The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 has been revised to reflect changes in the availability of gluten-free (GF) foods on prescription. These changes came into force in December 2018. Recommendations to CCGs are twofold: First, patients in receipt of NHS prescriptions for GF bread and/or mixes should be those diagnosed by their doctor as suffering from established gluten-sensitive enteropathies, including dermatitis herpetiformas andcoeliac disease; second, CCGs should support prescribers to prescribe in line with the revised regulations which allow for no GF products to be prescribed at NHS expense, other than GF bread and/or GF mixes.

What is coeliac disease (CD)?

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 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.

What are the consequences of non-adherence?

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.

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.

What will the revised regulations mean in practice?

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.) 2004. 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. This means that everything apart from GF bread and mixes will be ‘blacklisted’ and not available for prescribing at NHS expense. Prescribing regulations will be amended to reflect these changes. The CCGs can restrict this further by selecting bread only, mixes only, or they can choose to end prescribing of all GF foods if they feel this is appropriate for their population, while taking account of their legal duties to advance equality and have regard to reducing health inequalities.

How many units of GF food is required?

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.

Will CCGs be provided with guidance to support their prescribing policies?

NHS England has published national CCG guidance on prescribing GF 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.

Can patients who have purchased a pre-payment certificate to cover the cost of their GF prescriptions obtain a refund?

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.

When will the Drug Tariff be updated with the revised regulations?

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

Further resources and guidance for CCGs and prescribers

Coeliac UK website

NHS England. Prescribing Gluten-Free Foods in Primary Care: Guidance for CCGs. Available at: www.england.nhs.uk/wp-content/uploads/2018/11/prescribing-gluten-free-foods-primary-care-guidance-for-ccgs.pdf

NHS England. Prescribing Gluten-Free foods in Primary Care: Guidance for Clinical Commissioning Groups—frequently asked questions. www.england.nhs.uk/medicines/medicines-optimisation/prescribing-gluten-free-foods-in-primary-care-guidance-for-ccgs-faqs/