Written evidence from the British Specialist Nutrition Association (LTC 59)

The following response has been submitted by the British Specialist Nutrition Association (BSNA) Ltd. The BSNA is the trade association representing manufacturers of products designed to meet the nutritional needs of individuals at different life-stages or with specific health requirements. BSNA members include companies that manufacture gluten-free foods which are reimbursed on prescription for sufferers of coeliac disease.

1. Summary

The BSNA welcomes the Health Select Committee’s inquiry into the management of long term conditions given their prevalence and significant impact on health service budgets in England. This response deals with the diagnosis and management of coeliac disease on the NHS. We would welcome the opportunity to discuss these issues with you in more detail and answer any questions you may have.

The BSNA is the trade association representing manufacturers of products designed to meet the nutritional needs of individuals at different life-stages or with specific health requirements. BSNA members include companies that manufacture gluten-free foods available on prescription for sufferers of coeliac disease including: Dr. Schär, Juvela and Warburtons. The BSNA wishes to work with the Department of Health (DH) and with Clinical Commissioning Groups (CCGs) to create a sustainable solution for coeliac disease sufferers to continue to access staple gluten-free foods on prescription.

Executive Summary

1.1.              Coeliac disease is a long term, autoimmune condition triggered by intolerance to gluten, a protein found in wheat, rye and barley. Around 1 in 100 people in the UK are affected, although only 10-15% of those with the condition are diagnosed.

1.2.              Coeliac disease is not ‘curable’; the only treatment is adherence to a strict gluten-free diet. There is no medical intervention or alternative treatment programme. Without proper management, coeliac disease can lead to a greater incidence of chronic conditions including osteoporosis and cancer, placing unnecessary strain on health services.

1.3.              Management of coeliac disease can be delivered effectively in the community; with areas of England pioneering pharmacy led prescribing schemes that reduce the impact on primary and secondary care.

1.4.              A clearer patient pathway and earlier diagnosis would speed up the proper management of coeliac disease and reduce the health complications associated with it.

1.5.              Coeliac UK, the national charity working for people with coeliac disease, have developed national guidelines for the prescribing of gluten-free foods exist recommending basic unit allowances and appropriate staple products for prescription such as fresh bread and pasta. However, contrary to these guidelines, restrictions to the basic unit allowance as well as types of staple products prescribed have been imposed in various parts of the country. Those with coeliac disease greatly value the provision of gluten-free foods on prescription and have strongly indicated their opposition to unfair restrictions or barriers to access.

1.6.              The BSNA believes that the provision of an essential gluten-free prescription provides good value, fosters good dietary adherence, and, in the long-term, will help save the NHS money.

2. About coeliac disease

2.1.   Coeliac disease is an autoimmune disease which affects 1 in 100 people in the UK. For people with the condition, the consumption of gluten triggers an immune reaction, making the body attack itself. Eating gluten damages the lining of the small intestine and affects a patients’ ability to absorb nutrients from food properly.

2.2.   Coeliac disease is a life-long condition, the only treatment for which is adherence to a strict gluten-free diet. Coeliac disease requires on-going review and management.

2.3.   Coeliac disease isn't an allergy or an intolerance to gluten. In cases of coeliac disease, the immune system mistakes substances found inside gluten as a threat to the body and attacks them.

2.4.   Diagnosis times for coeliac patients average around 13 years as symptoms are commonly mistaken for other gastrointestinal disorders such as Irritable Bowel Syndrome (IBS). For a diagnosis of coeliac disease to be confirmed, patients need to undergo a small intestinal biopsy, although in certain instances children displaying symptoms can be put straight onto a gluten-free diet following blood tests.

2.5.   The main health risks linked to untreated and poorly managed coeliac disease include deficiencies of essential nutrients, leading to conditions such as anaemia; osteoporosis and associated increased risk of fractures due to a lack of calcium; it can lead to the development of bowel cancer and in women it can also cause infertility and adverse outcomes in pregnancy.

2.6.   The NICE 2009 guidelines state that “coeliac disease can be very effectively treated with a gluten-free diet. It is important to identify people with the undiagnosed disease so as to provide satisfactory individual treatment and also to improve the overall health of the community.”[1]

3. The need for gluten-free foods on prescription

3.1.   It is vital for people with coeliac disease to be able to access basic gluten-free foods, including fresh bread, on prescription. Adhering to a strict gluten-free diet is the medically advised treatment for coeliac disease. Choice is not an option as deviation from the diet will have a direct effect on health and morbidity.

3.2.   National prescribing guidelines titled ‘Gluten-free prescribing: a revised guide 2011’[2] which provides information on the recommended amounts and type of products available to coeliac patients on prescription was produced by the NHS and endorsed by Coeliac UK, the Primary Care Society of Gastroenterology and the British Dietetic Association. It highlights the importance of adherence to a gluten-free diet in order to minimise the risk of associated complications and reflects current guidance on the prescribing of gluten-free foods.

3.3.   Specialist gluten-free foods have been developed and made available on prescription to replace everyday starchy foods such as breads, flour, pasta and cereals. Prescription gluten-free food products are approved by the Department of Health’s Advisory Committee on Borderline Substances (ACBS). Only essential gluten-free foods which contribute to a healthy balanced diet are approved for availability on prescription.

3.4.   Prescription gluten-free products are specifically selected to provide a guaranteed supply of essential staple foods, which should provide around 15% of patients’ energy requirements.

3.5.   Patients can purchase gluten-free products including pastas and flour in certain larger supermarkets however these are often priced significantly higher than gluten-containing alternatives. This cost disproportionately affects people on lower incomes and those who live in more rural areas with little or no access to larger stores.

3.6.   The social and psychological impact of sticking to a life-long gluten-free diet is significant and, if managed inappropriately, may result in further hidden costs to the NHS including repeated visits to the GP, further investigations and related prescription costs.

3.7.   The annual ingredient cost in England of the 2012 provision of ACBS approved gluten-free foods was approximately £26.8 million Prescription Cost Analysis England 2012[3], NHS Information Centre, April 2013. Since the net ingredient cost for all prescriptions in England was £8.53 billion, gluten-free foods comprise only 0.31% of the total net ingredient cost for all prescribed products

4. Varying practice across the NHS

4.1.   Restrictions have been introduced by a number of Clinical Commissioning Groups[4] (and formerly PCTs) on cost rather than clinical grounds and run contrary to national guidance (as discussed above) developed by the patient group Coeliac UK. The Government publically stated support for coeliacs to have access to such products on the NHS.[5]

4.2.   The decision to withdraw patient access to a staple gluten-free food such as fresh bread conflicts with national guidance developed by the patients’ organisation Coeliac UK, as well as the Government’s publically stated support for coeliacs to access such staple products on prescription.

4.3.   Within the new NHS, CCGs should operate on a level playing field to provide access to essential staple gluten-free foods such as bread and flour on prescription, to allow those with coeliac disease to successfully manage their own condition.

4.4.   The transition to CCGs has made it more difficult to understand the policies being operated in different areas in the UK.

5. Impact of restrictions on patients

5.1.   Responding to a recent BSNA survey, over eight in ten (86%) people with coeliac disease agreed that accessing gluten free foods on prescription was important in aiding adherence to a gluten-free diet. The survey[6] indicated that the poorest rely more heavily on prescriptions to manage their condition, and appeared to have fewer options available to them.

5.2.   Two-thirds of those who had had their prescriptions limited or stopped reported a negative impact on their ability to manage their condition. One third of those surveyed said that cuts had made it more difficult for them to access gluten-free foods whether on prescription or in shops.

6. Supporting those with coeliac disease

6.1.   Clinically led NHS services for the diagnosis and management of coeliac disease can be delivered through a variety of routes including the acute care setting, community pharmacy and primary care practices.

6.2.   Following diagnosis of coeliac disease or dermatitis herpetiformis (DH), it is essential that referral is made to a dietitian for expert advice on following a gluten-free diet that is tailored to the individual.

6.3.   Coeliac UK, the national charity supporting people with coeliac disease, offers help and support to those diagnosed. It supports the move towards increasing pharmacy-led prescribing schemes and encourages those diagnosed with coeliac disease to see dieticians to help manage their condition. A dietitian can give individual advice and a step by step plan on how to remove gluten from the patient’s diet.

7. Managing coeliac disease through integrated care

7.1.   Regular review is part of the foundation of support for promoting good adherence to a gluten-free diet. Integrated care is also essential to the foundation of support.

7.2.   New more cost effective care pathways are currently being developed which will place primary care at the centre of on-going care for coeliac patients.

7.3.   Public Health England recently published its priorities for the year 2013–14 which included a commitment to ‘reducing the burden of disease’. Local Health and Wellbeing Boards are looking to focus on strategies which manage conditions and reduce the likelihood of future illness. Easy and widespread access to gluten-free food for coeliac patients is an example of this type of policy as it is the only way to help those with coeliac disease to overcome their symptoms and reduce the risk of associated long-term complications. The BSNA will look to work with Local Health and Wellbeing Boards to becoming good advocates for managing conditions.

Dieticians

7.4.   Community based specialist dieticians would be ideally placed to offer patients clinically led support in the community

7.5.   Given the importance of a gluten-free diet in the treatment of coeliac disease, Coeliac UK has set out steps to setting up a dietitian led coeliac clinic.[7] Diet is essential in the management of patients with coeliac disease and a dietitian is best placed to provide support and advice on individual nutritional requirements.

Pharmacy-led prescribing schemes

7.6.   Pharmacy led schemes can help improve compliance and diagnosis as they are more accessible to a greater number of people with coeliac disease.

7.7.   Pharmacy-led prescribing schemes see patients initially assessed by a dietician who will then assign them a recommended number of units of gluten-free foods required for a balanced diet. Once assessed under the scheme, community pharmacists are provided with a list of prescribable products from which patients can order up to the number of units that they are entitled to each month. The number of units is based on national guidance available from Coeliac UK.

7.8.   Schemes have been introduced in Bedfordshire, Cornwall and the Isles of Scilly, Cumbria, Derby, Northamptonshire, South West Essex and Tayside in Scotland. There are plans for such schemes to be rolled out across the whole of Scotland and in Wales.

7.9.   Coeliac UK has produced a toolkit[8] for Commissioners advising on the provision of gluten-free foods, which aims to support commissioners in developing a cost-effective, enhanced service through pharmacy-led prescriptions for patients with coeliac disease.

7.10.  Through the use of a pharmacy-led supply schemes, gluten-free foods are supplied directly from community pharmacists, thus minimising the workload for GP practices. A review of established schemes in Northamptonshire and Cumbria shows savings of between 20% and 40%. If this approach was applied nationally, there is the potential to save between £5 and £11 million per year in England alone, as well as freeing up GP time.[9]

7.5 The potential benefits of changing to pharmacy-managed supply of gluten-free foods include:

• improved dietary compliance and health outcomes, since some patients currently do not receive prescribed foods, when it is known that access to prescriptions is the single most important factor in helping adherence to the gluten-free diet
• release of clinical time (saving of 209,000 appointments or over 20,000 hours of GP time according to a 2002 RCGP estimate), which could be used for better management of patients with coeliac disease after diagnosis.
• prevention of overprescribing by application of the 2011 revised guidelines on appropriate consumption of gluten-free foods
• better cost control as more people with coeliac disease are diagnosed over the next few years. Currently it is estimated that only 10 –15% of people with coeliac disease are diagnosed
• dissemination of the 2009 NICE guidelines combined with improved GP training and

awareness of coeliac disease should result in increased diagnosis

• improvement in patient experience by creating a more flexible service
• increased patient choice.

May 2013