Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Transverse myelitis

Treatment: J1556-Bivigam

The insurer denied coverage for J1556-Bivigam

The denial is overturned 

Reviewer #2:

The patient is an adult. The patient was seen for transverse myelitis and progressive spastic paraparesis. The provider reported the patient developed transverse myelitis. The patient was treated with intravenous (IV) steroids, plasma exchange and Rituximab. The patient reported that plasma exchange helped the patient the most. The provider noted that the patient continued to progress. The patient was reported to be status post cervical decompression. The patient was treated with IV steroids, plasma exchange, and rituximab. The patient was left with residual paraparesis. Per the provider, the patient was on Ocrevus with intermittent plasma exchange. The patient had recent severe infections. The plan was to stop current treatment and switch the patient to monthly intravenous immunoglobulin (IVIG).

"Intravenous immunoglobulin (IVIG) is a pooled antibody, and a biological agent used to manage various immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory states. The ultimate goal of this therapy is to normalize a compromised immune system ... Other conditions that also benefit are those with B-cell depleting therapies such as lymphoma and geriatric patients with recurrent infections" (Arumugham, V. B., & Rayi, A. 2023).    

The scientific evidence in peer-reviewed literature supports a result of improvement in health outcome. Intravenous immunoglobulin (IVIG) is used to prevent further attacks as the patient's condition is noted to be progressive and current treatment has caused severe infections as per the provider.  

There is evidence that intravenous immunoglobulin (IVIG) is helpful in preventing attacks in multiple central nervous system (CNS) demyelinating diseases including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), which appears to be the patient's condition: "Results of this retrospective, multicenter, cohort study of adult patients with MOGAD suggest that maintenance intravenous immunoglobulin (IVIG) was associated with a reduction in disease relapse" (Chen, et al., 2022).     

J1556-Bivigam has final approval from the appropriate regulatory bodies for this diagnosis.

The patient is a good candidate for J1556-Bivigam. The patient has a diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) for which treatment with intravenous immunoglobulin (IVIG) has been shown to be effective.

J1556-Bivigam is the best available treatment for this patient at this time. The patient has failed other treatment options that included plasma exchange and Ocrevus as well as intravenous immunoglobulin (IVIG)  steroids.

The adverse risks are not increased over standard treatment/service. 

Intravenous immunoglobulin (IVIG) would be safer for this patient, who has been reported to have recurrent infections.

In summary, the denial of J1556-Bivigam should be reversed. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.