The National Institute for Health and Clinical Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on leukapheresis for inflammatory bowel disease in June 2005. In accordance with the Interventional Procedures Programme Process Guide, guidance on procedures with special arrangements are reviewed 3 years after publication and the procedure is reassessed if important new evidence is available.
The guidance was considered for reassessment in June 2008 and it was concluded that NICE will not be updating this guidance at this stage. However, if you believe there is new evidence which should warrant a review of our guidance, please contact us via the email address below.
Ulcerative colitis and Crohn’s disease are the most common forms of inflammatory bowel disease. Ulcerative colitis causes inflammation and ulceration of the rectum and sometimes the colon. Symptoms include bloody diarrhoea and rectal bleeding. Crohn’s disease usually causes inflammation and ulceration of the small and large intestines, but it can affect any part of the digestive tract. The main symptoms are abdominal pain, diarrhoea and weight loss. Both of these are chronic conditions, characterised by periods of clinical relapse and remission.
Conservative treatments include dietary measures, and medications to control inflammation. Immunosuppressants may be used if other medical therapies are ineffective at maintaining remission. Patients with ulcerative colitis that does not respond to medical therapy may be treated with surgery to remove the colon. Although surgery may also be used for patients with Crohn’s disease, it may not be curative and the disease often recurs in a different part of the digestive tract.
Leukapheresis involves extracorporeal removal of leukocytes from the blood, either by centrifugation or by passage of blood through an adsorptive system. In each system, venous blood is removed in a continuous flow, anticoagulated, processed to deplete the leukocytes, and returned to the circulation. A leukapheresis session takes approximately one to two hours. The procedure is usually carried out once or twice a week, for about 5 to 10 sessions.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.