Coverage for Intravenous Immune Globulin (IVIG) is determined according to individual or group customer benefits.

This policy only addresses non-specific pooled preparations of intravenous immune globulin. The policy does not address other immunoglobulin preparations that are specifically used for passive immunization to prevent or attenuate infection with specific viral diseases.

Intravenous immune globulin is indicated only if standard therapies have failed, become intolerable, or are contraindicated.

Intravenous immune globulin is eligible for the conditions listed below:

1. Acute or chronic idiopathic thrombocytopenia purpura (ITP)(287.31)
   
   

   NOTE:

   Of the IVIG preparations that can be used for the treatment of acute or chronic idiopathic thrombocytopenia purpura (ITP), RHOphylac (J2791) Rh (O)(D)(Immune Globulin Intravenous [Human]), an anti D Rh immunoglobulin (Ig) is only indicated to raise platelet counts in Rh (O)(D)-positive, non-splenectomized adult patients with chronic ITP. RHOphylac is not FDA approved for any other indication on this policy.
   
   

   
   
2. Treatment of primary immunodeficiencies, including congenital agammaglobulinemia (279.00, 279.03, 279.04, 279.09), hypogammaglobulinemia (279.00), common variable immunodeficiency (279.06), severe combined immunodeficiency (279.2-279.3), Wiskott-Aldrich syndrome (279.12), and X-linked immunodeficiency (279.04-279.05)
   
   

   NOTE:

   Other unspecified disorder of immune mechanism (279.9) may be given individual consideration.
   
   Vivaglobin, a subcutaneously administered immunoglobulin as an alternative to intravenous immunoglobulin therapy is medically necessary for patients with Primary Immune Deficiency Diseases only if standard therapies have failed, become intolerable, or are contraindicated.

   
   
3. Kawasaki disease (446.1)
4. Prevention of graft-versus-host disease in bone marrow transplant patients (996.85)
5. CIDP (chronic inflammatory demyelinating polyneuropathy)
6. Refractory dermatomyositis (710.3) 
7. Prevention of infection in:
   
   1. HIV-infected patients (042)
   2. Patients with primary defective antibody synthesis
   3. Bone marrow (V42.81) and renal (V42.0) transplant recipients considered at risk for cytomegalovirus infection and pneumonia
   4. Patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia
   5. Neonates predisposed to group B streptococcal infections
   6. Prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients (V42.7). Patients must receive injections at the time of liver transplant and throughout their lives.
      
      

      NOTE:

      HepaGamB (J1571, J1573) is the only immune globulin FDA approved for this indication.
      
      
      

8. Guillain Barre syndrome (acute infective polyneuritis)(357.0)
9. Multifocal motor neuropathy in patients with anti GM1 antibodies and conduction block (354.0-355.6, 355.71-355.79, 356.4-356.9, 357.0-357.7, 357.81-357.89, 357.9)
10. Fetal alloimmune thrombocytopenia (776.1)
11. Chronic, severe myasthenia gravis refractory to standard therapy (i.e., interferons, steroids)(358.00, 358.01) 

Intravenous immunoglobulin is considered not medically necessary and, therefore, not covered as a treatment of relapsing/remitting multiple sclerosis. A participating, preferred, or network provider cannot bill the member for the denied service.

The latest technology assessment published by the American Academy of Neurology on therapies for multiple sclerosis offered the following recommendations regarding intravenous immunoglobulin:

1. The studies of intravenous immunoglobulin to date, have generally involved small numbers of patients, have lacked complete data on clinical and MRI outcomes, or have used methods that have been questioned.
2. The current evidence suggests that intravenous immunoglobulin is of little benefit with regard to slowing disease progression.

Intravenous immune globulin administered for conditions other than those referenced above should be denied as not medically necessary and, therefore, not covered. A participating, preferred, or network provider cannot bill the member for the denied service.

Description

Immune globulin is one of five closely-related proteins found in the human body. These proteins are capable of acting as antibodies. Gammaglobulin is an intravenous or intramuscular drug which has IgG antibodies and is used for the prevention and treatment of specific disease.

Intravenous immune globulin (IVIG) is an antibody-containing solution obtained from the pooled plasma of healthy blood donors, containing antibodies to greater than 10 million antigens.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

Treatment of Multiple Sclerosis: Recent Trials and Future Perspectives, Current Opinion in Neurology, Vol. 12, No. 3, 06/99

Immune Globulin Intravenous (Human), USPDI - Vol. I, Edition 26, 2006, Micromedex, Inc.

Intravenous Immune Globulin Therapy, National Blue Cross Blue Shield Association Medical Policy Reference Manual, Policy No. 8.01.05, issued April 2005

CSL Behring LLC, Immune Globulin Intravenous (Human), 10% Liquid Privigen™ US package insert, Kankakee, IL: CSL Behring LLC, July, 2007