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Gammaked — Blue Cross Blue Shield of Alabama

Acquired Immune Deficiency secondary to Chronic Lymphocytic Leukemia

Preferred products

  • Hyqvia
  • Xembify
  • Hizentra

Initial criteria

  • ONE of the following:
  • ● Primary Immunodeficiency (PID)/Wiskott-Aldrich syndrome [e.g., x-linked agammaglobulinemia, common variable immunodeficiency, transient hypogammaglobulinemia of infancy, IgG subclass deficiency with or without IgA deficiency, antibody deficiency with near normal immunoglobulin levels, combined deficiencies (severe combined immunodeficiencies, ataxia-telangiectasia, x-linked lymphoproliferative syndrome)] AND BOTH of the following:
  •   – Patient age ≥ 2 years
  •   AND ONE of the following:
  •     ○ IgG level < 200 mg/dL
  •     OR
  •     ○ BOTH of the following:
  •       ■ History of multiple hard to treat infections as indicated by at least ONE of the following:
  •         – Four or more ear infections within 1 year
  •         – Two or more serious sinus infections within 1 year
  •         – Two or more months of antibiotics with little effect
  •         – Two or more pneumonias within 1 year
  •         – Recurrent or deep skin abscesses
  •         – Persistent thrush in the mouth or fungal infection on the skin
  •         – Need for intravenous antibiotics to clear infections
  •         – Two or more deep-seated infections including septicemia
  •       AND
  •       ■ Deficiency in producing antibodies in response to vaccination AND BOTH of the following:
  •          – Titers drawn before challenging with vaccination
  •          – Titers drawn between 4 and 8 weeks after vaccination
  • OR
  • ● Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) AND ALL of the following:
  •   – Requested agent is Hizentra or Hyqvia
  •   – Patient age ≥ 18 years
  •   – BOTH of the following:
  •     ■ Prescriber has assessed baseline disease severity utilizing an objective measure/tool (e.g., INCAT, Medical Research Council (MRC) muscle strength, 6-MWT, Rankin, Modified Rankin, etc.)
  •     ■ ONE of the following:
  •       – Requested agent will be used as initial maintenance therapy for prevention of disease relapses after treatment and stabilization with IVIG
  •       – Requested agent will be used for re-initiation of maintenance therapy after experiencing a relapse and requiring re-induction therapy with IVIG
  • OR
  • ● Acquired Immune Deficiency secondary to Chronic Lymphocytic Leukemia AND ONE of the following:
  •   – IgG level < 200 mg/dL
  •   OR BOTH of the following:
  •     ■ History of multiple hard to treat infections as indicated by at least ONE of the following:
  •       – Four or more ear infections within 1 year
  •       – Two or more serious sinus infections within 1 year
  •       – Two or more months of antibiotics with little effect
  •       – Two or more pneumonias within 1 year
  •       – Recurrent or deep skin abscesses
  •       – Persistent thrush in the mouth or fungal infection on the skin
  •       – Need for intravenous antibiotics to clear infections
  •       – Two or more deep-seated infections including septicemia