OHE has submitted a response to the public consultation on updating the principles that guide the development of NICE guidance and standards.
The National Institute for Health and Care Excellence (NICE) has been running a public consultation on updating the principles that guide the development of its guidance and standards. Underpinning the consultation is a draft document [PDF] setting out NICE’s key principles, bringing together existing statements about the Institute’s current practices. The final document is intended to replace NICE’s current guide to its Social Value Judgements [PDF]. The consultation runs until 11th February 2019, and OHE recently submitted a response.
OHE’s response focused on principles 5 and 6 of the draft document. Principle 5 describes how organisations representing patients, service users, carers and the wider public are involved in defining the scope of NICE products and are invited to submit evidence for its advisory committees to consider. This seems reasonably clear for input into specific guidance (e.g. the appraisal of a specific technology) but it is less clear whether and how these groups will have the opportunity to provide input into more general guidance and value judgements adopted by NICE and its advisory committees.
The Social Value Judgements guide states the following: “The NHS is funded from general taxation, and it is right that UK citizens have the opportunity to be involved in the decisions about how the NHS’s limited resources should be allocated” (p.10). It is unclear whether this statement still holds, and it appears that NICE’s Citizens Council has not been active in recent years. It would be helpful to see a commitment from NICE to consider research (e.g. from academic groups) that generates and analyses evidence on the views of different groups (e.g. public, patients) on issues related to social value. We believe that public sector resource allocation decisions should be informed by information on societal preferences.
More generally, while the new principles document is intended to replace the Social Value Judgements guide, we note that the content of the two documents differs considerably. The Social Value Judgements guide contains useful information on how NICE considers factors such as individual choice, rare conditions, rule of rescue, avoiding discrimination, equality and inequalities. In our consultation response, we suggested that NICE could provide information on whether there is anything from the soon-to-be-defunct guide that has not been absorbed into the various methods and process manuals.
Principle 6 notes that where specific criteria are satisfied, life-extending end of life treatments and highly specialised technologies may be recommended with cost-effectiveness estimates above the normally acceptable range. We have suggested that it would be helpful to provide a brief explanation of the rationale(s) for this. It is also unclear whether these are the only exceptions to the standard value for money assessment approach. For example, we note that the factors influencing judgements about the acceptability of a technology listed in section 6.3.3 of NICE’s Guide to Methods of Technology Appraisal (e.g. innovative nature of the technology, aspects that related to non-health objectives of the NHS) are not mentioned in the draft principles document. In addition, estimates of opportunity cost may be different for public health and social care interventions (compared to health care interventions), hence a different threshold, or alternative decision criteria, may be relevant. NICE’s position on this is unclear.
Finally, we note that NICE uses an opportunity cost threshold, while various Government departments use alternative approaches to assess value for money, such as a threshold or value of a statistical life based on willingness-to-pay data. Some explanation of the reason(s) for this difference would be useful.
OHE has undertaken research and written extensively about some of the issues raised in this consultation. Examples include:
- A journal article reviewing the methods used in NICE’s various health technology assessment programmes (subject of a previous blog post)
- A programme of research examining NICE’s policy for the appraisal of life-extending end of life treatments and the extent of public support for the policy (subject of several previous blog posts, including here)
- A consulting report examining the way in which treatments for very rare diseases are appraised (subject of a previous blog post)
- A journal article describing NICE’s social value judgements about equity in health and health care
- A blog post highlighting the application of NICE principles and social value judgements in a recent technology appraisal
- A programme of work seeking to better understand the opportunity costs of new health care technologies, highlighted in a previous blog post and a consulting report
- Ongoing research to explore the trade-offs being made in the allocation of taxation budgets across the public sector
For more information, please contact Koonal Shah.
Related research
Cowles, E., Marsden, G., Cole, A. and Devlin, N., 2017. A Review of NICE Methods and Processes Across Health Technology Assessment Programmes: Why the Differences and What is the Impact? Applied Health Economics and Health Policy, 15(4), pp.469-477. DOI. RePEc.
Shah, K.K., Cookson, R., Culyer, A. and Littlejohns, P., 2013. NICE’s Social Value Judgements about Equity In Health And Health Care. Health Economics, Policy and Law, 8(2), pp.145-165. DOI. RePEc.
Shah, K.K., 2017. Valuing Health at the End of Life. PhD thesis. Sheffield: University of Sheffield.
Towse, A. and Garau, M., 2018. Appraising Ultra-Orphan Drugs: Is Cost-Per-QALY Appropriate? A Review of the Evidence. Consulting Report. London: Office of Health Economics. RePEc.
