Specialty Drug Management Policy

Covers case‑by‑case approval of newly FDA‑approved specialty drugs for chronic/complex non‑cancer conditions when no specific eviCore guideline exists, and excludes cancer/related disorders, drugs not requested for an FDA‑approved indication or lacking Phase III (or Phase IIb single‑center) evidence, requests with prescribing‑information contraindications, or those missing required documentation. Key requirements: the request must be for an FDA‑approved indication supported by well‑designed clinical trial evidence, have no label contraindications, include all required labs/tests and documentation (including prior therapy trial/failure when specified), and use FDA‑approved dosing (specific eviCore guidelines override this policy).

"This policy addresses the management of newly approved specialty drug products by the United States Food & Drug Administration (FDA) that are used to treat chronic and complex diseases other than c..."