Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for home IVIG Octagam, 50 grams IV daily for two days every four weeks via infusion pump for a duration of one year. In this case, a provider letter reported that the patients diagnoses included acute autoimmune encephalomyelitis and that she had increased episodes of tics and obsessive-compulsive behaviors. Notes reported that the patient had multiple diagnoses including a diagnosis of pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS). The patient was on Medrol Dosepak and her mother reported improvements. Researchers report there are currently no randomized placebo-controlled trials establishing the best treatment of acute disseminated encephalomyelitis (ADEM), which is mainly based on expert opinions and observational studies. The authors further note that systemic corticosteroids are widely accepted as first-line therapy. Likewise, researchers report that there is a lack of evidence-based, prospective clinical trial data for the management of ADEM, and recommend plasmapheresis as a possible effective option for escalation therapy for patients who fail to demonstrate clinical improvement with steroids. Researchers report that IVIG has been effective in some children with acute disseminated encephalomyelitis who do not respond fully to corticosteroids, or who seem to experience recurrence of neurologic deficits on corticosteroid withdrawal, and that monthly intravenous immunoglobulin may also be considered for those children who are ultimately diagnosed with myelin oligodendrocyte glycoprotein antibody (MOG-Ab)-associated demyelination if they should relapse after their initial attack of acute disseminated encephalomyelitis. Thus, there is a lack of evidence in current medical literature supporting the efficacy and safety of IVIG for the treatment of autoimmune encephalomyelitis. Therefore, home IVIG Octagam, 50 grams IV daily for two days every four weeks via infusion pump for a duration of one year is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested home IVIG Octagam, 50 grams IV daily for two days every four weeks via infusion pump for a duration of one year is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1 and 2 are board certified in neurology with sub-specialty certification in neuromuscular medicine and are actively practicing. Physician reviewer 3 is board certified in neurology and is actively practicing. The reviewers are experts 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.