CurrentCentenePolicy CP.PHAR.463

Satralizumab-mwge (Enspryng)

Defines medical necessity criteria, prior authorization requirements, dosing limits, contraindications, and continuity/renewal criteria for Enspryng (satralizumab-mwge) for treatment of neuromyelitis optica spectrum disorder (NMOSD) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicySatralizumab-mwge (Enspryng)

Policy CodePolicy CP.PHAR.463

Change TypeCoverage criteria updatescontraindications and concurrent therapy list expandedcontinued approval duration increased

Effective Date08.14.20

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria; prior authorization may be required for rituximab as noted.

SourceLink

POLICY UPDATE CHANGES

Added requirement that member does not have active HBV or TB since both are contraindications.

Added requirement against concurrent use with rituximab, Soliris, or Uplizna (later expanded).

Specified Truxima as an additional preferred rituximab product.

Revised continued approval duration from 6 to 12 months.

Added step therapy bypass for IL HIM per IL HB 5395.

1FDA-approved indication(s)

120Max labeled dose (mg)

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Continued approval (months)

18+Approved age (years)

Coverage Summary

Enspryng (satralizumab-mwge) coverage policy CP.PHAR.463 defines medical necessity criteria, prior authorization requirements, dosing limits, contraindications, and continuity/renewal criteria for treatment of neuromyelitis optica spectrum disorder (NMOSD). Policy status: covered_with_criteria. Policy number: CP.PHAR.463. Status: CURRENT.

Thresholds

Age>= 18 years

Expanded Disability Status Scale (EDSS)Baseline EDSS < 6.5

Maximum dose120 mg at weeks 0, 2, and 4, then every 4 weeks thereafter

Relapses in prior 12 months>= 1 relapse

Relapses in prior 24 months>= 2 relapses

Medical Necessity Criteria

Initial Approval Criteria

Enspryng is medically necessary when ALL of the following are met:

ALL of the following

Initial Approval Core Criteria
- Diagnosis and Provider: Diagnosis of neuromyelitis optica spectrum disorder (NMOSD); Prescribed by or in consultation with a neurologist; Age is 18 years or older; Member has positive serologic test for anti-AQP4 (AQP-4) antibodies;
  Refer to Appendix D for serologic testing method (Euroimmun cell-binding kit).
- Relapse History: Member has experienced at least one relapse within the previous 12 months; Member has a history of at least two relapses during the previous 24 months.
- EDSS: Baseline Expanded Disability Status Scale (EDSS) score is < 6.5.

Coding

HCPCS / Misc billing codes referencedmixed

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Provider Actions & Billing Impact

Prior Authorization

Prior authorization and documentation required

Prior authorization may be required and the provider must submit supporting documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria.

Documentation Required

Serologic testing requirement

Document a positive anti-AQP4 (AQP-4-IgG) serologic test; AQP-4 seropositive status can be confirmed using a commercially available cell‑binding kit assay (Euroimmun cited as an example).

Denial Risk

Background, Evidence & Definitions

Enspryng (satralizumab-mwge) is an anti-interleukin-6 receptor antagonist and is FDA-approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Contraindications include active hepatitis B infection and active or untreated latent tuberculosis. The policy notes preferred therapeutic alternatives are rituximab products (including Ruxience and Truxima), and documents that concomitant use with rituximab and other specified agents is not permitted per the coverage criteria.

Source	Reference
Key trials	Yamamura et al. NEJM 2019; Traboulsee et al. Lancet Neurol 2020
Prescribing information	Enspryng Prescribing Information, Genentech, March 2022 (accessed April 17, 2025)

Term	Definition
AQP-4	aquaporin-4
NMOSD	neuromyelitis optica spectrum disorder
EDSS	expanded disability status scale

Revision History

09.29.20added

Added requirement that member does not have active hepatitis B infection or active/untreated latent tuberculosis (contraindications); reflected in 1Q2021 annual review per FDA labeling; marked as material.

02.21.21added

Initial 1Q2021 update: Added requirement prohibiting concurrent use with rituximab, Soliris, or Uplizna per FDA labeling; marked as material.

09.15.21revised

Policy Summary

PayerCentene

PolicySatralizumab-mwge (Enspryng)

Policy CodePolicy CP.PHAR.463

Change TypeCoverage criteria updatescontraindications and concurrent therapy list expandedcontinued approval duration increased

Effective Date08.14.20

Next Review Date

SourceLink

On This Page

EDSS must be measured at baseline.

Failure of rituximab

Rituximab failure: Failure of rituximab at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects.
Rituximab contraindication: Rituximab is contraindicated or causes clinically significant adverse effects.

Infectious Contraindications: Member does not have active hepatitis B infection (positive hepatitis B surface antigen and anti-hepatitis B virus tests) or active or untreated latent tuberculosis.

Active HBV or active/untreated latent TB are contraindications.

Concurrent Therapy Prohibition: Enspryng is not prescribed concurrently with rituximab, Bkemv, Soliris, Epysqli, Uplizna, or Ultomiris.

Concurrent prescribing with listed therapies is not allowed.

Dosing Limit: Dose does not exceed 120 mg at weeks 0, 2, and 4, and every 4 weeks thereafter.Maximum dose = 120 mg per labeled schedule

Continued Therapy (Renewal) Criteria

Member must meet one of the following and show benefit:

ALL of the following

Eligibility for continued therapy: Member is currently receiving medication via Centene benefit OR member has previously met initial approval criteria.
Evidence of benefit: Member is responding positively or demonstrating stabilization (examples include improvement or stabilization in frequency of relapse, EDSS, visual acuity).
Document clinical response or stabilization to justify ongoing therapy.
Continuity of care: If member is enrolled in a state/product with continuity of care regulations and currently receiving medication, continuity provisions apply (refer to state addendums CCPHARM.03A and CCPHARM.03B).
Concurrent Therapy Prohibition: Enspryng is not prescribed concurrently with rituximab, Bkemv, Epysqli, Soliris, Uplizna, or Ultomiris.
Dose Increase Limit: If request is for a dose increase, new dose does not exceed 120 mg every 4 weeks.<= 120 mg every 4 weeks
Approval duration for continued therapy: 12 months.

Other Diagnoses / Non-Formulary / Off-Label Handling

Requests for other diagnoses or non-formulary uses must follow these pathways:

Other/Non-Formulary/Off-Label Handling

Formulary pathway: If drug is on formulary/PDL: follow no-coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid).
Non-formulary pathway: If drug is NOT on formulary/PDL: follow non-formulary policy for the relevant line of business (CP.CPA.190 commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid).
Off-label routing: If requested use is not listed and initial diagnosis criterion does not apply: refer to off-label use policy (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid).

Contraindications and concurrent therapy

Claims may be denied if the member has active hepatitis B infection or active/untreated latent tuberculosis, or if Enspryng is prescribed concurrently with listed therapies.

Active hepatitis B infection and active or untreated latent TB are contraindications.
Concurrent prescribing with rituximab, Bkemv, Soliris, Epysqli, Uplizna, or Ultomiris is not allowed.

Billing Rule

Dosing limit enforcement

Dose must follow the labeled schedule and must not exceed the maximum labeled dose of 120 mg: initial doses at weeks 0, 2, and 4, then every 4 weeks thereafter. Requests for dose increases must not exceed the labeled maximum.

Dosing schedule: weeks 0, 2, and 4, then every 4 weeks.
Maximum labeled dose: 120 mg; dose increase requests must not exceed this labeled maximum.

Documentation Required

Response assessment for renewal

For renewal/continued therapy, document clinical response or stabilization to justify ongoing treatment — examples include changes in frequency of relapse, EDSS score, or visual acuity.

1Q2022 annual review: Specified Truxima as an additional preferred rituximab product (non-material).

05.15.24revised

3Q2024 annual review: Added Bkemv and Ultomiris to the list of therapies that Enspryng should not be prescribed concurrently with.

05.01.25revisedLatest

3Q2025 annual review: Revised continued approval duration from 6 to 12 months as NMOSD is a chronic condition (material); added step therapy bypass for Illinois HIM per IL HB 5395 (material); added Epysqli to the list of therapies that Enspryng should not be prescribed concurrently with.