This month, UK health technology assessment agency National Institute for Health and Care Excellence (NICE) made two welcome and forward-thinking announcements. These have the potential to greatly facilitate the entry of innovative digital health technologies into the UK market, including by creating greater alignment between the authorization and commissioning of a digital health technology application in the UK.
Although discussions of digital technologies and artificial intelligence (AI) are not new, the vague and often burdensome evidentiary framework means that many AI and algorithm-powered tools that can, for example, triage patients and diagnose conditions are not commercially available. However, many are now at the planning and development stage. NICE is looking to get ahead of the curve by taking a more innovative approach to assessing new technologies and guiding manufacturers about the data requirements. Other countries are likely to follow, or at least refer to, the models it is setting up.
Updated Evidence Standards
First, NICE has updated the evidence standards framework for digital health technologies that is used for commissioning and reimbursement assessments. The updates make it easier for digital health tool manufacturers to understand the evidence requirements applicable to their product to prove its clinical effectiveness and value to the UK’s health and care system.
We can expect a further update to the framework to come in autumn 2022 that will address the needs of manufacturers of AI and adaptive algorithms by introducing specific categories and classifications for each. Before this, NICE has indicated that it will engage with stakeholders globally to gather views, although it is not clear whether this will take place through a formal or informal consultation.
New Office for Digital Health
The second announcement on May 10 was that NICE is establishing a new Office for Digital Health. This has the aim of accelerating innovation in the digital health sector and pursuing NICE’s existing goal of close cooperation with the UK regulator, Medicines and Healthcare Products Regulatory Agency (MHRA), through an “innovative regulatory and access pathway for data driven technologies.”
Close cooperation between the regulator and the assessment agency is another area in which the UK is being innovative and distinguishing itself from other countries. Most countries follow the traditional route of keeping the approval and reimbursement procedures entirely distinct, often leaving companies unclear about what kinds of early interactions between agencies and regulators are acceptable. By aligning itself more closely with the MHRA, NICE will be able to engage with the right people earlier in order get products to patients more quickly. This is not the first step that the UK has taken toward increasing speed and alignment. At the end of last year, the MHRA set up the Innovative Licensing and Access Pathway in collaboration with NICE, the Scottish Medicines Consortium, National Health Service (NHS) England and NHS Improvement and other partners, to promote faster access to innovative medicines. This new procedure has been available to pharmaceutical companies from January 1, 2021.
The idea is that in the wake of Brexit, every time an innovative treatment is emerging, all stakeholders can get together to provide early-stage advice. They can then draw up an early roadmap for manufacturers and developers to successfully bring the product to the market.
Hopefully the UK’s Office for Digital Health will be a great success in enabling partnership projects and in producing evidence standards and specific policies that facilitate digital health technologies. This way innovators can generate the evidence they need faster, thus accelerating the availability of AI and algorithm-driven tools to patients and doctors.
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