Gamunex-c denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gamunex-C immune globulin injection (IVIG). Dysautonomia is an umbrella term referring to any disorder associated with dysfunction of the autonomic nervous system. There are many different mechanisms by which dysautonomia may arise, but there has been increasing evidence and awareness that it may be immune-mediated in some patients. Autoimmune autonomic dysfunction may be peripheral due to an immune-mediated small fiber polyneuropathy (SFPN) and may manifest clinically as postural tachycardia syndrome, orthostatic intolerance, orthostatic hypotension, inappropriate sinus tachycardia, gastrointestinal dysmotility, complex regional pain syndrome, and/or neurogenic bladder.

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Gamunex-C (immune globulin, IVIG).Gamunex-C (immune globulin intravenous, IVIG) is an appropriate treatment option for patients with a history of autoimmune encephalitis in the setting of primary immunodeficiency and complement deficiency. Additionally, Gamunex-C is indicated for the treatment of primary immunodeficiency diseases. IVIG therapy is commonly used to treat autoimmune neurological disorders, including autoimmune encephalitis, by providing antibodies that help modulate the immune system and reduce inflammation in the central nervous system. IVIG can help replace missing or deficient antibodies and provide passive immunity against infections.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for intravenous immunoglobulins (IVIG) therapy, Gamunex-C vial. Current medical literature offers limited data to support IVIG use in epilepsy. Overall, IVIG has not been demonstrated to be effective in the treatment of epilepsy and is most likely effective in patients with autoimmune encephalitis. According to one study, there is a lack of controlled trials to support IVIG use in electrical status epilepticus in sleep (ESES). One clinical study showed that children with GRIN2A and GRIN2D mutation related to ESES showed some improvement with IVIG but remained significantly developmentally impaired. In this case, the patient has ESES and possible Landau Kleffner syndrome of unknown etiology.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Gamunex-C. Small fiber polyneuropathy occurs because of injury to the small unmyelinated C or thinly myelinated nerve fibers, and causes symptoms of numbness, sensory loss, electric shock-like pain, cold-like pain, itching, burning, tingling, and pins and needles feeling. The first line treatment for small fiber neuropathy includes tricyclic antidepressants (TCAs) such as amitriptyline, nortriptyline, and clomipramine, serotonin and norepinephrine reuptake inhibitors (SNRIs), and anticonvulsants such as duloxetine, gabapentin, and pregabalin. In this case, the patient was diagnosed with a small fiber neuropathy secondary to inflammatory or post-infection, with symptoms of tingling and burning pain in her extremities, sensitivity to cold temperature, and difficulty ambulating.

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 Gamunex-c, then check the rights and deadlines that apply to your plan.