OBJECTIVES: The value of diagnostic tests often focuses on their performance (i.e., sensitivity, specificity, accuracy) and endpoints relevant for clinicians. As such, this presents an opportunity to design HEOR models to comprehensively quantify both short- and long-term outcomes derived from diagnostic procedures to improve the decision making process related with diagnostics tests. This research was designed to inform the development of a HEOR model framework to evaluate positron emission tomography (PET) and single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) modalities using radiopharmaceuticals, for coronary artery disease (CAD), incorporating short- and long-term perspectives.

METHODS: A structured literature review identifying clinical and economic outcome studies associated with MPI PET and SPECT to diagnose CAD was conducted.

RESULTS: The results demonstrated that for CAD, there are very few published economic evaluations, which use variable methodologies and reporting across a broad range of imaging modalities. The gap in outcomes evidence informed development of a multi-faceted valuation framework which includes the following parameters: diagnostic performance (i.e., sensitivity, specificity, accuracy), clinical utility (clinical behavior modification, e.g., earlier treatment), healthcare resource use (HCRU) efficiency (change in follow-up testing, e.g., fewer invasive tests), test-related complications, and clinical outcomes (e.g., earlier treatment leading to fewer adverse cardiac events). Challenges associated with connecting these disparate parameters in one model are discussed and demonstrate how a comprehensive evidence based HEOR model can substantiate the incremental costs associated with advanced imaging modalities for high-risk CAD patient subpopulations.

CONCLUSIONS: This research highlights the need to segment CAD patients by CAD pre-test probability and prioritize subpopulations where underlying disease mechanisms and patient anatomical imaging challenges limit the performance of current imaging diagnostics. Finally, the value of HEOR model development and real-world evidence generation to show the clinical utility and impact on HCRU associated with advanced imaging diagnostics in CAD is also underscored.