CurrentUnitedHealthcarePolicy 2025 P 2222-6

Enspryng (satralizumab-mwge) prior authorization/medical necessity

Defines UnitedHealthcare prior authorization and medical necessity requirements for Enspryng (satralizumab-mwge) for treatment of neuromyelitis optica spectrum disorder (NMOSD) in AQP4‑antibody positive adult patients, and who may prescribe. Affects providers seeking coverage for this medication.

Policy Summary

PayerUnitedHealthcare

PolicyEnspryng (satralizumab-mwge) prior authorization/medical necessity

Policy CodePolicy 2025 P 2222-6

Change TypeAnnual review — no material changes

Effective DateJan 17, 2026

Next Review DateN/A

Key ActionSubmit prior authorization showing NMOSD diagnosis, positive AQP4 serology, and prior rituximab failure/contraindication/intolerance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

AQP4-positiverequired serostatus for coverage

requiredrituximab requirement

P&T 2020-2025program approval history

Coverage and Medical Necessity Criteria

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Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Member has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD).

Supported by clinical documentation confirming NMOSD diagnosis.

Serostatus: Patient has a positive serologic test for anti‑aquaporin‑4 (AQP4) antibodies.

Prior rituximab requirement: History of failure, contraindication, or intolerance to rituximab therapy.

Step‑therapy requirement: prior rituximab trial must be documented unless contraindicated or not tolerated.

Relapse history

Relapse options
- Option 1: History of one or more relapses that required rescue therapy during the previous 12 months.
- Option 2: History of two or more relapses that required rescue therapy during the previous 24 months.

Prescriber: Prescribed by, or in consultation with, a neurologist.

Documentation of treating neurologist or documented consultation required.

Concomitant therapy exclusions: Patient is not receiving Enspryng in combination with any of the following for treatment of the same indication: (1) anti‑IL‑6 therapy (e.g., tocilizumab), (2) B‑cell depletion therapy (e.g., rituximab, inebilizumab), (3) complement inhibitors (e.g., eculizumab, ravulizumab), or (4) disease‑modifying therapies for multiple sclerosis (e.g., fingolimod, dimethyl fumarate, ocrelizumab).

Concurrent use with these agents is excluded.

Reauthorization / Continuation

Reauthorization will be approved when ALL of the following are met:

Clinical response: Documentation of positive clinical response to Enspryng therapy.

Clinical response should be described in chart notes (e.g., reduced relapse frequency, decreased disability, or other treating‑clinician assessment).

Prescriber: Prescribed by, or in consultation with, a neurologist.

Ongoing management documentation or consultation note required.

Concurrent use with these agents will prevent reauthorization.

Enspryng must not be administered concurrently with certain other immunomodulatory therapies for the same indication. Specifically, combination use with anti‑IL‑6 therapies (e.g., tocilizumab/Actemra), B‑cell depletion therapies (e.g., rituximab; inebilizumab/Uplizna), complement inhibitors (e.g., eculizumab; ravulizumab/Ultomiris), or disease‑modifying therapies for multiple sclerosis (e.g., fingolimod/Gilenya; dimethyl fumarate/Tecfidera; ocrelizumab/Ocrevus) is excluded for the same indication.

Caution is advised when managing immunosuppression and infection risk. Providers should ensure Enspryng is not prescribed in combination with these agents for the same indication and should document any prior therapies and the rationale for sequencing to avoid prohibited concomitant use.

Treatment with Enspryng is not supported when the required diagnostic and treatment prerequisites are not met. Specifically, coverage is limited to members with a diagnosis of neuromyelitis optica spectrum disorder (NMOSD) who have a positive anti‑aquaporin‑4 (AQP4‑positive) serologic test; requests for AQP4‑negative patients are not supported.

Requests lacking documentation of prior rituximab failure, contraindication, or intolerance do not meet criteria. In addition, Enspryng is not supported for diagnoses other than NMOSD or where the specified relapse history requirement is not documented.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required for Enspryng. Requests will be approved only when the initial criteria are met and required documentation is provided.

PA required — submit prior authorization request before dispensing.
Approval contingent on meeting ALL initial criteria (diagnosis, AQP4 seropositivity, rituximab step requirement, relapse history, neurology involvement, and absence of disallowed concomitant therapies).
Authorization duration: 12 months.

Step Therapy

Rituximab Step Requirement

Enspryng requires prior failure, contraindication, or intolerance to rituximab before initial approval will be granted. Document the rituximab trial details (dates, dose, reason for discontinuation or intolerance, and clinical response).

Must show prior rituximab therapy and reason for failure/contraindication/intolerance.
If rituximab was not used, provide documented medical justification for why rituximab is not appropriate.

Documentation Required

Reauthorization Documentation Required

Reauthorization requires documentation of continued benefit. Provide objective and subjective evidence of positive clinical response since initiation of Enspryng.

Documented positive clinical response (e.g., reduced relapse frequency, improved/stable neurologic exam, functional improvement).
Relevant clinical data: relapse history since treatment start, EDSS or other disability scores if available, imaging or lab results supporting response, and treating neurologist's assessment.
Authorization will be renewed for up to 12 months when reauthorization criteria are met.

Denial Risk

Denial Risk Conditions

Requests may be denied if key diagnostic or treatment criteria are not met or documented.

Denial risk if diagnosis is not neuromyelitis optica spectrum disorder (NMOSD) or if the submitted ICD-10 diagnosis does not support NMOSD.
Denial risk if AQP4 serostatus is negative or not reported.
Denial risk if prior rituximab therapy (or acceptable justification for not using it) is not documented.
Denial risk if relapse history criteria are not met or not documented.
Denial risk if prescribing clinician is not a neurologist or there is no documentation of neurology consultation.

OpenPayer

Enspryng (satralizumab-mwge) prior authorization/medical necessity

Coverage and Medical Necessity Criteria

What Providers Must Do

Key Definitions

Background and Clinical Context