CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Uplizna (inebilizumab-cdon) (Intravenous) Coverage Criteria

Clinical coverage and prior authorization criteria for Uplizna (inebilizumab-cdon) infusion therapy for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUplizna (inebilizumab-cdon) (Intravenous) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date12/01/2020

Next Review DateN/A

Key ActionObtain prior authorization and submit supporting medical records to demonstrate the diagnosis and that coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mgstandard dose per infusion

6 monthsinitial coverage duration

12 monthscontinuation coverage duration

J1823billing HCPCS code

G36.0; D89.84covered diagnosis codes

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Initial universal safety and eligibility

Covered when ALL of the following are met

Universal criteria: Patient is >= 18 years; prescribed by, or in consultation with, a neurologist; screened and confirmed negative for active hepatitis B virus (HBV) prior to initiating treatment; baseline serum immunoglobulin measured prior to start of therapy; no underlying immunodeficiency disorder (e.g., primary immunodeficiency, HIV); no live or live-attenuated vaccines within 4 weeks prior to start and none concurrently while on therapy; evaluated and screened for latent tuberculosis infection prior to initiating treatment with ongoing TB monitoring during therapy; no active infection including clinically important localized infections; will not be used in combination with other immunomodulatory biologic therapies or other therapies causing prolonged additive immunosuppression (excluding corticosteroids used as premedication, rescue therapy, or flare treatment)

Initial therapy — NMOSD

For NMOSD — Covered when ALL of the following are met

NMOSD diagnosis and disease activity: Submission of medical records by a neurologist confirming NMOSD with past medical history of optic neuritis OR acute myelitis OR area postrema syndrome OR acute brainstem syndrome OR symptomatic narcolepsy/acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions OR symptomatic cerebral syndrome with NMOSD-typical brain lesions; positive serologic test for anti-aquaporin-4 immunoglobulin G (AQP4-IgG)/NMO-IgG; alternative diagnoses (e.g., multiple sclerosis) have been ruled out; history of ≥1 relapse requiring rescue therapy in the prior year OR ≥2 relapses requiring rescue therapy in the prior 2 years; Expanded Disability Status Scale (EDSS) ≤ 7.5; AND for Medicaid members only: failure, contraindication, or intolerance to Enspryng (satralizumab)

Initial therapy — IgG4-RD

For IgG4-RD — Covered when ALL of the following are met

IgG4-RD diagnosis and severity: Confirmed diagnosis of IgG4-RD (e.g., physical exam, imaging, laboratory, or pathology findings); other mimicking conditions (e.g., malignancy, infection, other autoimmune disorders) have been ruled out; patient is experiencing or recently experienced an IgG4-RD flare that required corticosteroid treatment; disease is corticosteroid-refractory OR patient has a contraindication/intolerance to corticosteroids; patient is at high risk of recurrent flares based on history of disease in ≥2 organs/sites; at least one affected organ/site includes pancreas, bile ducts/biliary tree, orbits, lungs, kidneys, lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges, and/or thyroid gland

Continuation of therapy

For continuation — Covered when ALL of the following are met

General continuation: Patient continues to meet universal and indication-specific criteria (including concomitant therapy requirements and performance status) and has absence of unacceptable toxicity from the drug (e.g., serious or life-threatening infusion reactions, serious infections including PML, hypogammaglobulinemia necessitating IVIG or leading to recurrent infections)

NMOSD response criteria: Stabilization or improvement as evidenced by decrease in acute relapses, stability or improvement in EDSS, reduced hospitalizations, or reduction/discontinuation in plasma exchange treatments

IgG4-RD response criteria: Reduction in corticosteroid requirement for IgG4-RD flare treatment from baseline, reduction in IgG4-RD flares from baseline, or stabilization/improvement in symptoms, physical exam findings, imaging results, laboratory tests, and/or pathological findings in involved organs compared to baseline

Therapies used at doses or for conditions other than FDA-recognized or otherwise medically accepted indications are considered investigational and are not covered. The policy follows standard reference compendia and peer-reviewed literature to determine accepted indications; if a use is not recognized in these sources it will be treated as investigational and excluded from coverage.

Use of Uplizna that does not meet the policy criteria, or that is for an investigational indication, is not covered and may result in non-payment. Uplizna is covered under the Medical Benefit only when used within the guidelines set forth in this policy; uses outside these guidelines require an exception for consideration.

Prior Authorization, Documentation, and Step Therapy

Note

Coverage and prior auth overview

Uplizna (inebilizumab-cdon) is covered under the Medical Benefit when used within the policy guidelines. Use outside of these guidelines may result in non-payment unless approved under an exception process.

Prior Authorization

Prior Authorization Required

Coverage of Uplizna will be reviewed prospectively via the prior authorization process based on the criteria in this policy. Prior authorization is required before administration to determine medical necessity; failure to obtain prior authorization may result in denial of payment.

Prospective review via prior authorization

Step Therapy

Step therapy / prerequisite therapy

Step therapy requirements do not apply to Medicare members who have received Uplizna within the past 365 days. For other members, applicable step therapy or prerequisite therapy rules in the benefit plan and state Medicaid requirements (when applicable) apply. Note: the requirement to try and fail alternative therapy (e.g., Enspryng) only applies to Medicaid members where specified.

Medicare exemption: prior receipt within 365 days exempts from step therapy
Medicaid: additional step/agent-specific requirements may apply (e.g., failure/intolerance to Enspryng for NMOSD)

Documentation Required

Required supporting documentation

Submit supporting documentation with the prior authorization request to demonstrate the diagnosis and that all clinical criteria are met. For NMOSD, provide neurologist notes, relevant imaging, laboratory results including positive AQP4-IgG serology, relapse history, EDSS score, and documentation of failure/contraindication/intolerance to required agents when applicable. For IgG4-RD, submit pathology, imaging, labs, organ involvement documentation, prior corticosteroid response and rationale for steroid-refractory or intolerant status. Include HBV and TB screening results, baseline immunoglobulin levels, and documentation of absence of active infection or immunodeficiency as indicated by the criteria.

NMOSD: neurologist documentation, positive AQP4-IgG, relapse history, EDSS score, exclusion of MS and other diagnoses
IgG4-RD: pathology/imaging/labs, documentation of organ involvement and steroid-refractory or intolerant status
Baseline testing: HBV screening (negative for active HBV), baseline serum immunoglobulin, latent TB screening and ongoing monitoring, documentation of no active infection or immunodeficiency

Clinical Definitions

Neuromyelitis Optica Spectrum Disorder (NMOSD) — core clinical features and diagnostic notes

DefinitionA demyelinating disease characterized by core clinical features such as optic neuritis, acute myelitis, area postrema syndrome (unexplained hiccups or nausea/vomiting), acute brainstem syndrome, symptomatic narcolepsy or diencephalic syndrome with NMOSD-typical lesions, and symptomatic cerebral syndrome with NMOSD-typical brain lesions.

Diagnostic requirementDiagnosis typically relies on clinical presentation with one or more core clinical features and supportive NMOSD-typical MRI findings.

Serologic testingAnti‑aquaporin‑4 (AQP4) antibody (AQP4‑IgG) positivity supports the diagnosis and is required for Uplizna indication in NMOSD.

Clinical course relevant to coverageClinical history of relapses (e.g., ≥1 relapse requiring rescue therapy in prior year or ≥2 relapses in prior 2 years) is used to establish treatment eligibility under the policy.

Immunoglobulin G4-Related Disease (IgG4-RD) — disease description and commonly affected organs

DefinitionA fibroinflammatory condition affecting one or more organs that may require corticosteroid treatment and can be refractory or relapsing; commonly involved sites include pancreas, bile ducts, orbits, lungs, kidneys, lacrimal and major salivary glands, retroperitoneum, aorta, pachymeninges, and thyroid.

Diagnostic criteriaConfirmed diagnosis based on combination of physical exam, imaging, laboratory tests, and pathological findings in involved organs; other mimicking conditions (malignancy, infection, other autoimmune disorders) must be ruled out.

Treatment context for coveragePolicy supports use when patient has an IgG4‑RD flare that required corticosteroid treatment and disease is corticosteroid‑refractory or patient has contraindication/intolerance to corticosteroids.

Risk of recurrent diseaseHigh risk for recurrent flares (eg, history of disease in ≥2 organs/sites) is a coverage consideration under the policy.

OpenPayer

Uplizna (inebilizumab-cdon) (Intravenous) Coverage Criteria

Coverage and Medical Necessity Criteria

Billing and Diagnosis Codes

Prior Authorization, Documentation, and Step Therapy

Drug and Clinical Background

Clinical Definitions

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