Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for IVIG immunoglobulin replacement therapy. The Health Plan has denied this request indicating that the requested treatment is not medically necessary for treatment of the enrollees hypogammaglobulinemia and common variable immunodeficiency (CVID).At issue in this case is whether the requested IVIG immunoglobulin replacement therapy is medically necessary for treatment of the patients medical condition.In this case, the patient has evidence of hypogammaglobulinemia. Although stated there have been recurrent infections, per the practice parameters there is no supporting documentation: (chest x-ray (CXR); computed tomography (CT) chest; CT sinus; pharmacy antibiotic records; or antibiotic log) to confirm this. Laboratory tests show evidence of hypogammaglobulinemia but do not substantiate a history of recurrent severe sinopulmonary infections or other opportunistic infections seen with a primary antibody deficiency. The records provided do not clearly evaluate the patients ability to respond to infections or lack thereof; as required for the diagnosis of common variable immunodeficiency (CVID). The diagnosis of CVID requires significantly reduced total serum concentrations of immunoglobulin; low immunoglobulin A (IgA); and/or immunoglobulin M (IgM); poor or absent response to immunization and exclusion of other immunodeficiency states or causes. In this case, the patients immune status has not fully been evaluated. Although stated there have been recurrent infections, there is no supporting documentation (CXR; CT chest; CT sinus; antibiotic log) to confirm recurrent infections. The records shows that the patient has been vaccinated with pneumococcal vaccines and there are protective titers in greater than 50% of the serotypes tested. There is no documentation of a trial of prophylactic antibiotics.  There is no documentation of other therapies used and failed such as aggressive allergic rhinitis treatment, vaccinated with conjugate pneumococcal vaccine or trial of prophylactic antibiotics in the patient.  There are no evaluation and treatment of her asthma.  In this case, the patient is reported to have low total IgG, but none of the other criteria of CVID.  The use of intravenous immunoglobulin/subcutaneous immunoglobulin (IVIG/SVIG) in hypogammaglobulinemia is controversial as noted in the 2015 practice parameters. The treatment of hypogammaglobulinemia with replacement immunoglobulin, although U.S. Food and Drug Administration (FDA) approved, is controversial. Most experts recommend treatment which includes immunization with conjugated pneumococcal vaccine (Prevnar 7 or 13); aggressive treatment of other conditions predisposing to recurrent sinopulmonary infections (eg, asthma, allergic rhinitis); increased vigilance and appropriate antibiotic therapy for infections; prophylactic antibiotics and IVIG/SCIG. IVIG is a pooled blood product and there are significant risks involved in the administration of IVIG. This includes thrombosis, renal dysfunction, acute failure and infection. The records fail to demonstrate a primary immunodeficiency related to antibody deficiency. There is evidence of hypogammaglobulinemia but no further evaluation of the immune system. Therefore, the request for IVIG immunoglobulin replacement therapy is not medically necessary. Final Result: The reviewer determined that the requested treatment is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in allergy and immunology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.