Subcutaneous Immune Globulins (Cuvitru, Hizentra, Hyqvia)

Covers FDA‑approved subcutaneous immune globulins — Cuvitru, Hizentra, Hyqvia — for primary humoral immunodeficiency (specified congenital/acquired diagnoses) and Hizentra only for CIDP maintenance, with no approved off‑label compendial uses. Approval (6‑month) requires meeting product‑specific safety exclusions (no anti‑IgA antibodies/hypersensitivity; no hyperprolinemia for Hizentra; no hyaluronidase hypersensitivity for Hyqvia), initial criteria (IgG <400 mg/dL for primary immunodeficiency; Hizentra users must have had ≥3 months regular IVIG and Hizentra CIDP must follow IVIG stabilization), documentation of prior dosing/treatment for switching, and evidence of clinical response for reauthorization.

" - For an individual with immunoglobulin A (IgA) deficiency, does not have antibodies to IgA AND a history of hypersensitivity"

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