Early Value Assessment (EVA) for medtech

Why are we doing this?

A lot of digital health technologies and other medical technologies are coming onto the market. But there is no clear guidance for the NHS about which will make a real difference to patients. We provide expert opinion on which of these technologies could provide most value for the NHS, and what further evidence is needed.

EVA considers medical technologies that address national unmet needs, contributing to the NHS Long Term Plan. This will help people access the care they need quickly and easily.

About early value assessment

The EVA process and methods explores in detail the potential of technologies to:

• address unmet need
• assess existing evidence
• identify key gaps in evidence.

We will identify priority areas for health and social care, along with medical technologies suitable for national evaluation. We will then work with a range of stakeholders in the health and care system to confirm these topics and technologies.

The initial topics selected for consideration include:

• mental health: priority clinical areas
• cardiovascular: predicting risk of heart failure
• early cancer detection
• medical technologies that boost healthcare capacity.

Once a technology is recommended for early use in the NHS, we'll develop an evidence generation plan. This will detail the evidence that needs to be gathered while it's in use. When we have the evidence needed, we'll be able to make a full recommendation for using the technology.

Benefits for the NHS

The early value signal is expected to be particularly important in areas where there are many promising technologies with the same use case (purpose and benefits). When these technologies are implemented into local practice, NHS researchers can use our evidence generation requirements to guide them in producing real-world evidence.

EVA aims to support issues faced by the NHS and patients such as lengthy hospital waiting lists. It will do this by using digital technologies, devices, diagnostics, and therapeutics that can support remote monitoring, and that benefit from digital innovation.

Benefits for technology developers

EVA is expected to be particularly useful in areas where there are many promising technologies with the same purpose and benefits. NHS researchers can use our evidence generation plans to guide them in producing real-world evidence while these technologies are being used.

EVA aims to support issues faced by the NHS and patients such as lengthy hospital waiting lists. It will do this by using digital technologies, devices, diagnostics, and therapeutics that can support remote monitoring, and that benefit from digital innovation.

Which technologies is EVA for?

EVA is for promising medical technologies that meet a national unmet need. Technologies suitable for EVA are:

• appropriately CE marked or UKCA marked (a medical device)
• for Digital Technologies - in addition to the above, they must have Digital Assessment Criteria (DTAC) approval - for more information, visit the NHS England website 
• have the potential for patient and system benefit in an area of national unmet need
• supported by healthcare professionals and the healthcare system
• in need of further data collection or evidence generation before they can be recommended foruse in the NHS.

Digital technologies play an important role in EVA, but are not the main focus. We recognise that a large volume of digital health technologies are entering the UK market. EVA aims to give the NHS a clear signal about which of these work, offer good value for money, and meet system need. But, EVA is for all MedTech including devices, diagnostics, and therapeutics. We will continually review its focus and priorities.

What's different about EVA?

EVAs provide the NHS with guidance about the value of a technology, including a recommendation for use while evidence is generated. Unlike full NICE guidance (DG and MTG), technologies selected for EVA will not be expected to have a complete evidence base before they're recommended for use.

How topics are selected

We'll select technologies that address a clinical, system or service user problem as suggested by NHS England and stakeholder engagement. EVAs will look at technologies where their adoption will have the most impact and add value to the health and social care system.

The potential benefits of the technologies to the system and patients will be considered, as well as the availability of emerging technologies.

EVA outcomes

As part of the EVA process, the technologies are reviewed by a committee who will decide whether the technology should receive a recommendation for early use in the NHS. The committee will also state the conditions of the recommendation. This will include the key outcomes that need to be captured through evidence generation, and the timeframe over which this should happen. After this, the technology will be reviewed again by NICE in full guidance.

Developers of technologies that get a recommendation for early use will work with our teams to develop an evidence generation plan.

Evidence generation plans

Evidence generation plans will be developed to build on new or existing research or real-world data collection. Our objective is to allow technology developers to identify what evidence gaps need to be addressed and to give them opportunities to work with stakeholders who can help with further data collection and analysis by delivering the evidence generation plan. These include:

• community and voluntary sector organisations
• clinical and patient experts
• national or regional data repositories 
• potential funders for evidence generation
• commissioners and/or NHS providers
• third-party data experts (where relevant).

The aim is to support technology developers to produce the evidence needed for a NICE guidance update and a clear recommendation about future routine use of the technology in the NHS.

The requirements for each evidence generation plan will be different and will reflect existing evidence and the extent of evidence gaps identified by committee. The plan will then need to propose how the evidence gaps can be addressed and the depth of detail needed. Each plan will be developed through a systematic approach, addressing practical considerations and recognising the challenges in generating new evidence.

In some priority clinical areas, established programmes of funding may exist that could be linked to an EVA recommendation. Where these established programmes are not in place, the technology developer will need to seek their own funding. The EVA recommendation could help to support funding requests, for example from venture capitalists.

We will work with the technology developer to identify system partners who can support the delivery of evidence generation. We can also broker relationships, as needed, with potential data controllers and research funders.

This is an important project for us. We're taking tangible steps to transform the way we evaluate technologies. Our focus is on meeting the needs and priorities of people and the health and social care system. Enabling earlier access to innovation through faster assessments and timely guidance production is critical.

Great progress is already underway through positive collaboration with our partners. I’m genuinely excited about what we can achieve together.