Inebilizumab-cdon (Uplizna) — Coverage Criteria (Intravenous Infusion)
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Defines medical necessity, initial and continuation criteria, site-of-care requirements, dosing/HCPCS, and approval durations for inebilizumab-cdon (Uplizna) for NMOSD and IgG4-related disease for Blue Cross NC members.
For NMOSD indication, requirement added for at least one attack or relapse in the last 12 months prior to treatment with an immunotherapy or complement inhibitor, and requirement to have no alternative diagnoses explaining current symptoms.
Adjusted list and wording of drugs that must not be used in combination with inebilizumab for clarity.
New indication added for IgG4-related disease in adults with corresponding diagnostic and treatment-failure criteria.
Requirement that prescriber is a specialist or has consulted a specialist for all indications.
Site of Care criteria updated to add bypass conditions for severe adverse events or conditions increasing risk for severe adverse events.
Coverage and Medical Necessity Criteria
Initial Therapy - NMOSD
Covered when ALL of the following are met
see medical record documentation
medical record documentation required
optic neuritis; acute myelitis; area postrema syndrome (unexplained hiccups or nausea/vomiting); acute brainstem syndrome; symptomatic narcolepsy/diencephalic syndrome with NMOSD-typical MRI lesions; symptomatic cerebral syndrome with NMOSD-typical brain lesions
examples include eculizumab product, inebilizumab, ravulizumab, rituximab products, satralizumab
e.g., multiple sclerosis, ischemic optic neuropathy
examples: eculizumab product, ravulizumab, a rituximab product, satralizumab
satralizumab = Enspryng
e.g., hematologist, immunologist, neurologist
Duration of approval: 365 days
Initial Therapy - IgG4-RD
Covered when ALL of the following are met
medical record documentation required
examples: pancreas, major salivary glands, lacrimal glands, bile ducts, orbits, kidneys, lungs, aorta, retroperitoneum, pachymeninges, thyroid gland (Riedel's)
e.g., malignancy, infection, other autoimmune disorders
medical record documentation required
examples of inadequate response: ≥1 flare, new/worsening symptoms, no reduction in mass/organ size, no improvement in organ function, inadequate decreases in serum IgG4 from glucocorticoids alone
e.g., hematologist, immunologist, neurologist
Duration of approval: 365 days
Continuation Therapy - NMOSD
Covered when ALL of the following are met
documentation required
examples: eculizumab product, ravulizumab, a rituximab product, satralizumab
e.g., hematologist, immunologist, neurologist
Duration of approval: 365 days
Continuation Therapy - IgG4-RD
Covered when ALL of the following are met
documentation required
Duration of approval: 365 days
Site of Care Medical Necessity Criteria
Infusion site of care rules when medication administration requested in inpatient or outpatient hospital settings
Administration solely for infusion is not supported
a: history of severe adverse event (anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure); b: conditions increasing risk for severe adverse event (unstable renal function, cardiopulmonary conditions, unstable vascular access); c: history of mild adverse events not managed by pre-medication; d: inability to adhere to treatment schedule; e: new to therapy (initial or <3 months); f: re-initiation of therapy meeting defined gaps; g: change in product formulation
Patients with alternative diagnoses that explain the current disease presentation are excluded from coverage unless clinical documentation demonstrates those alternatives have been reasonably evaluated and ruled out. For the NMOSD criteria, examples of alternative diagnoses include multiple sclerosis and ischemic optic neuropathy; medical record documentation is required that no other diagnosis explains the presenting symptoms. For the IgG4-related disease (IgG4-RD) criteria, examples of alternative diagnoses include malignancy, infection, or other autoimmune disorders; documentation is required to demonstrate the diagnosis meets the 2019 ACR/EULAR classification criteria and that alternative causes have been excluded.
For initial therapy, the policy requires documented confirmation of the specific diagnosis: for NMOSD, documentation of anti‑AQP4 seropositivity and at least one core clinical characteristic (e.g., optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy/diencephalic syndrome, or symptomatic cerebral syndrome) and evidence of ≥1 attack or relapse in the prior 12 months; for IgG4‑RD, documentation that the patient fulfills the 2019 ACR/EULAR Classification Criteria with ≥20 inclusion points and has involvement of two or more organs/sites. All such documentation must explicitly address and exclude the alternative diagnoses listed above.
Inpatient administration is permitted only when the medical necessity criteria are met and the inpatient admission is not solely for the purpose of administering the infusion. Admissions that exist only to provide the infusion are not supported under this site-of-care policy. When inpatient administration is not justified for reasons beyond infusion delivery, the infusion should be provided in an appropriate outpatient setting (home-based infusion or physician office) consistent with the Site of Care Medical Necessity Criteria.
HCPCS / Billing Codes and Quantity Limits
| J1823 | inebilizumab-cdon (Uplizna) intravenous infusion |
Authorization, Documentation, and Prescriber Requirements
Prior authorization required for initial and continuation therapy
Prior authorization is required for both initial and continuation approvals of inebilizumab (J1823). Approvals are authorized for up to 365 days and are contingent on meeting the policy's listed medical necessity criteria.
- Applies to HCPCS code J1823.
- Duration of approval: 365 days.
NMOSD: trial of satralizumab and specialist prescriber required
For NMOSD initial approval, the patient must have tried and had an inadequate response to satralizumab (Enspryng) or have an intolerance, FDA‑labeled contraindication, or hypersensitivity to satralizumab. The prescriber must be a specialist in the patient's diagnosis area or have consulted with a specialist.
- Documentation of prior trial or intolerance to satralizumab is required.
- Specialist prescriber or documented specialist consultation required.
IgG4‑RD: trial of glucocorticoids and specialist prescriber required
For IgG4‑related disease initial approval, the patient must have tried and had an inadequate response to glucocorticoids (or have intolerance/FDA‑labeled contraindication/hypersensitivity to glucocorticoids). The prescriber must be a specialist in the patient's diagnosis area or have consulted with a specialist.
- Documentation of prior trial or intolerance to glucocorticoids is required.
- Specialist prescriber or documented specialist consultation required.
Required medical record documentation for diagnosis, antibody status, and ACR/EULAR fulfillment
Medical record documentation must support the diagnosis, antibody status for NMOSD (AQP4 seropositive), fulfillment of 2019 ACR/EULAR classification criteria and multi‑organ involvement for IgG4‑RD, prior therapy trials/intolerance, documentation of attacks/flares, and specialist prescriber or consultation.
- NMOSD: documentation of diagnosis, AQP4 antibody seropositivity, at least one core clinical characteristic, and ≥1 attack in prior 12 months.
- IgG4‑RD: documentation of diagnosis meeting 2019 ACR/EULAR criteria (≥20 inclusion points), two or more organs/sites involvement, and evidence of flare or recurrent disease.
- Documentation of prior therapy trials or documented intolerance/contraindication/hypersensitivity as applicable.
- Specialist prescriber or documented specialist consultation required for initial and continuation requests.
- Clinical response documentation required for continuation requests (disease stabilization or improvement for NMOSD; reduction in flares or no disease activity for IgG4‑RD).
Denial risk if required documentation or quantity limits are not provided
Requests may be denied if the medical record does not provide required documentation confirming diagnosis (NMOSD or IgG4‑RD), AQP4 antibody seropositivity for NMOSD, fulfillment of 2019 ACR/EULAR criteria and multi‑organ involvement for IgG4‑RD, required prior therapy failure/intolerance, or specialist prescriber/consultation; requests may also be denied if the requested quantity exceeds maximum units.
- Missing confirmation of AQP4 seropositivity for NMOSD can result in denial.
- Lack of documentation that glucocorticoids (IgG4‑RD) or satralizumab (NMOSD) were tried and inadequate or intolerable can lead to denial.
- Absence of specialist prescriber or consultation documentation may result in denial.
- Requests exceeding the maximum units allowed for the duration of approval may be denied.
Clinical Background
Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune demyelinating condition frequently associated with anti‑aquaporin‑4 (AQP4) antibodies and characterized by relapsing episodes affecting the optic nerves and spinal cord. Core clinical characteristics used to establish an NMOSD diagnosis include optic neuritis, acute myelitis, area postrema syndrome (unexplained hiccups or nausea/vomiting), acute brainstem syndrome, symptomatic narcolepsy or diencephalic syndromes with typical MRI findings, and symptomatic cerebral syndromes with NMOSD‑typical brain lesions. Inebilizumab (Uplizna) is used in AQP4‑seropositive adults with NMOSD to reduce relapses; the policy requires documented seropositivity, age ≥18 years, confirmation of at least one core clinical characteristic, and evidence of at least one attack or relapse in the prior 12 months before initiating therapy.
Key Definitions and Diagnostic Criteria
Policy Changes and Revision History
Added requirement for NMOSD that patient had ≥1 attack/relapse in prior 12 months and added exclusion of alternative diagnoses; clarified drugs prohibited in combination; added specialist prescriber/consultation requirement across indications; added similar 'no alternative diagnosis' requirement for IgG4-RD.
Updated Site of Care medical necessity criteria to add bypass conditions for patients with history of severe adverse events or conditions increasing risk of severe adverse events to align with Place of Service for Medical Infusions policy.
Added new indication for IgG4-related disease in adults with corresponding classification and treatment-failure criteria; set initial approval duration to 365 days and adjusted maximum units.
Added Site of Care medical necessity criteria to the policy.
Added maximum units and implemented medical policy formatting changes.
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