Aetna modified CPB 1012 for tildrakizumab-asmn (Ilumya) effective January 5, 2026. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its coverage policy for tildrakizumab-asmn (Ilumya) under CPB 1012 Aetna system, with changes taking effect January 5, 2026. This Aetna Ilumya coverage policy governs prior authorization, medical necessity criteria, and continuation of therapy for plaque psoriasis (ICD-10 L40.0–L40.9). The primary reimbursement code is HCPCS J3245 (injection, tildrakizumab, 1 mg), and billing teams should review the updated criteria before submitting any new or renewal precertification requests.
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; any provider prescribing or administering biologics for plaque psoriasis |
| Key Action | Audit all active and pending Ilumya prior authorization requests against the updated initial approval and continuation criteria before submitting new precertifications |
Aetna Ilumya Coverage Criteria and Medical Necessity Requirements 2026
Tildrakizumab-asmn billing starts with one non-negotiable: precertification is required for every Aetna member on every plan design. Call (866) 752-7021 or fax (888) 267-3277. No exceptions.
The updated coverage policy defines two separate tracks for initial approval. Your team needs to understand both before building out prior auth requests.
Track 1 — Prior biologic or targeted synthetic drug use. Aetna considers Ilumya medically necessary for adult members who have previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis. This includes agents like Sotyktu (deucravacitinib) or Otezla (apremilast). No body surface area (BSA) threshold is required under this track. Prior use of an appropriate agent is enough.
Track 2 — BSA or body area criteria. Aetna also considers Ilumya medically necessary for adult members with moderate to severe plaque psoriasis when any of the following body surface area or body area criteria are met — regardless of prior biologic history:
| # | Covered Indication |
|---|---|
| 1 | Crucial body areas affected — hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas |
| 2 | At least 10% BSA affected — no step therapy required at this threshold |
| 3 | At least 3% BSA affected — but only if the member also has an inadequate response or intolerance to phototherapy (CPT 96910, 96912, or 96913) or conventional pharmacologic treatment with methotrexate (J8610, J8611, J8612, J9250, J9255, or J9260), cyclosporine (J7502, J7515, or J7516), or acitretin; OR has a documented clinical reason to avoid all three conventional agents (see Aetna's Appendix in CPB 1012) |
This 3% BSA pathway is where most claim denials happen. If your documentation doesn't show prior conventional therapy failure or a clear contraindication to methotrexate, cyclosporine, and acitretin, the claim will not clear prior auth.
The TB Screening Requirement Is Mandatory for All Indications
Every Ilumya authorization — regardless of track — requires documented negative TB screening within 12 months of starting therapy. This applies to members who are new to biologics or targeted synthetic drugs. Acceptable tests include a tuberculosis skin test (TST, CPT 86580) or an interferon-gamma release assay (IGRA, CPT 86480 or 86481).
If the TB screen comes back positive, Aetna requires further workup to rule out active disease — which means a chest X-ray (CPT 71045, 71046, 71047, or 71048). Active TB disqualifies the member from receiving Ilumya. Latent TB requires treatment before starting Ilumya.
Build this TB documentation step into your precertification workflow. Missing it is an avoidable denial.
No Concurrent Biologic Use
Aetna will not approve Ilumya for any member currently using another biologic or targeted synthetic drug for the same indication. This is absolute. Document active medication lists carefully before submitting.
Prescribing Specialty Requirement
Ilumya must be prescribed by or in consultation with a dermatologist. If your practice is non-dermatology and you're managing a psoriasis patient on Ilumya, get that dermatology consultation documented before billing CPT 96372 for the injection.
Aetna Ilumya Continuation of Therapy Criteria 2026
Continuation authorization has its own medical necessity standard. Aetna considers ongoing Ilumya therapy medically necessary when the member — including new members switching to Aetna coverage — is using the drug for moderate to severe plaque psoriasis AND shows a positive clinical response. That means either:
- Reduction in BSA affected from baseline, or
- Improvement in signs and symptoms from baseline — such as reduced itching, redness, flaking, scaling, burning, cracking, or pain
One of these two conditions must be met. Document both baseline status and current status clearly in every renewal request. Vague notes like "patient responding well" will not support medical necessity the way quantified BSA measurements or symptom scoring will.
The real issue here is baseline documentation captured at initiation. If your team didn't record baseline BSA or symptom severity when the patient started Ilumya, continuation renewals become much harder to defend. Establish that baseline now for any patient approaching renewal.
Aetna Ilumya Exclusions and Non-Covered Indications
Aetna's position is direct: all indications for tildrakizumab-asmn other than moderate to severe plaque psoriasis in adults meeting the criteria above are considered experimental, investigational, or unproven.
There are no covered pediatric indications under this policy. There are no covered off-label uses. If your team sees Ilumya prescribed for anything other than adult plaque psoriasis, do not submit under J3245 expecting approval. It will deny.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Adult moderate to severe PsO — prior biologic/targeted synthetic use | Covered | J3245, L40.0–L40.9 | Prior auth required; no BSA threshold needed |
| Adult moderate to severe PsO — crucial body areas affected | Covered | J3245, L40.0–L40.9 | Prior auth required; no prior conventional therapy step required |
| Adult moderate to severe PsO — ≥10% BSA affected | Covered | J3245, L40.0–L40.9 | Prior auth required; no prior conventional therapy step required |
| Adult moderate to severe PsO — ≥3% BSA + failed/intolerant to phototherapy or methotrexate/cyclosporine/acitretin | Covered | J3245, L40.0–L40.9 | Prior auth required; document conventional therapy failure explicitly |
| Adult moderate to severe PsO — ≥3% BSA + clinical reason to avoid methotrexate, cyclosporine, and acitretin | Covered | J3245, L40.0–L40.9 | Prior auth required; reference CPB 1012 Appendix for qualifying reasons |
| Continuation of therapy — positive clinical response documented | Covered | J3245, L40.0–L40.9 | BSA reduction or symptom improvement from baseline required |
| All other indications (off-label, pediatric, non-PsO) | Not Covered — Experimental/Investigational | J3245 | Denials expected; no exceptions defined |
| Concurrent use with another biologic or targeted synthetic | Not Covered | J3245 | Absolute exclusion regardless of indication |
Aetna Ilumya Billing Guidelines and Action Items 2026
These steps apply to any practice billing J3245 for Aetna commercial plans.
| # | Action Item |
|---|---|
| 1 | Update your prior authorization checklist before submitting any new requests. The effective date is January 5, 2026. Any precertification submitted on or after that date must meet the updated CPB 1012 criteria. Check which track applies — prior biologic use (Track 1) or qualifying BSA/body area criteria (Track 2). |
| 2 | Document TB screening in every new Ilumya authorization. Attach TST (CPT 86580) or IGRA results (CPT 86480 or 86481) dated within 12 months of therapy initiation. If the screen was positive, include follow-up chest X-ray (CPT 71045–71048) and confirmation of no active disease. Missing TB documentation will stop the authorization. |
| 3 | Capture baseline BSA and symptom data at initiation. You'll need this for every continuation renewal. Record it as a numeric BSA percentage and a symptom inventory — itching, redness, flaking, scaling, burning, cracking, pain. This protects your renewals. |
| 4 | Verify prescribing specialty on every claim. Ilumya must be prescribed by or in consultation with a dermatologist. If the prescribing provider is not a dermatologist, confirm a documented consultation before billing CPT 96372 for the subcutaneous injection. |
| 5 | Audit active Ilumya patients for concurrent biologic use. Pull your active medication lists. Any member on a second biologic or targeted synthetic drug for the same indication is ineligible. Submitting for a patient with concurrent biologic use is a guaranteed denial. |
| 6 | Use the correct precertification contact. For Ilumya precertification, call (866) 752-7021 or fax the Statement of Medical Necessity (SMN) form to (888) 267-3277. Routing precertification through a general auth line risks delays. |
| 7 | Check conventional therapy documentation for the 3% BSA pathway. If your patient is in this subgroup, your authorization request must show documented failure of or intolerance to phototherapy (CPT 96910, 96912, or 96913) or conventional agents (methotrexate or cyclosporine or acitretin). Or it must show a documented clinical reason to avoid all three. Referencing the CPB 1012 Appendix in your submission strengthens this argument. |
If you're managing a high volume of psoriasis biologics across multiple payers and you're unsure how this update interacts with your current workflows, talk to your compliance officer or billing consultant before the January 5, 2026 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-asmn (Ilumya) Under CPB 1012
HCPCS Codes — Covered When Selection Criteria Are Met
| Code | Description |
|---|---|
| J3245 | Injection, tildrakizumab, 1 mg |
HCPCS Codes — Related Agents (Prior Therapy Documentation)
These codes support documentation of prior or conventional therapy. They are not covered codes for Ilumya itself but appear in CPB 1012 as relevant to step therapy requirements.
| Code | Description |
|---|---|
| J0139 | Injection, adalimumab, 1 mg |
| J1438 | Injection, etanercept, 25 mg |
| J1745 | Injection, infliximab, 10 mg |
| J3262 | Injection, tocilizumab, 1 mg |
| J7502 | Cyclosporine, oral, 100 mg |
| J7515 | Cyclosporine, oral, 25 mg |
| J7516 | Cyclosporine, parenteral, 250 mg |
| J8610 | Methotrexate, oral, 2.5 mg |
| J8611 | Methotrexate (Jylamvo), oral, 2.5 mg |
| J8612 | Methotrexate (Xatmep), oral, 2.5 mg |
| J9250 | Methotrexate sodium, 5 mg |
| J9255 | Injection, methotrexate (Accord), not therapeutically equivalent to J9250 or J9260, 50 mg |
| J9260 | Methotrexate sodium, 50 mg |
| Q5103 | Injection, infliximab-dyyb, biosimilar (Inflectra), 10 mg |
| Q5104 | Injection, infliximab-abda, biosimilar (Renflexis), 10 mg |
| Q5109 | Injection, infliximab-qbtx, biosimilar (Ixifi), 10 mg |
| Q5121 | Injection, infliximab-axxq, biosimilar (Avsola), 10 mg |
| Q5133 | Injection, tocilizumab-bavi (Tofidence), biosimilar, 1 mg |
| Q5135 | Injection, tocilizumab-aazg (Tyenne), biosimilar, 1 mg |
| Q5140 | Injection, adalimumab-fkjp, biosimilar, 1 mg |
| Q5141 | Injection, adalimumab-aaty, biosimilar, 1 mg |
| Q5142 | Injection, adalimumab-ryvk, biosimilar, 1 mg |
| Q5143 | Injection, adalimumab-adbm, biosimilar, 1 mg |
| Q5144 | Injection, adalimumab-aacf (Idacio), biosimilar, 1 mg |
| Q5145 | Injection, adalimumab-afzb (Abrilada), biosimilar, 1 mg |
CPT Codes — Related Procedures
| Code | Description |
|---|---|
| 71045 | Radiologic examination, chest; single view |
| 71046 | Radiologic examination, chest; two views |
| 71047 | Radiologic examination, chest; three views |
| 71048 | Radiologic examination, chest; four or more views |
| 86480 | Tuberculosis test, cell-mediated immunity antigen response; gamma interferon |
| 86481 | Tuberculosis test; enumeration of gamma interferon-producing T cells in cell suspension |
| 86580 | Skin test; tuberculosis, intradermal |
| 96372 | Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular |
| 96910 | Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B |
| 96912 | Photochemotherapy; psoralens and ultraviolet A (PUVA) |
| 96913 | Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision |
Key ICD-10-CM Diagnosis Codes
| 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 | Psoriatic arthropathy (header code) |
| L40.50 | Psoriatic arthropathy, unspecified |
| L40.6 | Psoriatic arthritis mutilans |
| L40.8 | Other psoriasis |
| L40.9 | Psoriasis, unspecified |
Note: Aetna's CPB 1012 lists the full L40 family but coverage is specifically for moderate to severe plaque psoriasis — most commonly billed under L40.0. Confirm ICD-10 specificity against your clinical documentation before billing. L40.7 does not appear as a standalone billable code in this policy and is not listed above.
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