Appeal type: Medical Necessity
Decision: Overturned

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. The authors report that in a retrospective study of 55 patients with small fiber polyneuropathy attributed to autoimmunity who received intravenous immunoglobulin for over three months, overall, 74% of patients rated themselves as improved, neurologists labeled 77% as responsive to intravenous immunoglobulin therapy, and 16% entered remissions that were sustained after intravenous immunoglobulin withdrawal. The authors concluded that the results suggested that intravenous immunoglobulin is safe and effective for rigorously selected small fiber polyneuropathy patients with apparent autoimmune causality. Oaklander notes that patients with symptoms consistent with distal small fiber polyneuropathy, objective confirmation of diagnosis, exclusion of other causes, failure to improve with symptom management, and, ideally, serologic markers of immunity/inflammation may be treated with immunomodulatory therapies. Ryabkova  and colleagues note that a major subset of patients with fibromyalgia, a disorder characterized by chronic widespread pain and non-pain symptoms such as fatigue, dysautonomia, and cognitive and sleep disturbances, are diagnosed with small fiber neuropathy. In this case, the patient has small fiber neuropathy, likely autoimmune in nature, given his history of fibromyalgia. The patients symptoms have not been controlled with conventional medical therapy and affect his activities of daily living.  Given that current medical literature provides evidence that patients with autoimmune small fiber neuropathy may improve clinically with intravenous immunoglobulin, the requested services are medically indicated. Therefore, 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) are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in neurology 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.