Discrepancies Between FDA-Required Labeling and Evidence that Payers Cite in Drug Coverage Policies

BACKGROUND: FDA-required labeling summarizes certain data that the FDA relies on in its drug approval process. However, when determining coverage of specialty drugs, health care payers may consider dissimilar evidence. OBJECTIVE: To compare evidence cited by the largest U.S. commercial payers in their specialty drug coverage policies with evidence featured in the labeling of the indicated drugs. METHODS: We used the Tufts Medical Center Specialty Drug Evidence and Coverage Database (SPEC)—a database of specialty drug coverage policies issued by 17 of the 20 largest U.S. commercial health care payers—to identify coverage policies for drugs indicated for multiple sclerosis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, and non-small cell lung cancer (NSCLC). These disease categories were selected because each was represented by multiple drugs. For each drug, we identified endpoints included in the clinical studies presented in the FDA-required labeling. Using SPEC, we identifi...