New Specialty Drugs

Covers newly approved specialty drugs or new FDA indications for chronic/complex non‑oncology diseases only for FDA‑approved indications supported by adequate clinical trial evidence (Phase III or Phase IIb single‑center) and excludes cancer/related disorders and off‑label uses. Approval is case‑by‑case and requires absence of prescribing‑information contraindications, submission of all required labs/tests and documentation of prior therapy failure when specified, dosing per FDA label, and is subject to existing eviCore guidelines and individual health‑plan limits.

"Requests for newly approved specialty drug products or new FDA-approved indications used to treat chronic and complex diseases other than cancer and related disorders."

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