Aetna modified CPB 1012 for tildrakizumab-asmn (Ilumya), effective January 5, 2026. Here's what changes for billing teams.
Aetna, a CVS Health company, updated its coverage policy for tildrakizumab-asmn (Ilumya) under CPB 1012 Aetna system. The policy governs medical necessity criteria for Ilumya in plaque psoriasis, billed primarily under HCPCS J3245 (injection, tildrakizumab, 1 mg). If your practice or health system handles dermatology billing for commercial Aetna members, this policy affects how you document and submit claims for one of the more commonly requested IL-23 inhibitors.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Tildrakizumab-asmn (Ilumya) — CPB 1012 |
| Policy Code | CPB 1012 |
| Change Type | Modified |
| Effective Date | January 5, 2026 |
| Impact Level | High |
| Specialties Affected | Dermatology (prescribing required); billing teams handling specialty pharmacy and infusion claims |
| Key Action | Confirm prior authorization documentation meets the updated step-therapy and BSA criteria before submitting J3245 claims |
Aetna Tildrakizumab Coverage Criteria and Medical Necessity Requirements 2026
The Aetna tildrakizumab-asmn coverage policy requires precertification for all participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate. You can also submit a Statement of Medical Necessity (SMN) form through Aetna's Specialty Pharmacy Precertification portal.
Prescribing must come from a dermatologist — or the prescribing physician must document a consultation with one. This is a hard requirement. If your practice is multi-specialty or you're billing on behalf of a primary care provider who co-manages psoriasis, flag this now. A claim submitted without dermatology involvement will not survive a prior authorization review.
Initial Approval: Two Pathways
Aetna lays out two routes to medical necessity approval for Ilumya.
Pathway 1 — Prior Biologic or Targeted Synthetic Use: The member has previously used a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis. Sotyktu (deucravacitinib) and Otezla (apremilast) are explicitly named as examples. There is no specific HCPCS code for Sotyktu or Otezla in the covered group — Aetna uses the prior-use history as documented evidence, not a code-based trigger.
Pathway 2 — Disease Severity Criteria: The member has not used a prior biologic or targeted synthetic, but meets severity thresholds. Aetna will consider Ilumya medically necessary when any of the following are true:
| # | Covered Indication |
|---|---|
| 1 | Crucial body areas are affected — hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas |
| 2 | At least 10% of body surface area (BSA) is affected |
| 3 | At least 3% BSA is affected AND the member has had an inadequate response or intolerance to phototherapy (UVB or PUVA, billed under CPT 96910, 96912, or 96913) OR pharmacologic treatment with methotrexate (J8610, J8611, J8612, J9250, J9255, J9260), cyclosporine (J7502, J7515, J7516), or acitretin |
That 3% BSA pathway also accepts documented clinical reasons to avoid methotrexate, cyclosporine, and acitretin — a Appendix-referenced list in the full policy. If you're documenting this route, you need that Appendix language reflected in the clinical notes, not just a generic "contraindicated" notation.
Continuation of Therapy
Aetna's reimbursement for ongoing Ilumya therapy requires demonstrated response. The member must show either a reduction in BSA affected from baseline or improvement in signs and symptoms — itching, redness, flaking, scaling, burning, cracking, or pain. This applies to new members who are already on Ilumya when they join an Aetna plan, not just members who started on the drug under Aetna coverage.
Document both baseline and current status at every renewal. If your clinical notes at reauthorization don't reference baseline BSA or symptom severity, you're setting up a claim denial.
Tuberculosis Screening Requirement
Before initiating Ilumya, every member new to biologic or targeted synthetic therapy must have a documented negative TB test within the past 12 months. Aetna accepts a tuberculosis skin test (TST, billed as CPT 86580) or an interferon-gamma release assay (IGRA, billed as CPT 86480 or 86481).
If the TB screen is positive, the member needs further workup — including a chest X-ray (CPT 71045, 71046, 71047, or 71048) — to rule out active disease. Active TB is a hard stop. Latent TB requires treatment initiation before Ilumya can start.
Build TB screening confirmation into your prior auth checklist. Missing this documentation is an easy, avoidable denial.
Combination Biologic Restriction
Members cannot use Ilumya at the same time as any other biologic or targeted synthetic drug for the same indication. If your patient is on another IL-17, IL-23, or TNF inhibitor for psoriasis, concurrent use is not covered. Document single-agent status clearly in prior auth submissions.
Aetna Tildrakizumab Exclusions and Non-Covered Indications
Aetna considers all indications outside of moderate to severe plaque psoriasis to be experimental, investigational, or unproven under CPB 1012. The policy does not enumerate specific excluded conditions — any use outside the covered plaque psoriasis criteria will not meet medical necessity under this policy. If you're seeing prescribers request Ilumya for anything outside plaque psoriasis, the auth will not go through — and a claim submitted without auth will deny on medical necessity grounds.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Moderate to severe plaque psoriasis — prior biologic or targeted synthetic use | Covered | J3245, L40.0–L40.9 | Must be adult member; prior use of biologic (e.g., Sotyktu, Otezla) documented |
| Moderate to severe plaque psoriasis — crucial body areas affected | Covered | J3245, L40.0–L40.9 | Hands, feet, face, neck, scalp, genitals/groin, intertriginous areas; prior auth required |
| Moderate to severe plaque psoriasis — ≥10% BSA | Covered | J3245, L40.0–L40.9 | Prior auth required; BSA documented in clinical notes |
| Moderate to severe plaque psoriasis — ≥3% BSA with inadequate response to phototherapy or conventional agents | Covered | J3245, J8610–J9260, J7502–J7516, 96910, 96912, 96913, L40.0–L40.9 | Must document failure of methotrexate, cyclosporine, acitretin, or UVB/PUVA — or clinical reason to avoid |
| Continuation of therapy — sustained or improved response | Covered | J3245, L40.0–L40.9 | Must show BSA reduction or symptom improvement from baseline; applies to new members on existing therapy |
| All other indications (off-label use) | Not Covered / Experimental | — | Aetna considers all other indications experimental or unproven |
| Concurrent use with another biologic or targeted synthetic | Not Covered | — | No combination biologic coverage for same indication |
Aetna Tildrakizumab Billing Guidelines and Action Items 2026
This is where the policy gets practical. The Ilumya billing guidelines under CPB 1012 have real teeth — and several spots where documentation gaps will produce denials.
| # | Action Item |
|---|---|
| 1 | Submit prior authorization before any Ilumya claim. This policy requires precertification of all Aetna commercial members. Call (866) 752-7021 or use the SMN fax line at (888) 267-3277. Do this before the first dose, not after. The effective date for this updated policy is January 5, 2026 — if you have pending auths, confirm they align with the updated criteria. |
| 2 | Document the prescribing dermatologist on every claim. The policy requires a dermatologist to prescribe or be in documented consultation. Add a field to your prior auth workflow to capture the dermatologist's NPI. If the prescriber is a primary care physician co-managing with a dermatologist, document the consultation in the chart. |
| 3 | Build a BSA baseline into every new patient chart. For patients qualifying under the severity pathways, you need baseline BSA documented at initiation. At renewal, you need a comparison point. Without it, continuation claims are vulnerable. Train your clinical staff to record BSA percentage at every relevant visit. |
| 4 | Confirm TB screening is in the chart before submission. For members new to biologic or targeted synthetic therapy, document the TB test result and date. CPT 86580 (TST) or CPT 86480/86481 (IGRA) must appear within 12 months of Ilumya initiation. If the screen was positive, show the chest X-ray (CPT 71045–71048) and the active disease ruling. If latent TB was identified, document that treatment started before Ilumya initiation. |
| 5 | Flag step-therapy documentation for Pathway 2 patients. If the patient is qualifying based on prior phototherapy or conventional agent failure, pull the billing records for CPT 96910, 96912, or 96913 (PUVA/UVB) and the pharmacy claims for methotrexate or cyclosporine codes. Attach these as supporting documentation in the auth. Aetna will look for them. |
| 6 | Review any concurrent biologic claims for the same patient. If a patient has active coverage for another biologic for psoriasis, Ilumya will not be covered concurrently. Check your active claims before submitting J3245 to avoid a denial that creates an accounts receivable problem. |
| 7 | Update your continuation-of-therapy reauthorization template. Renewal approvals require documentation of BSA reduction or symptom improvement from baseline. If your current template doesn't capture this comparison, revise it before January 5, 2026. If you're not sure whether your templates meet the updated criteria, talk to your compliance officer before the effective date. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Tildrakizumab Under CPB 1012
Covered HCPCS Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J3245 | HCPCS | Injection, tildrakizumab, 1 mg |
ICD-10-CM Diagnosis Codes
Note: The source policy lists all L40.x codes under the generic description "Psoriasis." Standard ICD-10-CM sub-descriptions are shown below for reference and are not part of the Aetna policy text.
| Code | Description |
|---|---|
| L40.0 | Psoriasis vulgaris |
| L40.1 | Generalized pustular psoriasis |
| L40.2 | Acrodermatitis continua |
| L40.3 | Pustulosis palmaris et plantaris |
| L40.4 | Guttate psoriasis |
| L40.5 | Arthropathic psoriasis |
| L40.6 | Other psoriasis (unspecified) |
| L40.7 | Other psoriasis |
| L40.8 | Other psoriasis |
| L40.9 | Psoriasis, unspecified |
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