1.1
Stoma care services should have access to the full range of one-piece closed bags available for prescription in the NHS, so that adults with a colostomy can have the most appropriate bag for them.
HealthTech draft guidance
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1 Recommendations
1.2
A healthcare professional and the person with a colostomy should decide together which one-piece closed bag to use.
1.3
There is not enough evidence to determine whether price variations between different one-piece closed bags for adults with a colostomy are justified. So, try using the least expensive bag if more than 1 bag is:
clinically appropriate
meets the preferences and needs of the person with a colostomy (including preventing leakage, seepage and peristomal skin complications).
What information is needed
More information is needed to determine whether price variation can be justified between one-piece closed bags for adults with a colostomy. Key outcomes and information that should be captured include:
leakage and seepage
peristomal skin complications
impact on psychological and social outcomes
health-related quality of life
healthcare resource use, particularly the number of appointments with clinical nurse specialists in stoma care
the specific bag used
how long a person uses one range or brand of bag before switching to another
supporting products used.
A core outcome set and validated patient-reported outcomes should also be developed to help consistency in outcome-reporting across studies. Evidence should be generated across different groups of adults with a colostomy who have complex needs.
This information could be collected through real-world evidence generation or formal research studies. For more detail, see sections 3.20, 3.21 and 3.22 of the guidance.
What this means in practice
Considerations for procurement and commissioning
Between April 2023 and March 2024, one-piece closed bags prescribed in primary care cost the NHS almost £92 million. There is a large difference in price between the cheapest and most expensive bags available on the drug tariff (£1.85 to £3.84; April 2024 pricing).
Based on the external assessment group's analysis, between 59.7% (for flat bags) and 77.5% (for non-flat bags) of the price of bags cannot be accounted for by the presence of potentially innovative features. There was also not enough clinical evidence to justify price variation.
One-piece closed bags with features that can be proven to improve or prevent leakage, seepage, peristomal skin complications and related psychological and social outcomes may be worth paying more for.
The maximum additional cost per bag that could be added to a baseline cost to completely prevent complications most important to users is £1.22 for regular leakage (4 times per month) and £2.39 for peristomal skin complications. Fully preventing complications is unlikely, so a maximum additional cost for a 50% reduction in complications is £0.59 for regular leakage and £1.15 for peristomal skin complications. But, these values are uncertain and do not consider an overlap of complication resolution.
Considerations for healthcare professionals
Choosing a one-piece closed bag should be free from sponsorship influence.
It should be a decision that is shared with the person with a colostomy and follow the principles of NICE's guidance on shared decision making.
Consider the quality of the clinical evidence when prescribing new bags with claimed innovations.
While clinical appropriateness and preferences and needs of the person with a colostomy should be prioritised, if there are multiple options which could be suitable then the least expensive bag should be tried first. This is because there is no evidence to support the price variation.
Considerations for people with a colostomy
Choosing a bag should be a joint decision between you and your healthcare professional to make sure a bag is clinically appropriate and meets your needs and preferences. Not all one-piece closed bags will be appropriate for you. You should be provided with information about those that are.
If there is more than 1 bag that is clinically appropriate and meets your needs and preferences, your healthcare professional may consider trying the least expensive bag first. This is because this assessment found no evidence to show why one bag should cost more than another.
Seek support from a healthcare professional if the one-piece closed bag you are using is causing complications such as leakage and skin irritation, to see if changing the bag type (or supporting products) may help reduce these.
Why the committee made these recommendations
The clinical evidence available on one-piece bags for adults with a colostomy is limited, low-quality and does not consistently report on outcomes important to users. There is not enough clinical evidence to show whether different bags (or their features) would benefit people with a colostomy. But the user-preference assessment found that having features that can reduce leakage, seepage and maintain peristomal skin health were most important when choosing a one-piece closed bag.
There is not enough evidence to determine whether differences between bags or features of bags justify the differences in costs. The cost-effective price is highly uncertain because of the lack of good-quality evidence. The economic evaluation found that bags or features that can prevent peristomal skin complications and leakage may have the biggest impact on costs and quality of life.
More evidence is needed to show if bags with potentially innovative features are more effective, to justify differences in price. Evidence should be collected for outcomes that are important to users, and that allow clinical and cost benefits to be assessed. This evidence should be collected across different groups of people with a colostomy to reflect the variation in this population.
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