Immune Globulin, subcutaneous (Hizentra, HyQvia, Gamunex-C, Gammagard, Gammaked)

SELF ADMINISTRATION / HOME HEALTH

Indications for Prior Authorization

  • Primary Immunodeficiency disorders
    • congenital agammaglobulinemia
    • X-linked agammaglobulinemia, combined immunodeficiency
    • hypogammaglobulinemia
    • common variable hypogammaglobulinemia/immunodeficiency
    • X-linked immunodeficiency
    • Wiskott-Aldrich syndrome
  • Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
    • Hizentra maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study.  Maintenance therapy beyond these periods should be individualized based upon the patient's response and need for continued therapy.

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee:

  • Indications not listed above
  • Isolated IgG4 deficiency
  • Selective IgA deficiency
  • Non-infusion related adverse drug reactions

All of the following must be met as a condition(s) for coverage:

Primary Immunodeficiency disorders:

  • History of recurrent bacterial infections; AND
  • Patient did not respond to IgG antibody production after challenge (diphtheria/tetanus toxoids/pneumococcal vaccine); AND
  • Decreased IgG concentrations documented on two or more occasions by an allergist or immunologist; AND
  • Unable to tolerate IVIG therapy infusion-related adverse event (anaphylaxis, aseptic meningitis or limited venous access)

Chronic inflammatory demyelinating polyneuropathy (CIDP):

  • Patient is 18 years of age or older, AND
  • Preivous treatment with IVIG (last dose 1 week before Hizentra start), AND
  • Patient had significant improvement in disability and has maintained improvement while on previous immunoglobulin therapy (IVIG)

Approval:

Review annually


Last review date: May 28, 2019