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Changes to Gluten-free Prescribing in Primary Care in England

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Why are gluten-free foods available on prescription?

Coeliac disease is a serious lifelong condition where the body’s immune system attacks its own tissues when gluten is eaten. The only medical treatment for coeliac disease is strict adherence to a lifelong gluten-free diet. However, adherence can be challenging with rates varying between 42-91%.[1]

Poor or non-adherence to treatment can result in serious, long-term health complications including osteoporosis, ulcerative jejunitis, intestinal malignancy, functional hyposplenism, vitamin D and iron deficiency as outlined by NICE.[2] For children, non-adherence can also result in complications such as faltering growth and delayed puberty.[3] Recent research has shown that a gluten-free prescription supports adherence to the diet.[4]

In practice, patients usually rely on a combination of naturally gluten-free foods and specially formulated gluten-free products, both on prescription and purchased in supermarkets, to replace key staple items in the diet and help increase dietary variety and nutritional adequacy.

Why is the prescribing of gluten-free foods changing?

The original policy aim of allowing the prescribing of gluten-free foods was to help support adherence to treatment, in patients with coeliac disease, when the availability of formulated gluten-free products was limited.

However, in recent years, Clinical Commissioning Groups (CCGs) have increasingly sought to restrict and remove gluten-free foods on prescription, primarily driven by the need for cost savings from local health budgets. This has resulted in significant prescribing variation and a postcode lottery for patients with coeliac disease, prompting the Department of Health and Social Care (DHSC) to undertake a consultation on the availability of gluten-free foods on prescription in primary care, in England.[5][6]

Department of Health & Social Care Gluten-Free Consultation 2017


A national consultation by the Department of Health and Social Care (DHSC) was held in 2017 to look at the availability of gluten-free foods on prescription in primary care and to assess whether to make changes to the prescribing legislation for gluten-free foods. A number of options were proposed, including: to make no changes to provision; to end the prescribing of gluten-free foods in primary care; or to only allow the prescribing of staple gluten-free foods, for example bread and flour.

The consultation received almost 8,000 responses from patients, healthcare professionals, national associations, patient associations, NHS organisations and manufacturers of gluten-free foods. The DHSC conducted an evidence base review and impact assessment. The report of responses from the public consultation, which was published in January 2018 alongside an updated impact assessment, indicated that the health minister’s preferred option was to restrict prescribing to a smaller range of gluten-free bread and mixes.

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Task and Finish Group

In February 2018, the DHSC convened a Task and Finish Group. The role of the group was to agree a product consideration process, definitions for bread and mixes, and a timetable. The overall objective was to provide a streamlined and cost-effective list of bread and mix products that will remain available on the NHS in primary care. Members of this group included: Coeliac UK; the British Dietetic Association (BDA); NHS Clinical Commissioners; and the British Specialist Nutrition Association (BSNA).  The group agreed that the list must allow for flexibility for patients who rely on gluten-free foods to ensure their continued adherence to a gluten-free diet.

Manufacturers were requested to complete a product appraisal form for each product they wished to remain available on the Drug Tariff and to submit this for review by the Advisory Committee on Borderline Substances (ACBS). This process was completed in the Summer and manufacturers were advised on which of their products have been accepted. 

The Department of Health & Social Care Consultation on an amendment to the Prescribing Regulations

In August 2018, the DHSC launched a consultation to seek views on the legislative changes to the availability of gluten-free foods which can be prescribed in primary care in England based on the Health Ministers preferred option, to allow the continued prescribing of bread and mixes. The consultation received 932 responses, and these were published in November 2018 along with an updated impact assessment.

Amendment to the Prescribing Regulations

An updated list of gluten-free products will appear in the ‘Borderline Substances’ section of the December 2018 Drug Tariff, with the amendment to the Prescribing Regulations coming into force on 4 December.[7] From this date GP surgeries in England will be permitted to issue prescriptions for gluten-free bread products and gluten-free mixes only. The Amended Regulation will also include a blacklist of all other gluten-free foods no longer available on prescription in England.

NHS England has published guidance to CCGs advising of the amendments to the prescribing regulations and highlighting that CCGs should align and take the guidance into account in formulating local policies.[8]

The objective of this guidance is to support CCGs in their decision-making with the wider objective being to address the unwarranted variation across England in terms of CCG prescribing policies and to provide clear national guidance to make local prescribing practices more effective. The DHSC has produced a FAQ document addressing common themes and questions.

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Definitions and clarifications

Gluten-free bread

includes not only loaves but other types of bread products, including, but not restricted to, rolls, baguettes and ethnic breads. Bread products can be fresh, ambient or part-baked. Pizza bases are no longer available on prescription in England.

Gluten-free mixes

within the amended regulation, mixes are defined as a ‘food mix’ and include multi-purpose/all-purpose mixes and bread mixes. Simple flours will no longer be available on prescription. Mixes are intended to enable patients to make different foods to help increase dietary variety and support adherence.

It is important to note that some low-protein products also bear the claim ‘gluten-free’. These products are not within the scope of these changes as they are prescribed for a different clinical indication.

Prescribing in Scotland, Wales and Northern Ireland

The DHSC Consultations on the availability of gluten-free foods in primary care, and subsequent amendments to the prescribing regulation and Drug Tariff, only apply in England. In Scotland, Wales and Northern Ireland the national policy on the prescribing of gluten-free foods remains unchanged, and as such the devolved nations have sought to understand the implications of the change in policy in England. As part of this, Scotland, Wales and Northern Ireland have been working with the DHSC to ensure continued access to a full list of previously approved ACBS products in these countries going forward.

For further information on BSNA member product availability lists, please contact:

Glutafin

Careline: 0800 988 2470 | Email: glutenfree@glutafin.co.uk | Website: www.glutafin.co.uk

Juvela

Advice line: 0800 783 1992 | Email: info@juvela.co.uk  | Website: www.juvela.co.uk


NHS England has produced a FAQ document addressing common themes and questions, which can be accessed here.

Equality and Health Inequalities – Full Analysis Form – Prescribing Gluten-free Foods in Primary Care: Guidance for CCGs


References

[1] Hall NJ et al. Systematic review: adherence to a gluten-free diet in adult patients with coeliac disease. Aliment Pharmacol Ther, 2009; 30(4): 315-30.

[2] NICE. NG20. Coeliac Disease: recognition, assessment and management. 2015

[3] Murch S et al. Joint BSPGHAN and Coeliac UK guidelines for the diagnosis and management of coeliac disease in children. Arch Dis Child, 2013 98(10): 806-11.

[4] Muhammad, H.; Reeves, S.; Ishaq, S.; Mayberry, J.; Jeanes, Y.M. Adherence to a Gluten Free Diet Is Associated with Receiving Gluten Free Foods on Prescription and Understanding Food Labelling. Nutrients 2017, 9, 705.

[5] Walker AJ, Curtis HJ, Bacon S, et al Trends, geographical variation and factors associated with prescribing of gluten-free foods in English primary care: a cross-sectional study. BMJ Open. 2018; 8:3.

[6] Department of Health and Social Care. 2018. Availability of gluten-free foods on NHS prescription. Available at: https://www.gov.uk/government/...

[7] Department of Health and Social Care. 2018. Gluten-free foods on NHS prescription. Available at: https://www.gov.uk/government/... 

[8] NHS England. 2018. Prescribing Gluten-Free Foods in Primary Care: Guidance for CCGs. Available at: https://www.england.nhs.uk/pub...