A more realistic approach to proving clinical utility is to satisfy the FTH levels up to the Patient Outcome Efficacy level. Although the final level (Societal Efficacy) is laudable, it isn’t practical for uncommon diseases.
Another critical problem is the lack of key opinion leaders (KOLs) recommending advanced biomarkers to other rheumatologists. KOLs commonly cite the strict ACR conflict of interest (COI) requirements as reasons. The problem with this is that it is challenging to find KOLs who aren’t involved with uncommon disease biomarker R&D.
Consequences of Barriers
More accurate testing is paramount as the rheumatologist shortage worsens. Patients need to rely more on primary care providers for diagnosis and management. Better testing is critical for earlier and more accurate diagnoses and more accurate ways of accessing disease activity to better guide therapeutic decisions (personalized medicine).
Who wins in the long run with the current system? The giant lab duopoly.
Who loses in the long run? Patients who could benefit from better biomarkers, such as those who could have benefited from CB-CAPS testing over the past 11 years. The tests could have diagnosed patients more accurately and at earlier stages of SLE, helped with more accurate disease activity determinations, and reduced more severe disease and deaths.
Advanced biomarker researchers and developers also forego reaping the rewards for their hard work and innovation. There should be incentives to help drive the search for better diagnostic tools.
Proposed Solutions
To advance rheumatic disease laboratory testing, we propose the following:
- The ACR should actively support novel biomarkers shown to benefit patient care;
- The ACR should be more flexible in addressing potential COI;
- The ACR should include advanced biomarkers in diagnostic and management guidelines;
- KOLs should include advanced biomarkers when teaching healthcare providers about rheumatic disease management;
- Disease management resources (like textbooks and UpToDate) should support novel biomarkers in disease management discussions;
- Academic centers should incorporate advanced biomarkers offered by proprietary labs;
- Fellowship programs should teach the latest research regarding novel biomarkers, even if not available at their institutions;
- Community rheumatologists should use advanced biomarkers in clinical practice and not primarily rely on in-house labs;
- Insurance companies should pay for novel biomarkers that show utility in peer-reviewed journals;
- Insurance companies should reimburse proprietary labs and not favor the duopoly;
- Insurance companies must stop mistaking classification criteria for diagnostic criteria;
- Insurance companies, KOLs, and rheumatology educational platforms should adopt transparent, objective systems (such as the FTH) for evaluating all biomarkers (old and new) for clinical utility; and
- The FDA and CMS should improve laboratory test approval processes.
Act Now
Suppose the rheumatology community does not vigorously support new biomarkers. In that case, insurance companies will likely raise up major challenges in covering their costs. However, if we work diligently on the proposed solutions above, insurance companies may realize the importance of providing better care for patients.
