CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Uplizna (inebilizumab-cdon)

This policy governs medical benefit coverage and prior authorization criteria for Uplizna (inebilizumab-cdon) for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUplizna (inebilizumab-cdon)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with supporting medical records to document diagnosis and meet indication-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mginitial and maintenance IV dose

6 monthsinitial coverage duration

12 monthscontinuation coverage duration

J1823HCPCS code

G36.0; D89.84diagnosis codes

Coverage criteria and requirements

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Coverage criteria and continuation requirements

Covered when ALL of the following universal and indication‑specific criteria are met. Requests are reviewed prospectively and prior authorization is required.

ALL of the following

ALL of the following
- Patient is 18 years or older
- Prescribed by, or in consultation with, a neurologist
ALL of the following
- Patient has been evaluated and screened for hepatitis B virus (HBV) prior to initiation and is confirmed negative for active HBV
- Patient has been evaluated and screened for latent tuberculosis (TB) prior to initiation and will receive ongoing monitoring
- Patient does not have an active infection, including clinically important localized infections
ALL of the following
- Patient does not have an underlying immunodeficiency disorder (e.g., primary immunodeficiency, HIV)
- Baseline serum immunoglobulin measured prior to start of therapy
ALL of the following
- Live or live-attenuated vaccines must not be administered within 4 weeks before initiation or concurrently during therapy
- Will not be used in combination with other immunomodulatory biologic therapies or other therapies causing prolonged additive immunosuppression (excluding corticosteroids for premedication, rescue, or flare treatment)

ALL of the following

Documentation from a neurologist confirming NMOSD diagnosis with supportive clinical features (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic diencephalic syndrome)
Positive serologic test for anti-AQP4-IgG (NMO-IgG) antibodies
Other diagnoses (e.g., multiple sclerosis) have been ruled out
History of relapses: either ≥1 relapse requiring rescue therapy within 1 year prior to screening OR ≥2 relapses requiring rescue therapy within 2 years prior to screening
Expanded Disability Status Scale (EDSS) score < 7.5
For Medicaid members ONLY: failure, contraindication, or intolerance to Enspryng (satralizumab)

ALL of the following

Confirmed diagnosis of IgG4‑related disease with supporting findings (physical exam, imaging, laboratory tests, pathology of involved organ/sites)
Patient is experiencing (or recently experienced) IgG4‑RD that required corticosteroid treatment
Other conditions that mimic IgG4‑RD have been ruled out (e.g., malignancy, infection, other autoimmune disorders)
One of
- Disease is refractory to corticosteroids
- Patient has a contraindication or intolerance to corticosteroid treatment

ALL of the following

Patient continues to meet universal and indication‑specific criteria
Absence of unacceptable toxicity (e.g., serious or life‑threatening infusion reactions, serious infections including PML, hypogammaglobulinemia necessitating IVIG or leading to recurrent infections)
Disease response (must demonstrate one or more)
- For NMOSD: evidence of response such as reduced hospitalizations, fewer acute relapses, stability or improvement in EDSS, or reduction/discontinuation of plasma exchange treatments
- For IgG4‑RD: evidence of response such as reduction in flares from baseline, reduced corticosteroid requirement for flare treatment from baseline, or stabilization/improvement in symptoms, imaging, laboratory tests, and/or pathology of involved organ/sites compared to baseline

ALL of the following

Medicare members who have previously received this medication within the past 365 days are not subject to step therapy requirements

Prior authorization and documentation

Prior Authorization

Prior Authorization & Documentation Requirements

Prior authorization is required. Coverage will be reviewed prospectively through the authorization process. Submit supporting medical records (chart notes, laboratory values, diagnostic test results, and consultant notes) to document the diagnosis, prior therapies, and rationale for Uplizna. For Medicare members, prior receipt of this medication within the past 365 days exempts the member from step therapy requirements.

Submit medical records/chart notes, laboratory and diagnostic test results to support diagnosis (eg, NMOSD, IgG4-RD)
Document prescriber specialty or consultation (prescribed by or in consultation with a neurologist when required)
Provide evidence of evaluation/screening: HBV screening (confirmed negative for active HBV), latent TB screening and ongoing monitoring, baseline serum immunoglobulin measurement, vaccination history (no live or live-attenuated vaccines within 4 weeks prior to and not concurrently with therapy)
Document absence of active infection and absence of underlying immunodeficiency (eg, HIV, primary immunodeficiency)
Document prior treatment history and failures/contraindications/intolerances to relevant therapies (eg, Enspryng requirement applies for Medicaid members)
Include EDSS score when applicable (eg, NMOSD requirement of EDSS < 7.5)
Confirm therapy will not be used in combination with other immunomodulatory biologic therapies causing prolonged additive immunosuppression (corticosteroids excluded for premedication/rescue)

Key definitions

NMOSD — definition and trial support

DefinitionNeuromyelitis optica spectrum disorder (NMOSD): autoimmune disorder characterized by relapsing optic neuritis, myelitis and other core clinical syndromes; indication for Uplizna in AQP4‑IgG positive adults

Evidence supporting useN-MOmentum trial demonstrated a 77% reduction in risk of NMOSD relapse versus placebo and 50% reduction in risk of disability worsening

Coverage noteCoverage provided under medical benefit when indication‑specific and universal criteria are met; prior authorization required

IgG4‑RD — definition and trial/criteria support

DefinitionImmunoglobulin G4‑related disease (IgG4‑RD): systemic fibroinflammatory condition affecting one or more organs; indication for Uplizna in adults

Evidence supporting usePhase 3 MITIGATE trial showed significantly longer time to first treated IgG4‑RD flare and a large reduction in risk of treated flares (hazard ratio 0.13; p<0.0001)

Key eligibility criteriaConfirmed diagnosis with supporting exam/imaging/labs/pathology; disease requiring corticosteroid treatment and refractory or intolerant to steroids; involvement of ≥2 organs or high risk of recurrent flares; at least one listed organ (e.g., pancreas, biliary tree, orbits, kidneys, lacrimal/salivary glands, retroperitoneum, aorta, pachymeninges, thyroid, lungs)

OpenPayer

Uplizna (inebilizumab-cdon)

Coverage criteria and requirements

Applicable codes and coverage durations

Prior authorization and documentation

Key definitions

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