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Evidence requirements for Med Tech Early Value Assessment at NICE in the United Kingdom

Analysis of five HTAs of digital and diagnostic technologies and strategic recommendations for evidence generation strategy in the UK (January 2024)


Health technology assessment plays an important role in market access for medical technologies in England. The National Institute for Health and Care Excellence (NICE) is the key HTA organization with several programs dedicated to assessing medical technologies.

NICE's early value assessment (EVA) program in medical technology, launched in 2022, assesses mostly digital technologies at an early stage in evidence generation. The program recommends the most promising technologies for use in the NHS while further evidence is being generated. NICE focuses on clinical effectiveness, safety, cost, and cost-effectiveness of the technologies. 

If an assessed technology is recommended in the EVA, NICE provides guidance on further evidence generation while the technology is still in use. Once the evidence is collected, NICE will re-appraise the technology and produce additional guidance on whether the technology should be adopted.

In this White Paper, we performed a review of five recent EVA assessments by NICE to present the evidence requirements for digital and diagnostic medical technologies in this particular HTA program. A review of five cases is followed by recommendations in relation to evidence generation for medical technologies, market access in England, and factors influencing the decision-making of NICE. The analysis was performed in January 2024.

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