Inebilizumab-cdon (Uplizna) — CPB 0975 | AETNA Coverage Update

Aetna modified CPB 0975 covering inebilizumab-cdon (Uplizna), effective December 20, 2025, expanding covered indications to include IgG4-related disease and generalized myasthenia gravis alongside the existing NMOSD indication. Here's what billing teams need to do.

Aetna, a CVS Health company, updated this Uplizna coverage policy to reflect FDA label expansions for Uplizna. The primary drug code is HCPCS J1823 (injection, inebilizumab-cdon, 1 mg), billed alongside infusion administration codes CPT 96365–96368. If your practice treats patients with NMOSD, IgG4-RD, or gMG and bills Aetna commercial plans, CPB 0975 Aetna now governs all three indications with distinct medical necessity criteria for each.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Inebilizumab-cdon (Uplizna) — CPB 0975
Policy Code	CPB 0975
Change Type	Modified
Effective Date	December 20, 2025
Impact Level	High
Specialties Affected	Neurology, Rheumatology, Infusion Centers, Specialty Pharmacy
Key Action	Update prior authorization workflows for IgG4-RD and gMG indications before billing J1823 under CPB 0975

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Aetna Inebilizumab-cdon Coverage Criteria and Medical Necessity Requirements 2025

Aetna considers Uplizna medically necessary across three distinct indications. Each has its own set of requirements. Meet all criteria for one indication — not a mix across indications.

Precertification is required for all three. Call (866) 752-7021 or fax (888) 267-3277. You can also submit a Statement of Medical Necessity form through Aetna's Specialty Pharmacy Precertification portal. Don't submit a claim for J1823 without prior authorization in place — that's a fast path to claim denial.

Aetna's site of care utilization management policy also applies here. Where the infusion happens affects reimbursement. Review the Site of Care for Specialty Drug Infusions policy separately before scheduling patients.

NMOSD Criteria

For neuromyelitis optica spectrum disorder (ICD-10 G36.0), the member must be anti-aquaporin-4 (AQP4) antibody positive. CPT codes 86051, 86052, and 86053 cover the three testing methods for AQP4 antibodies — ELISA, cell-based immunofluorescence, and flow cytometry respectively. Make sure that lab result is in the chart before submitting for precertification.

The member must also show at least one core clinical characteristic of NMOSD: optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy or acute diencephalic clinical syndrome with MRI lesions, or symptomatic cerebral syndrome with NMOSD-typical brain lesions.

Finally, the member cannot receive Uplizna at the same time as another biologic for NMOSD. Document this explicitly. Concomitant biologic use is a denial trigger.

IgG4-RD Criteria

IgG4-related disease (ICD-10 D89.84) is one of the two new indications added in this update. The Aetna inebilizumab-cdon coverage policy requires a confirmed clinical diagnosis — either clinical or radiologic involvement of a characteristic organ, or pathologic evidence from a characteristic organ.

Aetna also requires that alternative causes have been evaluated and ruled out. This is documented in Appendix B of the policy. Build a checklist of common IgG4-RD mimickers from that appendix and include it in your precertification package.

Two more criteria: the member must be experiencing an IgG4-RD flare requiring glucocorticoid initiation or continuation within the past four weeks, and must have a history of IgG4-RD affecting at least two organs or sites at any point in their disease course. That two-organ history requirement trips up a lot of cases — make sure the medical record documents prior organ involvement even if it's resolved.

Generalized Myasthenia Gravis Criteria

For gMG (ICD-10 G70.0 or G70.1), the medical necessity bar is high. The member must be AChR or MuSK antibody positive — CPT codes 86041, 86042, 86043 cover AChR binding, blocking, and modulating antibodies. CPT 86366 covers MuSK antibody testing.

MGFA clinical classification must be II through IV. The MG-ADL total score must be five or higher. And the member must have had an inadequate response or intolerable adverse event to at least two immunosuppressive therapies over the course of at least 12 months. Acceptable prior therapies include azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, and tacrolimus.

The policy source includes an additional step therapy pathway (criterion 4b) that was truncated in the available policy data. Don't assume a single-therapy failure is sufficient. Verify the complete criteria in the full CPB 0975 text before building your PA workflow for gMG.

Document each failed therapy with dates and outcomes. Aetna will look for that history. Without it, you'll get a denial on medical necessity grounds.

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Aetna Uplizna Exclusions and Non-Covered Indications

The policy does not explicitly list experimental or investigational designations for off-label uses within the summary provided. However, the policy is limited to the three approved indications above.

Any Uplizna use outside NMOSD, IgG4-RD, or gMG falls outside this coverage policy. Expect denial without a separate medical necessity argument and supporting clinical literature. Don't bill J1823 for off-label use and assume it will process — it won't.

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Coverage Indications at a Glance

Indication	Status	Relevant Codes	Notes Copy
Neuromyelitis optica spectrum disorder (NMOSD)	Covered	G36.0, J1823, 86051, 86052, 86053	AQP4 antibody positive required; no concomitant biologics; prior auth required
IgG4-related disease (IgG4-RD)	Covered (new)	D89.84, J1823	Confirmed diagnosis required; active flare on glucocorticoids; ≥2 organ history; prior auth required
Generalized myasthenia gravis (gMG)	Covered (new)	G70.0, G70.1, J1823, 86041, 86042, 86043, 86366	AChR or MuSK antibody positive; MGFA class II–IV; MG-ADL ≥5; ≥2 prior IST failures over 12 months (verify full criteria in CPB 0975); prior auth required

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Aetna Uplizna Billing Guidelines and Action Items 2025

The effective date for this modified coverage policy is December 20, 2025. If you're planning to bill for IgG4-RD or gMG patients, you need new workflows in place before submitting claims.

Copy Action Items

If your practice treats a mixed population across all three indications, talk to your compliance officer before December 20, 2025. The medical necessity criteria vary significantly by indication, and a generalized PA workflow creates real claim denial risk.

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CPT, HCPCS, and ICD-10 Codes for Inebilizumab-cdon (Uplizna) Under CPB 0975

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J1823	HCPCS	Injection, inebilizumab-cdon, 1 mg

Other CPT Codes Related to CPB 0975

These codes support the diagnostic and infusion billing for Uplizna. They are not the drug code itself, but they appear throughout the precertification and claims process.

Other HCPCS Codes Referenced in CPB 0975

These codes appear in CPB 0975. The Aetna policy does not assign a specific billing role to these codes within the context of Uplizna coverage. Include them in documentation only where clinically relevant and supported by the full policy text.

Key ICD-10-CM Diagnosis Codes

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