The National Institute for Health and Care Excellence ("NICE") has published a revised timetable for reviewing its methods and processes for health technology assessments ("Methods Review"). NICE's assessments determine which new medicines are considered as representing sufficient value for money to be paid for by the National Health Service ("NHS") in England, Wales and Northern Ireland.

Originally, a six week public consultation on proposed changes was scheduled for Summer 2020 with publication of an updated NICE manual expected in December 2020. Instead a public consultation on changes to NICE's methods will now begin in November 2020 and separate consultation on changes to NICE's processes will be launched in February 2021. This will then be followed by a stakeholder consultation on a draft updated programme manual for such assessments in June 2021 and NICE anticipates that its final programme manual will be published in September 2021.

The change in timing is particularly relevant to products under NICE assessment between now and the end of 2021 which may have benefitted (or not) from any changes that are introduced as a result of the Methods Review, particularly products for rare diseases and cell and gene therapies.

What is NICE reviewing?

NICE agreed to review its methods for technology appraisals ("TA"), highly specialised technologies ("HST") as part of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access agreement between the government and industry. In addition to TA and HST, the Methods Review also includes NICE's medical technologies evaluation programme and diagnostics assessment programme.

The areas under review include:

• clarifying further the selection criteria for evaluation of treatments through the HST or TA programme;
• how uncertainty can be accounted for and reduced, for example, by utilising data analytics and real-world evidence;
• how improvements in quality of life can be incorporated into economic analyses, for example, by using patient reported outcome measures;
• the methods needed to properly assess the clinical and cost effectiveness of technologies which are used at different points in the care pathway; and
• certain technology-specific issues, for example, how the new regulations on medical devices and in vitro diagnostic devices may affect the current methods used by NICE.

The main aim of the Methods Review is to update NICE's evaluation methods and processes in the context of new technologies such as personalised medicines, digital health programmes and the use of cell and gene therapies. The outcome is intended to speed up access to new and promising health technologies, better support market access and simplify the health technology assessment process. The extent to which the Methods Review achieves this will very much depend on the balance struck between adding flexibility in the assessment process and the need to maintain budgetary certainty for the NHS.

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