CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Enspryng (satralizumab) — Coverage Criteria for AQP4-antibody Positive NMOSD

Coverage and authorization criteria for Enspryng (satralizumab-mwge) for treatment of adult patients with AQP4-antibody positive neuromyelitis optica spectrum disorder (NMOSD) under Neighborhood Health Plan of Rhode Island (Medicaid scope).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnspryng (satralizumab) — Coverage Criteria for AQP4-antibody Positive NMOSD

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2021

Next Review DateN/A

Key ActionObtain prior authorization and document AQP4-antibody positivity, neurologist prescriber, baseline labs, and required clinical criteria for a 6-month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization period

18+minimum age

1 syringe/28dmaintenance limit

3 syringes/28dloading limit

Coverage Criteria for Enspryng (satralizumab)

Initial Therapy — Enspryng (satralizumab)

Covered when ALL of the following are met

Initial Authorization for NMOSD: Member is 18 years of age or older; documentation of anti-aquaporin-4 (AQP4) antibody positivity; documentation of one or more core clinical characteristics of NMOSD (e.g., optic neuritis, acute myelitis, area postrema syndrome [unexplained hiccups or nausea/vomiting], acute brainstem syndrome, symptomatic cerebral syndrome with NMOSD-typical lesions, or symptomatic diencephalic syndrome); diagnosis of multiple sclerosis or other alternative diagnoses have been ruled out; history of ≥2 relapses requiring rescue therapy within the last 12 months prior to initiation; member will not receive the requested drug concomitantly with other biologics for NMOSD; member has an Expanded Disability Status Score (EDSS) of < 6.5; prescribing physician is a neurologist; baseline liver transaminase and neutrophil counts completed prior to treatment; negative tuberculin test prior to initiation; screened and confirmed negative for active hepatitis B prior to initiation; prescribed dose and quantity fall within FDA-approved labeling.

Continuation Therapy — Enspryng (satralizumab)

Covered for continuation when ALL of the following are met

Continuation Authorization for NMOSD: Documentation of positive clinical response to therapy (e.g., reduction in number of relapses); submission of liver transaminase and neutrophil counts for monitoring; member will not receive the requested drug concomitantly with other biologics for NMOSD; EDSS remains < 6.5 as documented; prescribing physician is a neurologist; prescribed dose and quantity remain within FDA-approved labeling.

All indications other than AQP4-antibody positive neuromyelitis optica spectrum disorder (NMOSD) are considered experimental/investigational and not medically necessary. Coverage for Enspryng is limited to the FDA‑approved indication and only when all applicable clinical criteria in this policy are satisfied.

Use of Enspryng for non‑AQP4‑antibody positive NMOSD or for any other indications not listed in this policy is not medically necessary (considered experimental/investigational) and will not be covered.

Coding and Authorization Details

Product referencemixed

Enspryng (satralizumab-mwge)

Product name and formulation as referenced in policy

Authorization duration

Initial authorization period6 months (initial authorization may be granted for treatment of NMOSD when all clinical criteria are met)

Continuation (renewal) authorization period6 months (continuation authorizations are granted when continuation criteria are met, including documented clinical response and required labs)

Timing for lab monitoring and documentationBaseline liver transaminase and neutrophil counts required prior to initiation; ongoing submission of these labs required for continuation

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Enspryng (satralizumab) for treatment of AQP4‑antibody positive NMOSD. Initial and continuation authorizations may be granted for up to 6 months when all clinical criteria are met. Submit prior authorization requests with supporting clinical documentation (diagnosis, antibody status, relapse history, EDSS, and prescriber specialty).

Affected therapy: Enspryng (satralizumab) — prior authorization required
Authorization duration: up to 6 months for initial and continuation when criteria met
Submit clinical documentation with PA request: diagnosis, AQP4 antibody positive result, relapse history, EDSS score, prescriber specialty

Step Therapy

No step therapy requirements apply to access Enspryng for covered indication — members do not need to fail or try alternative NMOSD biologic therapies prior to authorization when approval criteria are met.

Documentation Required

Required Clinical & Laboratory Documentation

Required clinical and laboratory documentation must be submitted for initial and continuation authorization requests. Documentation must include: prescriber specialty (neurologist), confirmation of AQP4‑antibody positive status, documentation of qualifying NMOSD core clinical characteristic(s), history of relapses (≥1–2 relapses requiring rescue therapy within prior 12 months as specified by policy), Expanded Disability Status Scale (EDSS) score (<6.5), baseline and ongoing liver transaminases and neutrophil (absolute neutrophil) counts, negative tuberculosis testing prior to initiation, and HBV screening confirming no active hepatitis B. Also document that the member will not receive Enspryng concomitantly with other biologics for NMOSD and that the prescribed dose/quantity align with FDA labeling.

Prescriber: Board-certified neurologist (required)
AQP4‑antibody positive result (required)
Documentation of qualifying NMOSD clinical characteristic(s) and exclusion of alternate diagnoses (e.g., multiple sclerosis)
Relapse history as specified (relapses requiring rescue therapy in prior 12 months)
EDSS score documented (<6.5)
Baseline liver transaminases and absolute neutrophil count prior to initiation and periodic monitoring for continuation
Negative tuberculin test prior to initiation
HBV evaluation and no active HBV infection
Statement that Enspryng will not be used with other NMOSD biologics

Denial Risk

Indication Restriction — Experimental/Investigational

Use of Enspryng for indications other than AQP4‑antibody positive NMOSD (adult patients) is considered experimental and investigational and is not medically necessary — such requests will be denied.

Definitions and Clinical Measures

AQP4‑antibody positive NMOSD

DefinitionNeuromyelitis optica spectrum disorder (NMOSD) in patients with detectable anti‑aquaporin‑4 (AQP4) antibodies; Enspryng is indicated for adult patients who are AQP4‑antibody positive.

Eligibility contextCoverage restricted to AQP4‑antibody positive NMOSD when all policy criteria are met (e.g., age ≥18, core clinical characteristics, exclusion of MS/alternatives).

Non‑covered usesAll other indications (non‑AQP4 NMOSD or other uses) are considered experimental/investigational and not medically necessary.

EDSS < 6.5

Threshold definitionExpanded Disability Status Scale (EDSS) less than 6.5 as required by the policy; describes limited ambulation (inability to take more than a few steps; restricted to wheelchair and may need aid in transferring; can wheel self but cannot carry on in standard wheelchair for a full day and may require a motorized wheelchair).

Relevance to eligibilityEDSS < 6.5 is a required criterion for both initial authorization and continuation of Enspryng under this policy.

DocumentationPrescribing clinician must document the member's EDSS score in the prior authorization submission.

OpenPayer

Enspryng (satralizumab) — Coverage Criteria for AQP4-antibody Positive NMOSD

Coverage Criteria for Enspryng (satralizumab)

Coding and Authorization Details

Provider Actions, Prior Authorization & Documentation

Background

Definitions and Clinical Measures