CurrentAvMedPolicy N/A

Enspryng (satralizumab) prior authorization for NMOSD

Defines pharmacy prior authorization and step-edit requirements for Enspryng (satralizumab-mwge) for treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) for AvMed members. Applies to prescribers requesting coverage through the specialty pharmacy process.

Policy Summary

PayerAvMed

PolicyEnspryng (satralizumab) prior authorization for NMOSD

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribing physician must sign and fax the prior authorization form to 1-305-671-0200 with required member and prescriber information and supporting documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

18+Minimum age

120 mg q4wMaintenance dosing

Coverage Criteria

inv-01: Initial Therapy — Covered when ALL of the following are met.

Covered when ALL of the following are met:

Prescriber and member eligibility: Prescribing physician must be a neurologist; member must be 18 years of age or older; prescriber-signed prior authorization form submitted with required member and prescriber contact information.

Initial authorization duration: 6 months.

Diagnosis confirmation: Medical records/chart notes must support a diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD) with documentation of at least one NMOSD clinical syndrome (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy/diencephalic syndrome, or symptomatic cerebral syndrome) and, when applicable, positive serologic test for AQP4-IgG (submit lab results); multiple sclerosis and other diagnoses must be ruled out.

Relapse history: Member has either at least one relapse in the previous 12 months OR at least two relapses in the previous 24 months with at least one relapse in the prior 12 months.

Policy Summary

PayerAvMed

PolicyEnspryng (satralizumab) prior authorization for NMOSD

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribing physician must sign and fax the prior authorization form to 1-305-671-0200 with required member and prescriber information and supporting documentation.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-02: Reauthorization — Reauthorization covered when ALL of the following are met.

Reauthorization covered when ALL of the following are met:

Continued eligibility: Member continues to meet all initial authorization criteria and provider attests absence of unacceptable toxicity from therapy (e.g., tuberculosis, hepatitis B reactivation, infusion reactions, serious infections).

Reauthorization duration: 12 months.

Clinical response: Provider must submit clinical notes documenting clinical improvement (fewer relapses from baseline) or stabilization of patient relapses while on Enspryng therapy.

Add-on therapy, dose escalation of immunosuppressive therapy, or additional rescue therapy from baseline while on Enspryng will be considered treatment failure and not meet reauthorization criteria.

Coding and Dosing

Form fieldsmixed

N/A	No specific billing or NDC codes provided on form; diagnosis field requests ICD code if applicable.

Maximum dosing interval — inv-06

Maximum dosing interval120 mg every 4 weeks (maximum quantity)

Recommended maintenance dosingMaintenance dose: 120 mg once every 4 weeks

Loading regimen contextLoading dose: 120 mg once every 2 weeks for 3 doses (weeks 0, 2, and 4)

Minimum age — inv-07

Minimum age for coverage18 years

Prescriber requirement linked to ageMember must be 18 years of age or older as part of initial authorization criteria

Authorization duration contextMinimum age applies to initial authorization (6 months)

Enspryng (satralizumab) — inv-17

Product and strengthEnspryng (satralizumab) — 120 mg

Recommended dosing scheduleLoading: 120 mg at weeks 0, 2, and 4; maintenance: 120 mg every 4 weeks

Maximum quantityMaximum quantity: 120 mg every 4 weeks

Provider Actions & Documentation Requirements

Prior Authorization

Submission requirements

Prior authorization form must be signed by the prescribing physician (hand-signed; preprinted stamps not valid) and include complete member and prescriber information. Fax the completed form to 1-305-671-0200. No additional phone calls will be necessary if all information (including phone and fax numbers) is correct. Authorization may be delayed or denied if the submission is incomplete, incorrect, or illegible.

Fax: 1-305-671-0200
Prescriber signature required (physician hand-signed)
Ensure phone and fax numbers and all member/prescriber fields are complete

Step Therapy

Step therapy / prior treatment requirement

Prior to approval, the member must have trial and inadequate response or intolerance to rituximab within the 12 months prior to initiating Enspryng, OR documentation of a contraindication to rituximab plus failure of other specified therapies as shown below. Step therapy verification may be completed via pharmacy paid claims or submitted chart notes.

Required trial: rituximab with inadequate response or intolerance within prior 12 months
If contraindication to rituximab: member must have tried and failed at least ONE of the specified treatments during the prior 12 months
If no rituximab use and contraindication present: member must have failed ≥2 immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate) OR failed ≥1 immunosuppressive therapy and required chronic plasmapheresis/plasma exchange (PE) or IVIG

Documentation Required

Required supporting documentation

Providers must submit supporting clinical documentation to substantiate diagnosis and prior treatment history. Include medical records/chart notes, laboratory results (including serologic test results for anti-AQP4-IgG/NMO-IgG), documentation of relapses, baseline and ongoing safety labs, and evaluations for latent infections. Failure to provide required documentation may result in denial.

Medical records/chart notes supporting NMOSD diagnosis and documentation that alternate diagnoses (e.g., multiple sclerosis) have been ruled out
Positive AQP4-IgG/NMO-IgG lab results (submit lab report)
Documentation of relapse history (dates, clinical findings, MRI when available) to meet relapse criteria (≥1 relapse in prior 12 months OR ≥2 relapses in prior 24 months with ≥1 in past 12 months)
Documentation of prior rituximab use or contraindication and records of trials/failures of immunosuppressive therapies
Baseline liver transaminase and neutrophil count prior to treatment and plan for ongoing monitoring
Evaluation and screening documentation for latent tuberculosis and hepatitis B prior to initiation
Provider attestation that Enspryng will not be used in combination with disallowed therapies (e.g., MS disease-modifying therapies, other complement inhibitors, IL-6 inhibitors, anti-CD20/CD19 therapies)
For reauthorization: clinical notes documenting clinical improvement (fewer relapses from baseline) or stabilization and absence of unacceptable toxicity

Denial Risk

Incomplete or illegible submission — risk of delay or denial

If information on the request form or supporting documents is incomplete, incorrect, or illegible (including missing phone/fax numbers or absent prescriber signature), the authorization process can be delayed or the request may be denied.

Ensure all fields on the PA form are complete and legible
Hand-signed prescribing physician signature required (preprinted stamps not acceptable)
Include reliable contact information (phone and fax) to avoid processing delays

Initial Therapy (Drug-specific)

inv-14: Initial Therapy (Drug-specific) — Initial authorization criteria.

Initial authorization criteria

Dose and duration: Loading: 120 mg at weeks 0, 2, and 4; maintenance: 120 mg every 4 weeks. Initial authorization duration 6 months.120 mg every 4 weeks

Maximum quantity: 120 mg every 4 weeks.

Age and prescriber: Member must be 18 years of age or older and the prescribing physician must be a neurologist.18 years

Diagnosis and confirmation: Documentation supporting NMOSD diagnosis including specified clinical syndrome(s) and positive AQP4-IgG serology where applicable; multiple sclerosis and other diagnoses ruled out (submit lab results and chart notes).

Relapse history: At least one relapse in the prior 12 months OR at least two relapses in the prior 24 months with at least one occurring in the prior 12 months.

Historical relapse definition applies.

Prior treatments: Inadequate response or intolerance to rituximab within 12 months OR documented contraindication to rituximab plus failure of specified immunosuppressive therapies (failed >=2 agents; or failed >=1 plus chronic PE/IVIG).

Previous therapies will be verified via pharmacy paid claims or chart notes.

Safety screening: No active clinically important infection; baseline liver transaminase and neutrophil count submitted prior to treatment and will be monitored; screening for latent TB and hepatitis B prior to initiation.

Concomitant therapy restrictions: Enspryng will NOT be used in combination with disease-modifying therapies for MS, other complement inhibitors, IL-6 inhibitors, anti-CD20 or anti-CD19 therapies.

Reauthorization / Continuation Criteria

inv-15: Reauthorization — Reauthorization requirements.

Reauthorization requirements

Monitoring and toxicity: Provider attests absence of unacceptable toxicity (e.g., tuberculosis, hepatitis B reactivation, infusion reactions, serious infections) and continues required laboratory monitoring (liver transaminases, neutrophil count); provider documents continued eligibility.

Reauthorization length: 12 months.

Clinical improvement or stabilization: Provider submits clinical notes documenting clinical improvement (fewer relapses from baseline) or stabilization of relapses while on Enspryng therapy.

Add-on therapy, dose escalation, or additional rescue therapy from baseline while on therapy will be considered treatment failure and will not meet reauthorization criteria.

Step Therapy Requirements

Step	Prior trial(s) required before approval	Notes
1	Trial and inadequate response or intolerance to rituximab within the 12 months prior to initiating Enspryng	If contraindication to rituximab, member must have tried and failed at least one specified immunosuppressive therapy during the prior 12 months and either failed ≥2 immunosuppressive agents (e.g., azathioprine, cyclosporine, mycophenolate) or failed ≥1 plus required chronic plasmapheresis/plasma exchange (PE) or IVIG.
	Failure is defined as inadequate response or intolerance as documented in medical records	Documentation (pharmacy claims or chart notes) must be provided; use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Background

Neuromyelitis Optica Spectrum Disorder (NMOSD) is an inflammatory central nervous system disorder characterized by relapses such as optic neuritis and transverse myelitis; seropositivity for aquaporin-4 immunoglobulin G (AQP4-IgG) is a disease-defining biomarker. Satralizumab (Enspryng) is indicated to reduce relapse risk in NMOSD and requires baseline infection screening and ongoing safety monitoring prior to and during therapy (no active clinically important infection; screen for latent TB and hepatitis B; monitor liver transaminases and neutrophil counts).

Historical relapse definition — inv-13

Definition (short)Historical relapse: new onset or worsening of neurologic symptoms with objective change on exam or MRI persisting >24 hours and/or requiring treatment.

Objective change criteriaObjective change may be clinical findings, MRI findings, or both

Persistence thresholdSymptoms or findings persist for more than 24 hours

OpenPayer