The National Health Service urgent cancer referral pathway for suspected urological cancers: early economic evaluation of a risk prediction test.

OBJECTIVES: In the UK, the number of patients urgently referred for suspected cancer is increasing, and providers are struggling to cope with demand. We explore the potential cost-effectiveness of a new risk prediction test - the PinPoint test - to triage and prioritize patients urgently referred with suspected urological cancers. METHODS: Two simulation models were developed to reflect the diagnostic pathways for patients with (i) suspected prostate cancer, and (ii) bladder or kidney cancer, comparing the PinPoint test to current practice. An early economic analysis was conducted from a UK National Health Service (NHS) perspective. The primary outcomes were the percentage of individuals seen within 2 weeks and health care costs. An exploratory analysis was conducted to understand the potential impact of the Pinpoint test on quality-adjusted life years gained. RESULTS: Across both models and applications, the PinPoint test led to more individuals with urological cancer being seen within 2 weeks. Using PinPoint only to prioritize patients led to increased costs overall, whereas using PinPoint to both triage and prioritize patients led to cost savings. The estimated impact on life years gained/lost was very small and highly uncertain. CONCLUSIONS: Using the PinPoint test to prioritize urgent referrals meant that more individuals with urological cancer were seen within 2 weeks, but at additional cost to the NHS. If used as a triage and prioritization tool, the PinPoint test shortens wait times for referred individuals and is cost saving. More data on the impact of short-term delays to diagnosis on health-related quality of life is needed.

Integrating Early Economic Evaluation into Target Product Profile development for medical tests: advantages and potential applications.

Target Product Profiles (TPPs) outline the characteristics that new health technologies require to address an unmet clinical need. To date, published TPPs for medical tests have focused on infectious diseases, mostly in the context of low- and middle-income countries. Recently, there have been calls for a broader use of TPPs as a mechanism to ensure that diagnostic innovation is aligned with clinical needs, yet the methodology underpinning TPP development remains suboptimal. Here, we propose that early economic evaluation (EEE) should be integrated within the TPP methodology to create a more rigorous framework for the development of "fit-for-purpose" tests. We discuss the potential benefits that EEE could bring to the core activities underpinning TPP development-scoping, drafting, consensus building, and updating-and argue that using EEE to help inform TPPs provides a more objective, evidence-based, and transparent approach to defining test specifications.

EARLY COST-EFFECTIVENESS ANALYSIS OF NEW MEDICAL TESTS: RESPONSE.

As strong advocates and adopters of early cost-effectiveness modeling for test evaluation, we were excited to see the recent article "The Early Bird Catches the Worm: Early Cost-Effectiveness Analysis of New Medical Tests," in which Buisman and colleagues present a succinct and generalizable framework for conducting this type of analysis. The authors have done an excellent job in identifying and summarizing the key components of this methodology, as well as highlighting fundamental differences between early analyses versus the traditional late-stage approach. As the number of medical tests coming to market continues to grow, there is an ever growing need to develop rigorous methodology in this area, and we commend the authors for this timely work.