New Specialty Drugs

Covers newly FDA‑approved specialty drugs for non‑oncology indications when safety/effectiveness are demonstrated by well‑designed trials; cancer indications and non‑FDA or unsupported uses are excluded. Approval is case‑by‑case and requires documentation of the FDA‑approved indication and trial evidence, absence of prescribing‑information contraindications, required labs/tests, documentation of prior therapy failure if mandated, dosing limited to the FDA‑approved dose, and plan‑level benefit exclusions may further restrict coverage.

"Newly approved specialty drug products by the FDA used to treat chronic and complex diseases other than cancer and related disorders."

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