CurrentUnitedHealthcarePolicy CS2025D0074P

Ilumya (tildrakizumab) for plaque psoriasis — Medical Benefit Drug Policy (provider-administered)

This policy governs medical benefit drug coverage criteria for Ilumya (tildrakizumab) as a provider-administered subcutaneous treatment for adults with moderate to severe plaque psoriasis and specifies prior authorization and reauthorization requirements for UnitedHealthcare plans. It excludes certain states where state-specific policies apply.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) for plaque psoriasis — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0074P

Change TypeMaterial revision (updated targeted immunomodulator examples) + non‑material state applicability language

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit medical records documenting diagnosis and prior therapy trials, including a 3-month methotrexate trial (unless contraindicated), and confirm Ilumya is not used with other targeted immunomodulators when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate this Medical Benefit Drug Policy does not apply to the state of Arizona; refer to the state's Medicaid clinical policy.

Updated list of examples of targeted immunomodulators with which the patient received previous treatment and/or must not be receiving in combination with Ilumya; replaced Stelara (ustekinumab) with ustekinumab.

12 monthsMax initial authorization

J3245HCPCS

L40.0Diagnosis

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Indicated population

Coverage Criteria for Ilumya (tildrakizumab)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Therapy for provider-administered Ilumya: Diagnosis of chronic moderate to severe plaque psoriasis; AND at least one of: greater than or equal to 3% body surface area involvement, palmoplantar involvement, facial or genital involvement, or severe scalp psoriasis; AND prior trials and/or intolerance to required topical therapies (corticosteroids such as betamethasone, clobetasol, desonide OR history of failure/contraindication/intolerance to a topical vitamin D analog e.g., calcitriol, calcipotriene OR tazarotene); AND history of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated or clinically significant adverse effects occurred; AND prior treatment with a targeted immunomodulator (examples listed) and/or history of failure to three targeted immunomodulators (document dates and durations); AND physician attestation that the patient is unable to self-administer or there is no competent caregiver (physician must submit explanation) if provider administration is requested; AND dosing in accordance with the FDA-approved labeling; AND patient is not receiving Ilumya in combination with another targeted immunomodulator; AND prescribed by or in consultation with a dermatologist; AND initial authorization will be for no longer than 12 months.

See policy for list of topical therapies and examples of targeted immunomodulators (e.g., adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, apremilast).

Continuation Therapy — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Continuation/Reauthorization: Documentation of positive clinical response to Ilumya therapy; AND physician attestation that the patient is unable to self-administer or there is no competent caregiver to administer the drug (physician must submit explanation) if provider administration continues; AND dosing in accordance with the FDA-approved labeling; AND patient is not receiving Ilumya in combination with another targeted immunomodulator; AND reauthorization will be for no longer than 12 months.

Positive clinical response documentation required.

This Medical Benefit Drug Policy does not apply to certain states. Refer to the state-specific policy or guideline where noted. States listed include Arizona (refer to the state's Medicaid clinical policy), Indiana (see Immunomodulators for Inflammatory Conditions for Indiana), Kansas (refer to the state's Medicaid clinical policy), Louisiana (refer to the state's Medicaid clinical policy), and North Carolina (no state-specific policy noted).

Ilumya (tildrakizumab) must not be used in combination with another targeted immunomodulator. Use of Ilumya concurrently with other targeted immunomodulators (examples listed in the policy) is considered not covered under these criteria.

Billing and Diagnosis Codes

HCPCS CodeHCPCS

J3245

Injection; tildrakizumab, 1 mg

Diagnosis CodeICD-10

L40.0

Psoriasis vulgaris

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ilumya (tildrakizumab) for provider administration. Submit a complete prior authorization request with supporting medical records documenting diagnosis, prior therapy trials, and rationale for provider administration when the patient cannot self-administer.

Affected drug: Ilumya (tildrakizumab)
Initial authorization: up to 12 months
Reauthorization: up to 12 months

Documentation Required

Submission of Medical Records

Provide medical records (e.g., chart notes, laboratory values) documenting the diagnosis of chronic moderate to severe plaque psoriasis, extent of disease (for example BSA ≥3%, palmoplantar, facial/genital, or severe scalp involvement), and all prior therapies tried, with dates and durations.

Documented BSA or description of affected sites

Clinical 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 an IL-23 antagonist indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Definitions

Ilumya (tildrakizumab) — Definition

Drug classInterleukin-23 (IL-23) antagonist

Generic nameTildrakizumab

Brand nameIlumya

Mechanism of actionHumanized IgG1/k monoclonal antibody that selectively binds the p19 subunit of IL-23, inhibiting interaction with the IL-23 receptor and downstream pro‑inflammatory cytokine release

FDA-indicated populationAdults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) for plaque psoriasis — Medical Benefit Drug Policy

Policy CodePolicy CS2025D0074P

Change TypeMaterial revision (updated targeted immunomodulator examples) + non‑material state applicability language

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

Chart notes showing prior topical and systemic therapy trials, including methotrexate dose and duration

Dates and duration for each targeted immunomodulator trial

Step Therapy

Required Prior Therapy Trials

The policy requires trial and failure (or documented contraindication/intolerance) of specified topical therapies and systemic therapy prior to approval. This includes failure, contraindication, or intolerance to a topical corticosteroid AND one of: a vitamin D analog or tazarotene, and a documented 3-month trial of methotrexate at maximally indicated dose unless contraindicated.

Topical corticosteroids (e.g., betamethasone, clobetasol, desonide)
Vitamin D analogs (e.g., calcipotriene) OR tazarotene
Methotrexate: 3-month trial at maximally indicated dose unless contraindicated

Step Therapy

Targeted Immunomodulator History

Document history of trials with targeted immunomodulators. Approval requires failure, contraindication, or intolerance to three targeted immunomodulators FDA‑approved for plaque psoriasis (include drug name, dates, and duration). Also document any prior treatment with other FDA‑approved targeted immunomodulators (e.g., adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, apremilast).

List three failed/ intolerant/contraindicated targeted immunomodulators with dates and durations
Note prior treatments with agents such as adalimumab, ustekinumab, Skyrizi (risankizumab), Tremfya (guselkumab), Cosentyx (secukinumab), Taltz (ixekizumab), Otezla (apremilast)

Documentation Required

Physician Attestation for Provider Administration

If the patient cannot self-administer and there is no competent caregiver, the physician must provide an attestation and narrative explanation supporting provider administration. Without this attestation and explanation, requests for provider administration may be denied.

Physician attestation and explanation required for provider-administered dosing

Denial Risk

Denial Conditions and Risk

Failure to supply required medical records or failure to document prior therapy trials, targeted immunomodulator history, or physician attestation may result in denial of coverage. Ensure all requested documentation is included with the prior authorization submission to avoid processing delays or non‑coverage.

Incomplete records or missing trial documentation = denial risk
Provide complete dates, durations, and reasons for discontinuation (failure, intolerance, contraindication)