Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Subcutaneous Immune Globulin (SCIG) Therapy
Subcutaneous Immune Globulin may be considered medically necessary for the treatment of primary immunodeficiencies when ALL of the following criteria are met:
- Standard therapies have failed, become intolerable, or are contraindicated; and
- Laboratory evidence of immunoglobulin deficiency; and
- Persistent and severe infections despite treatment with prophylactic antibiotics; and
- Documented inability to mount an adequate immunologic response to inciting antigens; and
- Lack of appropriate rise in antibody titer following provocation with a polysaccharide antigen. For example, an adequate response to the pneumococcal vaccine may be defined as at least a 4-fold increase in titers for at least 50% of serotypes tested; or
- Lack of appropriate rise in antibody titer following provocation with a protein antigen. For example, an adequate response to tetanus/diphtheria vaccine may be defined as less than a 4-fold rise in titers 3-4 weeks after vaccine administration; and
- Other unspecified disorder of immune mechanism may be given individual consideration.
Primary immunodeficiencies also include:
- Congenital agammaglobulinemia; or
- Hypogammaglobulinemia; or
- Common variable immunodeficiency (CVID); or
- Severe combined immunodeficiency; or
- Wiskott-Aldrich syndrome; or
- X-linked agammaglobulinemia (XLA).
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Subcutaneous Immune Globulin (Hizentra) may be considered medically necessary for the treatment of CIDP in Adults when ALL of the following criteria are met:
- Individual has confirmed diagnosis of CIDP by genetic or molecular testing; and
- Individual has shown improvement on intravenous immune globulin (IVIG) therapy.
Continuation of SCIg (Hizentra) may be medically necessary for individuals who demonstrate a clinically meaningful response as indicated by documentation of stable or improved symptoms.
Other applications of SCIg therapy are considered experimental/investigational, because their safety and/or effectiveness cannot be established by review of the published peer-reviewed literature