BSACI statement: NICE approval of Palforzia, a treatment for peanut allergy in children and young people
BSACI welcomes the approval of Palforzia by a NICE technology appraisal committee on 2 February 2022. Palforzia (marketed by Aimmune Therapeutics UK) is the first oral immunotherapy product to be licenced for food allergy. Palforzia contains precise amounts of defatted peanut powder. It works by gradually increasing the body’s ability to tolerate small amounts of peanut, and can help reduce the severity of allergic reactions after being exposed to peanut.
Given the potential for allergic reactions, including potentially life-threatening anaphylaxis whilst on treatment, the BSACI emphasises that prior to introducing Palforzia into routine clinical practice at an individual Trust level, there is a need for NHS Trusts to ensure that staff are adequately trained and that appropriate safety mitigation strategies are in place. Only through these measures does the BSACI consider that the safety profile of Palforzia, demonstrated in clinical trials can be replicated in the clinical setting.
The approval of Palforzia represents a major step forward for the management of food-allergic patients in the NHS. There are approximately 140,000 eligible patients with peanut allergy, but only a handful of specialist services able to provide the multiple visits needed to administer the treatment. These visits require significant space and staff resources, which many services lack. The BSACI are concerned that even with the number of eligible patients limited to 600 in the first year (and 1000 thereafter), there is a real risk that pressure to provide Palforzia in the context of current service limitations will negatively impact other patients. We are concerned as to the disconnect between the public promotion of the treatment following NICE authorisation and ‘on the ground’ reality of delivery, with no clarity around funding mechanisms and no apparent clear accountability for this delivery.
Treatments recommended by NICE in its technology appraisal programmes must be funded by the NHS, by law, through what is called the ‘funding directive’. Normally, when the funding directive is applied, the NHS England (NHSE) has 90 days to make the treatment available. This 90 day period is to allow local Clinical Commissioning Groups (CCGs) to make arrangements to support the NICE recommendation, and does not apply to the availability of the treatment by individual NHS Trusts. The legislation allows for extensions of this 90 day period where there is a need to ensure “(i) training is, (ii) certain health service infrastructure requirements including goods, materials or other facilities are, or (iii) other appropriate health services resources, including staff, are, in place” to support patient safety.
BSACI looks forward to receiving greater clarity from NHSE with regards to funding support to enable the infrastructure and staff changes required to deliver this treatment as well as guidance relating to the triaging of patients, given the anticipated mismatch of demand and capacity.
The BSACI Paediatric Allergy Committee is currently developing guidance to support healthcare professionals who wish to establish an oral immunotherapy service using Palforzia, which should be available by October 2022.
BSACI Trustees, 29 April 2022
 Turner PJ, Makwana N, Roberts G, Fox AT. NICE and easy? Ensuring equitable access to NICE-approved treatments in children and young people. Arch Dis Child. 2022 Apr 22. doi: 10.1136/archdischild-2022-324139.
 The National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013. Available at: https://www.legislation.gov.uk/uksi/2013/259/contents/made