CurrentMass General Brigham Health PlanPolicy N/A

Enspryng (satralizumab-mwge) coverage

Defines prior authorization, quantity limits, and clinical criteria for coverage of Enspryng (satralizumab-mwge) for adult members with AQP4-positive neuromyelitis optica spectrum disorder under the pharmacy/specialty benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyEnspryng (satralizumab-mwge) coverage

Policy CodePolicy N/A

Change TypeRevised

Effective DateOct 1, 2025

Next Review DateJul 9, 2025

Key ActionSubmit prior authorization with documentation of positive AQP4 immunoassay and evidence of at least one NMOSD core clinical characteristic; reauthorization requires documentation of clinical response.

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the Plan and require that AQP4 antibody is confirmed by immunoassay; added symptomatic cerebral syndrome with NMOSD-typical brain lesions as a core characteristic; updated reauthorization criteria to require documentation of clinical response to therapy.

12 monthsApproval duration

1 mL/28dQuantity limit

18+Age requirement

AQP4+Serologic requirement

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Initial Therapy

Covered when ALL of the following are met

Initial Authorization Criteria: Member has a diagnosis of neuromyelitis optica spectrum disorder; member is anti-aquaporin-4 (AQP4) antibody positive confirmed by immunoassay; member exhibits at least one core NMOSD characteristic (optic neuritis; area postrema syndrome; acute myelitis; acute brainstem syndrome; symptomatic cerebral syndrome with NMOSD-typical brain lesions; symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions); member will not receive the requested drug concomitantly with other biologics for the treatment of NMOSD; member is 18 years of age or older.

Continuation Therapy

Reauthorization/Continuation of Therapy — Requests for reauthorization will be approved when

Reauthorization Criteria: Documentation of a positive clinical response to therapy (e.g., reduction in number of relapses); member will not administer the requested medication in combination with other biologics for the treatment of NMOSD; initial approvals and reauthorizations limited to 12 months.

The policy prohibits concomitant administration of Enspryng with other biologic therapies for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Coverage is allowed only when the member will not receive the requested drug in combination with other NMOSD biologics; requests that propose concurrent biologic therapy for NMOSD are not eligible for approval. This requirement applies to both initial authorizations and reauthorizations.

Enspryng is not covered for patients who do not meet the serologic, age, or clinical diagnostic requirements. Specifically, coverage is limited to adults 18 years or older who are AQP4 antibody positive confirmed by immunoassay and who demonstrate at least one core NMOSD characteristic (for example optic neuritis, area postrema syndrome, acute myelitis, acute brainstem syndrome, symptomatic cerebral syndrome with NMOSD-typical brain lesions, or symptomatic narcolepsy/acute diencephalic syndrome with NMOSD-typical diencephalic MRI lesions). Use in members who are AQP4 antibody negative, are younger than 18 years, or lack documented NMOSD clinical characteristics is not covered under this policy.

Initial Authorization Criteria

Initial Therapy

Initial authorization criteria

Initial: Member is 18 years or older; diagnosis of neuromyelitis optica spectrum disorder; AQP4 antibody positive confirmed by immunoassay; presence of at least one listed NMOSD core characteristic (optic neuritis; area postrema syndrome; acute myelitis; acute brainstem syndrome; symptomatic cerebral syndrome with NMOSD-typical brain lesions; symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions); no concomitant NMOSD biologic therapy.

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization may be reviewed for members new to the plan within 90 days who are currently receiving the medication (excludes samples or manufacturer patient assistance programs).

Applies to members new to the plan within 90 days who are currently receiving the medication

Step Therapy

Step Therapy / Specialty Fulfillment

Step therapy / specialty fulfillment — designated as Step Therapy/Quantity Limit and specialty limited to contracted specialty pharmacy.

Designated specialty — must be filled at a contracted specialty pharmacy (Medical and Specialty Medications).
Quantity limit and Step Therapy applies; benefit: Pharmacy Benefit/Medical Benefit (as applicable).
Contact: AII Plans Phone: 877-519-1908 Fax: 855-540-3693; Non-Specialty All Plans Phone: 800-711-4555 Fax: 844-403-1029

Documentation Required

Required Documentation

Required documentation for initial and continuation authorization: positive anti‑AQP4 immunoassay result, documentation of NMOSD diagnosis with at least one core NMOSD characteristic, and for reauthorization documentation of positive clinical response to therapy (e.g., reduction in relapses).

Initial: positive anti‑aquaporin‑4 (AQP4) antibody confirmed by immunoassay.
Initial: diagnosis of neuromyelitis optica spectrum disorder (NMOSD).
Initial: at least one core NMOSD characteristic (optic neuritis; area postrema syndrome with unexplained hiccups or nausea/vomiting; acute myelitis; acute brainstem syndrome; symptomatic cerebral syndrome with NMOSD‑typical brain lesions; symptomatic narcolepsy/acute diencephalic syndrome with NMOSD‑typical diencephalic MRI lesions).
Initial and Continuation: member must be >= 18 years of age.
Continuation/Reauthorization: documentation of positive clinical response to therapy (e.g., reduction in number of relapses).
Continuation/Reauthorization: member will not receive the requested drug concomitantly with other biologics for treatment of NMOSD.

Denial Risk

Denial Triggers

Triggers for denial — authorization will be denied if the member is not AQP4 positive by immunoassay, does not have an NMOSD diagnosis with required core characteristic, is under 18 years of age, the request is for concomitant use with other NMOSD biologics, or required reauthorization documentation demonstrating clinical response is not provided.

Not AQP4 antibody positive by immunoassay.
No diagnosis of NMOSD with at least one core characteristic.
Member age < 18 years.
Requested concomitant use with other biologics for NMOSD.
Missing reauthorization documentation of clinical response (e.g., no evidence of relapse reduction).

Definitions and NMOSD Core Characteristics

NMOSD core characteristics

Optic neuritisInflammation of the optic nerve causing visual disturbance

Area postrema syndromeEpisode of otherwise unexplained hiccups or nausea and vomiting

Acute myelitisInflammation of the spinal cord producing motor, sensory, or autonomic dysfunction

Acute brainstem syndromeBrainstem dysfunction consistent with NMOSD presentation

Symptomatic cerebral syndrome with NMOSD-typical brain lesionsCerebral symptoms accompanied by brain lesions typical for NMOSD

Symptomatic narcolepsy or acute diencephalic clinical syndromeDiencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions

Item	Requirement / Limit	Specialty Fulfillment	Prior Authorization
Enspryng 120 mg/mL (1 mL) prefilled syringe
Quantity limit: 1 mL per 28 days
Must be filled at a contracted specialty pharmacy; designated specialty medication
Prior authorization required; may be reviewed for members new to the plan within 90 days who are currently receiving the medication

Policy Summary

PayerMass General Brigham Health Plan

PolicyEnspryng (satralizumab-mwge) coverage

Policy CodePolicy N/A

Change TypeRevised

Effective DateOct 1, 2025

Next Review DateJul 9, 2025

SourceLink

On This Page

OpenPayer

Enspryng (satralizumab-mwge) coverage

Coverage Criteria for Enspryng (satralizumab-mwge)

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Coding and Quantity Limits

Provider Actions, Documentation, and Denial Triggers

Definitions and NMOSD Core Characteristics

Background

Step Therapy and Specialty Fulfillment

Quantity Limit Details

Site of Care Requirements