Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Autoimmune encephalitis.
Treatment:  Panzyga 10% (1g/10ml) [gram/milliliter] vial.

The insurer denied coverage for Panzyga 10% (1g/10ml) vial.  The denial is overturned.
 
According to the clinical documentation provided for review, the patient is an adolescent female with a past medical history (PMH) of anxiety, asthma, and autoimmune encephalitis. The treating provider is requesting plan approval for treatment with Panzyga 10% (1g/10ml) vial.

The patient was seen to establish care for catatonia. The treating provider noted that the patient suffers from autoimmune encephalitis. The patient had benefit after she received intravenous immunoglobulin (IVIG). In the assessment the provider noted the autoimmune encephalitis and that the plan was to continue with IVIG. 

The patient has auto-immune encephalitis, and the patient is responding to IVIG. The patient should continue with IVIG, as it helped. Switching medication(s) would jeopardize the patient's clinical stability. Therefore, the request is approved and medically necessary for this patient and supported in multiple referenced studies. 

"Interpretation: IVIG improved neurological functional outcomes, and the improvement was evident by day 8. Adverse effects were tolerable. These data provide the prospective evidence regarding the efficacy of IVIG in improving the functional outcomes of autoimmune encephalitis." (Lee, et al., 2022).

"Autoimmune encephalitis (AE) is a group of disorders causing synaptic receptor dysfunction with a broad range of neurological symptoms that has been historically difficult to differentiate clinically. Today, AE represents an excellent example of the rapid determination of the cause of a disease and the ability to identify potential treatments using relatively simple basic science techniques of investigation. Of the number of autoimmune encephalitis identified thus far, one of the best examples of the impact of basic science studies on disease management is NMDA receptor mediated autoimmune encephalitis (NMDAr-AE). In this review, we will provide an overview of the epidemiology of NMDAr-AE, clinical features and treatments, and the basic science tools and techniques that were used to identify the cause, correlate symptoms to underlying pathophysiology, and to understand the mechanism of disease pathology." (Kolls, et al., 2020). 

"Autoimmune encephalitis refers to acute to subacute, progressive inflammation of the brain associated with antibodies against neuronal cell surface and synaptic protein, most commonly being anti - NMDA receptor encephalitis. It is frequently associated with underlying malignancy and needs appropriate screening. This condition is usually treatment responsive with immunotherapy and has better outcomes if initiated early in the clinical course. This activity outlines the pathophysiology, clinical presentation, and management of autoimmune encephalitis and reviews the role of the interprofessional team in managing patients with this condition." (Gole, et al., 2023). 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Panzyga 10% (1g/10ml) vial is substantiated.