OBJECTIVES: Personalized medicine driven by diagnostics has potential to improve patient outcomes and save costs for payers. However, a significant number of diagnostics are unable to receive reimbursement coverage for market access. The objective of this analysis was to understand the evidence requirements for diagnostics based on review of NICE Health Technology Assessment (HTA) reports.

METHODS: A systematic review of all 2011-2022 NICE diagnostic HTAs was conducted using NOVEL-HTA database. HTA Reports were reviewed for all key reasons for not recommending a diagnostic device. For selected reports, we analyzed the NICE’s final determination and developed insights and lessons learned.

RESULTS: During 2011-2022, there were 41 diagnostics related guidance published by NICE. Twenty (~50%) of the diagnostics were issued a final determination of “not recommended” or “not enough evidence to recommend”. In 8 of these 20 assessments, NICE indicated, there was not enough evidence to determine impact of the diagnostic on treatment decision and patient management. In 7 assessments, uncertainty or lack of cost-effectiveness was cited as the main reason. Interestingly, in 6 assessments, NICE questioned the accuracy of the diagnostics, which is also assessed by regulatory agency, implying need for more collaborative effort between regulatory and HTA agencies. In 5 assessments, NICE indicated it was unclear how the diagnostic improved clinical and patient outcomes. In 2 assessments, NICE strongly criticized the claimed benefits of the diagnostic saying it “lacks face validity”.

CONCLUSIONS: Nearly half of the diagnostics were not recommended by NICE. Insights and lessons from these case studies could help manufacturers design value focused evidence generation strategy.