Box 1.

NICE’s articulations of its policy on innovation as a social value

Guide to the methods of technology appraisal (3rd edition, Apr 2004): “Above a most plausible ICER of £20,000/QALY, judgements about the acceptability of the technology as an effective use of NHS resources are more likely to make more explicit reference to factors including […] the innovative nature of the technology” (NICE, 2004)

Guide to the methods of technology appraisal (4th edition, Jun 2008): “Above a most plausible ICER of £20,000 per QALY gained, judgements about the acceptability of the technology as an effective use of NHS resources will specifically take account of the following factors […] The innovative nature of the technology, specifically if the innovation adds demonstrable and distinctive benefits of a substantial nature which may not have been adequately captured in the QALY measure” (NICE, 2008b)

Social value judgements: Principles for the development of NICE guidance (2nd edition, Jul 2008): “Above a most plausible ICER of £20,000 per QALY gained, judgements about the acceptability of the intervention as an effective use of NHS resources will specifically take account of the following factors […] When the intervention is an innovation that adds demonstrable and distinct substantial benefits that may not have been adequately captured in the measurement of health gain” (NICE, 2008a)

Guide to the methods of technology appraisal (5th edition, Apr 2013): Section 2, “Developing the scope”: “Other issues likely to impact upon appraisal … the potential innovative nature of the technology, in particular its potential to make a significant and substantial impact on health-related benefits that are unlikely to be included in the QALY calculation during assessment” Section 6, “The appraisal of evidence and structured decision-making”: “Above a most plausible ICER of £20,000 per QALY gained, judgements about the acceptability of the technology as an effective use of NHS resources will specifically take account of the following factors […] The innovative nature of the technology, specifically if the innovation adds demonstrable and distinctive benefits of a substantial nature which may not have been adequately captured in the reference case QALY measure” (NICE, 2013a)

Single technology appraisal: User guide for company evidence submission template (Jan 2015) “If you consider the technology to be innovative, with potential to make a substantial impact on health-related benefits that are unlikely to be included in the quality-adjusted life year (QALY) calculation:  state whether and how the technology is a ‘step-change’ in the management of the condition  provide a rationale to support innovation, identifying and presenting the data you have used” (NICE, 2015a)