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

Coverage for molecular biomarker testing to guide targeted therapy selection in RA is limited to adults with moderately to severely active RA who have failed, are intolerant of, or have contraindications to at least one csDMARD and who are either b/tDMARD‑naïve or being considered for a change in targeted therapy after failure/contraindication/intolerance. Tests must predict response to targeted/biologic therapy with demonstrated analytical validity, clinical validity, and clinical utility supported by peer‑reviewed evidence, be validated (including independent algorithm validation if applicable), performed per intended use, and successfully 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)."

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