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Early value assessment – driving innovation into the hands of health and care professionals

Health Technology Assessment bodies such as NICE are continuously looking for ways to improve guidance and provide quicker access for patients to medication and medical devices. In the medical device sector, one of the ways NICE aims to provide quicker access is through the Early Value Assessment (EVA) initiative, which launched in 2022.

NICE showcased the initiative at a webinar on 18 July titled Early value assessment – driving innovation into the hands of health and care professionals.

The event, chaired by Mark Chapman, interim director of medical technology at NICE, included a panel of experts: Andrew Davies, digital health lead at the Association of the British Pharmaceutical Industry (ABPI), and three NICE programme directors – Pall Jónsson, Sarah Byron (programme director for devices, diagnostics and digital) and Mark Salmon (programme director for information resources).

Topics included:

·      NICE’s 2022/2023 vision

·      What is early value assessment?

·      Early value assessment pilot studies

·      Benefits and challenges of the EVA

The webinar concluded with a short Q&A with the audience.

Panellist Sarah Byron discussed the importance of EVA and how it will differ from the approach NICE has typically taken for medical device assessments. An important difference between the two approaches is the inclusion of evidence generation, which will include recommendations and evidence generation before the evaluation stage. Evidence generation will include an evidence generation plan consisting of uniform guidance for all to follow.

The panel discussed the importance of this step and how NICE hopes it will enable a more clear, consistent submission of evidence, so that manufacturers will know what type and what standard of evidence NICE expect.

Panellist Mark Salmon also discussed the anticipated new process of signalling topics to NICE for review. While the current process is done through Health Tech Connect, NICE envisions this will eventually start to shift to the NHS innovation service. Users of Health Tech Connect will still get support but this will begin to phase out.

Anticipated benefits and possible initial challenges of the EVA were discussed. Aside from earlier access to patients, benefits will also include a clearer pathway to market access for industry, quicker early value signals to the health and care system, and increased signals on promising medical technologies that address national unmet needs, all of which offer not only patient, but also commissioner, manufacturer and national benefits.

The panel also discussed new pilot studies being undertaking for EVA for both digital health and non-digital health technologies. NICE will look at 10 technologies, with the first two pilot studies getting underway in June 2022. Topic selection and criteria were discussed alongside the available support and process. The panel stressed this will be a test-and-try pilot and there are still things to learn along the way.

The webinar concluded with a Q&A session with the panel, and a positive end goal in sight for the development of new healthcare devices.

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