Overview

This document addresses the use of Enspryng (satralizumab-mwge), a humanized monoclonal antibody directed against IL-6 receptors. Enspryng is approved for treatment of neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a severe autoimmune disease of the central nervous system caused by immune-mediated demyelination and axonal damage predominantly targeting optic nerves and spinal cord. This damage is triggered by antibodies against aquaporin-4 (AQP4), which are considered biomarkers for NMOSD. The disease is characterized by clusters of attacks of optic neuritis or transverse myelitis with partial recovery between attacks. Progressive visual impairment and paralysis may be caused by repeated attacks, so long-term prevention therapy should be offered to all patients. Treatment may include off label immunosuppressive therapies including rituximab, azathioprine, and mycophenolate. Three agents are FDA approved for NMOSD: Enspryng, Uplizna and Soliris. Enspryng has a unique mechanism of action by suppressing inflammation triggered by IL-6 pathways. It is given via subcutaneous administration once every 4 weeks. It has demonstrated efficacy in combination with stable immunosuppressive therapy and as monotherapy in AQP4 seropositive individuals. To date there is insufficient evidence to support its use in seronegative individuals. Enspryng can increase the risk of infection, as it is an immunosuppressant. It is contraindicated in those with active hepatitis B (HBV) infection and those with active or untreated latent tuberculosis (TB). Prior to initiation of therapy, all individuals should receive HBV screening, TB screening, and assessment of liver transaminases and serum bilirubin. Individuals should also receive all immunizations according to guidelines prior to initiating therapy.

Clinical Criteria

When a drug is being reviewed for coverage under a member's medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Enspryng (satralizumab-mwge)

Requests for initiation of therapy with Enspryng (satralizumab-mwge) may be approved if the following criteria are met:

1. Individual is 18 years of age or older; AND
2. Individual has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD); AND
3. Documentation is provided that NMOSD is seropositive as verified by the presence of anti-aquaporin-4 (AQP4) antibodies; AND
4. Documentation is provided that individual has a history of at least 1 acute attack or relapse in the last 12 months prior to initiation of therapy (Yamamura 2019, Traboulsee 2020); AND
5. If initiating therapy, individual has been evaluated and tested for Hepatitis B Virus (HBV) infection and latent tuberculosis infection.

Requests for continued use of Enspryng (satralizumab-mwge) in NMOSD may be approved if the following criteria are met:

• Documentation is provided that individual has experienced a clinical response (for example, a reduction in the frequency of relapse).

Requests for Enspryng (satralizumab-mwge) may not be approved for the following:

1. Individual is using in combination with rituximab, eculizumab, or inebilizumab; OR
2. Individual has active hepatitis B (HBV) infection or active or untreated latent tuberculosis [repeat testing not required for continuation of therapy]; OR
3. When the above criteria are not met and for all other indications.

Initial and Continuation Approval Duration

1 year

Quantity Limits

Enspryng (satralizumab-mwge) Quantity Limit

Enspryng (satralizumab-mwge) 120 mg/mL prefilled syringe

• 1 syringe per 28 days

Drug Limit Override Criteria

• Initiation of therapy for neuromyelitis optica spectrum disorder (NMOSD): May approve one additional syringe (120 mg/mL) in the first 28 days (4 weeks) of treatment

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J3490
• J3590
• C9399

Unclassified drugs (when specified as Enspryng (satralizumab-mwge)

Unclassified biologics (when specified as Enspryng (satralizumab-mwge)

Unclassified drugs or biologicals (when specified as Enspryng (satralizumab-mwge)

ICD-10 Diagnosis

All diagnoses

Document History

Revised: 11/17/2023