ModifiedUnitedHealthcarePolicy 2025 P 2222-6

Enspryng™ (satralizumab) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Defines UnitedHealthcare Commercial Plan prior authorization and medical necessity criteria for initiating and continuing Enspryng (satralizumab-mwge) for neuromyelitis optica spectrum disorder (NMOSD), including prescribing specialist, concomitant therapy exclusions, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyEnspryng™ (satralizumab) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2222-6

Change TypeAnnual review — non‑material revisions

Effective DateJan 17, 2026

Next Review Date

Key ActionPrior authorization/medical necessity required for Enspryng; initial and reauthorization decisions per stated clinical criteria. Authorization will be issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual review in 10/2025 with updates to examples of complement inhibitors and an updated statement for concomitant use.

Effective date set to 1/17/2026

12Authorization duration (months)

2Relapse threshold options

4Concomitant therapy classes excluded

6P&T review years listed

Coverage Summary

This policy defines UnitedHealthcare Commercial Plan prior authorization and medical necessity criteria for initiating and continuing Enspryng (satralizumab-mwge) for neuromyelitis optica spectrum disorder (NMOSD). Coverage stance: covered_with_criteria. Authorization will be issued for 12 months, and therapy must be prescribed by, or in consultation with, a neurologist. Policy effective date: 1/17/2026. Policy/Program number: 2025 P 2222-6.

Quick facts and thresholds

Policy number2025 P 2222-6

Effective date1/17/2026

Authorization duration12 months

Relapse threshold options>=1 relapse requiring rescue therapy in previous 12 months OR >=2 relapses requiring rescue therapy in previous 24 months

Concomitant therapy classes excludedAnti-IL6 therapy; B-cell depletion therapy; Complement inhibitors; MS disease-modifying therapies

Relapse history (12 months) threshold>= 1 relapse requiring rescue therapy in previous 12 months

Relapse history (24 months) threshold>= 2 relapses requiring rescue therapy in previous 24 months

Initial Therapy Criteria

Initial Authorization

Enspryng will be approved based on all of the following criteria:

ALL of the following

Diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
Patient has a positive serologic test for anti-aquaporin-4 (AQP4) antibodies
History of failure, contraindication, or intolerance to rituximab therapy
ONE of
- History of one or more relapses that required rescue therapy during the previous 12 months>= 1 relapse in 12 months

Continuation Therapy Criteria (Reauthorization)

Reauthorization (Continuation Therapy)

Enspryng will be approved based on all of the following criteria:

ALL of the following

Documentation of positive clinical response to Enspryng therapy
Prescribed by, or in consultation with, a neurologist
Concomitant therapy exclusion
- Anti-IL6 therapy (e.g., Actemra (tocilizumab))
- B-cell depletion therapy (e.g., rituximab, Uplizna (inebilizumb-cdon))

Concomitant Therapy Exclusions

Enspryng will not be approved if prescribed in combination for the same indication with any of the following therapy classes: Anti-IL6 therapies (e.g., Actemra (tocilizumab)); B-cell depletion therapies (e.g., rituximab, Uplizna (inebilizumb-cdon)); Complement inhibitors (e.g., eculizumab, Ultomiris (ravulizumab), etc.); Disease-modifying therapies for multiple sclerosis (e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.). Combination use with these agents disqualifies approval per the concomitant therapy exclusion.

Applicable Codes

Relevant diagnosis codes referenced (ICD-10)ICD-10

No codes listed

Drug codes / IdentifiersNDC|HCPCS|mixed

No codes listed

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required

PA/medical necessity required for Enspryng; initial and reauthorization decisions follow the policy's clinical criteria. Authorization will be issued for 12 months.

Documentation Required

Documentation of antibody status and prior therapy

Initial: document NMOSD diagnosis, positive anti‑AQP4 antibody serology, and history of failure, contraindication, or intolerance to rituximab. Reauthorization: document positive clinical response to Enspryng.

NMOSD diagnosis
Positive anti‑AQP4 antibody serology
History of failure, contraindication, or intolerance to rituximab (initial)

Clinical Evidence & Sources

P&T approval dates: 10/2020, 10/2021, 10/2022, 10/2023, 10/2024, 10/2025. Key clinical trials/sources: N Engl J Med. 2019;381(22):2114-2124; Lancet Neurol. 2020;19(5):402-412; Enspryng package insert, March 2022.

Background

Indication: Enspryng (satralizumab-mwge) is an IL-6 receptor antagonist indicated for treatment of NMOSD in adult patients who are AQP4 antibody positive. This policy sets prior authorization and medical necessity criteria for UnitedHealthcare Commercial Plans covering initiation and continuation of Enspryng, including requirements for AQP4 seropositivity, prior rituximab failure/contraindication/intolerance for initial approval, neurologist involvement, relapse history thresholds for initiation, prohibition on concomitant use with specified therapy classes, and 12-month authorization duration.

Definitions

Rescue therapyAcute treatment administered for NMOSD relapse (documented as requiring such therapy).

Positive clinical responseDocumentation that the patient has benefited from Enspryng therapy as assessed by the treating clinician (no further specification in policy).

Revision History

2025-10revised

Annual review in 10/2025 with updates to examples of complement inhibitors and an updated statement for concomitant use.

2026-01-17revisedLatest

Policy effective date set to 1/17/2026.

Policy Summary

PayerUnitedHealthcare

PolicyEnspryng™ (satralizumab) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2222-6

Change TypeAnnual review — non‑material revisions

Effective DateJan 17, 2026

Next Review Date

Key ActionPrior authorization/medical necessity required for Enspryng; initial and reauthorization decisions per stated clinical criteria. Authorization will be issued for 12 months.

SourceLink

On This Page

History of two or more relapses that required rescue therapy during the previous 24 months>= 2 relapses in 24 months

Prescribed by, or in consultation with, a neurologist

Concomitant therapy exclusion

Anti-IL6 therapy (e.g., Actemra (tocilizumab))
B-cell depletion therapy (e.g., rituximab, Uplizna (inebilizumb-cdon))
Complement inhibitors (e.g., eculizumab, Ultomiris (ravulizumab), etc.)
Disease modifying therapies for the treatment of multiple sclerosis (e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.)

Complement inhibitors (e.g., eculizumab, Ultomiris (ravulizumab), etc.)

Disease modifying therapies for the treatment of multiple sclerosis (e.g., Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Ocrevus (ocrelizumab), etc.)

Documentation of positive clinical response to Enspryng (reauthorization)

Documentation Required

Specialist involvement

Prescribed by, or in consultation with, a neurologist is required for both initial authorization and reauthorization.

Billing Rule

Concomitant therapy exclusion

Patient must not be receiving Enspryng in combination with specified agents for treatment of the same indication; combination use disqualifies approval.

Anti‑IL6 therapy (e.g., Actemra / tocilizumab)
B‑cell depletion therapy (e.g., rituximab, Uplizna / inebilizumab‑cdon)
Complement inhibitors (e.g., eculizumab, Ultomiris / ravulizumab)
Disease‑modifying therapies for multiple sclerosis (e.g., Gilenya / fingolimod, Tecfidera / dimethyl fumarate, Ocrevus / ocrelizumab)

Note

Automated approval pathway note

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD‑10) and/or claim logic in some programs; automated approval processes and supply limits may apply.