by NHS Diabetes. While that best practice remains relevant, Roche Diabetes Care is concerned the closure of NHS Diabetes and poor awareness of their previous work will leave CCGs and commissioners without the necessary information required to understand and appropriately design and commission high-quality diabetes services.

34.             While the NHS Diabetes website will be kept open for several months, we would like to see the expert knowledge and best practice transferred and made available on the new NHS Improvement website, with commissioners being encouraged to engage with existing best practice.

Conclusion

35.             Long-term conditions account for: 50 per cent of GP appointments, 70 per cent of bed days and 70 per cent of health and care budgets.

36.             The technology for self-monitoring and management is available. Remote and other forms of diagnostic monitoring are being further developed to support self and directed management approaches.

37.             However, the uptake of innovative technology by the NHS is slow. Whilst recognising that to derive the maximum benefits from the use of such technology, services must be redesigned – and not just to realise the potential savings or to release resources for reinvestment – but to achieve the holistic benefits for the individual, as well as society as a whole, the examples above show what can be achieved within the current NHS and social care model. The potential for the use of such technology within a new model of care, such as the Chronic Care Model, is arguably greater still.

About Roche Diagnostics UK

38.             Roche Diagnostics is the world’s largest in vitro diagnostics company, supplying high quality products and services which are used to diagnose and monitor medical conditions and facilitate medical research. From small devices used directly by patients or healthcare professionals, to large diagnostic instruments found in hospital laboratories, Roche has a track record of developing new and innovative devices.

39.             Roche has pioneered the development of hand held systems, empowering patients with diabetes and those receiving anticoagulation therapy, to monitor their own long-term conditions easily and accurately.

Roche Diabetes Care’s Accu-Chek® brand is the world leader in diabetes care, with a diverse portfolio of products designed to help people with diabetes live healthy, productive lives and to make managing diabetes easier.

May 2013