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Guidance assessment consultation document for HTE10048 Compression products for treating venous leg ulcers: late-stage assessment

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1 Recommendations

1.1

When choosing compression products to treat venous leg ulcers, price variation for compression hosiery over compression bandaging is justified, provided that the hosiery is clinically appropriate and meets the needs and preferences of the person with a venous leg ulcer.

1.2

There is not enough evidence to determine whether price variation is justified for compression wraps over other compression products.

1.3

NHS trusts should provide access to a range of compression products, so that a product that is clinically appropriate and meets people's needs and preferences is available for everyone with a venous leg ulcer.

1.4

A healthcare professional and the person with the venous leg ulcer should decide together which compression product to use (see the NICE page on shared decision making). Decisions should take into account how the choice of compression product might affect the person's quality of life, including:

  • ability to complete activities of daily living

  • adherence with the treatment regimen

  • physical health

  • mental health and wellbeing

  • relationships with others, including whether people have informal carer support at home.

What information is needed

More information is needed to determine whether compression wraps are clinically and cost effective compared with compression hosiery or compression bandaging. Evidence should be of sufficient sample size to detect a statistically significant difference, report details of concomitant treatments and ideally be done in a community setting in the NHS.

Key outcomes that should be captured include:

  • clinical performance outcomes of compression wraps, including:

    • health-related quality of life

    • time to complete wound healing

    • duration of treatment

    • adverse events

  • preferences of the person with a venous leg ulcer, including:

    • comfort

    • ease of application

    • bulkiness of the product

  • resource use, including:

    • number of products prescribed

    • frequency of visits by healthcare professionals.

What this means in practice

Considerations for procurement and commissioning

  • According to the National Wound Care Strategy Programme, in 2019 there were around 739,000 leg ulcers in England with estimated associated healthcare costs of £3.1 billion per year. Venous leg ulcers account for 60% to 80% of all leg ulcers.

  • The price varies between and within different types of compression products.

  • Many factors can influence which type of compression product is best to treat a person's venous leg ulcer. Commissioners and procurement specialists should work with healthcare professionals in NHS trusts to ensure access to a range of compression products.

  • Evidence suggests the clinical effectiveness of compression hosiery and bandaging is broadly similar. Economic modelling suggests that compression hosiery, which enables self-management, is cost effective compared with compression bandaging, which relies on regular visits from a nurse to change the dressing. Compression wraps also have the potential to enable self-management, but there is more uncertainty about their effectiveness.

  • NICE's resource impact assessment estimated potential savings of £528,000 based on 2,000 people using compression bandaging, and assuming that 30% of them switch to hosiery.

Considerations for wound management formulary groups

  • These recommendations are not intended to restrict choice. When developing a formulary, a range of compression bandages and other types of compression products, including both compression hosiery and compression wraps, will be needed to provide options for different clinical and patient preference scenarios.

  • Aids, such as hosiery applicators or waterproof protectors, to support people using compression products should also be considered. Decision making should prioritise cost-effective options, taking into account the factors listed in recommendation 1.4.

Considerations for healthcare professionals

  • These recommendations do not replace clinical reasoning. If more than one type of compression product is clinically appropriate, the choice of dressing should be based on the preferences of the person with the leg ulcer and cost effectiveness, taking into account the factors listed in recommendation 1.4.

  • Additional items, such as hosiery applicators and waterproof bandage protectors, should be offered alongside the compression product if appropriate.

  • Healthcare professionals should work with commissioners and procurement specialists who cover their NHS trust to ensure access to a range of compression products.

Considerations for people with venous leg ulcers

  • People with venous leg ulcers should be involved when deciding which compression product to use. They should be given information on the compression product that is being prescribed and, where possible, offered options that meet their needs. People should ask for products that support the use of the compression product, such as waterproof protectors for compression bandages.

  • People with venous leg ulcers should be given support if they experience any issues or wish to change to another type of compression product.

Why the committee made these recommendations

There are many compression products available to treat venous leg ulcers. This assessment aims to determine whether the differences in clinical, economic and non-clinical outcomes attributed to the different types of compression products could justify price variation.

Evidence from clinical trials shows that the clinical effectiveness of 2-layer compression bandaging, 4-layer compression bandaging and 2-layer compression hosiery is broadly similar. But there is limited evidence on the clinical effectiveness of compression wraps compared with these products.

The economic model suggests that compression hosiery is more cost-effective than compression bandaging and compression wraps over time periods of up to 1 year. It also suggests that compression wraps are most cost effective in the long term (up to 5 years). But this is uncertain because the data for compression wraps is limited. A large UK study also showed that compression hosiery was cost effective compared with 4-layer compression bandaging.

So, price variation for compression hosiery over compression bandaging is justified, but there is not enough evidence to determine whether price variation is justified for compression wraps over other compression products.