OTH-04 Development of a licenced Faecal Microbiota Transplant service for patient treatment in the NHS

Introduction Faecal Microbiota Transplant (FMT) is an efficacious treatment for recurrent Clostridium difficile infection (CDI) and has shown encouraging signals for inflammatory bowel disease. Access to FMT services in the NHS has been limited by the regulation of FMT as a medicinal product in the UK. To enable inter-institution supply, FMT manufacturers are required to hold a Specials licence from The Medicines and Healthcare products Regulatory Agency. Methods In 2017 the first licenced FMT service in UK was created at the University of Birmingham Microbiome Treatment Centre. Policies and procedures were developed using the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide), which were used and maintained within a quality management system. The frozen FMT bank utilises anonymous unrelated healthy donors and provides FMT on a named patient basis for the treatment of CDI and supplies clinical trials via an investigational medicinal product (IMP) licence. Results Since August 2018, 53 faecal microbiota transplants have been supplied for recurrent and refractory CDI to 21 NHS Trusts across England and Wales. Twelve of these Trusts did not have access or perform FMT prior to the introduction of this service. In 98% (52/53) of cases FMT was delivered either within 48 hours or on the day of request if >48 hours from request. Clinical response to treatment was observed in 76% (16/21) of patients, with 88% (14/16) of these patients remaining symptom free at 90 days. In 2018 the service became the sole supplier of FMT under the 201–019 NHS Innovation and Technology Tariff. Under the IMP licence the service has successfully supplied over 360 faecal microbiota transplants for the pilot stage of a multi-centre trial of FMT in UC (STOP-Colitis). Conclusions Development of a licenced FMT facility at the University of Birmingham has improved equality of access to this novel treatment across the NHS. FMT has been provided within a zero cost model for CDI and is available generally within 48 hours of request. Patients with CDI benefit from improved care from this service, which limits morbidity and mortality from this severe infection. Supply via an IMP licence has enabled the required FMT infrastructure to be developed to support prospective FMT research in the UK.