Early Value Assessment; NICE’s new push for digital, diagnostics and devices

As absolutely no one has failed to notice, the coronavirus pandemic has injected new energy into the digital transformation agenda. Incoming NHS Transformation Director Tim Ferris has continued to focus on the broader potential of MedTech 24 months after virtual wards, remote monitoring technologies, and teleconsultations became usual practice. Now, regulatory and reimbursement agencies are starting to catch up.

Not least NICE, who in light of this new golden age of MedTech, is re-considering the evaluation framework for MedTech and how to accelerate access to innovation. One proposed solution is the new Early Value Assessment(EVA) Pilot announced in mid-June. NICE says that the EVA aims to provide a cohesive and attractive pathway for MedTech innovations – digital, diagnostics, and devices – that address national unmet need, such as mental health or cancer. Products that are deemed eligible will go through a light touch assessment. The most promising technologies will receive an evidence generation plan, developed in conjunction with NICE and other partners. This should enable technologies to develop the right type of evidence to be re-appraised and receive a positive recommendation by NICE.

The shift to an earlier, advisory role on evidence generation is perhaps recognition that the current HTA appraisal model is not optimal for all health technologies, and UK patients are missing out as a result. Indeed, the digital technologies route, piloted in 2019, has only seen one positive recommendation by NICE in three years[i].

EVA represents a departure of NICE’s usual ways of working. For the first time, NICE will consider system efficiency savings in addition to therapeutic efficacy and cost-effectiveness. No doubt, a move to support with post-covid elective recovery. Alongside industry, NICE will now face the challenges of making evidence generation work: uncertainty, evolving landscapes, and varying data infrastructures. NICE’s attitude to ‘test and learn’ and recognition that it ‘does not always have the answers’ is cause for concern. Without clear guidelines and transparency of process, companies will have no assurance of fairness and it is not clear how success will be measured.

Many unknowns remain. It is unclear how this route will integrate with existing HTA programmes, or whether mandated funding will be made available to EVA recipients. Surely, if NICE aims to develop an attractive national pathway for MedTech, this should be the first port of call? A national pathway with no funding can only go so far.

Ultimately, EVA has the potential to represent a positive step forward to reduce unwarranted variation in the adoption and uptake of MedTech. However, two vital and enormous questions remain – these relate to the process and funding. NICE has given no indications of how long the process will take, what submissions will be required of companies, or what governance structures will sit around the process. Equally, the potential impact of the EVA will be limited until funding is available for HTA for MedTech.

Evidence generation requires time and money so the benefits of this new approach will likely only be felt in the medium- to long-term. As more detail emerges, industry will no doubt be keen to engage with NICE to improve the process iteratively. Only through collaboration will meaningful change be brought about; industry must be bought into this new pathway if it is to succeed.

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[i] https://www.nice.org.uk/news/article/nice-recommends-offering-app-based-treatment-for-people-with-insomnia-instead-of-sleeping-pills