The National Institute for Clinical Excellence (NICE) has begun a consultation on its topic selection process.


Topic selection is the process by which NICE decides which device or diagnostic should be selected for producing guidance on. Topics chosen are intended to protect patient safety and support healthcare professionals in using devices and diagnostics, so those delivering care can provide the best possible quality of service and outcomes. Topic selection is impacted upon by a number of factors, which include ministerial referral and company notifications, and has a significant impact on NHS expenditure.

The proposals consulted on intend to clarify the selection criteria for the development of NICE guidance on medical devices or diagnostics. The proposals set out NICE's intention to:

  • appraise all new active substances and licence extensions for existing medicines, along with all new or significantly modified interventional procedures; 
  • move away from the 15 criteria currently used, in favour of a more streamlined process;
  • replace the three current topic selection panels with a single oversight panel, the Topic Selection Oversight Panel (TSOP);
  • include lay members on the new TSOP;
  • remove the requirement to develop and consult on a scope in relation to scoping and routing decisions before topic selection for Technology Appraisals and Highly Specialised Technologies; and
  • create a formal process whereby stakeholders can challenge topic selection routing decisions.

The objectives of the proposals are to:

  • consolidate the existing eligibility, selection and routing criteria for topic selection;
  • align decision-making and stakeholder engagement processes to enhance efficiency, accountability and governance; and
  • improve descriptions of the topic selection processes and decisions to enhance transparency.

The consultation window closes on 19 November 2020. Further details are available on the NICE website.

Should you require any advice or support on submitting a response to NICE, or wish to discuss the above in further detail, please don't hesitate to contact us.

Key Contacts

Louise Dobson

Louise Dobson

Partner, Dispute Resolution
United Kingdom

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Stephanie Townley

Stephanie Townley

Legal Director, Infrastructure, Projects & Energy
Manchester

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Chris Hardy

Chris Hardy

Associate, Infrastructure Projects & Energy
Manchester, UK

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