Oli Hudson, content director at Wilmington Healthcare, looks at what the latest changes proposed by NICE could mean for industry.
The National Institute for Health and Care Excellence (NICE) has opened a public consultation on its process of new topic selection.
This one is not to be confused with the NICE methods consultation (beginning November 2020) or the process consultation (February 2021).
What’s on offer here is a welcome consolidation of the topic selection landscape, which as far as medtech is concerned is fairly complex. Healthtech Connect, launched in 2019, offers one starting point, but topics can also be suggested by NHS England and Improvement. Furthermore, external topic selection panels and committees, or decision-making groups involving predominantly health system partners and NICE staff, have been used inconsistently.
There are also different topic selection processes for pharma (eg, PharmaScan) and specialist interventions (eg, via the NIHR) – with differing rates of responsiveness and support compared with the medical devices process.
NICE proposes that all these processes be simplified into one topic selection ‘manual’ and a single topic selection ‘panel’.
The Topic Selection Oversight Panel (TSOP) is slated to replace the three existing topic selection panels to oversee the application of the identification, selection and routing criteria. It will consist of NICE staff, supported where necessary by DHSC, NHSE/I, and, for the first time, lay members.
Why is this happening?
Juggling these various panels and processes has not been easy for NICE, which takes a lot of flak about its speed and scope.
Also, new responsibilities have recently been added to its work. For example, the Accelerated Access Review, the Life Sciences Sector Deal 2 and the NHS Long Term Plan all place greater demands on NICE to issue more guidance on more things, more quickly and with a greater degree of implementation support.
Then there is the need to adapt the process to new technologies that don’t necessarily fit into existing processes, such as integrated technologies which could include a combination of digital, diagnostic or treatment components.
What are the new criteria?
NICE says topics will be selected if they have “benefits that are likely to be highly disruptive or lead to a stepwise change to an established care pathway in the UK and… a systematic assessment of the cost and system impacts is needed.”
Such benefits will need to be supported by evidence of effectiveness, information about the expected resource impact of adopting the technology, advice from experts (such as patients, carers, clinicians and commissioners) that confirms the benefits are desirable, and are likely to be realised when adopted in the UK health and care system.
What is of note in the new system?
Cost has of course always been a huge consideration in the NICE HTA process, but the emphasis here appears to be changing to a fuller consideration of the system impact of an innovation. This will segue into a discussion about system finance, which is being developed over a near parallel timeline.
Importantly the new consultation stresses that all new or significantly modified interventional procedures that will protect patient safety will be selected if they are available to the NHS or independent sector, or about to be used outside of formal research, with the press release saying “these proposals will ensure we can continue to meet [our] ambitions at a time of unprecedented change in the healthcare system.”
Perhaps there is some ownership here of some truths that have developed over the course of the pandemic – that disruptive changes are costly in themselves, and come with upstream and downstream costs, but what’s important in the final analysis is benefit to the whole system; the significant disruptive innovations need to be adopted at pace; and that patient safety is at a premium.
The consultation on the proposals runs until 19 November.
