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  • Question on Document

    Please indicate which stakeholder group listed most closely represents you:
    1. Industry (manufacturer of medicines, health technologies or equipment)
    2. Trade body / association
    3. Consultancy
    4. University / academic
    5. Government department
    6. Other public sector organisation
    7. Voluntary and community sector organisation
    8. Health or social care practitioner
    9. Member of the public
    10. Other (provide detail)
  • Question on Document

    Have we considered all the relevant evidence in preparation for adopting the EQ-5D-5L value set? Is our interpretation of the evidence appropriate?
  • Question on Document

    Are the changes to the NICE technology appraisal and highly specialised technologies guidance manual (PMG36) appropriate?
  • Question on Document

    Are the changes to the developing NICE guidelines manual (PMG20) appropriate?
  • Question on Document

    Is it clear when alternative methods for capturing health-related quality of life may be accepted, and what the preferred hierarchy is for selecting from the available alternatives?
  • Question on Document

    Beyond what is described in the equality and health inequality impact assessment, are there any aspects of the proposed changes that need particular consideration to ensure they do not result in unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
  • Question on Document

    If you have any further comments in relation to the proposed changes set out in this consultation, please include them here.

Appendix A: Proposed changes to NICE manuals

Table A1. Proposed changes to NICE technology appraisal and highly specialised technologies guidance manual (PMG36)

Section

Current wording

Proposed change

4.2.2, Table 4.1

Health effects should be expressed in quality-adjusted life years (QALYs). The EQ‑5D is the preferred measure of health-related quality of life in adults.

Replace with new text:

Health effects should be expressed in quality-adjusted life years (QALYs). The EQ‑5D-5L is the preferred measure of health-related quality of life in adults.

4.3.6

Given the need for consistency across evaluations, the EQ‑5D measurement method is preferred to measure health-related quality of life in adults. Preference values from the EQ‑5D should be applied to measurements of health-related quality of life to generate health-related utility values.

Replace with new text:

Given the need for consistency across evaluations, the EQ‑5D-5L measurement method is preferred to measure health-related quality of life in adults. Companies, academic groups and others preparing evidence submissions for NICE should use the EQ-5D-5L descriptive system and value set (Rowen et al. 2026) for reference-case analyses.

Add new section 4.3.7:

In some cases, data may only be available from the EQ-5D-3L descriptive system. If data was gathered using the EQ-5D-3L descriptive system, utility values in reference-case analyses should be calculated by mapping the 3L descriptive system data onto the 5L value set. If analyses use data gathered using both EQ-5D-3L and EQ-5D-5L descriptive systems, the 5L value set should be used to derive all utility values, with 3L mapped onto 5L when needed. The mapping function developed by the Decision Support Unit (Hernández Alava et al. 2017), using the 'EEPRU dataset' (Hernández Alava et al. 2023), should be used for reference-case analyses.

4.3.8

If not available in the relevant clinical trials, EQ‑5D data can be sourced from the literature. When taken from the literature, the methods for identifying the data should be systematic and transparent. Clearly explain the justification for choosing a particular data set. When more than 1 plausible set of EQ‑5D data is available, sensitivity analyses should be done to show the effect of the alternative utility values.

Replace with new text (now 4.3.9):

If not available in the relevant clinical trials, EQ‑5D-5L data can be sourced from the literature. When taken from the literature, the methods for identifying the data should be systematic and transparent. Clearly explain the justification for choosing a particular data set. When more than 1 plausible set of EQ‑5D-5L data is available, sensitivity analyses should be done to show the effect of the alternative utility values.

4.3.9

When EQ-5D data is not available, this data can be estimated by mapping other health-related quality-of-life measures or health-related benefits seen in the relevant clinical trials to EQ-5D. This is considered to be a departure from the reference case. The mapping function chosen should be based on data sets containing both health-related quality-of-life measures and its statistical properties. It should be fully described, its choice justified, and it should be adequately shown how well the function fits the data. Present sensitivity analyses to explore variation in using mapping algorithms on the outputs.

Replace with new text (now 4.3.10):

When EQ-5D data is not available (from either the EQ-5D-3L or EQ-5D-5L descriptive systems, or from the literature), this data can be estimated by mapping other health-related quality-of-life measures or health-related benefits seen in the relevant clinical trials onto the EQ-5D-5L value set. This is considered to be a departure from the reference case. The mapping function chosen should be based on data sets containing both health-related quality-of-life measures and its statistical properties. It should be fully described, its choice justified, and it should be adequately shown how well the function fits the data. Present sensitivity analyses to explore variation in using mapping algorithms on the outputs.

4.3.12

A hierarchy of preferred health-related quality-of-life methods is presented in figure 4.1. Use figure 4.1 for guidance when the EQ-5D is not available or not appropriate. See the proposed changes to figure 4.1 supporting document (PDF).

Replace with new text (now 4.3.13) and amended figure 4.1:

A hierarchy of preferred health-related quality-of-life methods is presented in figure 4.1. Use figure 4.1 for guidance when the EQ-5D-5L data is not available, or the EQ-5D measure is not appropriate. See the proposed changes to figure 4.1 supporting document (PDF).

4.3.16

The EQ‑5D‑5L is a new version of the EQ‑5D, with 5 response levels. NICE does not recommend using the EQ‑5D‑5L value set for England published by Devlin et al. (2018). Companies, academic groups and others preparing evidence submissions for NICE should use the 3L value set for reference-case analyses. If data was gathered using the EQ-5D-5L descriptive system, utility values in reference-case analyses should be calculated by mapping the 5L descriptive system data onto the 3L value set. If analyses use data gathered using both EQ-5D-3L and EQ-5D-5L descriptive systems, the 3L value set should be used to derive all utility values, with 5L mapped onto 3L when needed. The mapping function developed by the Decision Support Unit (Hernández Alava et al. 2017), using the 'EEPRU dataset' (Hernández Alava et al. 2023), should be used for reference-case analyses. We support sponsors of prospective clinical studies continuing to use the 5L version of the EQ-5D descriptive system to collect data on quality of life.

Delete section 4.3.16 (updated guidance on value set and mapping moved to section 4.3.6)

Table A2. Proposed changes to developing NICE guidelines manual (PMG20)

Section

Current wording

Proposed change

7.4, table 7.1

Measuring and valuing health effects: Quality-adjusted life years (QALYs): the EQ-5D-3L is the preferred measure of health-related quality of life in adults

(See our position statement on the EQ-5D-5L)

Replace with new text:

Measuring and valuing health effects: Quality-adjusted life years (QALYs): the EQ-5D-5L is the preferred measure of health-related quality of life in adults. The UK value set for the EQ‑5D-5L (Rowen et al. 2026) should be used to generate utility values.

7.7, subsection 'Measuring and valuing effects for health interventions'

As outlined in NICE technology appraisal and highly specialised technologies guidance: the manual (2022) and the accompanying NICE position statement on use of the EQ-5D-5-level (5L) valuation set for England (updated October 2019), we do not currently recommend using the EQ‑5D 5L valuation set. Guideline development teams should use the 3-level (3L) valuation set for reference-case analyses, when available.

Delete this paragraph

7.9 references

Add reference:

Rowen D, Mukuria C, Bray N, et al. (2026) A UK value set for the EQ-5D-5L. Value in Health (forthcoming)