Off-Label/Unproven Specialty Drug Treatment – Commercial Medical Benefit Drug Policyopen_in_new

UnitedHealthcare may cover off‑label or unproven uses of FDA‑approved specialty drugs under the medical benefit—excluding self‑administered pharmacy meds, vaccines, and oncology/therapeutic radiopharmaceuticals addressed elsewhere—only when ALL policy criteria are met. Key requirements: the drug must be FDA‑approved and not excluded by UHC, treat a chronic/serious or Serious Rare Disease, patient not enrolled in an eligible clinical trial, no prior failure of the same drug, documented failure/contraindication/intolerance to standard therapies, clinical support from specified compendia or two peer‑reviewed articles, and when the drug/indication is listed as “unproven” or not addressed, DPIS/Medical Director review and an approved benefit exception (with member plan/state/federal mandates superseding).

"Off-label or unproven indications of FDA‑approved medications administered or supervised as specialty drugs (provider‑administered or patient self‑administered) covered under the medical benefit wh..."