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

Coverage is limited to adults (>=18) with confirmed moderately to severely active rheumatoid arthritis who have failed, are intolerant of, or have contraindications to at least one csDMARD and who have not had predictive testing previously; patients may be eligible prior to initiating b/tDMARD or when considering an alternate targeted class after failure of an initial targeted therapy. Tests must predict response/non‑response to at least one class of targeted/biologic RA therapies with accuracy and reproducibility beyond existing clinical data, be performed per the test's validated intended use/population, demonstrate AV/CV/CU (with peer‑reviewed clinical validity), have independently validated algorithms if applicable, and complete the MolDX Technical Assessment to be considered reasonable and necessary.

"Patient is an adult (age >= 18) with a confirmed diagnosis of moderately to severely active rheumatoid arthritis (RA)."