Specific Antibody Deficiency denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Hizentra 8 gm subcutaneously every week for one year. Selective antibody deficiency with normal serum immunoglobulin concentrations is a deficiency of specific antibody response to polysaccharide antigens with intact response to protein antigens and normal serum level of IgG and IgG subclass. Immunoglobulin replacement therapy with intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin preparations is a treatment option for this group of patients with recurrent infections that persist after immunizing and antibiotic treatment. Wasserman reports that immunoglobulin replacement therapy is the cornerstone of management for most primary immunodeficiency disease patients, and that immunoglobulin replacement therapy leads to significant decreases in the number of infections.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Hizentra 13 gram subcutaneous infusion (CPT code J1559) administered at an ambulatory infusion center every week.The submitted documentation supports that the requested medication is medically necessary. Researchers note that human immunoglobulin preparations for intravenous or subcutaneous administration are the cornerstone of treatment in patients with primary immunodeficiency diseases affecting the humoral immune system. In this case, the patient’s laboratory data support the diagnosis of specific antibody deficiency. In 2017, the patient’s pneumococcal antibody titers were only positive for 4 out of 14 antibody titers and did not improve upon vaccination with pneumovax and rechecking the values four weeks after vaccination.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for subcutaneous immune globulin (SCIG).As noted in the medical literature, “immunoglobulin therapy is a key element in the management of most patients with primary immunodeficiency disease”. A study indicated that “the diagnosis of specific antibody deficiency (SAD) should be given to patients older than two years with recurrent respiratory tract infections, normal immunoglobulin and IgG subclass levels, and impaired response to pneumococcal capsular polysaccharide.` The authors noted that patients with SAD benefit from additional immunization with conjugate pneumococcal vaccines, intensified use of antibiotics, and in some cases a period of IgG replacement therapy.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Gammagard liquid subcutaneous. Per one study, a diagnosis of unspecified hypogammaglobulinemia can be applied in patients who have (1) significant morbidity from infections, (2) abnormal levels of serum immunoglobulins, (3) normal cellular immunity, (4) no other potential immune deficiency diagnosis, and (5) no other conditions predisposing to humoral immunodeficiency. The management of IgG subclass deficiency includes allergy therapy, antibiotics, and the cautious use of polyclonal human IgG in selected patients.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving specific antibody deficiency, then check the rights and deadlines that apply to your plan.