CurrentMass General Brigham Health PlanPolicy N/A

Enspryng (satralizumab-mwge) coverage

Defines prior authorization, clinical criteria, and coverage limits for Enspryng (satralizumab-mwge) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyEnspryng (satralizumab-mwge) coverage

Policy CodePolicy N/A

Change TypeMaterial updates to initial and reauthorization criteria

Effective DateOct 1, 2025

Next Review DateJul 9, 2025

Key ActionObtain prior authorization and submit documentation confirming AQP4 immunoassay positivity and clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Updated language for members new to the Plan and clarified initial criteria to require that AQP4 antibody is confirmed by immunoassay.

Added symptomatic cerebral syndrome with NMOSD-typical brain lesions as a core NMOSD characteristic.

Updated reauthorization criteria to require documentation of clinical response to therapy.

12 monthsapproval duration

18+minimum age

1 mL/28 daysquantity limit

AQP4+serology requirement

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Coverage Criteria for Enspryng (satralizumab-mwge)

Initial Authorization

Authorization may be granted when ALL of the following are met:

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

Represented as a single AND group per policy text

Continuation of Therapy (Reauthorization)

Requests for reauthorization will be approved when the following criteria are met:

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.

Require clinical response documentation

Use of Enspryng in combination with other biologic therapies for the treatment of neuromyelitis optica spectrum disorder (NMOSD) is excluded. The policy requires that the member will not receive the requested drug concomitantly with other biologics for the treatment of NMOSD as a condition of both initial authorization and reauthorization.

Treatment with Enspryng is not supported when the member is AQP4 antibody negative, does not meet the NMOSD diagnostic/core clinical feature requirements, or is younger than 18 years of age. For initial authorization, coverage requires a diagnosis of NMOSD, immunoassay-confirmed anti-aquaporin-4 (AQP4) antibody positivity, and documentation of at least one core NMOSD characteristic (for example, optic neuritis; acute myelitis; area postrema syndrome; acute brainstem syndrome; symptomatic narcolepsy or diencephalic syndrome with NMOSD-typical diencephalic MRI lesions; or symptomatic cerebral syndrome with NMOSD-typical brain lesions). For continuation of therapy, reauthorization additionally requires documentation of a positive clinical response to therapy (e.g., reduction in number of relapses).

Product, Quantity Limits, and Approval Duration

Pharmacy product and quantity limitNDC | product descriptorCovered

Enspryng 120mg/mL (1mL) prefilled syringe

Quantity limitation: 1 mL per 28 days

inv-06: Approval duration

Approval durationInitial approvals and reauthorizations will be for 12 months.

Quantity limit (related)Enspryng 120mg/mL (1mL) prefilled syringe: 1 mL per 28 days.

ApplicationApplies to both initial authorizations and continuations of therapy (reauthorizations).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Dispensing

Prior authorization is required under the pharmacy benefit. This medication is designated as a specialty product and must be dispensed through a contracted specialty pharmacy.

Program type: Prior Authorization (Pharmacy benefit)
Specialty dispensing: must be filled at a contracted specialty pharmacy
Benefit: Pharmacy benefit only

Step Therapy

No step therapy requirement is specified for this drug; step therapy does not apply.

Key Definitions

inv-12: AQP4 antibody positive

DefinitionPresence of anti-aquaporin-4 (AQP4) antibodies confirmed by use of immunoassay.

Requirement for coverageAQP4 antibody positivity by immunoassay is required for authorization of Enspryng.

PopulationApplies to adult patients (age ≥18 years) with NMOSD seeking coverage for Enspryng.

inv-13: Core NMOSD clinical characteristics

Core characteristic — optic neuritisOptic neuritis.

Core characteristic — acute myelitisAcute myelitis.

Core characteristic — area postrema syndrome

Background

Enspryng (satralizumab-mwge) is an interleukin‑6 (IL‑6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are AQP4 antibody positive. NMOSD is characterized by relapsing inflammatory events such as optic neuritis, acute myelitis, area postrema syndrome, and other brainstem, diencephalic, or cerebral syndromes; the policy requires immunoassay confirmation of AQP4 antibody positivity and presence of at least one core NMOSD clinical characteristic for coverage.

Revision History and Policy Changes

2025-10-01policy_effective_dateLatest

Policy effective date updated to 10/01/2025 reflecting revisions to initial and reauthorization criteria and review outcomes.

2025-07-09policy_review_and_revision

Reviewed and updated at July P&T: clarified review for members new to the plan within 90 days, required AQP4 antibody confirmation by immunoassay, added symptomatic cerebral syndrome with NMOSD-typical brain lesions to core characteristics, and updated reauthorization criteria to require documentation of clinical response; noted effective date 10/01/2025.

2021-03-17

Policy Summary

PayerMass General Brigham Health Plan

PolicyEnspryng (satralizumab-mwge) coverage

Policy CodePolicy N/A

Change TypeMaterial updates to initial and reauthorization criteria

Effective DateOct 1, 2025

Next Review DateJul 9, 2025

Key ActionObtain prior authorization and submit documentation confirming AQP4 immunoassay positivity and clinical response for reauthorization.

SourceLink

On This Page

Documentation Required

Required Documentation

Documentation must demonstrate the diagnosis and supporting laboratory/clinical evidence for neuromyelitis optica spectrum disorder (NMOSD) and prior response for continuation requests.

Diagnosis: Documentation of NMOSD
AQP4 antibody: Immunoassay-confirmed anti‑aquaporin‑4 (AQP4) antibody positivity
Core clinical characteristics: Evidence of ≥1 NMOSD core feature (optic neuritis; acute myelitis; area postrema syndrome; acute brainstem syndrome; symptomatic narcolepsy/acute diencephalic syndrome with NMOSD‑typical diencephalic MRI lesions; symptomatic cerebral syndrome with NMOSD‑typical brain lesions)
Age: Documentation of member age (member must be ≥18 years)
Continuation: Documentation of positive clinical response to therapy for reauthorization (e.g., reduction in relapses)
Concomitant therapy: Documentation that the member will not receive the requested drug concomitantly with other biologics for NMOSD

Denial Risk

Triggers for Denial

Requests may be denied if the request does not meet the documented diagnostic or safety criteria.

AQP4 antibody negative or not confirmed by immunoassay
Member is under 18 years of age
Lack of at least one NMOSD core clinical characteristic
Request indicates concurrent use with other biologic therapies for NMOSD
Missing documentation of diagnosis, antibody status, or clinical response for continuation

Area postrema syndrome (episode of otherwise unexplained hiccups or nausea and vomiting).

Core characteristic — acute brainstem syndromeAcute brainstem syndrome.

Core characteristic — symptomatic narcolepsy/diencephalic syndromeSymptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions.

Core characteristic — symptomatic cerebral syndromeSymptomatic cerebral syndrome with NMOSD-typical brain lesions.

Policy created and reviewed at March P&T; initial effective date set to 05/01/2021.