Table 1:
Challenges Identified for Economic Evaluations of NGS Tests
| Study Questions & Model Structure |
| Complex Model Structure: Modeling multiple pathways, results, & testing uses (as a result of multiple genes being tested). May include modeling potential interactive effects (e.g., of life expectancy across multiple conditions). |
| Timeframe: Modeling upstream (e.g., equipment purchase) and downstream (e.g., recurring testing & storage costs) costs & outcomes specific to NGS when relevant. May include potential savings if doing test up-front with later use of results. |
| Secondary Findings: Incorporating possibility of secondary findings and their impact (positive & negative) when relevant |
| Type of Analysis and Comparators Used: Determining appropriate type of analysis and using approaches other than CEA when relevant; using appropriate comparators that take into account what NGS is being compared to and whether substitution or addition |
| Directly Attributable Outcomes: Identifying costs/outcomes directly attributable to NGS when necessary to parse out |
| Measuring Costs & Outcomes |
| Broad Measures of Patient Outcomes: Quantifying range of outcomes for person being tested when relevant, e.g., measuring personal utility to patients because of psychological benefits from having a diagnosis etc. |
| Broad Measures of Health Outcomes Beyond Person Tested: Modeling individual outcomes beyond person being tested when relevant (e.g., modeling impact on family members) |
| Broad Measures of Societal Outcomes: Modeling impact beyond patient outcomes (e.g., education, employment) |
| Data Aggregation: Aggregating data from multiple sources when necessary to measure NGS impact, e.g., combining data from multiple studies |
| Data Availability & Quality |
| Data Availability Issues: Examining lack of evidence and data variability as relevant to NGS, e.g., prevalence, penetrance, clinical utility, race-specific inputs |
| Statistical Issues: Examining statistical issues as relevant to NGS, e.g., triangulating and integrating data sources, using value of information analysis |
CEA, cost-effectiveness analysis; NGS, next-generation sequencing