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    Minor amendments to existing manual content

    Table 2. Minor amendments to existing manual content

    Existing wording

    Suggested section

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    [contents: What the manual contains]

    Page 11 to 13

    Update accordingly. TBC

    In addition to evidence on the technology's effects and costs, health technology evaluation should consider a range of other relevant issues. For example:

    • the impact of having a condition or disease, the experience of having specific treatments or diagnostic tests for that condition, the experience of the healthcare system for that condition

    • organisational issues that affect patients, carers or healthcare providers

    • NICE's legal obligations on equality and human rights

    • the requirement to treat people fairly

    3.1.4

    In addition to evidence on the technology's effects and costs, health technology evaluation should consider a range of other relevant issues. For example:

    • the impact of having a condition or disease, the experience of having specific treatments or diagnostic tests for that condition, the experience of the healthcare system for that condition

    • organisational issues that affect patients, carers or healthcare providers

    • NICE's legal obligations on equality and human rights

    • the requirement to treat people fairly

    • issues relating to health inequalities.

    Qualitative research can explore areas such as values, preferences, acceptability, feasibility and equity implications. Many elements of the decision problem can be informed by qualitative evidence. When this evidence is submitted it can be particularly useful to assess aspects including, but not limited to:

    • patients' experience and quality of life as a result of having a disease or condition

    • patients' experience and quality of life as a result of having a treatment or test

    • any subgroups of patients who may need special consideration in relation to the technology

    • patients' view on the acceptability of different types of treatment, device or test

    • views of carers

    • views of people with experience using the device or a comparator device

    • views of treating clinicians

    • views on the feasibility of guidance implementation.

    3.3.18

    Qualitative research can explore areas such as values, preferences, acceptability, feasibility and equity implications. Many elements of the decision problem can be informed by qualitative evidence. When this evidence is submitted it can be particularly useful to assess aspects including, but not limited to:

    • patients' experience and quality of life as a result of having a disease or condition

    • patients' experience and quality of life as a result of having a treatment or test

    • any subgroups who may need special consideration in relation to the technology or who experience health inequalities

    • patients' view on the acceptability of different types of treatment, device or test

    • views of carers

    • views of people with experience using the device or a comparator device

    • views of treating clinicians

    • views on the feasibility of guidance implementation.

    This outline should include, but is not limited to, evidence sources to be used, evidence likely to become available during the evaluation and how this might be managed, the planned approach to disease and economic modelling, potential challenges in interpreting the evidence, and the proposed approach to handling of uncertainty

    5.5.3

    This outline should include, but is not limited to:

    • evidence sources to be used

    • evidence likely to become available during the evaluation and how it might be managed

    • any plans to submit quantitative evidence on health inequalities issues

    • the planned approach to disease and economic modelling

    • potential challenges in interpreting the evidence, and

    • the proposed approach to handling of uncertainty.

    NICE invites non-company stakeholders to make a submission providing information on the potential clinical effectiveness and value for money of a technology, using the appropriate templates available on the NICE website. The submission should reflect the experience of patients, healthcare professionals and commissioners of current standard treatment in the NHS in England. It should also reflect the potential impact of using the new technology on health-related quality of life. Implementation issues, such as staffing and training needs, should also be included. Stakeholders are given the same number of days and deadline to provide their submission to NICE after the invitation to participate. After receiving the evidence submissions, NICE sends them to the EAG and technical team for consideration.

    5.5.32

    NICE invites non-company stakeholders to make a submission providing information on the potential clinical effectiveness and value for money of a technology, using the appropriate templates on the NICE website. The submission should reflect the experience of patients, healthcare professionals and commissioners of current standard treatment in the NHS in England. It should also reflect the potential impact of using the new technology on health-related quality of life. If appropriate, it may also demonstrate any potential impacts on health inequalities. Implementation issues, such as staffing and training needs, should also be included. Stakeholders are given the same number of days and deadline to provide their submission to NICE after the invitation to participate. After receiving the evidence submissions, NICE sends them to the EAG and technical team for consideration.

    Above a most plausible ICER of £20,000 per QALY gained, or £100,000 per QALY gained for highly specialised technologies, decisions about the acceptability of the technology as an effective use of NHS resources will specifically consider the following factors:

    • The degree of certainty and uncertainty around the ICER.

    • Aspects that relate to uncaptured benefits and non-health factors.

    6.3.5

    Above a most plausible ICER of £20,000 per QALY gained, or £100,000 per QALY gained for highly specialised technologies, decisions about the acceptability of the technology as an effective use of NHS resources will specifically consider the following factors:

    • The degree of certainty and uncertainty around the ICER.

    • Aspects that relate to uncaptured benefits and non-health factors.

    • Aspects that relate to how the technology affects health inequalities.