Eculizumab — CPB 0807 | AETNA Coverage Update

Aetna modified CPB 0807 for eculizumab (Soliris, Bkemv, Epysqli), effective December 12, 2025. Here's what billing teams need to know before submitting claims.

Aetna, a CVS Health company, updated its eculizumab coverage policy under CPB 0807 in the Aetna system to refine medical necessity criteria across multiple indications — including atypical hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and generalized myasthenia gravis (gMG). This policy governs HCPCS codes J1299, Q5151, and Q5152 for eculizumab infusions billed under commercial plans. If your practice treats any of these conditions, the criteria thresholds and combination therapy restrictions in this update will directly affect your prior authorization approvals and reimbursement.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Eculizumab (Soliris, Bkemv, Epysqli) — CPB 0807
Policy Code	CPB 0807
Change Type	Modified
Effective Date	December 12, 2025
Impact Level	High
Specialties Affected	Hematology, Nephrology, Neurology, Ophthalmology, Rheumatology
Key Action	Verify all active eculizumab patients meet updated indication-specific criteria before December 12, 2025 and resubmit precertification where needed

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Aetna Eculizumab Coverage Criteria and Medical Necessity Requirements 2025

Aetna's eculizumab coverage policy requires precertification for all three products — eculizumab (Soliris), eculizumab-aeeb (Bkemv), and eculizumab-aagh (Epysqli) — across all applicable commercial plan designs. Call (866) 752-7021 or fax (888) 267-3277 to submit precertification requests. The site of care utilization management policy also applies, so confirm your infusion setting meets Aetna's site-of-care requirements before billing CPT 96413–96417.

This coverage policy applies to commercial plans only. For Medicare, Aetna directs providers to Medicare Part B criteria — CPB 0807 does not govern those claims.

Atypical Hemolytic Uremic Syndrome (aHUS)

Aetna considers eculizumab medically necessary for aHUS not caused by Shiga toxin when all three of the following are met:

#	Covered Indication Copy
1	ADAMTS-13 activity level above 5%
2	Absence of Shiga toxin
3	The drug will not be used in combination with another complement inhibitor (e.g., Ultomiris / ravulizumab, billed under J1303)

The ADAMTS-13 threshold matters here. If your patient's lab workup doesn't document that level explicitly, expect a denial. Get that result in the chart before you submit the precertification request.

Paroxysmal Nocturnal Hemoglobinuria (PNH)

For PNH, Aetna requires all four of the following:

That last point is worth reading twice. Voydeya combination is explicitly permitted. Every other complement inhibitor is a hard stop. If your patient is on a combination regimen, document why Voydeya is or isn't part of the picture before you seek prior authorization.

The flow cytometry requirement connects directly to your billing. CPT 88184 (first marker, technical component) and 88185 (each additional marker) will appear on claims supporting PNH diagnosis. Make sure those results are in the record and tie to the GPI-AP threshold Aetna specifies.

Generalized Myasthenia Gravis (gMG)

This is the most document-intensive indication in CPB 0807. Medical necessity requires all five of the following:

The 12-month step therapy requirement is the one that trips up prior auth submissions most often. Document the specific agents tried, the duration, and the clinical outcome for each. Azathioprine, cyclosporine, methotrexate, mycophenolate, tacrolimus, and corticosteroids all count — their HCPCS codes (J7500, J7501, J7515, J7516, J7518, J7519, J7507, J7508) may appear on the patient's medication history and support your step therapy documentation.

The Fc receptor blocker restriction is new territory for many practices. If your gMG patient received efgartigimod alfa (J9332) or rozanolixizumab (J9333), eculizumab is not approvable without stopping those agents first. Check the full medication list before submitting.

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Aetna Eculizumab Exclusions and Non-Covered Indications

Aetna considers eculizumab experimental and investigational for a long list of conditions where the evidence base hasn't cleared their threshold. The policy explicitly calls out the following as non-covered:

The real issue here is that many of these ICD-10 codes appear in the policy's code table — not because they're covered, but because they're referenced as non-covered or investigational. If your billing team sees those codes in the policy document and assumes coverage, that's a claim denial waiting to happen. Confirm the indication group before billing.

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Coverage Indications at a Glance

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Aetna Eculizumab Billing Guidelines and Action Items 2025

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Eculizumab Under CPB 0807

Eculizumab Product HCPCS Codes

Code	Type	Description Copy
J1299	HCPCS	Injection, eculizumab, 2 mg
Q5151	HCPCS	Injection, eculizumab-aagh (Epysqli), biosimilar, 2 mg
Q5152	HCPCS	Injection, eculizumab-aeeb (Bkemv), biosimilar, 2 mg

Infusion Administration CPT Codes

Diagnostic / Supporting CPT Codes

Comparator / Step Therapy HCPCS Codes (Referenced in Criteria)

Key ICD-10-CM Diagnosis Codes

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