CurrentUnitedHealthcarePolicy IEXD0074.10

Ilumya (tildrakizumab) — Provider‑Administered (coverage criteria)

Medical benefit policy governing provider‑administered Ilumya (tildrakizumab) for adults with moderate to severe plaque psoriasis, including initial and continuation authorization criteria, exclusions, documentation, and billing codes.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) — Provider‑Administered (coverage criteria)

Policy CodePolicy IEXD0074.10

Change TypeRevised preferred biologic product references

Effective DateJun 1, 2025

Next Review Date

Key ActionSubmit prior authorization with medical records documenting diagnosis, ≥3% BSA (or special‑site involvement), required prior therapy trials, and clinician attestation if provider administration is needed.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria to update list of preferred biologic products and examples of targeted immunomodulators to reference preferred product lists rather than specific brands.

Archived previous policy version IEXD0074.09.

J3245HCPCS code

L40.0Diagnosis code

12 monthsAuth period

>=3% BSAMinimum extent

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Coverage Criteria for Ilumya (tildrakizumab)

Initial Therapy

Covered when ALL of the following are met for provider-administered Ilumya (initial):

Initial Authorization - All: Patient has chronic moderate to severe plaque psoriasis; >=3% body surface area involvement or palmoplantar, facial, genital, or severe scalp psoriasis; history of failure, contraindication, or intolerance to at least one specified topical therapy (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar); history of failure to a three-month trial of methotrexate at maximally indicated dose unless contraindicated or clinically significant adverse effects; history of failure, contraindication, or intolerance to three biologic products including one preferred adalimumab product and one preferred ustekinumab product (or equivalents); physician attestation that the patient is unable to self-administer or lacks a competent caregiver to administer the drug, with explanation; patient is not receiving Ilumya in combination with another targeted immunomodulator; dosing is in accordance with FDA-approved labeling; prescribed by or in consultation with a dermatologist; initial authorization for no longer than 12 months.

Preferred product lists referenced at UHCprovider.com

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation Authorization - All: Documentation of positive clinical response to Ilumya therapy; physician attestation that the patient is unable to self-administer or lacks a competent caregiver to administer the drug, with explanation; patient is not receiving Ilumya in combination with another targeted immunomodulator; dosing is in accordance with FDA-approved labeling; reauthorization for no longer than 12 months.

Ilumya (tildrakizumab) must not be used in combination with another targeted immunomodulator. Combination therapy with another targeted immunomodulator (for example, tumor necrosis factor inhibitors, other IL‑23 or IL‑17 inhibitors, JAK inhibitors, or other specified targeted agents) is an exclusion for coverage and will preclude approval for both initial and continuation authorizations of provider‑administered Ilumya. The policy lists examples of targeted immunomodulators that are not to be used concurrently with Ilumya; refer to the full criteria for specific product examples and the drug coverage tools on UHCprovider.com for preferred‑product guidance.

Requests for Ilumya will be denied or considered not medically necessary when the stated coverage criteria are not met. Common reasons include: disease extent below the policy threshold (less than 3% body surface area involvement and no qualifying special‑site disease), failure to document required prior treatment trials (topical therapies and a three‑month methotrexate trial at maximally indicated dose unless contraindicated), lack of documented failure/contraindication/intolerance to the required number of biologic products, concurrent use of another targeted immunomodulator, or dosing not consistent with FDA‑approved labeling. For continuation requests, lack of documentation of a positive clinical response or missing physician attestation regarding inability to self‑administer are also grounds for noncoverage.

Applicable Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J3245

Injection, tildrakizumab, 1 mg

Applicable Diagnosis CodesICD-10

L40.0

Psoriasis vulgaris

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation Ilumya (tildrakizumab) requests. Initial authorization is limited to no longer than 12 months; reauthorization (continuation) is also limited to no longer than 12 months. Submit medical records (chart notes, laboratory values) supporting the diagnosis and prior therapy trials.

Initial and reauthorization requests: limit ≤ 12 months
Ilumya to be obtained under the pharmacy benefit (self‑administered, subcutaneous)

Step Therapy

Step Therapy Requirements

Step therapy must be documented before coverage of Ilumya for plaque psoriasis. The patient must have failed, had a contraindication to, or been intolerant of required prior therapies as specified below.

Failure/intolerance/contraindication to required topical therapies: corticosteroids, vitamin D analogs (e.g., calcipotriene), tazarotene, calcineurin inhibitors (tacrolimus, pimecrolimus), anthralin, or coal tar
History of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated or intolerant

Definitions and Drug Information

Ilumya (tildrakizumab) — key identity and indication

Generic nametildrakizumab

Brand nameIlumya

Mechanism of actionHumanized IgG1/k monoclonal antibody targeting the p19 subunit of IL-23 (IL-23 antagonist)

FDA indicationTreatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Administration route / settingSubcutaneous injection (self-administered under pharmacy benefit; provider-administered covered per policy when criteria met)

Moderate to severe plaque psoriasis (policy definition)

Background

Tildrakizumab (Ilumya) is a humanized IgG1/k monoclonal antibody that selectively binds the p19 subunit of interleukin‑23 (IL‑23), inhibiting IL‑23 receptor interaction and downstream pro‑inflammatory cytokine release. It is indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Revision History and Policy Updates

2025-06-01Revised coverage criteriaLatest

Updated preferred biologic product references: replaced explicit 'Stelara (ustekinumab)' with 'one of the preferred ustekinumab products' and moved preferred-product details to drug coverage tools on UHCprovider.com; examples of targeted immunomodulators updated to reference ustekinumab generally.

2025-06-01Archived prior version

Archived previous policy version IEXD0074.09.

Documentation Required

Required Documentation for Initial and Continued Therapy

Provide comprehensive documentation with both initial and continuation requests. For initial therapy include diagnosis and extent of disease; for continuation include objective evidence of clinical benefit.

Initial therapy documentation: diagnosis of chronic moderate to severe plaque psoriasis; documentation of ≥3% body surface area (BSA) involved OR special‑site involvement (palmoplantar, facial, genital) OR severe scalp psoriasis; medical records demonstrating required prior topical therapies and methotrexate trial (or documentation of contraindication/intolerance); documentation of failure/intolerance/contraindication to required biologic trials when applicable
Continuation therapy documentation: objective documentation of positive clinical response to Ilumya (e.g., BSA improvement, physician assessment), continued adherence to FDA‑approved dosing, and physician attestation if patient is unable to self‑administer or lacks a competent caregiver (must include explanation)
Other required documentation: prescriber specialty (dermatologist or consultation with dermatologist), attestation that Ilumya is not being used in combination with another targeted immunomodulator