NICE consultation launched to simplify how medicines are selected for evaluation

NICE consultation launched to simplify how medicines are selected for evaluation

The National Institute for Health and Care Excellence (NICE) has launched a public consultation on proposals to simplify and update the processes it uses when selecting topics for the development of its guidance on health technologies.

The proposals clarify the criteria that would see a device or diagnostic selected for NICE guidance development. In particular, these include where the costs and impacts are expected to be significantly cost incurring or cost saving, or there is uncertainty about the likely cost or the impact it would have on the healthcare system.

For medicines, the proposals confirm the commitment in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access that NICE will appraise all new active substances and significant licence extensions for existing medicines, except where there is a clear rationale not to do so (for example, if the topic is a duplicate or has a significant overlap with an existing topic or policy arrangement).

Similarly, all new or significantly modified interventional procedures that will protect patient safety will be selected if they are available to the NHS or independent sector, or about to be used outside of formal research.

This approach would move away from the 15 criteria currently used to select topics for evaluation by NICE’s Centre for Health Technology Evaluation and provide a clearer and simpler process.

Other key proposals in the consultation include:

  • Topic Selection Oversight Panel (TSOP)
    This single topic selection panel will replace the 3 existing topic selection panels to oversee the application of the identification, selection and routing criteria. This will ensure efficiency and consistency in the decision-making process. The TSOP will include senior NICE staff and will retain the capacity for external expertise to be provided from the Department of Health and Social Care and NHS England and Improvement. Membership will also be extended to include lay members for the first time.
  • Creating consistency with other NICE guidance development processes
    This would happen by removing the need to develop and consult on a scope to inform selection and routing decisions before a topic is selected for the TA or HST programmes. Instead, this will happen closer to the guidance development stage, as is currently the case for cancer medicine topics.
  • Introducing a formal process for stakeholders
    This would be introduced to challenge all topic selection routing decisions.

The consultation on the proposals runs until 19 November and NICE anticipates publishing the final updated methods and processes in September 2021. Full details of the consultation can be found here.

Helen Knight, programme director for Technology Appraisals and Highly Specialised Technologies at NICE, said: “Topic selection plays an important role in the development of NICE guidance and is designed to ensure that the guidance we produce is on topics that support healthcare professionals and others to provide care of the best possible quality.
“These proposals will ensure we can continue to meet these ambitions at a time of unprecedented change in the healthcare system.”