Gammagard denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gammagard intravenous immune globulin infusions (35 grams infused every four weeks for six months). Hypogammaglobulinemia may occur in persons with systemic lupus erythematosus (SLE) and is a potential risk factor for infection. Researchers note that SLE patients have an intrinsically dysfunctional immune system which is exacerbated by disease activity and leaves them vulnerable to infection. Management of hypogammaglobulinemia in persons with SLE should be individualized and tailored to a patient’s individual risk of infection.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Gammagard intravenous immunoglobulin infusions (35 grams daily for three days, then 52 grams for one to two days every three to four weeks for one year). Finnerup and colleagues report that inadequate response to drug treatments constitutes a substantial unmet need in patients with neuropathic pain. Liu and colleagues explain that small fiber polyneuropathy may have various underlying causes, including associations with systemic autoimmune conditions, and that intravenous immunoglobulin is a first-line treatment for immune-mediated neuropathies such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gammagard infusions 60 grams every four weeks. This patient’s records document small fiber neuropathy, which the provider noted is likely due to Sjogren’s. The provider has recommended treatment with Gammagard infusions. There is a lack of prospective randomized controlled clinical studies demonstrating the long-term safety and efficacy of intravenous immunoglobulin (IVIG) for the treatment of patients with small fiber neuropathy. Gaillet and colleagues reported data suggesting that IVIG treatment can be effective and well-tolerated in patients with small fiber neuropathy. However, the authors concluded that their findings “have to be confirmed in a randomized double-blinded placebo-controlled trial.” IVIG has been approved by the U.S.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gammagard 75 grams, every four weeks x 11 refills. Autoimmune encephalitis is an often rapidly progressive inflammatory neurological disease with subacute onset. A diagnosis of autoimmune encephalitis is supported by the presence of subacute onset, altered mental status, or psychiatric symptoms, as well as new focal central nervous system, seizures not explained by a known seizure disorder, cerebrospinal fluid (CSF) pleocytosis, or magnetic resonance imaging (MRI) features suggestive of encephalitis. In addition, the patient should be evaluated for other diseases that can mimic autoimmune encephalitis and cause rapidly progressive encephalopathy.

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 Gammagard, then check the rights and deadlines that apply to your plan.