Table 1 Rapid evidence generation for genomic technologies: current and proposed paradigms
Current paradigm | Proposed paradigm | ||
|---|---|---|---|
Evidence of clinical utility | Absent for many genomic technologies as randomized controlled trials are not an economically feasible design in this context | Evidence generation is possible through three building blocks for a collaborative model: (i) risk sharing between payers and manufacturers to enable temporary coverage of promising genomic tests, (ii) leveraging existing data networks with necessary advances for integrating genomic information, and (iii) endorsement and engagement from key stakeholders | |
Insurance coverage | No insurance coverage of many genomic technologies due to lack of clinical utility evidence | Temporary coverage of “promising” genomic tests that have proven analytical and clinical validity with early evidence of impact for clinical care | |
No market access or low utilization of many genomic technologies for manufacturers | Risk sharing between payers and manufacturers | ||
Efforts to generate evidence on clinical utility | Disease-, study-specific efforts | Accruing real-time data among large populations within a single, large health-data network | |
Numerous networks and consortiums but limited scope and funds and a long time before evidence is produced | Collaborative model that needs a coordinating center with collaborating institutions that may be funded by public and private agencies including NIH | ||
Data elements necessary for determining clinical utility | Patient demographics, identifiers | Present in EHR data if used | Present in insurance claims and EHR data |
Genomic test order, utilization, results | Poorly captured in some EHR systems if used | Advances are needed to (i) better capture tests performed including specific billing codes, (ii) make test results easily accessible in electronic health data, (iii) build a common data model to aggregate data from different health systems and insurers | |
Subsequent treatments/management | Incomplete records in EHR systems if used | Insurance claims and EHR data contain fairly complete medical and pharmacy utilization records | |
Stakeholder collaboration | Depending on studies | Collaboration between payers, manufacturers, provider groups, patients, academics/researchers | |
