1 Recommendations

1.1

There is not enough evidence to determine whether price variation is justified between different one-piece closed bags for adults with a colostomy.

1.2

Stoma care services should have access to a broad 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.

1.3

A healthcare professional and the person with a colostomy should decide together which one-piece closed bag to use. Decisions should take into account clinical appropriateness and the person with a colostomy's needs and preferences (including preventing leakage, seepage and peristomal skin complications [PSC]), which may change over time.

1.4

If more than 1 one-piece closed bag is clinically appropriate and meets the needs and preferences of the person with a colostomy, use the least expensive option.

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
PSCs
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 1 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, including those who have complex needs (such as stoma or skin complications, or other conditions that could affect outcomes).

This information could be collected through real-world evidence generation or formal research studies. For more detail, see sections 3.21 to 3.23.

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 least and most expensive bags available on the Drug Tariff (£1.85 to £3.84; April 2024 pricing).
Current price variation cannot be justified by the presence of potentially innovative features because the external assessment group's (EAG) regression analysis shows limited correlation between the current price of bags and whether they have potentially innovative features.
There is uncertainty in how much the NHS should pay for one-piece closed bags that prevent complications. The EAG's analysis calculated the maximum extra cost per one-piece closed bag to completely or partially (a 50% reduction) prevent complications. To completely prevent regular leakage (4 times per month) the estimated extra cost per bag is £1.22 and for PSCs it is £2.39. For partial prevention, the extra cost is £0.59 for regular leakage and £1.15 for PSCs. But these values are uncertain because of limited evidence and do not consider an overlap of complications.
It may be worth paying more for one-piece closed bags with features that are proven to improve or prevent leakage, seepage, PSCs and related psychological and social outcomes.

Considerations for healthcare professionals

Choosing a one-piece closed bag should be free from sponsorship influence.
Decide together with the person with a colostomy which one-piece closed bag to use, 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.
When choosing a bag, clinical appropriateness and the needs and preferences of the person with a colostomy should be prioritised. But if more than 1 bag is suitable, the least expensive option should be used. This is because there is no evidence to justify variations in price.
These recommendations are not intended to affect existing bag use if the choice is clinically appropriate and meets the needs and preferences of the person with a colostomy. These recommendations should be considered when people with a colostomy are switching bags.

Considerations for people with a colostomy

You and your healthcare professional should decide together which one-piece closed bag to use. The bag you choose should be clinically appropriate and meet your needs and preferences. There is a range of one-piece closed bags (from a number of companies) available for prescription in the NHS. But not all one-piece closed bags will be appropriate for you. You should be given information about those that are.
If more than 1 bag is clinically appropriate and meets your needs and preferences, your healthcare professional will offer you the least expensive one. This is because this assessment found no evidence to show why one bag should cost more than another.
Your needs and preferences may change over time. Seek support from a healthcare professional if the one-piece closed bag you use causes complications, such as leakage or skin irritation, to see if changing the bag type (or supporting products) helps.

Why the committee made these recommendations

The clinical evidence available on one-piece closed bags for adults with a colostomy is limited, of 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, when choosing a one-piece closed bag, features that can reduce leakage, seepage and maintain peristomal skin health are most important.

The cost-effective price for a bag is highly uncertain because of the lack of good-quality evidence. There is also not enough evidence to show whether differences between bags or features of bags justify the differences in costs. But the economic evaluation found that bags or features that can prevent PSCs and leakage may have the biggest impact on costs and quality of life.

More evidence is needed on outcomes that are important to people with a colostomy, and that allow clinical and cost benefits to be assessed. This evidence should be collected across different groups of people.