The UK’s National Institute for Health and Care Excellence (NICE) has clarified its guidelines on the process of appealing against its guidance for technology appraisals and highly specialised technologies, the decisions of which are crucial to the life sciences industry. Maria Isabel Manley and Victoria Kerr explain the changes.
One of the main roles of NICE is to publish guidance which recommends the use of particular health technologies by the UK’s National Health Service. This includes technology appraisals and recommendations on the use of new and existing treatments, including medicines, medical devices, diagnostic techniques, surgical procedures and health promotion activities.
NICE has recently been reviewing the process of appealing against its decisions on which guidance to issue on particular technologies. On 26 April, it published a new manual setting out the process for appealing against the decisions of both its technology appraisals and its highly specialised technologies evaluations.
These appraisals are crucial to the UK life sciences industry because they are the key to effective market access and to the successful launch of a product on the market. Increased clarity in the guidance on the rules applicable to the appeal process – in instances where the outcome of the technology evaluation is negative – is therefore very welcome.
The new manual will apply to any appeal against a final technology appraisal draft guidance decision from NICE which is made on or after 1 June. Six key changes set out in the new manual are:
The previous manual still applies to all appeals against technology appraisal draft guidance issued up to and including 31 May 2023.
London
mmanley@sidley.com
London
vkerr@sidley.com
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