Early Value Assessments (EVAs) for Medtech by NICE: What Can We Learn so Far?

OBJECTIVES: To optimise the opportunities brought by technological advances, the NHS must identify which technologies provide the most value for money and ensure early patient access. In 2022 NICE launched their Early Value Assessment (EVA) programme to facilitate this process. This research provides an overview of the technologies selected for the programme to date, and insights into the evidence reviewed and recommendations made.

METHODS: All published EVAs were included. For each, the guidance document and evidence generation plan were reviewed. Data were extracted on the technology (type, number of technologies assessed/recommended), clinical evidence (evidence submitted, clinical-effectiveness, safety), economic evidence (evidence submitted/reviewed, findings), potential benefits and evidence generation plan. The data were analysed qualitatively and quantitatively.

RESULTS: Fourteen EVAs were identified: 10 included digital technologies and four included diagnostics. Of the digital technologies, 5 were for mental health indications, and 5 for bariatric, respiratory, musculoskeletal and oncology indications. Indications for the diagnostics were cardiology, oncology, urinary and neonatal.

A total of 90 technologies were assessed, some within multiple indications. Forty-two technologies were recommended for use alongside data collection. Where a technology was not recommended, and had UK Conformity Assessed (UKCA) approval, NICE stipulated it should only be accessed through company, research or non-core NHS funding.

NICE reviewed the available evidence for each technology to assess potential benefits for the NHS. Most commonly these were identified as clinical and resource benefits, followed by improving patient access. Where technologies were not approved, evidence was deemed insufficient to determine the clinical or cost benefits of the technology.

CONCLUSIONS: The EVA approach enables a rapid, early, evaluation of technologies clinical effectiveness and value for money. Although the included technologies have tended to have a limited evidence base, approval alongside an evidence generation plan still required sufficient evidence to show potential clinical or cost benefits.