ModifiedUnitedHealthcarePolicy CSOH2026D0091.E

Uplizna (inebilizumab-cdon) medical benefit drug policy — Ohio

Defines UnitedHealthcare Ohio coverage, medical necessity criteria, and authorization requirements for Uplizna (inebilizumab-cdon) for NMOSD, IgG4‑RD, and generalized myasthenia gravis; applies to Ohio only and affects prescribers and prior authorization reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyUplizna (inebilizumab-cdon) medical benefit drug policy — Ohio

Policy CodePolicy CSOH2026D0091.E

Change TypeCriteria revised and ICD‑10 codes added

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization with required medical records demonstrating diagnosis, serology, prior therapy history, MG-ADL baseline and ≥2‑point improvement for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Removed criterion requiring history of one or more relapses requiring rescue therapy in prior 12 months or two or more relapses requiring rescue therapy in prior 24 months for NMOSD initiation.

Added language indicating Uplizna is proven and medically necessary for treatment of gMG in patients who are anti-AChR or anti-MuSK antibody positive when specified criteria are met.

Added ICD-10 diagnosis codes G70.00 and G70.01 to Applicable Codes.

Revised continuation authorization criteria for gMG to require demonstration of ≥2 point improvement in MG-ADL and not receiving Uplizna sooner than 6 months from prior cycle.

Reauthorization will be for no more than 12 months.

Uplizna must be dosed according to the U.S. FDA labeled dosing for gMG and must not be used in combination with a complement inhibitor, an FcRn blocker, or immune globulin for the same indication.

Continuation (reauthorization) requires documentation of clinical benefit including at least a 2-point improvement or maintenance in MG-ADL score and documentation of baseline immunosuppressive therapy status.

Policy supporting sections (Background, Clinical Evidence, FDA, References) were updated to current information.

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3Indications covered

12 moMax authorization

J1823HCPCS

2ICD‑10 codes added

≥2 ptsRequired MG‑ADL response

Coverage and Medical Necessity Criteria

Prior Authorization

Prior Authorization and Authorizations

Prior Authorization Required. Initial and reauthorization requests for Uplizna (inebilizumab-cdon) must be submitted and will be reviewed against the coverage criteria in this policy. Initial and reauthorization approvals will be issued for no more than 12 months.

Submit prior authorization requests with complete medical records to document that coverage criteria are met.
Initial authorizations: limited to a maximum duration of 12 months.
Reauthorizations (continuation of therapy): will be approved for no more than 12 months per approval.

Billing Rule

ICD-10 Additions and Reauthorization Limit

ICD-10 Coding and Reauthorization Limit — Provider action

When applicable, include ICD-10 diagnosis codes G70.00 (Generalized myasthenia gravis without (acute) exacerbation) or G70.01 (Generalized myasthenia gravis with (acute) exacerbation) on claims and prior authorization submissions as appropriate.
Reauthorization approvals are limited to 12 months; requests exceeding a 12-month period are not consistent with this policy and may be denied.

Note

Verify Plan and Governing Requirements

Verify plan-specific authorization rules and any federal/state/contractual requirements before submission. This policy describes UnitedHealthcare standard benefit plan criteria; other plan designs or state/federal mandates may impose different requirements.

Check member’s benefit plan and any state (e.g., Ohio Administrative Code), federal, or contractual requirements that may affect coverage.
If federal, state, or contractual requirements conflict with this policy, the governing rules prevail and should be followed.

Documentation Required

Initial gMG Documentation Requirements

Required documentation for initial gMG therapy. Submit supporting medical records with the initial authorization request to demonstrate the criteria below are met.

Chart notes and history confirming diagnosis of generalized myasthenia gravis (gMG).
Serologic testing results demonstrating anti-AChR positive or anti-MuSK positive status.
MGFA Clinical Classification documented as class II, III, or IV at initiation.
MG-ADL total score documented and ≥ 5 at initiation.
Documentation that the patient has not previously failed Uplizna for gMG.
For AChR-positive patients: documentation of failure of at least two immunosuppressive agents over ≥12 months OR failure of ≥1 immunosuppressive agent plus ≥4 courses of plasmapheresis/IVIG over ≥12 months without control.
For MuSK-positive patients: documentation of failure of at least one immunosuppressive agent over ≥12 months.
Documentation of prior rituximab failure or intolerance where required by the specific indication (NMOSD/IgG4-RD pathways) when applicable.

Documentation Required

Reauthorization Documentation Requirements

Required documentation for reauthorization (continuation of gMG therapy). Submit medical records demonstrating clinical benefit and adherence to policy conditions.

Chart notes showing prior treatment with Uplizna and dates of infusions.
Objective evidence of benefit: documentation of at least a 2-point improvement in MG-ADL score from pre-treatment baseline.
Clinical documentation of reduction in signs and symptoms of myasthenia gravis.
Documentation of maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (IST) doses prior to starting Uplizna. Note: escalation of IST, addition of rescue therapy, or increased rescue therapy while on Uplizna is considered treatment failure.
Confirmation that Uplizna is not being co-administered with a complement inhibitor, an FcRn blocker, or immune globulin for the same indication.
Confirmation that dosing and timing follow the U.S. FDA labeled schedule and that reauthorization requests do not exceed 12 months.

Step Therapy

Prior Therapy and Baseline IST Requirements

Step therapy / prior therapy and baseline IST requirements — summary of provider obligations.

For gMG (AChR-positive): document prior failure of at least two immunosuppressive agents over ≥12 months, or documented failure as defined above (including repeated courses of plasmapheresis/IVIG) when applicable.
For MuSK-positive gMG: document prior failure of at least one immunosuppressive agent over ≥12 months.
Baseline immunosuppressive therapy (IST) should be maintained, reduced, or discontinued before initiating Uplizna as specified; initiating Uplizna without a baseline IST or while requiring escalation/rescue therapy is not consistent with continuation criteria and may be considered treatment failure.
If rituximab or other specified ISTs are required by indication pathways, document history of failure, intolerance, or contraindication as applicable.

Note

Supporting Information and Policy History

Documentation and supporting information — policy history and supporting evidence have been updated.

Policy history notes the addition of ICD-10 codes G70.00 and G70.01 and updates to Background, Clinical Evidence, FDA, and References sections.
Include supporting clinical evidence and relevant test results with submissions to facilitate timely review.
This section contains summary statements; the Background/Clinical Evidence/FDA/References sections in the full policy provide supporting context.

Denial Risk

Denial Risk / Missing Explicit Denial Triggers

No explicit denial criteria beyond failure to meet the medical necessity and documentation requirements are listed in this section. However, requests that do not supply the required documentation or that do not meet the policy’s clinical criteria may be denied.

There are no standalone denial triggers listed verbatim in this section beyond noncompliance with the listed criteria.
Providers must supply complete medical records and required scores (e.g., MG-ADL, MGFA class, serology) because incomplete submissions may result in denial.
Reauthorization requests exceeding 12 months or requests where Uplizna is prescribed in combination with prohibited therapies for the same indication may be denied.

Applicable Codes and Scoring Thresholds

Applicable HCPCSHCPCS

J1823

Injection, inebilizumab-cdon, 1 mg

Applicable ICD-10 Diagnosis CodesICD-10

D89.84	IgG4-related disease
G36.0	Neuromyelitis optica (Devic)
G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Applicable ICD-10 Diagnosis Codes (added)ICD-10

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Applicable ICD-10 Diagnosis CodesICD-10

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Applicable ICD-10 Codes AddedICD-10

G70.00	Myasthenia gravis without (acute) exacerbation (as added to Applicable Codes)
G70.01	Myasthenia gravis with (acute) exacerbation (as added to Applicable Codes)

Added ICD-10 Diagnosis CodesICD-10

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

Added ICD-10 Diagnosis CodesICD-10

G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

inv-23: MG-ADL score threshold at initiation (>= 5)

MG-ADL initiation thresholdMG-ADL total score ≥ 5 at initiation of therapy

Use contextRequired for initial authorization for generalized myasthenia gravis (gMG)

Source measureMyasthenia Gravis-Activities of Daily Living scale (MG-ADL)

inv-24: MG-ADL improvement for continuation (>= 2 point improvement)

Required improvement for continuation>= 2 point improvement in MG-ADL from pre-treatment baseline for reauthorization

Required Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior authorization required — ≤12 month approvals

Prior authorization is required; initial and reauthorization approvals will be for no more than 12 months and must document that the patient meets the indication‑specific criteria.

Include supporting clinical documentation with requests.
Authorizations (initial and reauth) limited to ≤12 months.

Prior Authorization

gMG prior authorization — documentation required, initial ≤12 months

Prior authorization for gMG requires submission of specified documentation (diagnosis, serology, MGFA class, MG‑ADL, prior therapy history); initial authorization will be for up to 12 months.

Document anti‑AChR or anti‑MuSK positivity and MG‑ADL ≥5 at initiation.
Initial authorization limited to no more than 12 months.

Prior Authorization

Background and Supporting Information

Inebilizumab‑cdon is a CD19‑directed humanized afucosylated IgG1 monoclonal antibody thought to act by binding CD19 on B cells and causing antibody‑dependent cellular cytolysis. The agent is indicated for NMOSD, IgG4‑RD, and gMG in adults and has randomized trial data that inform the policy’s clinical criteria.

The policy’s supporting information — Background, Clinical Evidence, FDA, and References — was updated to incorporate current information. These updates are recorded in the revision history entries and inform the clinical rationale underlying the coverage criteria.

Policy history contains multiple entries noting that Background, Clinical Evidence, FDA, and References were revised to reflect the most current information. Those updates are summarized in the supporting information sections of the policy history.

Definitions and Clinical Measures

inv-71: NMOSD definition — demyelinating disorder features and diagnostic context

DefinitionA demyelinating disorder diagnosed by a neurologist with characteristic clinical features (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome) and positive AQP4-IgG serology

Diagnostic contextOther diagnoses (e.g., multiple sclerosis) must be ruled out before diagnosis

FDA indicationInebilizumab (Uplizna) indicated for AQP4-IgG positive NMOSD in adults

inv-72: IgG4-Related Disease (IgG4-RD) definition — fibroinflammatory multiorgan autoimmune condition

DefinitionA fibroinflammatory, often multiorgan autoimmune condition with characteristic histologic and immunologic findings (plasma cell infiltration, storiform fibrosis, venular obliteration) and disproportionate IgG4 class-switching

Diagnostic support

Policy Updates and Change Log

2026-04-01RevisionLatest

Added ICD-10 diagnosis codes G70.00 and G70.01 to Applicable Codes and clarified that reauthorization will be for no more than 12 months; restated dosing and prescriber requirements for gMG.

2026-04-01Code Addition & Reauthorization LimitLatest

ICD-10 diagnosis codes G70.00 and G70.01 were added to the policy's applicable diagnosis codes; reauthorization approvals are limited to no more than 12 months.

Policy Summary

PayerUnitedHealthcare

PolicyUplizna (inebilizumab-cdon) medical benefit drug policy — Ohio

Policy CodePolicy CSOH2026D0091.E

Change TypeCriteria revised and ICD‑10 codes added

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization with required medical records demonstrating diagnosis, serology, prior therapy history, MG-ADL baseline and ≥2‑point improvement for reauthorization.

SourceLink

On This Page

DocumentationSubmission of medical records (e.g., chart notes, laboratory tests) demonstrating the ≥2 point MG-ADL improvement

Additional reauthorization criteriaAlso requires reduction in signs/symptoms of MG and maintenance/reduction/discontinuation of baseline IST (no escalation/add-on)

inv-25: MG-ADL threshold — MG-ADL total score >= 5 at initiation

MG-ADL initiation thresholdMG-ADL total score ≥ 5 at initiation

Clinical class requirementMGFA Clinical Classification class II, III, or IV at initiation

Serology requirementPositive anti-AChR OR anti-MuSK antibody test

inv-26: MG-ADL response for continuation — improvement/maintenance of >=2 points from baseline

MG-ADL response for continuationImprovement and/or maintenance of at least a 2 point improvement in MG-ADL from pre-treatment baseline required for reauthorization

Documentation neededMedical records showing prior Uplizna treatment and objective benefit (MG-ADL scores, chart notes)

Concurrent therapy restrictionNot receiving Uplizna in combination with complement inhibitors, FcRn blockers, or immune globulin for same indication

inv-27: MG-ADL improvement — >= 2 point improvement from pre-treatment baseline (continuation requirement)

MG-ADL improvement requirement>= 2 point improvement from pre-treatment baseline for continuation (reauthorization)

Evidence standardImprovement must be documented in submitted medical records (chart notes, laboratory tests)

Treatment-failure definitionAdd-on or escalation of baseline IST or additional rescue therapy while on Uplizna is considered treatment failure

inv-28: Treatment interval — Uplizna should not be given sooner than 6 months from the start of previous treatment cycle

Minimum dosing intervalUplizna should not be given sooner than 6 months from the start of the previous treatment cycle

Initial dosing timingFirst initial dose followed by subsequent infusions no sooner than two weeks after first initial dose and every 6 months thereafter

Authorization implicationReauthorization requires documentation that dosing interval has been respected

Authorization/reauthorization — FDA dosing and neurologist requirement

Authorization and reauthorization must follow U.S. FDA labeled dosing for gMG and be prescribed by or in consultation with a neurologist.

Dosing must match the FDA label for gMG.
A neurologist must prescribe or be consulted.

Documentation Required

Submit medical records, labs, MG‑ADL, and prior therapy history

Submit medical records (chart notes, laboratory values, MG‑ADL scores) and documentation of prior therapies and treatment response or intolerance to support initial and continuation requests.

Include baseline and follow‑up MG‑ADL scores and lab data.
Provide prior therapy timelines and outcomes.

Documentation Required

Initial gMG documentation — diagnosis, antibodies, MGFA class, MG‑ADL ≥5

For initial gMG authorization, provide records confirming diagnosis, antibody positivity (anti‑AChR or anti‑MuSK), MGFA class II–IV at initiation, and MG‑ADL total score ≥5 at initiation.

Document antibody test results and clinical classification at treatment start.
Include baseline MG‑ADL score (≥5).

Documentation Required

Continuation documentation — prior Uplizna and ≥2‑point MG‑ADL improvement

For continuation/reauthorization, submit records showing prior Uplizna treatment and objective benefit defined as at least a 2‑point improvement in MG‑ADL from baseline.

Provide objective MG‑ADL change from pre‑treatment baseline (≥2 points).
Show reduction in MG signs/symptoms and IST maintenance/reduction/discontinuation.

Documentation Required

Reauthorization documentation — chart notes/labs showing ≥2‑point MG‑ADL benefit

Reauthorization requests must include chart notes and labs demonstrating improvement and/or maintenance of at least a 2‑point MG‑ADL improvement from baseline and clinical benefit.

Reauthorization will be for no more than 12 months.
Include documentation of clinical benefit and IST dosing status.

Denial Risk

Denial risk — noncompliant requests may be denied

Requests that do not meet the documented medical necessity criteria may be denied; ensure all coverage criteria are met and documented.

Confirm indication, serology, prior therapy history, and MG‑ADL thresholds are met.

Denial Risk

Documentation‑triggered denials — missing required records

Failure to submit required records (chart notes, labs) confirming diagnosis, serology, MGFA class, MG‑ADL score, prior treatment history, or treatment response may lead to denial.

Provide complete medical records to avoid documentation‑triggered denials.

Denial Risk

Combination therapy and timing — prohibited combinations and interval

Do not use Uplizna in combination with a complement inhibitor, an FcRn blocker, or immune globulin for the same indication; doing so (or giving Uplizna sooner than 6 months from prior cycle) creates a denial risk.

Examples of prohibited agents are listed in policy (eculizumab, ravulizumab, zilucoplan; nipocalimab, rozanolixizumab, efgartigimod; Hizentra, Gammagard).
Maintain at least a 6‑month interval from the start of the previous treatment cycle.

Prior Authorization

Reauthorization limited to 12 months

Reauthorization approvals will be for no more than 12 months; seeking reauthorization beyond 12 months may be noncompliant and trigger denial.

Submit reauthorization requests for periods ≤12 months.
Policy history clarifies reauthorization limit of 12 months.

Denial Risk

Reauthorization requests >12 months risk denial

Requests for reauthorization that exceed a 12‑month duration may be denied per the policy history clarifying the maximum reauthorization interval.

Ensure requested reauthorization duration does not exceed 12 months.

Note

Confirm federal/state/contract rules — they prevail if conflicting

Verify and follow applicable federal, state (OAC), or contractual benefit plan requirements before using this policy; those requirements govern in the event of conflict and failure to follow them may result in denial.

Check federal, state (OAC), or contractual rules prior to submission.
Governing requirements take precedence over this policy when conflicts exist.

Diagnosis supported by ACR/EULAR classification criteria demonstrating organ involvement and positive inclusion/negative exclusion criteria

Clinical courseVariable disease with flares, potential for irreversible organ damage; goal of therapy is to reduce inflammation and prevent flares

inv-73: Generalized Myasthenia Gravis (gMG) definition — antibody-positive adult patients meeting MGFA II–IV and MG-ADL thresholds

DefinitionAutoimmune neuromuscular disease; policy covers adult patients who are anti-AChR or anti-MuSK antibody positive meeting MGFA Clinical Classification II–IV

Coverage prerequisitesRequires positive serology (anti-AChR or anti-MuSK), MGFA II–IV, MG-ADL threshold ≥5 at initiation, and prior immunosuppressive therapy history as specified

Clinical trial supportEfficacy demonstrated in randomized placebo-controlled trials (238 patients randomized)

inv-74: MG-ADL — Myasthenia Gravis-Activities of Daily Living scale, baseline thresholds and change scores

MeasureMyasthenia Gravis-Activities of Daily Living scale (MG-ADL)

Initiation thresholdMG-ADL total score ≥ 5 at initiation of therapy

Continuation benchmark≥2 point improvement from pre-treatment baseline required for reauthorization; documentation via medical records

inv-75: QMG score — Quantitative Myasthenia Gravis score used as secondary endpoint

DefinitionQuantitative Myasthenia Gravis (QMG) score: a 13-item scale (0–39) assessing muscle weakness used as a secondary endpoint in gMG trials

ScoringEach item scored 0–3; higher total indicates more severe impairment

Trial useUsed as secondary efficacy endpoint in pivotal gMG randomized trials

inv-76: InterQual — third-party clinical criteria UnitedHealthcare may use

RoleInterQual criteria may be used by UnitedHealthcare as a third-party tool to assist in benefit administration

GuidanceInterQual is an external decision-support resource and does not replace clinical judgment or policy wording

ApplicabilityVerify plan-specific federal, state (OAC), or contractual requirements as they may govern in case of conflict

2026-04-01ICD-10 Addition & Reauthorization ClarificationLatest

Policy history notes addition of ICD-10 codes G70.00 and G70.01 and clarifies reauthorization will be for no more than 12 months.

2026-04-01Revision NoteLatest

Revision-history content updated supporting information (Background, Clinical Evidence, FDA, References); this chunk does not list prior authorization codes or requirements.

2026-04-01Supporting Information UpdateLatest

Supporting Information sections were updated; the policy-history entry does not specify prior authorization requirements.

2026-04-01Supporting Information UpdateLatest

Policy history records updates to Background, Clinical Evidence, FDA, and References and does not address prior authorization specifics in this entry.

2026-04-01ICD-10 Codes AddedLatest

Added ICD-10 diagnosis codes G70.00 (Myasthenia gravis without exacerbation) and G70.01 (Myasthenia gravis with exacerbation) to the Applicable Codes list.

2026-04-01ICD-10 AdditionLatest

Policy history documents the addition of ICD-10 diagnosis codes G70.00 and G70.01 to Applicable Codes.

2026-04-01ICD-10 Codes AddedLatest

Multiple revision-history entries record that ICD-10 codes G70.00 and G70.01 were added to the policy's Applicable Codes and supporting information was updated.