CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Uplizna (inebilizumab-cdon) (Intravenous)

Clinical coverage and prior authorization criteria for intravenous Uplizna 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)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit supporting medical records demonstrating the diagnosis and criteria (e.g., AQP4‑IgG positivity for NMOSD or diagnostic evidence for IgG4‑RD).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Adults ≥18 yrsage requirement

6 monthsinitial authorization

12 monthsrenewal authorization

J1823billing code

NMOSD (AQP4+) & IgG4‑RDcovered diagnoses

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Universal Initial Criteria

Covered when ALL of the following universal conditions are met:

Universal initial criteria: Patient is 18 years or older; Prescribed by, or in consultation with, a neurologist; Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment and confirmed negative for active HBV; Baseline serum immunoglobulin measured prior to the start of therapy; No underlying immunodeficiency disorder (e.g., primary immunodeficiency, HIV); Live or live-attenuated vaccinations will not be administered within the 4 weeks prior to the start of therapy and will not be administered concurrently while on therapy; Patient has been evaluated and screened for latent TB infection prior to initiating treatment and will receive ongoing monitoring for TB during treatment; Patient does not have an active infection, including clinically important localized infections; Will not be used in combination with other immunomodulatory biologic therapies or other therapies which can result in prolonged additive immunosuppression (excluding corticosteroids used as premedication, rescue therapy, or flare treatment).all

From Initial Criteria section

NMOSD (AQP4+) Initial Criteria

For NMOSD (AQP4‑IgG positive) — Covered when ALL of the following are met:

NMOSD diagnostic criteria: Submission of medical records by a neurologist confirming NMOSD clinical features (e.g., optic neuritis; acute myelitis; area postrema syndrome; acute brainstem syndrome; symptomatic narcolepsy or acute diencephalic syndrome with NMOSD-typical lesions; or symptomatic cerebral syndrome with NMOSD-typical brain lesions); Positive serologic test for anti‑AQP4‑IgG/NMO‑IgG antibodies; Alternative diagnoses (including 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 Score (EDSS) ≤ 7.5; Patient has experienced failure, contraindication, or intolerance to Enspryng (satralizumab) — this Enspryng requirement applies ONLY to Medicaid members.

Prescriber: Prescribed by or in consultation with a neurologist.

IgG4‑Related Disease Initial Criteria

For IgG4‑Related Disease — Covered when ALL of the following are met:

IgG4‑RD diagnostic and prior therapy criteria: Confirmed diagnosis of IgG4‑RD supported by clinical findings (physical exam, imaging, laboratory, or pathological findings); Other conditions that mimic IgG4‑RD (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 refractory to corticosteroids OR patient has a contraindication or intolerance to corticosteroid treatment; Patient is at high risk of recurrent disease flares based on history of disease in ≥2 organs/sites; At least one affected organ/site is among typical sites (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 of therapy — Covered when ALL of the following are met:

Ongoing criteria: Patient continues to meet universal and indication-specific relevant criteria (including concomitant therapy requirements and performance status); Absence of unacceptable toxicity from the drug (examples include serious or life‑threatening infusion reactions, serious infections including PML, hypogammaglobulinemia necessitating IVIG or leading to recurrent infections); Evidence of disease response compared to baseline as defined per indication: for NMOSD — stabilization or improvement in neurologic symptoms (decreased acute relapses, stable/improved EDSS), reduced hospitalizations, or reduction/discontinuation in plasma exchange treatments; for IgG4‑RD — reduction in corticosteroid requirement for flare treatment, reduction in IgG4‑RD flares, or stabilization/improvement in symptoms, exam, imaging, laboratory, or pathological findings.

Use of therapies at doses or for conditions other than those recognized as medically accepted indications is considered investigational. Investigational status is determined by reference to standard compendia or peer‑reviewed medical literature (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) showing sufficient evidence to support the use. Neighborhood Health Plan of Rhode Island does not provide coverage for drugs when used for investigational purposes.

Specifically, use of Uplizna (inebilizumab‑cdon) for conditions or dosing regimens that are not recognized as medically accepted indications per standard reference compendia is considered investigational/not covered. The policy’s dosing schedule (initial 300 mg IV on day 1 and day 15, then 300 mg IV every 6 months) defines the approved regimen; deviations from these approved doses or indications without supporting compendia/literature evidence will be treated as investigational.

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required; coverage will be reviewed prospectively and must meet the listed clinical criteria for NMOSD (AQP4+) or IgG4‑RD as outlined in the policy.

Applies to J1823 (injection, inebilizumab‑cdon, 1mg).

Step Therapy

Step therapy / prerequisite therapy

Step therapy rules differ by program: Medicare members who previously received this medication within the past 365 days are exempt from step therapy; for Medicaid members, failure, contraindication, or intolerance to Enspryng (satralizumab) is required for NMOSD.

Medicare exemption: prior receipt within 365 days removes step therapy requirement.
Medicaid requirement (NMOSD only): documented failure/contraindication/intolerance to Enspryng.

Documentation Required

Required supporting documentation

Submit supporting medical records to demonstrate the diagnosis and meeting of criteria, including chart notes, laboratory results (e.g., anti‑AQP4‑IgG), imaging, and pathology as applicable.

For NMOSD: neurologist chart notes documenting NMOSD clinical features and positive anti‑AQP4‑IgG testing; documentation ruling out multiple sclerosis.
For IgG4‑RD: exam, imaging, lab, and pathology reports confirming IgG4‑RD and documentation ruling out mimicking conditions.

Denial Risk

Use and prior authorization — nonpayment risk

Use outside the specified guidelines or without prior authorization may result in non‑payment; coverage is reviewed prospectively through the prior authorization process.

Requests must meet the policy's listed clinical criteria to be approved.

Definitions and Clinical Features

Clinical features and diagnostic support for NMOSD and IgG4‑RD

Core NMOSD clinical featuresOptic neuritis; acute myelitis; area postrema syndrome (unexplained hiccups or nausea/vomiting); acute brainstem syndrome; symptomatic narcolepsy/diencephalic syndrome with NMOSD-typical diencephalic MRI lesions; symptomatic cerebral syndrome with NMOSD-typical brain lesions

IgG4‑RD diagnostic supportConfirmed diagnosis supported by physical exam, imaging, laboratory tests, and pathology of involved organs; other mimicking conditions (malignancy, infection, other autoimmune disorders) ruled out

Typical IgG4‑RD organ sitesPancreas, bile ducts/biliary tree, orbits, lungs, kidneys, lacrimal glands, major salivary glands, retroperitoneum, aorta, pachymeninges, thyroid gland

IgG4‑Related Disease — diagnostic and disease severity features

Required diagnostic elements for IgG4‑RDConfirmed diagnosis via exam, imaging, labs, and pathology of involved organs

Rule out mimicsExclude malignancy, infection, and other autoimmune disorders prior to coverage

Corticosteroid response and refractory statusPatient must have experienced an IgG4‑RD flare requiring corticosteroids and be steroid‑refractory or have contraindication/intolerance to corticosteroids

High‑risk organ involvementHigh risk defined as disease in ≥2 organs/sites; at least one affected organ should be among typical sites (see list)

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

OpenPayer

Uplizna (inebilizumab-cdon) (Intravenous)

Coverage Criteria for Uplizna (inebilizumab-cdon)

Coding and Billing

Provider Actions and Prior Authorization

Background

Definitions and Clinical Features