NICE Review on its Drug Development Guidances

| By | Guidance, NICE
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Following approval at its recent Board meeting NICE has confirmed the details of its review of the methods it uses to develop guidance on drugs, medical devices and diagnostics.

The purpose of the review is to optimise NICE’s evaluation methods to support the ambition of the NHS to provide high quality care that offers good value to patients and to the NHS. For medicines, the review is linked to the commitments in the 2019  Voluntary Scheme for Branded Medicines Pricing and Access.

Engagement with key stakeholders has resulted in a short-list of topics that will be considered in the review. For each, a case for change will be explored, and proposals presented for public consultation in summer of 2020.

The review will cover NICE’s technology appraisals (TA), highly specialised technologies (HST), medical technologies, and diagnostics assessment programmes.

Sir Andrew Dillon, NICE chief executive, said:

This update is part of the regular review and refresh of our methods to ensure that they are robust and up-to-date. NICE is undertaking this review at a time of unprecedented change in the healthcare system, where developments such as personalised medicine, digitalisation of health, and use of cell and gene therapy, mean products are becoming ever more challenging to evaluate. Keeping NICE’s methods up to date is an important contribution to managing these changes. The expanded Accelerated Access Collaboration, and the development of NHS England’s commercial framework are other important elements. NICE encourages people who are interested in the methods and process review to register an interest on the NICE website to ensure they receive regular updates on this work.

A broad set of topics will be considered in the review, ranging from modifiers used in decision making to costs used in health technology assessment, and equality considerations in guidance development.

The review will also look at how uncertainty – for example with the available evidence or the assumptions made within economic modelling – is explored or quantified, and what can be done to try and reduce that uncertainty. This will include thinking about how data analytics and real-world evidence can be used.

Other topics, scheduled for consideration in 2020 include:

  • How quality of life is incorporated into economic analyses and considered by committees.
  • Technology-specific issues (for example, addressing the challenges of evaluating the new generation of treatments that have been developed to target tumours according to their genetic make-up rather than where they originate in the body).
  • The methods needed to assess the clinical and cost effectiveness of the position of technologies in the care pathway.

The criteria used for selecting topics for evaluation through NICE’s HST programme will also be reviewed in order to make them clearer and more specific.

Details of further review topics that will be completed after 2020 have also been announced. These include looking at the best ways to evaluate new and emerging genomic technologies and testing strategies, reviewing and, where necessary, updating the methodology for producing guidance on medical devices and diagnostics that address antimicrobial resistance, and reviewing the methods used to assess digital health technologies and assessing future needs in this area.

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