Intravenous Immune Globulin 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 intravenous immune globulin 2 g/kg initial dose, and then 1 g/kg monthly. Findings: The physician reviewer found that Wynford-Thomas and colleagues describe myelin oligodendrocyte glycoprotein (MOG) antibody associated disease as an inflammatory demyelinating condition of the central nervous system characterized by a monophasic or relapsing course of neurological dysfunction, which does not meet the typical criteria for multiple sclerosis or other known neuroinflammatory conditions and occurs in the presence of serum MOG antibodies detected using specific cell-based assays, with a relapsing course reported in 44% to 83% of patients that more commonly involves the optic nerve.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for intravenous immune globulin (IVIG) infusion, Gammagard. Based on the records, this patient has been diagnosed with necrotizing autoimmune myopathy and has been receiving monthly IVIG in combination with methotrexate and low-dose prednisone. Clinical documentation demonstrates normalization and stabilization of the patient’s creatine kinase (CK) and transaminase levels, with continued clinical stability and no evidence of relapse while maintained on this regimen. The patient’s CK and inflammatory markers remain within normal limits. This objective biochemical response supports treatment efficacy.

Where the denial was upheld

Physician 1The patient is a 40-year-old woman who achieved pregnancy through in vitro fertilization. She has a history of polycystic ovary syndrome. The patient has an elevated antinuclear antibody (ANA) titer of 2.3 and is on progesterone. There is an apparent history of miscarriage; however, there are no details regarding the number of miscarriages, at what gestational age, and whether there were previous successful pregnancies. A request has been made for intravenous immune globulin (IVIG) therapy. The Health Plan has denied authorization for IVIG therapy on the basis it is considered experimental.IVIG therapy is unproven in the treatment of recurrent miscarriage. It has not yet been shown to be beneficial in randomized, controlled studies. In addition, there is no evidence that this patient’s prior loss is in relation to the autoimmune event.

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested infusions of intravenous immune globulin (IVIG) for treatment of the enrollee’s medical condition. Findings: The physician reviewer found that PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) is a term used for children that have abrupt onset of tics and/or obsessive compulsive disorder symptoms following group A beta hemolytic streptococcal (GABHS) infection.

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 Intravenous Immune Globulin, then check the rights and deadlines that apply to your plan.