New Medical Drug Management Policy

This policy covers case-by-case medical necessity review for newly FDA‑approved drugs or new FDA‑approved indications for chronic and complex non‑cancer diseases (cancer and related disorders are excluded) when formal guidelines aren’t yet available. Coverage requires an FDA‑approved indication supported by Phase III or Phase IIb (single‑center) trial evidence, no prescribing‑information contraindications, submission of any required lab/test results, confirmation that combination use is not contraindicated, documentation of prior therapy failure when specified, and dosing per the FDA‑approved prescribing information (subject to any plan-specific limits).

"This policy addresses the management of newly approved medical drug products or new indications by the United States Food & Drug Administration (FDA) that are used to treat chronic and complex dise..."

Sign up to see full coverage criteria, indications, and limitations.