Unlabeled uses of intravenous immune globulin

Abstract

A literature review identified more than 150 unlabeled uses of IVIG. The evidence for these uses is being interpreted in different ways by various reviewing organizations.

Descriptive Review and Analysis of Immunoglobulin Utilization Management from 2,548 Prior Authorization Requests

“…Of these, only 97 have been reviewed by expert consensus, leaving the burden on the health plan to research available medical evidence for the remaining indications-a time-consuming process with the potential for inconsistent interpretation. 4 We found that only a small percentage of total requests were for indications with a current lack of consensus. An unexpected outcome was the high percentage of these cases that ultimately were authorized.…”

“…5 In a separate study, Leong et al (2008) determined that interpretation of the medical evidence for Ig therapy among several types of organizations is inconsistent. 4 The goal of our analysis was to characterize the indications for which Ig is currently being requested and to look at other factors, including patient demographics, supporting evidence, and benefit coverage outcomes, to enhance the body of knowledge surrounding this therapy. The PA process used by health plans provides a dataset uniquely suited to capturing this information, whereas a retrospective claims analysis would not have captured requests denied by the health plans.…”

Pattern of intravenous immunoglobulins (IVIG) use in a pediatric intensive care facility in a resource limited setting

“…Off-label indications include several hematological, neurological, autoimmune and other disorders like multiple sclerosis, graft-versus-host disease in transplant patients, and prevention of antiphospholipid syndrome in miscarriage, severe asthma, Guillain-Barré syndrome, and progression of human immunodeficiency virus after delivery 5 . Mechanism of action is either as a substitute of missing antibodies at replacement doses (200-400 mg/kg/month) in the treatment of primary and secondary antibody deficiencies.…”

Acute Hemolysis After High-Dose Intravenous Immunoglobulin Therapy in Highly HLA Sensitized Patients

“…Low-dose IVIG, 0.2 to 0.6 g/kg, has been used safely for the treatment of these disorders (1). IVIG is now used in higher immunomodulatory doses for the treatment of various autoimmune, inflammatory, and infectious diseases (2)(3)(4). For transplant recipients, IVIG has become the mainstay of therapy to desensitize highly HLA-sensitized patients and to treat antibody mediated rejection (AMR).…”