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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    HEALTHTECH PROGRAMME

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    GID-HTE10027 TAVI draft guidance [noACIC].docx

    Guidance development process

    Late-stage assessment (LSA) guidance evaluates categories of technologies that are already in widespread use within the NHS. It assesses whether price variations between technologies in a category are justified by differences in innovation, clinical effectiveness and patient benefits. This will support NHS commissioners, procurement teams, patients and clinicians to choose technologies that maximise clinical effectiveness and value for money.

    Find out more on the NICE webpage on late-stage assessment (LSA) for medtech.

    This guidance does not replace existing guidance on when to use TAVI to treat aortic stenosis. It only provides information on which valves should be considered once the decision to do TAVI has been made, and on the evidence comparing different types of valve.

    The National Institute for Health and Care Excellence (NICE) is producing guidance on using transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis in the NHS in England. The medical technologies advisory committee has considered the evidence and the views of clinical and patient experts.

    This document has been prepared for public consultation. It summarises the evidence and views that have been considered, and sets out the recommendations made by the committee. NICE invites comments from registered stakeholders, healthcare professionals and the public. This document should be read along with the evidence (the external assessment report).

    The advisory committee is interested in receiving comments on the following:

    • Has all of the relevant evidence been taken into account?

    • Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

    • Are the recommendations sound, and a suitable basis for guidance to the NHS?

    Equality issues

    NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. Please let us know if you think that the recommendations may need changing to meet these aims. In particular, please tell us if the recommendations:

    • could have a different effect on people protected by the equality legislation than on the wider population, for example by making it more difficult in practice for a specific group to access the technology.

    • could have any adverse effect on people with a particular disability or disabilities.

    Please provide any relevant information or data you have about such effects and how they could be avoided or reduced.

    Note that this document is not NICE's final guidance on transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis. The recommendations in section 1 may change after consultation.

    After consultation, the committee will meet again to consider the evidence, this document and comments from the consultation. After considering the comments the committee will prepare its final recommendations. For further details, see NICE health technology evaluations: the manual and NICE's late-stage assessment interim process and methods statement.

    Key dates

    Closing date for comments: 2 September 2024

    Second medical technologies advisory committee meeting: 17 October 2024