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Changes to medicines and medical devices evaluation proposed

As part of wide-reaching work being carried out to review the methods and processes NICE uses to develop guidance, the organisation has launched a public consultation on proposals for changing how it selects the topics it will develop guidance on.

Covering guidance on medicines, medical devices and diagnostics, the proposals clarify the criteria which would see a device or diagnostic selected for NICE guidance development.

In particular, these include where costs and impacts are expected to be significantly cost-incurring or cost-saving – or there is uncertainty around the likely cost or the impact it would have on the healthcare system.

With regard to medicines, the new proposals would confirm the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access that pledged NICE would appraise all new active substances and significant licence extensions for existing medicines, except where there was a clear rationale not to do so.

This was for example if the topic was a duplicate or had significant overlap with an existing topic or policy arrangement.

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

This proposed 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.

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.”

Other key proposals include:

  • Replacing the 3 existing topic selection panels with a single topic selection panel – the Topic Selection Oversight Panel (TSOP) to oversee the application of the identification, selection and routing criteria. Membership of the panel will include lay members for the first time.
  • 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.
  • Introducing a formal process for stakeholders to challenge all topic selection routing decisions.

The consultation on the proposals runs until 19 November. This will be followed by a separate public consultation on the case for change to its processes in February and March 2021.

NICE anticipates publishing the final updated methods and processes in September 2021.

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