Application of Health Technology Assessment (HTA) to Evaluate New Laboratory Tests in a Health System: A Case Study of Bladder Cancer Testing

Abstract

We describe the methods and decision from a health technology assessment of a new molecular test for bladder cancer (Cxbladder), which was proposed for adoption to our send-out test menu by urology providers. The Cxbladder health technology assessment report contained mixed evidence; predominant concerns were related to the test’s low specificity and high cost. The low specificity indicated a high false-positive rate, which our laboratory formulary committee concluded would result in unnecessary confirmatory testing and follow-up. Our committee voted unanimously to not adopt the test system-wide for use for the initial diagnosis of bladder cancer but supported a pilot study for bladder cancer recurrence surveillance. The pilot study used real-world data from patient management in the scenario in which a patient is evaluated for possible recurrent bladder cancer after a finding of atypical cytopathology in the urine. We evaluated the type and number of follow-up tests conducted including urine cytopathology, imaging studies, repeat cystoscopy evaluation, biopsy, and repeat Cxbladder and their test results. The pilot identified ordering challenges and suggested potential use cases in which the results of Cxbladder affected a change in management. Our health technology assessment provided an objective process to efficiently review test performance and guide new test adoption. Based on our pilot, there were real-world data indicating improved clinician decision-making among select patients who underwent Cxbladder testing.

Laboratory Demand Management Strategies—An Overview

“…One possibility for achieving appropriate test selection may be to conduct a health technology assessment prior to test implementation. Landaas et al [ 53 ] describe an approach whereby the Laboratory Formulary Committee, comprising different medicine professionals, and the Smart Innovation staff of the local hospital analyzed a new molecular bladder cancer test according to a locally implemented health technology assessment program. In conclusion, the committee currently does not support system-wide use, but decided to start a small pilot study.…”

Assessing the early impact of a hospital-based health technology assessment program, smart innovation

“…Analyses were performed using the R statistical software [R v4.0.2, (13) using RStudio v1. 3.1073] yielding a p-value significance of differences between the UWMC and the controls for the number of procedures per quarter. Human subjects' review was approved by the UWMC's Institutional Review Board (IRB).…”

“…HTA is less common within hospitals and health systems (1). The premise of hospital-based health technology assessment (HB-HTA) is that more informed and structured decisions about the adoption and use of health technologies will improve clinical outcomes and hospital efficiency (2;3). The emergence of HB-HTA activities was derived from the necessity to mitigate the risk of adopting new technologies without sufficient evidence of clinical benefit and potential cost impact (1).…”

“…The emergence of HB-HTA activities was derived from the necessity to mitigate the risk of adopting new technologies without sufficient evidence of clinical benefit and potential cost impact (1). Given that most hospitals make technology decisions at the system level, clinical efficacy, safety, utilization, and cost data should be used to inform these decisions (2;3). However, new technology decision making in hospitals is influenced by a variety of competing interests of various stakeholder groups, including clinicians, hospital financial leadership, patients, and contracted vendors (2).…”

“…We describe Smart Innovation in more detail in a previously published paper (2). In brief, the program provides a process and decision framework to evaluate new technologies objectively, and it works with clinical and executive committees to inform adoption decisions (2;3). The program reviews new technologies that are requested by providers and utilizes nine dimensions of evidence and is considered a comprehensive HB-HTA program (2;3).…”