Guselkumab (Tremfya) — CPB 1011 | AETNA Coverage Update

Aetna modified CPB 1011 for guselkumab (Tremfya), effective January 14, 2026. Here's what billing teams need to know before submitting claims.

Aetna, a CVS Health company, updated its guselkumab (Tremfya) coverage policy under CPB 1011 Aetna system, adding Crohn's disease and ulcerative colitis as covered indications alongside existing psoriasis and psoriatic arthritis criteria. The primary billing code for this drug is HCPCS J1628 (injection, guselkumab, 1 mg). If your practice bills J1628 for any of these four indications, this policy change directly affects your prior authorization process, your step therapy documentation, and your exposure to claim denial.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Guselkumab (Tremfya) — CPB 1011
Policy Code	CPB 1011
Change Type	Modified
Effective Date	January 14, 2026
Impact Level	High
Specialties Affected	Dermatology, Rheumatology, Gastroenterology
Key Action	Update prior auth workflows for UC and Crohn's disease; confirm prescriber specialty meets Aetna's specialty-matching requirements before January 14, 2026

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Aetna Guselkumab Coverage Criteria and Medical Necessity Requirements 2026

The real issue with CPB 1011 is that it ties medical necessity to a layered set of conditions. Each indication has its own step therapy path, its own weight and age threshold, and its own prescriber specialty requirement. Miss any one of those layers, and you get a denial.

Start here: every approval under this Aetna guselkumab coverage policy requires the prescribing physician to match the indication. Dermatologists cover plaque psoriasis (PsO). Rheumatologists or dermatologists cover psoriatic arthritis (PsA). Gastroenterologists cover ulcerative colitis (UC) and Crohn's disease (CD). If your referring provider doesn't match, submit a consultation note from the right specialist before billing J1628.

Prior authorization is required for the IV formulation. Call (866) 752-7021 or fax (888) 267-3277 to precertify intravenous guselkumab (Tremfya IV). The subcutaneous form flows through specialty pharmacy channels. Know which formulation your provider ordered before you route the prior auth request — the two have different channels.

Plaque Psoriasis (PsO) — Initial Approval Criteria

Members must be at least six years old and weigh at least 40 kg. After that, Aetna splits into two pathways:

Pathway 1: The member has already tried a biologic or targeted synthetic drug indicated for moderate-to-severe plaque psoriasis (e.g., Sotyktu, Otezla). Prior biologic use is enough — no additional BSA or location criteria needed.

Pathway 2: No prior biologic use. The member must meet at least one of these:

#	Covered Indication Copy
1	Crucial body areas affected (hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas)
2	At least 10% of body surface area (BSA) affected
3	At least 3% BSA affected, plus either an inadequate response or intolerance to phototherapy (CPT 96910, 96912, or 96913 — UVB or PUVA) or to methotrexate (J8610, J8611, J8612, J9250, J9255, J9260), cyclosporine (J7502, J7515, J7516), or acitretin — or a documented clinical reason to avoid all three

Document BSA percentages explicitly in the medical record. Vague language like "extensive disease" will not clear prior auth. Aetna wants a number.

Psoriatic Arthritis (PsA) — Initial Approval Criteria

Same age and weight floor — six years old, 40 kg minimum.

Pathway 1: Prior biologic or targeted synthetic drug use (e.g., Rinvoq, Otezla) for active PsA. Prior use clears the criteria.

Pathway 2: No prior biologic. Aetna then splits by disease severity:

#	Covered Indication Copy
1	Mild to moderate disease: Member needs an inadequate response to methotrexate, leflunomide, or another conventional synthetic drug like sulfasalazine — or an intolerance/contraindication — or documented enthesitis
2	Severe disease: Severity alone qualifies. Get the severity documented in the chart with specific clinical markers

Ulcerative Colitis and Crohn's Disease — Initial Approval Criteria

These are the new indications added in the January 14, 2026 update, and the criteria here are notably cleaner than PsO and PsA. Aetna covers guselkumab for moderately to severely active UC and for moderately to severely active CD. The policy does not layer in the same step therapy requirements seen in the PsO and PsA pathways — at least not at the initial approval level.

That simplicity is worth noting. If you're a GI practice that has been waiting to use Tremfya for IBD patients, the prior authorization path is more direct here than in the dermatology and rheumatology criteria. The prescriber must be a gastroenterologist, and the chart must support moderate-to-severe disease classification.

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Aetna Guselkumab Exclusions and Non-Covered Indications

Aetna is explicit: all indications not listed above are considered experimental, investigational, or unproven. That's not a soft guideline — it means claims submitted with off-label diagnoses will be denied on medical necessity grounds.

If a provider orders guselkumab for a condition outside PsO, PsA, UC, or CD, you will not get reimbursement under this coverage policy. Don't submit and hope. Check the indication first.

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Coverage Indications at a Glance

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Aetna Guselkumab Billing Guidelines and Action Items 2026

Here's what your billing team and prior auth staff need to do right now.

Copy Action Items

If you're a multispecialty group adding GI to your Tremfya billing for the first time, loop in your compliance officer before the effective date. The GI pathway is new under this policy, and your internal workflows probably aren't set up for it yet.

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CPT, HCPCS, and ICD-10 Codes for Guselkumab Under CPB 1011

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J1628	HCPCS	Injection, guselkumab, 1 mg

Key ICD-10-CM Diagnosis Codes

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