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

Coverage is limited to adults with confirmed moderately to severely active rheumatoid arthritis who have failed, are contraindicated to, or are intolerant of at least one csDMARD, and who either are b/tDMARD‑naïve or are being considered for an alternate targeted therapy class after b/tDMARD failure. Covered tests must predict response/non‑response to at least one targeted or biologic therapy with superior accuracy and reproducibility versus existing clinical data, be used in the validated intended population, demonstrate AV/CV/CU with peer‑reviewed evidence (including independent algorithm validation if applicable), and successfully complete a MolDX Technical Assessment. Tests previously performed for predictive therapy selection, those lacking AV/CV/CU or independent validation, or tests used outside their validated intended use are not covered.

"Patient is an adult with a confirmed diagnosis of moderately to severely active rheumatoid arthritis (RA)."