Off-Label/Unproven Specialty Drug Treatment
Defines UnitedHealthcare's medical benefit parameters for coverage review of FDA-approved specialty drugs requested for off-label or unproven indications, including when Drug Policy Interpretation Service (DPIS) review and benefit exception/plan notification are required. Applies to provider-administered, supervised specialty drugs and patient self-administered specialty drugs covered under the medical benefit.
Coverage Rationale Description added review requirements for provider administered or supervised specialty drugs or patient self-administered specialty drugs covered under the medical benefit to indicate DPIS research is required when a corresponding policy does not address the requested indication or when no policy exists.
Indications of Coverage language revised to state the patient is not currently in an eligible clinical trial (replaced prior wording referencing 'has not been in or is not currently in an eligible clinical trial').
Definition of 'Serious Rare Disease' updated.
References section formatting corrected (09/01/2025).
Previous policy version 2024D0054L archived.