NICE's early value assessment: an external assessment group's commentary on the challenges and opportunities of NICE's new life cycle approach to HealthTech.

The National Institute for Health and Care Excellence (NICE) early value assessment (EVA) was launched in 2022 as a process to assess new technologies that have the potential to meet an unmet need or demand. The recommendations that result from the process are best viewed as a type of managed entry agreement - that is, time-limited and conditional on further evidence being generated. This commentary, from authors in PenTAG (an external assessment group involved in assessing medical technologies for NICE, based at the University of Exeter), explores the challenges that have arisen during 3 years of performing EVAs, offers some thoughts on EVA's role in evidence generation, and their fit in NICE's wider evidence landscape. The commentary identifies areas for potential improvement in terms of timelines, scoping and protocol development, searching, reviewing, and economic modeling. Many of the suggested changes are relatively minor tweaks to the process, or requests for clearer guidance or expectation management. We conclude that, with some changes to the EVA process and its accompanying guidance, the assessments could become more efficient. In summary, the EVA represents NICE's life cycle approach in their HealthTech program, wherein evidence is collected along the life cycle to help monitor initial assumptions and recommendations made. The process is designed to continuously capture incremental innovation over the lifetime of a medical device. As such, EVAs reflect a small but important shift in how health technology assessment is practiced.