Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for rituximab infusions. Findings:  The physician reviewer found that issued practice guideline recommendations for disease-modifying therapies (DMTs) for adults with multiple sclerosis (Rae-Grant, et al.). Per the AAN, Clinicians should offer DMTs to people with relapsing forms of MS with recent clinical relapses or MRI activity. The AAN noted that, since adherence to treatment may be an issue for people with MS, discussing adherence issues before initiating DMT is part of good clinical practice. Efforts to increase adherence may improve outcomes. Standard treatment for relapsing remitting multiple sclerosis includes a number of DMTs approved by the U.S. Food and Drug Administration (FDA) for the long-term treatment of relapsing remitting multiple sclerosis. Data from randomized controlled trials supporting the effectiveness of rituximab for relapsing remitting multiple sclerosis are limited, but nonrandomized studies and the positive trials for ocrelizumab, which has a similar mechanism of action, increase confidence that rituximab is safe and beneficial for this patient population (Whittam, et al.). In an observational study of 256 patients with stable relapsing remitting multiple sclerosis who switched to rituximab or fingolimod after stopping natalizumab due to JC virus antibody positivity, the rituximab group had lower rates of clinical relapse, adverse events, and treatment discontinuation compared with the fingolimod group (Alping, et al.). In this case, the patient has multiple sclerosis with evidence of lesions in the brain and cervical spine cord, JC virus positivity. Based on the current studies, rituximab can be comparable in efficacy to other disease modifying therapies and is often used in pediatric patients with MS with similar safety, tolerability and side effect profiles as in adults. In addition, rituximab treatment has been associated with a lower discontinuation rate and has been beneficial in cases where compliance may be an issue. For these reasons, the requested rituximab infusions are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested rituximab infusions are 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 medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer 1 is board certified in neurology with special qualification in child neurology and is actively practicing. Physician reviewer 2 is board certified in neurology and is actively practicing. Physician reviewer 3 is board certified in neurology with special qualification in child 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.