Colostomy surgery is an operation to divert 1 or both ends of the colon through an opening in the abdomen (NHS, 2020). A bag (also known as a pouch or appliance) can be placed over the stoma to collect bodily waste (faeces). A colostomy may be needed during the treatment of conditions such as bowel cancer, anal cancer, vaginal or cervical cancer, ovarian cancer, Crohn’s disease, diverticular disease, incontinence endometriosis, Hirschsprung’s disease, birth defects or trauma. Colostomy surgery may be temporary and can be reversed, or it can be permanent. It is estimated that there are over 200,000 people with a stoma in the UK (Colostomy UK, 2024). Open Prescribing reports that 1-piece closed bags were prescribed on 428,464 prescriptions in England between February 2023 to January 2024, costing the NHS £92 million. Bags for people with a colostomy are made up of a baseplate that attaches to the skin around the stoma, and a bag that collects bodily waste (faeces). Typically, people with a colostomy use 1-piece closed bags. The baseplate of 1-piece closed bags can be flat, convex or concave to suit different body shapes and can be made of different materials. Baseplates may have different types of adhesives and come in different shapes and sizes to try and improve durability, stop leakage and reduce creasing around the stoma opening. Bags also come in different sizes, colours and may have additional innovative features designed to suit specific user needs. NICE is scoping for an assessment on 1-piece closed bags as part of a new process called late-stage assessment (LSA). LSA aims to assess technologies that are in widespread or established use in the NHS. Over time, technologies often undergo continuous or incremental innovation and adaptation. LSA will assess if the value added by incremental innovation justifies any price variation.
 
Status In progress
Technology type Device
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources

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Timeline

Key events during the development of the guidance:

Date Update
05 December 2024 A survey will be done from 6th December 2024 to 10th January 2025 to gather feedback from key stakeholders on the committee’s initial findings. The survey will seek to clarify how NICE’s recommendations on these products could be used in practice to ensure patients are able to access the most effective products for their needs, whilst ensuring the best value for money for the NHS. Following this feedback, we will update stakeholders with how we plan to proceed.
30 October 2024 Development of this guidance has been paused so that we can carefully consider how to present the committee’s findings in a way that is most useful for NHS commissioners, practitioners and the people they care for. We will provide an update in due course and where appropriate will reach out to stakeholders during this pause. Please note: development of all other late stage assessment pilot guidance topics will continue as planned unless otherwise notified by NICE, alongside scoping work for future Late Stage Assessment topics to be undertaken during 2025/26.
18 October 2024 Consultation - Draft guidance. We will provide you with an update when we have more details about the updated schedule and next steps.
19 September 2024 Committee meeting: 1
10 June 2024 Final Assessment Protocol Published
23 April 2024 Scope published
22 April 2024 The revised timeline for the Late stage assessment will be published on the webpage in due course.
05 April 2024 Scoping workshop
26 February 2024 In progress. In Development
13 February 2024 Awaiting development. Status change linked to Topic Selection Decision being set to Selected