Octagam 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 Concurrent use of brand name Rituxan with Octagam, or in the alternative, Ruxience with Octagam. Treatment of severe pemphigus vulgaris (PV) must be individualized based on the clinical findings, presentation, and laboratory test values. The U.S. Food and Drug Administration (FDA) has approved Rituxan for treating patients with PV. In addition, intravenous immunoglobin (IVIG) is supported for the treatment of patients with PV. Severe PV can lead to major side effects, particularly when involving mucosal surfaces such as the mouth, as is occurring for the patient since these erosions can cause severe pain and difficulty in eating. Overall, the patient’s records document a severe case of PV, as noted in the chart and in the letter by the provider.

Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Octagam injection intravenous immune globulin (IVIG) non-lyophilized (e.g., liquid). There are currently conflicting data regarding the efficacy of IVIG in the treatment of patients with pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS). Based on review of the evidence, experts studying PANDAS recommend reserving treatment with IVIG for patients with severe symptoms. For this patient, there is a history of positive response to treatment with IVIG on at least two separate occasions, following failure of other conventional treatments. This response suggests there may be an unidentified autoimmune component contributing to the patient’s symptoms.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Octagam 50 gm intravenous (IV) daily for four days x one course, then 50 gm IV daily for two days every four weeks x 16 weeks. Small fiber neuropathy (SFN) occurs as a result of injury to the small unmyelinated C-fibers or thinly myelinated nerve fibers, causing symptoms of numbness, sensory loss, electric shock-like pain, cold-like pain, itching, burning, tingling, and a feeling of pins and needles. In this case, the patient has a diagnosis of SFN, likely due to an inflammatory cause. The patient reports symptoms including burning in her feet, stiffness in her legs and hips, progressive muscle weakness, tingling and numbness in the hands and feet, and spasms of the lower limbs.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for intravenous immune globulin (IVIG) infusion (Octagam). The precise mechanism of action of IVIG products such as Octagam in multiple sclerosis (MS) is not fully understood but is thought to involve multiple effects on the immune system, including the modulation of autoantibodies, complement activation, cytokines, and inflammatory mediators. No research has been identified that specifically addresses the efficacy of Octagam for severe MS exacerbation with residual weakness. American Academy of Neurology (AAN) guidelines recommend corticosteroids as the primary treatment for acute, significant MS symptoms, with no significant difference noted between oral and intravenous formulations.

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