ModifiedAmeriHealth Caritas VIP CarePolicy MA08.126c

Inebilizumab-cdon (Uplizna) Coverage Policy

Customize your policy alerts

Sign up for amerihealth_caritas_vip_care Policy MA08.126c alerts

Get alerted when Policy MA08.126c changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs medical-benefit coverage and prior authorization requirements for intravenous inebilizumab-cdon (Uplizna) in adult Medicare Advantage members with NMOSD, IgG4-related disease, or generalized myasthenia gravis when applicable medical-necessity and dosing criteria are met.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyInebilizumab-cdon (Uplizna) Coverage Policy

Policy CodePolicy MA08.126c

Change TypeModified

Effective DateJun 18, 2026

Next Review DateNot specified

Key ActionSubmit a new approval when the member's dose, frequency, or regimen changes.

SourceLink

POLICY UPDATE CHANGES

The policy was updated with new medical necessity criteria reflecting FDA labeling for adult individuals with IgG4-related disease and myasthenia gravis.

3Covered adult indications

300 mg IVInitial and subsequent dose

2 weeksInitial infusion interval

Every 6 months

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmeriHealth Caritas VIP CarePolicy MA08.126c

Inebilizumab-cdon (Uplizna) Coverage Policy

Customize your policy alerts

Sign up for amerihealth_caritas_vip_care Policy MA08.126c alerts

Get alerted when Policy MA08.126c changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyInebilizumab-cdon (Uplizna) Coverage Policy

Policy CodePolicy MA08.126c

Change TypeModified

Effective DateJun 18, 2026

Next Review DateNot specified

Key ActionSubmit a new approval when the member's dose, frequency, or regimen changes.

SourceLink

POLICY UPDATE CHANGES

The policy was updated with new medical necessity criteria reflecting FDA labeling for adult individuals with IgG4-related disease and myasthenia gravis.

3Covered adult indications

300 mg IVInitial and subsequent dose

2 weeksInitial infusion interval

Every 6 months

Subsequent infusion frequency

Not coveredAll other uses

Covered Indications and General Criteria

Neuromyelitis optica spectrum disorder (NMOSD)

Covered for adult individuals when all of the following criteria are met, including dosing and frequency:

NMOSD coverage criteria

ALL of the following
- The individual has a diagnosis of neuromyelitis optica spectrum disorder (NMOSD).
- The individual is anti-aquaporin-4 (AQP4) antibody seropositive.
- Relapse history
  - The individual has a history of one or more relapses requiring rescue therapy within the past year.>=1 qualifying relapse within 1 year
  - The individual has a history of two or more relapses requiring rescue therapy within the past 2 years.>=2 qualifying relapses within 2 years
Required dosing and frequency
- Initial dose: administer a 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.300 mg IV on day 1 and 300 mg IV 2 weeks later
- Subsequent doses: beginning 6 months from the first infusion, administer a single 300 mg intravenous infusion every 6 months.300 mg IV every 6 months

Immunoglobulin G4-related disease (IgG4-RD)

Covered for adult individuals when all of the following criteria are met, including dosing and frequency:

IgG4-RD coverage criteria

ALL of the following
- The individual has a diagnosis of immunoglobulin G4-related disease (IgG4-RD).
- The individual has newly diagnosed or recurrent IgG4-RD that requires glucocorticoid treatment.
- There is a confirmed history of involvement of at least two organs or sites at any time during the course of the disease.>=2 organs/sites involved
Required dosing and frequency

Generalized myasthenia gravis (gMG)

Covered for adult individuals when all of the following criteria are met, including dosing and frequency:

gMG coverage criteria

ALL of the following
- The individual has a diagnosis of generalized myasthenia gravis (gMG).
- The individual has autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK).
- The individual has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II, III, or IV.MGFA Class II-IV
- MG-ADL score

Uses of inebilizumab-cdon outside the covered indications are considered experimental/investigational and are not covered. Coverage may be considered only when the indication qualifies as an accepted off-label use under the Company's policy for off-label coverage of prescription drugs and biologics.

Pediatric use is not established because the safety and effectiveness of inebilizumab-cdon (Uplizna) have not been established in the pediatric population, including pediatric NMOSD. The covered indications in this policy are limited to adult individuals.

Initial Therapy Dosing

Initial therapy dosing

For each covered indication, the initial regimen is:

Initial Uplizna regimen

Administer 300 mg by intravenous infusion.300 mg IV on day 1
Administer a second 300 mg intravenous infusion 2 weeks later.300 mg IV 2 weeks after the first infusion

Subsequent Therapy Dosing

Subsequent dosing

Subsequent dosing is covered when the member continues to meet the applicable indication criteria and receives the specified regimen:

Subsequent Uplizna dosing

Beginning 6 months from the first infusion, administer a single 300 mg intravenous infusion every 6 months.300 mg IV every 6 months
Any change in dose, frequency, or regimen requires submission for a new approval.

Drug Quantity and Frequency

Inebilizumab-cdon (Uplizna) dosing

Dose per infusion300 mg by intravenous infusion

Initial scheduleTwo initial infusions: the first infusion followed 2 weeks later by a second 300-mg infusion

Subsequent scheduleOne 300-mg intravenous infusion every 6 months, starting 6 months from the first infusion

Billing Codes and Clinical Thresholds

CPT Procedure CodesCPT

N/A

ICD-10 Procedure CodesICD-10

N/A

HCPCS Level II CodesHCPCS

J1823

Injection, inebilizumab-cdon, 1 mg

Revenue CodesRevenue

N/A

NMOSD relapse history

Within the past yearOne or more relapses requiring rescue therapy within the year

Within the past 2 yearsTwo or more relapses requiring rescue therapy in the past 2 years

Required featureEach qualifying relapse must have required rescue therapy

MG-ADL qualifying score

MG-ADL score 6–10More than 50% of the score must be attributed to non-ocular items

MG-ADL score ≥11A score of 11 or greater qualifies

Authorization and Documentation Requirements

Prior Authorization

Meet Indication and Dosing Criteria

Meet indication and dosing criteria before requesting authorization. Prior authorization must establish that the member is an adult, has a covered indication, meets all disease-specific criteria, and will receive inebilizumab-cdon (Uplizna) at the policy-specified dose and frequency. When criteria are met, the drug is covered under the medical benefits of the applicable Medicare Advantage product.

NMOSD: Diagnosis of neuromyelitis optica spectrum disorder; anti-aquaporin-4 (AQP4) antibody seropositive; and either one or more relapses requiring rescue therapy within the past year or two or more such relapses within the past 2 years.
IgG4-RD: Diagnosis of immunoglobulin G4-related disease; newly diagnosed or recurrent disease requiring glucocorticoid treatment; and a confirmed history of involvement of at least two organs or sites.
gMG: Diagnosis of generalized myasthenia gravis; AChR or MuSK autoantibodies; MGFA Clinical Classification Class II-IV; MG-ADL score 6-10 with more than 50% attributed to non-ocular items or MG-ADL score at least 11; QMG score at least 11; and a stable dose of corticosteroid, specified non-steroidal immunosuppressive therapy, or both.
Policy dosing for each covered indication: Initial 300-mg intravenous infusion followed 2 weeks later by a second 300-mg intravenous infusion; beginning 6 months from the first infusion, a single 300-mg intravenous infusion every 6 months.

Clinical Background

Inebilizumab-cdon (Uplizna) is a CD19-directed monoclonal antibody and B-cell-depleting biologic that depletes B cells producing autoantibodies against aquaporin-4. The policy addresses adult neuromyelitis optica spectrum disorder (NMOSD), immunoglobulin G4-related disease (IgG4-RD), and generalized myasthenia gravis (gMG) when the specified clinical, serologic, disease-history, background-treatment, and dosing criteria are met.

NMOSD is a relapsing autoimmune inflammatory disorder that commonly affects the optic nerves and spinal cord. Coverage decisions for inebilizumab-cdon are based on the applicable disease-specific requirements rather than diagnosis alone.

Clinical Definitions and Assessment Scales

MGFA Clinical Classification Classes II–IV

Class IIMild weakness affecting muscles other than the ocular muscles; ocular weakness of any severity may also occur

Class IIIModerate weakness affecting muscles other than the ocular muscles; ocular weakness of any severity may also occur

Class IVSevere weakness affecting muscles other than the ocular muscles; ocular weakness of any severity may also occur

Subclasses A and BSubclass A is predominantly limb or axial involvement; subclass B is predominantly oropharyngeal or respiratory involvement

Quantitative Myasthenia Gravis (QMG) score

Total score rangeThe QMG total score ranges from 0 to 39

Administration Setting

Billing Rule

Use the appropriate infusion setting

When the drug can be administered in various settings, reimbursement may be limited to the most appropriate and cost-effective setting consistent with the member’s medical needs, condition, monitoring, and coincident services.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyInebilizumab-cdon (Uplizna) Coverage Policy

Policy CodePolicy MA08.126c

Change TypeModified

Effective DateJun 18, 2026

Next Review DateNot specified

Key ActionSubmit a new approval when the member's dose, frequency, or regimen changes.

SourceLink

On This Page

Initial dose: administer a 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.300 mg IV on day 1 and 300 mg IV 2 weeks later

Subsequent doses: beginning 6 months from the first infusion, administer a single 300 mg intravenous infusion every 6 months.300 mg IV every 6 months

The MG-ADL score is between 6 and 10, with more than 50% of the score attributed to non-ocular items.

MG-ADL 6-10 and >50% non-ocular contribution

The MG-ADL score is 11 or greater.MG-ADL >=11

The Quantitative Myasthenia Gravis (QMG) score is 11 or greater.QMG >=11

The individual is receiving a stable dose of a corticosteroid, a specified non-steroidal immunosuppressive therapy, or a combination of both.

Required dosing and frequency

Initial dose: administer a 300 mg intravenous infusion followed 2 weeks later by a second 300 mg intravenous infusion.300 mg IV on day 1 and 300 mg IV 2 weeks later
Subsequent doses: beginning 6 months from the first infusion, administer a single 300 mg intravenous infusion every 6 months.300 mg IV every 6 months

Assessment contextThe MG-ADL evaluates ocular and non-ocular activities and symptoms

QMG qualifying score

Qualifying thresholdQMG score ≥11

Total score rangeThe QMG total score ranges from 0 to 39

InterpretationHigher scores indicate worse disease severity

Prior Authorization

New Approval for Regimen Changes

A dose, frequency, or regimen change requires a new approval. Submit the revised treatment plan to the Company as part of utilization management before billing the changed regimen.

Changes may include adjustments related to member weight, incomplete therapeutic response, or other clinical factors.

Documentation Required

Maintain Medical Necessity Records

Maintain medical-record and facility documentation demonstrating the medical necessity of the care provided. The Company may review or audit services regardless of provider participation status.

Documentation may include professional provider office records, hospital records, nursing home records, home health agency records, therapy records, and test reports.
All requested documentation must be available to the Company.

Documentation Required

Support Dosing Exceptions

If requesting an amount of inebilizumab-cdon (Uplizna) outside the policy's dosing and frequency requirements, submit supporting published peer-reviewed literature. The request may also be evaluated using Company-recognized pharmacology compendia and applicable off-label coverage policy requirements.

The provider is responsible for supplying the published peer-reviewed clinical support with the dosing exception request.

Billing Rule

Submit Changed Regimens for New Approval

Submit any dose, frequency, or regimen change for a new approval before the changed treatment is administered or billed. Accurate member information is required for approval of the requested dose and frequency.

The Company reserves the right to conduct postpayment review and audit procedures for claims submitted for inebilizumab-cdon (Uplizna).

Unsupported block type: billing_rule

Unsupported block type: denial_risk

Severity interpretationHigher scores indicate worse disease severity

Score componentsScores may be categorized into ocular components ranging from 0–23 and generalized components ranging from 0–16

Myasthenia Gravis Activities of Daily Living (MG-ADL)

Functional assessmentMG-ADL assesses activities and symptoms affected by myasthenia gravis

DomainsDomains include talking, chewing, swallowing, breathing, brushing, arising, double vision, and eyelid droop

Severity levelsItems range from no impairment or normal function to severe impairment, including need for assistance, ventilator support, or inability to perform a function

Neuromyelitis optica spectrum disorder (NMOSD)

ConditionA relapsing, autoimmune, inflammatory disorder

Typical areas affectedThe optic nerves and spinal cord are typically affected

AQP4 associationAt least two thirds of cases are associated with aquaporin-4 antibodies and complement-mediated damage to the central nervous system

Immunoglobulin G4-related disease (IgG4-RD)

ConditionA rare, chronic autoimmune condition in which the immune system attacks healthy organs

Disease featuresInflammation, fibrosis, and often tumor-like masses that can mimic cancer

Organs that may be affectedThe pancreas, salivary glands, kidneys, and aorta may be affected

Treatment responseThe condition typically responds well to steroid treatment

Generalized myasthenia gravis (gMG)

ConditionA chronic autoimmune neuromuscular disease causing skeletal-muscle weakness

Activity and rest patternWeakness usually worsens after periods of activity and improves after periods of rest

Muscles commonly involvedEye and eyelid, facial, chewing, talking, and swallowing muscles are often involved; breathing, neck, and limb muscles may also be affected

Underlying mechanismThe weakness results from an antibody-mediated, T-cell-dependent immunological attack directed at proteins in the postsynaptic membrane of the neuromuscular junction