CurrentUnitedHealthcarePolicy IEXD0074.10

Ilumya (tildrakizumab) — provider‑administered coverage criteria for plaque psoriasis

Medical benefit drug policy describing coverage criteria for provider‑administered Ilumya (tildrakizumab) for adults with moderate to severe plaque psoriasis under UnitedHealthcare Individual Exchange plans (excludes MA, NV, NY).

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) — provider‑administered coverage criteria for plaque psoriasis

Policy CodePolicy IEXD0074.10

Change TypeRevised coverage criteriaupdated preferred biologic list

Effective DateJun 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit medical records documenting diagnosis, BSA ≥3% or special‑site involvement, prior therapy trials, and history of failure/intolerance to at least three biologic products when applicable.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria: Updated list of preferred biologic products with which the patient must have a history of failure, contraindication, or intolerance (at least three); replaced Stelara (ustekinumab) wording with 'one of the preferred ustekinumab products'; updated examples of targeted immunomodulators.

J3245HCPCS code

L40.0Diagnosis code

>=3%Min BSA

3Biologic failures required

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Coverage Criteria for Ilumya (tildrakizumab)

Initial and continuation therapy criteria

Ilumya is proven and medically necessary for provider administration for the treatment of moderate to severe plaque psoriasis when ALL of the following are met:

Primary diagnosis: Diagnosis of chronic moderate to severe plaque psoriasis.

Disease extent or site: Greater than or equal to 3% body surface area involvement; or palmoplantar, facial, genital involvement, or severe scalp psoriasis.BSA >= 3% or special-site involvement

Initial documentation: For initial therapy, submission of medical records (chart notes, laboratory values) documenting diagnosis and the disease extent/site and prior therapy history.

Topical and systemic therapy trials: History of failure, contraindication, or intolerance to at least one topical therapy (e.g., vitamin D analogs, corticosteroids, tazarotene, calcineurin inhibitors, anthralin, coal tar) AND history of failure to a three-month trial of methotrexate at maximally indicated dose unless contraindicated or clinically significant adverse effects occurred.3 months methotrexate unless contraindicated

Topical examples: vitamin D analogs (calcitriol, calcipotriene); corticosteroids (betamethasone, clobetasol, desonide); tazarotene; calcineurin inhibitors (tacrolimus, pimecrolimus); anthralin; coal tar.

Prior targeted immunomodulator treatment: Patient has been previously treated with a targeted immunomodulator FDA-approved for plaque psoriasis (examples include etanercept, certolizumab, golimumab, abatacept, adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tofacitinib, baricitinib, upadacitinib, apremilast).

Biologic product failures: History of failure, contraindication, or intolerance to three biologic products (examples and preferred products guidance provided; refer to UHC drug coverage tools for preferred products list).>=3 biologic products

Examples include preferred adalimumab products, certolizumab, preferred ustekinumab products, risankizumab, etc.

Combination therapy: Patient is not receiving Ilumya in combination with another targeted immunomodulator.

Combination agents listed in policy (e.g., etanercept, certolizumab, golimumab, abatacept, adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tofacitinib, baricitinib, upadacitinib, apremilast).

Prescriber and dosing: Prescribed by or in consultation with a dermatologist and dosing is in accordance with FDA-approved labeling.

Initial authorization up to 12 months; reauthorization up to 12 months.

Continuation of therapy: Documentation of positive clinical response to Ilumya therapy; physician attestation required if patient is unable to self-administer or lacks a competent caregiver (explanation must be submitted); dosing must remain in accordance with FDA labeling; patient must not be receiving Ilumya in combination with another targeted immunomodulator.

Reauthorization will be for no longer than 12 months.

Ilumya (tildrakizumab) will not be covered when it is administered in combination with another targeted immunomodulator. Examples of targeted immunomodulators listed in the policy include biologics and targeted oral agents such as etanercept, certolizumab, golimumab, abatacept, adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tofacitinib, baricitinib, upadacitinib, and apremilast.

The listing of procedure and diagnosis codes in this policy is provided for reference only and does not imply coverage. Benefit determination and whether a service or code is covered are governed by the member’s specific benefit plan document and applicable laws; inclusion of a code here is not a guarantee of payment or reimbursement.

Coding and Diagnosis

Covered HCPCS CodesHCPCSCovered

J3245

Injection; tildrakizumab, mg

Diagnosis CodesICD-10

L40.0

Psoriasis vulgaris

Body surface area involvement

BSA threshold for initial therapyGreater than or equal to 3% body surface area involvement

Special-site criteria (alternative to BSA)Palmoplantar, facial, genital involvement, or severe scalp psoriasis

Documentation required for initial therapySubmit medical records/chart notes and laboratory values documenting BSA or special-site involvement

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization and Duration

Prior authorization required. Initial and reauthorization approvals are limited to a maximum duration of 12 months.

Initial authorization: up to 12 months
Reauthorization: up to 12 months

Step Therapy

Topical and Systemic Step Therapy

Requirement: Patient must have history of failure, contraindication, or intolerance to at least one topical therapy and a three-month trial of methotrexate at maximally indicated dose (unless contraindicated or not tolerated) before Ilumya (tildrakizumab) will be approved.

Topical therapies include vitamin D analogs (e.g., calcipotriene), corticosteroids (e.g., betamethasone, clobetasol, desonide), tazarotene, calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar
Methotrexate trial: 3 months at maximally indicated dose unless contraindicated or clinically significant adverse effects occur

Definitions

Definition of moderate to severe plaque psoriasis

Core definitionPlaque psoriasis meeting criteria for systemic therapy or phototherapy (i.e., moderate to severe disease)

Objective example — extentGreater than or equal to 3% body surface area involvement

Objective example — special sitesPalmoplantar, facial, genital involvement, or severe scalp psoriasis

Clinical context — indicationIlumya is indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Background

Tildrakizumab 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 FDA-indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and is administered under provider supervision in accordance with FDA-approved dosing.

Revision History and Policy Changes

2025-06-01RevisionLatest

Revised coverage criteria: updated list of preferred biologic products (requirement of failure/contraindication/intolerance to at least three), replaced wording for ustekinumab to 'one of the preferred ustekinumab products', updated examples of targeted immunomodulators, and archived prior supporting information (previous policy version IEXDO074.09).