IVIg Patient Resource Center
Advocacy for Patients is creating this IVIg Patient Resource Center to assist patients whose physicians prescribe intravenous immune globulin (IVIg) to treat a wide range of illnesses, for which insurance companies may deny coverage. Our goal is to empower you by teaching you how to file a winning appeal to convince your insurer to cover IVIg for your medical needs.
Most often, when an insurance company denies coverage of IVIg, it is on the ground that the treatment is "experimental or investigational." Insurers may take this position when IVIg - indeed, any treatment - is prescribed for what's called an "off-label use." An "off-label use" is a use that is not listed in the labeling approved by the Food and Drug Administration (FDA).
As a general rule, when an insurer denies coverage of an off-label use, it is very hard to convince them to make an exception. However, we have had good success with getting coverage for off-label uses of IVIg largely because there is a wealth of medical literature supporting these uses.
Indeed, in a 1982 policy guidance, the FDA itself explained that:
Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such "unapproved" or, more precisely, "unlabeled" uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature.
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Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations, subsequently confirmed by well-planned and executed clinical investigations. Before such advances can be added to the approved labeling, however, data substantiating the effectiveness of a new use or regimen must be submitted by the manufacture to the FDA for evaluation. This may take time and, without the initiative of the drug manufacturer whose product is involved, may never occur. For that reason, accepted medical practice often includes drug use that is not reflected in approved drug labeling.
FDA Drug Bulletin: Information of Importance To Physicians and Other Health Professionals
(April 1982, Volume 12 Number 1, Pages 4-5).
Thus, simply because a treatment is off-label does not mean that it should not be prescribed, or that it is properly excluded from insurance coverage on the ground that it is experimental or investigational. However, insurance companies routinely deny coverage for off-label uses, even when the use is well supported by the medical literature.
Although insurers deny many treatments because they are "off-label," this is especially common regarding IVIg because it has so many uses. As you probably know, IVIg is a blood product administered intravenously, although administration of immune globulin - including self-administration - by subcutaneous or intramuscular injection is becoming more common. Immune globulin is extracted from plasma of thousands of blood donors.
IVIg is used to treat primary and secondary immune deficiencies, some autoimmune illnesses, and acute infections. For patients with immune deficiencies, IVIg is a plasma protein replacement therapy, remediating reduced or eliminated immune IGg antibody production capabilities, thereby helping to prevent infection. For patients with autoimmune diseases, IVIg is thought to control inflammation. In addition, IVIG may be considered a modulator of the immune system, which has been shown to be beneficial in treating numerous autoimmune diseases such as relapsing and remitting multiple sclerosis, dermatomyositis, chronic inflammatory demyelinating polyneuropathy (CIDP) and more (see list of uses, below). For more information about IVIg in general, see the Alliance for Plasma Therapies at Plasmaalliance.org.
For more information on IVIg, see also the Plasma Proteins Therapeutics Association (PPTA); the Immune Deficiency Foundation; and the Jeffrey Modell Foundation.
IVIg is FDA-approved for the following uses:
• Allogeneic bone marrow transplant
• Chronic inflammatory demyelinating polyneuropathy (CIDP)
• Chronic lymphocytic leukemia
• Idiopathic thrombocytopenic purpura
• Kawasaki disease
• Kidney transplant with a high antibody recipient or with an ABO incompatible donor.
• Pediatric HIV
• Primary immunodeficiencies
However, IVIg is prescribed for many other uses, which are called "off-label" uses because they go beyond the uses for which there is FDA approval. Some of these off-label uses are the following:
• Dermatomyositis and polymyositis
• Graves' ophthalmopathy
• Guillain-Barre syndrome
• Lambert-Eaton syndrome
• Multifocal motor neuropathy
• Multiple sclerosis
• Muscular Dystrophy
• Myasthenia gravis
• Transverse myelitis
• Stiff person syndrome
• Systemic lupus erythematosis
The following materials should help patients to advocate for themselves when an insurance company denies coverage of IVIg on the ground that it is "experimental or investigational" because the prescribed use is "off-label":
• General Information on How To File Insurance Appeals
• Information Pertaining to Specific Diseases
PLEASE NOTE: Nothing on this website should be construed as medical or legal advice. It is informational only. If you have questions about whether IVIg is right for you, seek the advice of a licensed health care provider. There may be adverse reactions to IVIg, as well as drug interactions of which you should be aware before beginning treatment. Speak with your physician for more information.