Coeliac disease (CD) is a serious medical condition where the body’s immune system attacks its own tissue when gluten is eaten.

The only medical treatment for CD is strict adherence to a gluten-free (GF) diet for life. Gluten is not necessary for a healthy diet and patients can safely exclude it from their diet and still eat healthily without purchasing formulated foods. Naturally GF foods include meat, fish, vegetables, fruit, rice and most dairy products.

In practice, patients usually adhere to a GF diet through some combination of naturally GF food and formulated GF food both purchased privately and obtained through prescription.

Non-adherence to GF diets can cause serious health problems. According to NICE, those who are not following a strict GF diet are at a higher risk of long term complications, including osteoporosis, ulcerative jejunitis, intestinal malignancy, functional hyposplenism, vitamin D deficiency and iron deficiency. Other guidance, that of the British Society of Gastroenterology, identifies CD patients as being at increased risk of osteoporosis and bone fracture.

GF foods are available on prescription to patients diagnosed with gluten sensitivity enteropathies, including CD. The aim of prescribing GF foods was to encourage patients to adhere to a GF diet, when availability of formulated GF foods was limited. This helped prevent more complex health problems from developing.

As formulated GF foods (and naturally GF foods including meat, fish, vegetables, fruit, rice and most dairy products) are now more widely available to purchase in supermarkets and other outlets, the aim of changes is to make savings through restricting the prescribing of GF foods to a more limited list of products, whilst maintaining adherence among patients and so avoiding detrimental health effects. The savings mean the NHS will be able to invest more in other treatments.

Data from 2017 shows that nationally the NHS spent £15.7 million on the basic cost of GF foods. This mainly related to the prescribing of staple foods such as bread, flour and mixes but also to non-staple items including cakes, pastries and cereals which were all prescribed at NHS expense.

In March 2017, the Department of Health & Social Care (DHSC) published the consultation ‘Availability of gluten-free foods on prescription.’ This presented respondents with 3 options for change:

Option 1: Make no changes to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004. Under this option GF foods would continue to be prescribed in primary care at NHS expense.

Option 2: To add all GF foods to Schedule 1 of the above regulations to end the prescribing of GF foods in primary care. Under this option no GF foods would be available on prescription in primary care.

Option 3: To only allow the prescribing of certain GF foods (e.g. bread and mixes) in primary care, by amending Schedule 1 of the above regulations.

The consultation was published on GOV.UK.

The consultation received almost 8,000 responses. These came from a wide range of stakeholders including patients, members of the public, health care professionals, manufacturers of GF foods, charities and NHS organisations.

Option 3, which restricts GF prescriptions to certain bread and mixes, was the chosen outcome. This delivers savings to the NHS and helps mitigate the risk that those on lower incomes would not be able to purchase their own GF foods from retail outlets where prices can sometimes be higher and availability more limited. The majority of respondents preferred this option. Changes made will apply to primary care prescribing and will not impact secondary care settings

In August 2018, DHSC carried out a second consultation which shared a draft copy of the revised regulations and invited scrutiny of these to ensure they would work in practice. The consultation received over 900 responses from a range of stakeholders including patients and carers of patients, members of the public, dietitians, pharmacists and NHS Clinical Commissioning Groups (CCGs). The majority of respondents agreed that the revised regulations would be understood by the service and would provide a staple list of gluten-free bread and mix products. The revised regulation came into force in December 2018.

The consultation was published on GOV.UK.

The GF food list as published in Part XV of the Drug Tariff will be smaller and mean that patients with established gluten sensitive enteropathies will retain access to GF bread and mixes on NHS prescription. GF products that fall outside the category of a bread or a mix will no longer be prescribed at NHS expense. Prescribing regulations will be amended to reflect these changes.

The drug tariff is available on the NHS Business Services Authority website.

Categories of GF foods listed in the Drug Tariff before the revised regulations came into force in December 2018 included bread, pasta, flour, grains, biscuits, mixes, cereals and pizza bases.

Availability of GF foods on NHS prescription varied according to local CCG policy. Some followed guidelines that are provided by the charity for patients with coeliac disease, Coeliac UK, whilst others restricted prescribing to certain products and/or patient groups, or have restricted GF products all together. The new regulations are intended to reduce variation.

The amended regulations are intended to reduce the variation in the provision of GF foods on prescription. All GF food, other than bread and mixes, will be included in Schedule 1 of the “National Health Services (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004. This means that everything apart from GF bread and mixes will be ‘blacklisted’ and not available for prescribing at NHS expense.

CCGs are encouraged to align their local policies with the amended regulations. Under the new legislation, CCGs can restrict further by selecting bread only, mixes only or can choose to end prescribing of all GF foods if they feel this is appropriate for their population, whilst taking account of their legal duties to advance equality and have regard to reducing health inequalities.

The GP or dietitian is ultimately responsible for determining the number of Gluten Free Food units a patient requires, depending upon their age and gender, and whether they are pregnant or breastfeeding. The amount of GF food required for adequate nutritional intake need not all be met by items available on prescription. Coeliac UK have published guidance on this.

NHS England has published national CCG guidance on Prescribing Gluten-Free Foods in Primary Care. This guidance has been reviewed and endorsed by the Low Priority Prescribing clinical working group. The guidance provides recommendations that encourage CCGs to align their local policies with national arrangements.

Manufacturers should apply to the Advisory Committee on Borderline Substances (ACBS) in the usual way, although considering the new regulations, only applications for GF foods in the categories of bread and mixes will be considered by the ACBS. Details of how to do this are available on the gov.uk website.

There cannot be a refund on a partly used pre-paid certificate in light of the amended prescribing regulations of GF foods. Changes to GF prescribing were announced in February 2018 giving patients and NHS services an extended period of notice before the amended regulations came into force in December 2018.

Patients can only claim a refund of a prescription prepayment certificate if they become entitled to free NHS prescriptions. More information is available on the NHS Business Authority website.

Pre-payment certificates cover all prescription medicines and not just GF food so can continue to be used until they expire.

The December edition of the Drug Tariff reflects the new position.

The amended regulations came into force in December 2018.