FDA-Approved Drugs, Biologicals, Cellular and Gene Therapies

This policy covers FDA‑approved drugs, biologicals, cellular and gene therapies (medical benefit for non–self‑administered products; self‑administered products via pharmacy benefits) for FDA‑labeled indications and certain other uses, including cancer therapies (including metastatic/advanced cancers targeting a patient’s specific genetic mutation), diagnoses with neuromuscular/neurological/cognitive impairment, and (Illinois only) quality‑of‑life therapies for children with clinical or genetic impairments. Coverage is limited to uses consistent with FDA labeling, specified standard compendia (e.g., DrugDex, AHFS‑DI, Lexi‑Drugs, NCCN) or peer‑reviewed literature (often requiring two articles), requires regimen consistency with authoritative sources and physician documentation (initial three‑month approval for mutation‑targeted off‑label cancer use), and is subject to member contract, state law, contraindications and provision of requested supporting documentation.