ModifiedUnitedHealthcarePolicy CSIND0223.06

Uplizna (inebilizumab-cdon) — Medical Benefit Drug Policy (Indiana)

Defines UnitedHealthcare Community Plan medical benefit coverage criteria for Uplizna (inebilizumab-cdon) for treatment of NMOSD and IgG4-related disease in Indiana members.

Policy Summary

PayerUnitedHealthcare Community Plan

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

Policy CodePolicy CSIND0223.06

Change TypeCriteria added and revised (IgG4-RD coverage criteriacombination-therapy clarification)

Effective DateSeptember 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documenting diagnosis confirmation (AQP4-IgG for NMOSD or ACR/EULAR for IgG4‑RD), required prior-therapy failures/intolerances, and FDA‑labeled dosing.

SourceLink

POLICY UPDATE CHANGES

Replaced criterion requiring 'the patient is not receiving any of [the listed therapies] in combination with Uplizna' with 'the patient is not receiving any of [the listed therapies] in combination with Uplizna for treatment of the same indication'.

Added coverage criteria indicating Uplizna is proven and medically necessary for treatment of IgG4-RD when specific diagnostic and therapeutic failure/intolerance criteria are met.

Added ICD-10 diagnosis code D89.84 to applicable codes.

Updated Background, Clinical Evidence, FDA, and References sections.

J1823listed drug HCPCS code

D89.84, G36.0listed diagnosis codes

12 months

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Coverage Criteria for Uplizna (inebilizumab-cdon)

Initial Therapy - NMOSD

Covered when ALL of the following are met for initial NMOSD therapy:

NMOSD Initial - diagnostic confirmation: Diagnosis of neuromyelitis optica spectrum disorder (NMOSD) by a neurologist confirming required clinical syndrome(s)

Syndromes include optic neuritis; acute myelitis; area postrema syndrome (unexplained hiccups or nausea/vomiting); acute brainstem syndrome; symptomatic narcolepsy or acute diencephalic syndrome with NMOSD-typical diencephalic MRI lesions; or symptomatic cerebral syndrome with NMOSD-typical brain lesions.

AQP4 serology and exclusion: Positive serologic test for anti-aquaporin-4 immunoglobulin G (AQP4-IgG)/NMO-IgG antibodies and multiple sclerosis or other diagnoses have been ruled out

Prior therapy or intolerance requirement: Either history of failure of rituximab therapy OR history of intolerance or contraindication to rituximab with physician attestation that the same intolerance or severe adverse event would not be expected to occur with Uplizna

Relapse history criteria: Either history of one or more relapses that required rescue therapy during the previous 12 months prior to initiating Uplizna OR history of two or more relapses that required rescue therapy during the previous 24 months prior to initiating Uplizna

Dosing and prescriber: Inebilizumab (Uplizna) is initiated according to the U.S. FDA labeled dosing for NMOSD and prescribed by, or in consultation with, a neurologist

Concomitant therapy exclusion: Patient is not receiving Uplizna in combination with multiple sclerosis disease-modifying therapies, complement inhibitors, anti-IL6 therapy, or anti-CD20 therapy for the treatment of the same indication

Examples listed in policy include dimethyl fumarate, fingolimod, ocrelizumab; eculizumab, crovalimab, ravulizumab; tocilizumab; rituximab.

Authorization duration: Initial authorization will be for no more than 12 months

Continuation Therapy - NMOSD

Covered when ALL of the following are met for continuation of NMOSD therapy:

Clinical response: Documentation of positive clinical response

Dosing: Inebilizumab (Uplizna) is dosed according to the U.S. FDA labeled dosing for NMOSD

Concomitant therapy exclusion: Patient is not receiving Uplizna in combination with multiple sclerosis disease-modifying therapies, anti-IL6 therapy, complement inhibitors, or anti-CD20 therapy for the treatment of the same indication

Examples listed in policy include dimethyl fumarate, fingolimod, ocrelizumab; tocilizumab; eculizumab, crovalimab, ravulizumab; rituximab.

Reauthorization duration: Reauthorization will be for no more than 12 months

Initial Therapy - IgG4-RD

Covered when ALL of the following are met for initial IgG4-RD therapy:

Diagnosis confirmation: Diagnosis of IgG4-related disease (IgG4-RD) with confirmation by a positive assessment using the ACR/EULAR classification criteria

Confirmation demonstrated by involvement of ≥1 organ consistent with IgG4‑RD; negative exclusion criteria; and positive inclusion criteria using clinical, serologic, radiology, and/or pathology findings.

Glucocorticoid prior failure: History of failure, contraindication, or intolerance to glucocorticoids

Rituximab prior therapy requirement: Either history of failure of rituximab therapy OR history of intolerance or contraindication to rituximab with physician attestation that the same intolerance or severe adverse event would not be expected to occur with Uplizna

Dosing and prescriber: Inebilizumab (Uplizna) is initiated according to the U.S. FDA labeled dosing for IgG4-RD and prescribed by, or in consultation with, a specialist with expertise in IgG4-RD

Continuation Therapy - IgG4-RD

Covered when ALL of the following are met for continuation of IgG4-RD therapy:

Clinical response: Documentation of positive clinical response

Dosing and prescriber: Inebilizumab (Uplizna) is dosed according to the U.S. FDA labeled dosing for IgG4-RD and prescribed by, or in consultation with, a specialist with expertise in IgG4-RD

Concomitant therapy exclusion: Patient is not receiving Uplizna in combination with a disease-modifying therapy for the treatment of IgG4-RD (e.g., rituximab)

Reauthorization duration: Reauthorization will be for no more than 12 months

Initial Therapy - IgG4-Related Disease (revised/added)

Covered when ALL of the following are met for Initial Therapy:

Initial Therapy for IgG4-RD: 1) Diagnosis of IgG4-related disease; 2) Confirmation of IgG4-RD by ACR/EULAR classification criteria demonstrated by: involvement of ≥1 organ consistent with IgG4‑RD; exclusion criteria negative; inclusion criteria positive (clinical, serologic, radiology, pathology as applicable); 3) Both: history of failure, contraindication, or intolerance to glucocorticoids AND one of: history of failure of rituximab therapy OR (history of intolerance or contraindication to rituximab AND physician attestation that the same intolerance/severe adverse event would not be expected with Uplizna); 4) Uplizna initiated per U.S. FDA labeled dosing for IgG4-RD; 5) Prescribed by or in consultation with a specialist experienced in IgG4-RD; 6) Patient is not receiving Uplizna in combination with a disease-modifying therapy for the treatment of IgG4-RD (e.g., rituximab); 7) Initial authorization limited to no more than 12 months.

Structured as AND of listed requirements

Continuation Therapy - IgG4-Related Disease (revised/added)

Covered when ALL of the following are met for Continuation of Therapy:

Continuation Therapy for IgG4-RD: 1) Documentation of positive clinical response; 2) Uplizna dosed per U.S. FDA labeled dosing for IgG4-RD; 3) Prescribed by or in consultation with a specialist experienced in IgG4-RD; 4) Patient is not receiving Uplizna in combination with a disease-modifying therapy for the treatment of IgG4-RD (e.g., rituximab); 5) Reauthorization limited to no more than 12 months.

Reauthorization conditions

For both initial and continuation therapy, patients must not be receiving Uplizna in combination with multiple sclerosis disease-modifying therapies, complement inhibitors, anti-IL6 therapy, or anti-CD20 therapy for the treatment of the same indication. Examples listed in the policy include MS disease-modifying agents (e.g., dimethyl fumarate, fingolimod, ocrelizumab), complement inhibitors (e.g., eculizumab, crovalimab, ravulizumab), anti-IL6 therapy (e.g., tocilizumab), and anti-CD20 agents (e.g., rituximab).

Coverage is explicitly clarified to prohibit use of Uplizna in combination with another disease-modifying therapy when the therapies are given for the same indication (for example, Uplizna plus rituximab for treatment of IgG4-related disease or NMOSD). The revision replaces a broader prohibition with the specific wording that combination therapy is disallowed when both agents are intended to treat the same disease.

Clinical trial evidence demonstrates a clear benefit of inebilizumab in patients with NMOSD who are AQP4-IgG–positive; the pivotal randomized trial showed a large reduction in attack risk in the AQP4-IgG–positive subgroup. By contrast, patients who were AQP4-IgG–negative showed no evidence of benefit in the trial, and the policy states that use in seronegative NMOSD is not supported by trial evidence and may be considered not medically necessary if seropositivity criteria are not met.

Requests for coverage may be denied if the patient does not meet the required diagnostic confirmation, prior-therapy or step-therapy requirements (for example, history of rituximab failure or documented rituximab intolerance where required), dosing per the U.S. FDA label, specialist prescribing or consultation, or the required documentation elements. Additionally, prescribing Uplizna in combination with prohibited therapies for the same indication or failing to provide required documentation of clinical response or diagnostic confirmation are listed triggers for denial.

Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J1823

Injection, inebilizumab-cdon, 1 mg.

Diagnosis CodesICD-10

D89.84	IgG4-related disease
G36.0	Neuromyelitis optica [Devic]

Applicable ICD-10 Diagnosis CodesICD-10

D89.84

IgG4-related disease

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation therapy with Uplizna (inebilizumab-cdon). Initial and reauthorization requests will be approved for no more than 12 months.

Prior authorization required for Uplizna (inebilizumab-cdon) for IgG4-RD per coverage criteria.
Initial and reauthorization approvals limited to ≤ 12 months.

Documentation Required

Required Clinical Documentation for IgG4-RD

For IgG4-related disease (IgG4-RD), the diagnosis must be confirmed using the ACR/EULAR classification criteria. Documentation must demonstrate organ involvement consistent with IgG4-RD, exclusion of alternative diagnoses (clinical, serologic, radiology, pathology), and positive inclusion criteria findings.

Diagnosis confirmation via ACR/EULAR classification criteria is required for initial approval.

Background and Drug Information

Inebilizumab (Uplizna) is a CD19-directed humanized afucosylated IgG1 monoclonal antibody that targets CD19 on B lymphocytes, producing antibody-dependent cellular cytolysis and resulting in B‑cell depletion. The agent is FDA‑indicated for adult patients with neuromyelitis optica spectrum disorder (NMOSD; particularly AQP4‑IgG–positive disease) and for immunoglobulin G4‑related disease (IgG4‑RD). Clinical trials reported reduced NMOSD attacks in AQP4‑IgG–positive patients and reduced IgG4‑RD flares and steroid use in treated patients.

Definitions and Diagnostic Criteria

NMOSD diagnostic features — clinical history

Optic neuritisPast medical history of optic neuritis is a qualifying clinical feature for NMOSD diagnosis.

Acute myelitisPast medical history of acute myelitis is a qualifying clinical feature for NMOSD diagnosis.

Area postrema syndromeEpisode of otherwise unexplained hiccups or nausea and vomiting consistent with area postrema syndrome.

Acute brainstem syndromePast medical history of acute brainstem syndrome is a qualifying clinical feature for NMOSD diagnosis.

Diencephalic/narcolepsy syndromeSymptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions.

Symptomatic cerebral syndromeSymptomatic cerebral syndrome with NMOSD-typical brain lesions.