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The new manual will apply to any appeal against a final technology appraisal draft guidance decision from NICE which is made on or after 1 June.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:

  • A new section clarifying who may bring an appeal. The previous guidance specifies that only consultees involved in a technology appraisal or a highly specialised technologies evaluation may appeal. The updated guidance now provides a helpful defined list of ‘consultee organisations’ that are permitted to lodge an appeal. It also clarifies that the ability to become a consultee ends at the point when the final draft guidance is issued to stakeholders, whether this happens after consultation or without consultation.
  • Clarification of the procedure for commencing judicial review proceedings in instances where some of the grounds for appeal are dismissed at scrutiny.
  • Clarification on the oral hearing process, including on the confidentiality of the data submitted and the process for declaring conflicts of interests.
  • All data considered relevant to the appeal must have already been submitted to the technology appraisal committee. New evidence or information cannot be presented in the appeal letter or at the hearing. The new manual clarifies that stakeholders who consider that new data casts doubt on a recommendation should seek a review of the guidance, rather than lodging an appeal.
  • Shortening of the timescale for the appeal panel to release and publish an appeal decision.
  • Clarifying at which point after the publication of guidance and the publication of an appeal decision an application for judicial review should begin.

The previous manual still applies to all appeals against technology appraisal draft guidance issued up to and including 31 May 2023.