New Medical Drug / Indication

Covers case‑by‑case authorization of newly FDA‑approved drugs or new FDA indications for chronic and complex non‑cancer diseases and excludes cancer and related disorders. Key requirements: request must be for an FDA‑approved indication supported by adequate clinical trial evidence, have no prescribing‑information contraindications, include required lab/test results and documentation of prior therapy failure when applicable, and follow FDA‑approved dosing (coverage may be further limited by specific health plan provisions).

"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..."

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