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    HEALTHTECH PROGRAMME

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    1 Recommendations

    1.1

    There is not enough evidence to determine whether incremental innovations can justify price variations between different transcatheter heart valves for transcatheter aortic valve implantation (TAVI) in adults with aortic stenosis.

    1.2

    Use the least expensive option available that is clinically appropriate for TAVI in the person with aortic stenosis.

    1.3

    NHS trusts should provide access to a range of valves, so that the most clinically appropriate valve is available for everyone with aortic stenosis.

    What information is needed

    More information is needed to determine whether price variation can be justified between different transcatheter heart valves. Details of all patients should be entered into the UK TAVI registry to enable robust comparisons. Key outcomes and information that should be captured include:

    • mortality

    • stroke

    • paravalvular leak or aortic regurgitation

    • permanent pacemaker implantation

    • reintervention

    • the specific valve used.

    All primary studies and analyses of real-world data should adjust for a range of confounding factors including:

    • the anatomy of the valve being replaced

    • the level and distribution of calcium around the valve

    • the person's surgical risk

    • the person's age, sex, comorbidities and previous medicine use.

    These outcomes and baseline characteristics will also need to be recorded in the UK TAVI registry.

    What this means in practice

    Procurement and commissioning considerations

    • Analyses from the economic evaluation done for NICE's guideline on heart valve disease presenting in adults: investigation and management indicated that a transcatheter heart valve would have to cost £14,800 or less for the procedure to be cost effective for all surgical risks. Most of the transcatheter heart valves currently available in the NHS cost more than £14,800 at their list price.

    • 'Added value' agreements between companies and NHS Supply Chain allow for part of the cost of a valve to be returned to an NHS trust based on the number of valves purchased. This can typically only be spent on structural heart-related items or staff within the trust, so will not be resource-releasing for the NHS. Most of the transcatheter heart valves currently available in the NHS cost more than £14,800 even after accounting for 'added value' agreements. The NHS may benefit more from negotiating prices that would be cost-effective across all surgical risk groups than from using those with 'added value' agreements.

    • The number of TAVI procedures done annually is rising (NICOR UK TAVI registry 2024 summary report).

    Why the committee made these recommendations

    Transcatheter heart valves are used to replace a narrowed aortic valve or a failed bioprosthetic valve in people with aortic stenosis. There are many transcatheter heart valves available, which vary in features and cost. This assessment aims to determine whether the differences in clinical, economic and non-clinical outcomes between the different valves attributed to innovative features or characteristics of the valves could justify price variation.

    For most people with aortic stenosis, many of the available valves could be used and are likely to be clinically comparable. For some people a specific valve may be more appropriate. The effectiveness of individual valves is likely to depend both on the features of the valve and the characteristics of the person with aortic stenosis.

    Analyses of real-world data from the UK TAVI registry are limited because of unrecorded confounders (factors that may affect the results), missing data and short follow up. There is no high-quality published evidence that is as relevant to the UK population as the TAVI registry. The results from an economic evaluation based on the real-world data analyses are too uncertain to determine whether the differences in cost between valves are justified.

    More evidence is needed to show if differences in price between valves can be justified by differences in effectiveness. New valves should be able to show that they work as well as other valves. Evidence needs to be comparative and needs to adjust for baseline characteristics that have a large impact on outcomes. These baseline characteristics will also need to be recorded in the UK TAVI registry. This is to ensure that results reflect the performance of the valve used and not the people it is used in.