CurrentAnthemPolicy CC-0173

Enspryng (satralizumab-mwge) — Clinical coverage criteria for NMOSD

Clinical coverage criteria for initiation and continuation of Enspryng (satralizumab-mwge) under the member's medical benefit, including required testing and combination-therapy exclusions for adults with NMOSD.

Policy Summary

PayerAnthem

PolicyEnspryng (satralizumab-mwge) — Clinical coverage criteria for NMOSD

Policy CodePolicy CC-0173

Change TypeReviewed — no material changes

Effective Date12/22/2025

Next Review DateNov 14, 2026

Key ActionObtain prior authorization with documentation of age ≥18, AQP4 seropositive NMOSD, ≥1 relapse in prior 12 months, and HBV/TB screening prior to initiation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Min age

1 relapseRelapse requirement

1 syringe/28dQuantity limit

Seropositive requiredAQP4 status

Prohibited with 4 agentsCombination use

Coverage Criteria for Enspryng (satralizumab-mwge)

Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria: 1. Individual is 18 years of age or older; 2. Individual has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD); 3. Documentation is provided that NMOSD is seropositive as verified by the presence of anti‑aquaporin‑4 (AQP4) antibodies; 4. Documentation is provided that the individual has a history of at least one acute attack or relapse in the last 12 months prior to initiation of therapy; 5. Prior to initiation, the individual has been evaluated and tested for hepatitis B virus (HBV) infection and for latent tuberculosis infection (and liver transaminases/bilirubin assessed as clinically indicated).

Approval duration: 1 year.

Continuation Therapy

Covered when ALL of the following are met:

Continuation approval criteria: 1. Individual has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD); 2. Documentation that NMOSD was seropositive (AQP4) prior to initiation of Enspryng; 3. Documentation of clinical response (for example, a reduction in relapse frequency).

Policy Summary

PayerAnthem

PolicyEnspryng (satralizumab-mwge) — Clinical coverage criteria for NMOSD

Policy CodePolicy CC-0173

Change TypeReviewed — no material changes

Effective Date12/22/2025

Next Review DateNov 14, 2026

Key ActionObtain prior authorization with documentation of age ≥18, AQP4 seropositive NMOSD, ≥1 relapse in prior 12 months, and HBV/TB screening prior to initiation.

SourceLink

On This Page

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Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Enspryng (satralizumab-mwge). Requests for initiation will be reviewed against core approval criteria and supporting documentation; initial and continuation approvals are granted for up to 1 year when criteria are met.

PA required for initiation and continuation; Approval duration: 1 year
Core initiation criteria include: age ≥ 18, diagnosis of NMOSD, documented AQP4 seropositivity, and a history of ≥1 relapse or acute attack within the prior 12 months
Core continuation criteria include: documented AQP4 seropositivity prior to initiation and evidence of clinical response (e.g., reduced relapse frequency)
Pre-initiation testing required: Hepatitis B screening, TB screening, and assessment of liver transaminases and bilirubin
Enspryng is contraindicated in active HBV infection and active or untreated latent TB

Step Therapy

Step Therapy Statement

No formal step-therapy sequence is mandated within this policy. Clinicians may consider other FDA-approved or off-label therapies for NMOSD (for context: Uplizna, eculizumab, ravulizumab, and commonly used off-label immunosuppressants such as rituximab, azathioprine, and mycophenolate), but switching or prior use of these agents is not required by this document prior to PA approval for Enspryng.

Documentation Required

Required Documentation

Providers must submit documentation to support medical necessity and PA review. Incomplete documentation may delay or result in denial of the request.

Diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
Laboratory confirmation of anti–aquaporin-4 (AQP4) antibody seropositivity (performed prior to initiation)
Clinical history documenting at least one acute attack/relapse within 12 months prior to initiation (for initial requests)
For continuation requests: evidence of clinical response (for example, reduced frequency of relapses) and documentation that AQP4 seropositivity was established prior to treatment start
Results of HBV screening and TB screening prior to initiation
Baseline liver transaminases and serum bilirubin test results
Record of prior NMOSD therapies, including dates and responses (if applicable)

Denial Risk

Triggers for Denial

The following conditions are common triggers for denial of a PA request for Enspryng.

Absence of required prior authorization or missing/insufficient documentation to verify criteria
Patient is AQP4 seronegative or no laboratory evidence of AQP4 antibody positivity
No history of ≥1 relapse/acute attack in the 12 months before initiation (for initial therapy requests)
Concomitant use of disallowed combination therapies: rituximab, eculizumab, inebilizumab, or ravulizumab
Active hepatitis B infection or active/untreated latent tuberculosis
Requests for indications other than NMOSD or for uses not supported by the criteria

Background

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune central nervous system disorder characterized by recurrent attacks such as optic neuritis and transverse myelitis. Enspryng (satralizumab-mwge) is an interleukin-6 receptor antagonist given subcutaneously and is indicated for adult NMOSD patients who meet the policy criteria. Per this policy, approval for initiation requires the individual to be ≥18 years old, have a diagnosis of NMOSD with documented AQP4 antibody seropositivity, and a history of at least one acute attack or relapse in the prior 12 months. Before starting therapy, patients should be evaluated and tested for hepatitis B virus and latent tuberculosis as part of baseline screening.

J3590	Unclassified biologics (when specified as [Enspryng] (satralizumab-mwge))
C9399	Unclassified drugs or biologicals (when specified as [Enspryng] (satralizumab-mwge))

OpenPayer

Enspryng (satralizumab-mwge) — Clinical coverage criteria for NMOSD

Coverage Criteria for Enspryng (satralizumab-mwge)

Coding and Quantity Limits

Provider Actions and Documentation Requirements

Background

Definitions