CurrentCignaPolicy IP0078

Enspryng (satralizumab) for NMOSD — Prior Authorization and Medical Necessity Criteria

This Cigna coverage policy governs prior authorization and medical necessity criteria for Enspryng (satralizumab-mwge) subcutaneous injection for treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults, and applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyEnspryng (satralizumab) for NMOSD — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy IP0078

Change TypeAnnual review — material and non-material edits

Effective DateAug 15, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and submit required documentation (e.g., positive AQP4-IgG test and prescriber statement of clinical benefit) to receive approval for up to 1 year.

SourceLink

POLICY UPDATE CHANGES

Added criteria pathway for patients currently receiving Enspryng to be approved for 1 year if they meet specified criteria.

Added documentation requirement language specifying that documentation is required where noted and may include chart notes, labs, claims records, or other information.

Expanded 'Concomitant Use' exclusion to include Ultomiris (ravulizumab) in addition to rituximab, Soliris (eculizumab), and Uplizna (inebilizumab).

Title changed from satralizumab-mwge to Enspryng.

1 yearapproval duration

≥18minimum age

AQP4‑IgG+diagnostic status

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PA requiredadministrative

Coverage and Medical Necessity Criteria

COVERAGE CRITERIA

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- i: Patient is ≥ 18 years of age
- ii: Diagnosis was confirmed by a positive blood serum test for anti-aquaporin-4 antibody [documentation required]
- iii: The medication is being prescribed by or in consultation with a neurologist
B) Patient is Currently Receiving Enspryng
- i: Patient is ≥ 18 years of age
- ii: Diagnosis was confirmed by a positive blood serum test for anti-aquaporin-4 antibody
- iii: According to the prescriber, patient has had clinical benefit from the use of Enspryng (examples include reduction in relapse rate, reduction in symptoms such as pain, fatigue, or motor function, or slowing of progression)
- iv: The medication is being prescribed by or in consultation with a neurologist

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Enspryng is considered not medically necessary for uses outside the FDA‑approved indication of AQP4‑IgG‑positive neuromyelitis optica spectrum disorder (NMOSD). This includes, but is not limited to, concomitant use with a rituximab product, eculizumab (Soliris), ravulizumab (Ultomiris), or inebilizumab (Uplizna), for which there is no evidence to support combined therapy and which are specifically listed as exclusions.

Use of Enspryng for any indication other than the FDA‑approved indication — treatment of NMOSD in AQP4‑IgG‑positive adults — is considered not medically necessary and will not be covered under this policy.

Coding and Patient Eligibility

Covered CPT Codesmixed

No codes listed

inv-05: Minimum age

Minimum age≥ 18 years

Approval duration1 year when initial or continuation criteria are met

DocumentationAge must be documented as part of prior authorization request

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Enspryng. All approvals are issued for 1 year when initial or continuation criteria are met. Because of the specialized skills required for evaluation and diagnosis and the monitoring required for adverse events and long-term efficacy, Enspryng must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior authorization required
Approvals issued for 1 year when initial or continuation criteria are met
Prescribed by or in consultation with a specialist (neurologist)

Step Therapy

Therapeutic Context (No Mandated Step Therapy)

The Neuromyelitis Optica Study Group (NEMOS) recommends multiple first-choice therapies for AQP4-IgG–positive NMOSD (Enspryng, eculizumab [Soliris], ravulizumab [Ultomiris], inebilizumab [Uplizna], and rituximab). There is no mandated step-therapy sequence; choice of treatment should be individualized based on disease activity/severity, onset of action, ability to combine with other immunosuppressants, comorbidities, family planning considerations, administration route/frequency, side-effect profile, and patient/physician preference. If a patient fails one first-choice therapy, another first-choice therapy may be tried; second-choice options include azathioprine, mycophenolate mofetil, or low-dose oral glucocorticoids.

Definitions

inv-12: NMOSD

DefinitionNeuromyelitis optica spectrum disorder (NMOSD) is a rare, relapsing autoimmune disorder of the brain and spinal cord characterized by optic neuritis and/or myelitis.

Key clinical featuresOften causes significant, permanent vision and/or spinal cord damage (e.g., blindness, impaired mobility); symptoms may include pain, paralysis, bowel/bladder dysfunction, loss of visual acuity, and motor impairment.

Diagnostic markerAnti-aquaporin-4 (AQP4) antibody positivity required for coverage consideration (positive blood serum test).

inv-13: Enspryng

Generic and brand nameSatralizumab-mwge (Enspryng)

Drug classInterleukin-6 (IL-6) receptor antagonist

Background

Neuromyelitis optica spectrum disorder (NMOSD) is a rare, relapsing autoimmune disorder that primarily affects the optic nerves and spinal cord, commonly presenting with optic neuritis and/or myelitis and risking permanent vision loss or spinal cord–related disability. Long‑term immunotherapy is recommended for patients who are anti‑aquaporin‑4 (AQP4) antibody positive. Enspryng (satralizumab‑mwge) is an interleukin‑6 receptor antagonist indicated for treatment of NMOSD in adults who are AQP4‑IgG positive; this policy establishes prior authorization and medical necessity criteria for its use in that population.

Policy Summary

PayerCigna

PolicyEnspryng (satralizumab) for NMOSD — Prior Authorization and Medical Necessity Criteria

Policy CodePolicy IP0078

Change TypeAnnual review — material and non-material edits

Effective DateAug 15, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and submit required documentation (e.g., positive AQP4-IgG test and prescriber statement of clinical benefit) to receive approval for up to 1 year.

SourceLink

On This Page

No mandated step therapy — multiple first-choice therapies available
Therapy choice individualized; may try another first-choice agent if one fails
Second-choice options: azathioprine, mycophenolate mofetil, low-dose oral glucocorticoids

Documentation Required

Required Supporting Documentation

Documentation is required where noted in the criteria. Acceptable documentation may include, but is not limited to, chart notes, laboratory test results, and claims records. A positive blood serum test for anti–aquaporin-4 antibody is required and documentation of this test result must be provided for initial therapy and for patients currently receiving Enspryng when specified in criteria. Where clinical benefit is attested for patients currently receiving Enspryng, prescriber documentation describing benefit (for example, reduced relapse rate or symptom improvement) should be included.

Documentation examples: chart notes, lab tests, claims records
Positive anti–AQP4 antibody test documentation required where noted
Prescriber statement of clinical benefit may be required for continuation approvals

Denial Risk

Non‑Covered Uses / Concurrent Therapy

Enspryng is considered not medically necessary for uses other than the FDA‑approved indication (Neuromyelitis Optica Spectrum Disorder) and is specifically not covered for concomitant use with the following therapies due to lack of evidence supporting combined use: rituximab products; eculizumab intravenous infusion (Soliris® and biosimilars); ravulizumab-cwvz intravenous infusion (Ultomiris®); and inebilizumab-cdon intravenous infusion (Uplizna®).

Concomitant use with rituximab products is not covered
Concomitant use with eculizumab (Soliris, biosimilars) is not covered
Concomitant use with ravulizumab (Ultomiris) is not covered
Concomitant use with inebilizumab (Uplizna) is not covered
Enspryng for indications other than NMOSD is not covered

Denial Risk

Coding Mismatch — Denial Risk

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes referenced in this policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service; lack of covered codes or unsupported indications in the claim may result in denial.

Claims without covered diagnosis/procedure codes per policy will be denied as not covered
Use most appropriate codes as of date of service

Indication summaryIndicated for treatment of NMOSD in adults who are anti-aquaporin-4 (AQP4) antibody positive; coverage requires prescription by or in consultation with a neurologist and documentation of AQP4-IgG positivity.

Coverage limitationUse for indications other than AQP4-IgG–positive NMOSD is considered not medically necessary per policy.