MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis

Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD

This is a limited coverage policy for molecular biomarker tests to guide targeted therapy selection in Rheumatoid Arthritis (RA). Coverage criteria: The patient is an adult with a confirmed diagnosis of moderately to severely active RA. The patient has a history of failure, contraindication, or intolerance to at least one first-line therapy for the treatment of RA (i.e., conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs)) despite adequate dosing. The patient has not initiated a biologic or targeted synthetic therapy (b/tDMARD) for RA (i.e., Tumor Necrosis Factor-alpha inhibitor [TNFi], Janus Kinase [JAK] inhibitor, etc.) OR has initiated b/tDMARD therapy and is being considered for an alternate class of targeted therapies as a result of failure, contraindication, or intolerance to the initial targeted therapy despite adequate dosing. The test predicts response and/or non-response to at least one class of targeted or biologic therapies for RA according to multiple validated response/remission criteria (a) with an accuracy that exceeds that which can be obtained from the combination of existing clinical and other data AND (b) with demonstrated reproducibility across clinical study cohorts. Testing using molecular biomarkers has not been previously performed for predictive therapy selection in RA. Testing is performed according to the intended use of the test in the intended patient population for which the test was developed and validated. The test demonstrates analytical validity (AV), clinical validity (CV) and clinical utility (CU), establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management in a clearly defined population. Clinical validity of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed published literature for the intended use of the test in the intended population. If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm. The lab providing the test is responsible for clearly indicating to treating physicians the population and indication(s) for test use. The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) Technical Assessment that ensures that AV, CV, and CU criteria set in this policy are met to establish the test as Reasonable and Necessary. If applicable, performance characteristics are equivalent or superior to the average performance of other similar tests (for the same intended use) evaluated by this contractor upon successful completion of a technical assessment. Since the clinical utility of predictive testing is largely dependent upon consensus-based management recommendations, this coverage decision is subject to change pending changes in the literature and in consensus guidelines. Finally, new tests that become available with significantly improved performance may render older tests no longer compliant with this policy.