Ustekinumab — CPB 0912 | AETNA Coverage Update

TL;DR: Aetna, a CVS Health company, modified CPB 0912 governing ustekinumab coverage policy, effective September 26, 2025. Billing teams using J3357, J3358, and the biosimilar Q-codes need to verify prior authorization requirements and medical necessity criteria before submitting claims.

Aetna's CPB 0912 Aetna system update covers nine ustekinumab products — including Stelara, seven biosimilars (Otulfi, Selarsdi, Wezlana, Imuldosa, Steqeyma, Pyzchiva, Yesintek), and Starjemza — across four approved indications. The policy applies to commercial medical plans only. If your practice bills ustekinumab billing for any of these products, the coverage criteria, prescriber restrictions, and step-therapy requirements in this updated policy directly affect your approval rates.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Ustekinumab — CPB 0912
Policy Code	CPB 0912
Change Type	Modified
Effective Date	September 26, 2025
Impact Level	High
Specialties Affected	Dermatology, Rheumatology, Gastroenterology, Hematology/Oncology
Key Action	Confirm prescriber specialty matches indication before submitting prior auth for J3357, J3358, or any biosimilar Q-code

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Aetna Ustekinumab Coverage Criteria and Medical Necessity Requirements 2025

Aetna's ustekinumab coverage policy requires prior authorization for every product in this class — no exceptions. Call (866) 752-7021 or fax your Statement of Medical Necessity form to (888) 267-3277. This is not a new requirement, but the updated CPB 0912 Aetna criteria tighten the medical necessity documentation your team needs to have ready.

Prescriber Specialty Requirements

Aetna locks each indication to a specific prescriber type. A prescription from the wrong specialty triggers a denial — even if the clinical criteria are otherwise met. Map these before you submit:

If your ordering provider doesn't match the indication, get a consultation note in the chart before prior authorization. A claim denial on prescriber mismatch is entirely avoidable.

Plaque Psoriasis (PsO) — Medical Necessity Criteria

Members must be six years of age or older. Then one of the following pathways applies:

Pathway 1 — Prior biologic or targeted synthetic use: The member previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis (e.g., Sotyktu, Otezla). This is the cleanest path. Document the prior therapy and response in your prior auth submission.

Pathway 2 — Disease severity: The member has moderate to severe plaque psoriasis and meets at least one of these criteria:

#	Covered Indication Copy
1	Crucial body areas are affected — hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas
2	At least 10% body surface area (BSA) affected
3	At least 3% BSA affected plus either an inadequate response or intolerance to phototherapy (UVB, PUVA) or conventional drugs (methotrexate, cyclosporine, acitretin), or a documented clinical reason to avoid those drugs

The 3% BSA pathway is where most denials happen. Document the step-therapy failure explicitly — dates, doses, and outcomes for methotrexate, cyclosporine, or acitretin.

Psoriatic Arthritis (PsA) — Medical Necessity Criteria

Again, members must be six or older. Two pathways:

Pathway 1 — Prior biologic or targeted synthetic use: Prior treatment with a biologic or targeted synthetic drug for active psoriatic arthritis (e.g., Rinvoq, Otezla).

Pathway 2 — Disease-based criteria:

#	Covered Indication Copy
1	Mild to moderate disease: Member failed or is intolerant of methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) — or has enthesitis.
2	Severe disease: Severity alone qualifies, with no step-therapy requirement.

Enthesitis as a standalone qualifier is notable. If your rheumatologist documents enthesitis, you don't need to show conventional drug failure. Make sure that's captured in the chart.

Crohn's Disease and Ulcerative Colitis — Medical Necessity Criteria

Both indications require moderately to severely active disease. The policy doesn't list additional step-therapy requirements beyond disease severity for CD and UC. Your gastroenterologist still needs to confirm the diagnosis and disease activity level in writing for the prior auth.

Immune Checkpoint Inhibitor-Related Toxicity

Ustekinumab covers ICI-related toxicity when prescribed by a gastroenterologist, hematologist, or oncologist. This indication reflects ustekinumab's role in managing refractory immune-mediated colitis from checkpoint inhibitors. Document the underlying cancer treatment and the toxicity diagnosis clearly — ICD-10 codes for the adverse effect and the underlying neoplasm both belong on the claim.

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Aetna Ustekinumab Exclusions and Non-Covered Indications

The policy flags several coverage restrictions worth noting.

Active or untreated latent tuberculosis: Ustekinumab is not covered for members with active TB (ICD-10 A15.0–A15.9) or untreated latent TB disease. Your TB screening documentation — CPT 86580 (intradermal skin test), 86480–86481 (gamma interferon assays) — must show negative or treated results before approval.

Concurrent biologics: Several HCPCS codes are explicitly marked "not covered with ustekinumab" in the policy:

#	Excluded Procedure Copy
1	J0717 — certolizumab pegol (Cimzia)
2	J1602 — golimumab intravenous (Simponi Aria)
3	J1745 — infliximab (Remicade) and biosimilars Q5103, Q5104, Q5121

Concurrent billing of these agents with J3357 or J3358 will generate a claim denial. If a patient is transitioning between biologics, document the discontinuation date of the prior agent.

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Coverage Indications at a Glance

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Aetna Ustekinumab Billing Guidelines and Action Items 2025

This policy is live as of September 26, 2025. If your team hasn't audited your ustekinumab claims workflow since then, start now.

Copy Action Items

If your payer mix is complex or you bill multiple biosimilars across indications, talk to your compliance officer before assuming this update is a direct one-to-one swap from a prior policy version.

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CPT, HCPCS, and ICD-10 Codes for Ustekinumab Under CPB 0912

HCPCS Codes — Covered When Selection Criteria Are Met

CPT Codes — Related Supporting Codes

HCPCS Codes — Related Conventional and Concomitant Therapy Codes

Key ICD-10-CM Codes — Exclusion Flag

Note: The full ICD-10-CM code set under CPB 0912 includes 259 codes. The A15 series is flagged as a coverage exclusion. All other covered diagnosis codes support the approved indications above. Access the complete code list at app.payerpolicy.org/p/aetna/0912.

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