CurrentColorado Rocky Mountain Health PlansPolicy IEXD0074.11

Ilumya (Tildrakizumab) — Provider‑administered coverage criteria

Governs medical benefit coverage and provider‑administered use of Ilumya (tildrakizumab) for adults with moderate to severe plaque psoriasis under Individual Exchange plans (all states except Nevada). Affects prescribing clinicians and providers requesting prior authorization for provider‑administered dosing.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyIlumya (Tildrakizumab) — Provider‑administered coverage criteria

Policy CodePolicy IEXD0074.11

Change TypeClinical/coverage revisions

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit prior authorization with medical records documenting diagnosis, disease extent (≥3% BSA or special‑site involvement), prior topical and methotrexate trials, and required biologic history.

SourceLink

POLICY UPDATE CHANGES

Replaced references to 'targeted immunomodulator' with 'systemic targeted immunomodulator'.

Added Bimzelx (bimekizumab-bkzx) and Sotyktu (deucravacitinib) to the list of systemic targeted immunomodulators to avoid combination with Ilumya and to the list of previously tried agents.

Removed several agents (Olumiant, Orencia, Rinvoq, Simponi, Xeljanz) from the example lists of systemic targeted immunomodulators.

Added instruction to refer to the UnitedHealthcare Commercial policy version for Nevada.

>=3%Minimum BSA

J3245HCPCS

L40.0Diagnosis

<=12m

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Ilumya (tildrakizumab)

Initial Therapy

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

Diagnosis and disease extent: Diagnosis of chronic moderate to severe plaque psoriasis; and 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

chunk 4

Topical therapy trial: History of failure, contraindication, or intolerance to at least one topical therapy (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar).

chunk 4

Methotrexate trial: History of failure to a three-month trial of methotrexate at maximally indicated dose unless contraindicated or clinically significant adverse effects are experienced.3 months at maximally indicated dose

chunk 5

Biologic trial(s): History of failure, contraindication, or intolerance to three biologic products (examples include a preferred adalimumab product, a preferred ustekinumab product, Cimzia (certolizumab), Skyrizi (risankizumab)).3 biologic products

chunk 7

No concurrent systemic targeted immunomodulator: Patient is not receiving Ilumya in combination with another systemic targeted immunomodulator (examples listed in policy) for the same indication.

chunk 8

Administration and prescriber: Ilumya to be provider-administered as a subcutaneous injection; dosing in accordance with the United States Food and Drug Administration approved labeling; prescribed by or in consultation with a dermatologist.

chunk 4, chunk 8

Physician attestation for inability to self-administer: Physician attestation that the patient is unable to self-administer or there is no competent caregiver to administer the drug; physician must submit explanation.

chunk 8

Authorization duration: Initial authorization will be for no longer than 12 months.<= 12 months

chunk 8

Continuation Therapy

Covered when ALL of the following are met for continuation of provider-administered Ilumya:

Clinical response: Documentation of positive clinical response to Ilumya therapy.

chunk 8

No concurrent systemic targeted immunomodulator: Patient is not receiving Ilumya in combination with another systemic targeted immunomodulator for the same indication.

chunk 8

Dosing compliance: Dosing is in accordance with the United States Food and Drug Administration approved labeling.

Ilumya must not be used in combination with another systemic targeted immunomodulator for treatment of the same indication. Examples of systemic targeted immunomodulators to avoid combining with Ilumya include: adalimumab, Bimzelx (bimekizumab-bkzx), Cimzia (certolizumab), Cosentyx (secukinumab), Enbrel (etanercept), Otezla (apremilast), Skyrizi (risankizumab), Siliq (brodalumab), Sotyktu (deucravacitinib), Taltz (ixekizumab), Tremfya (guselkumab), and ustekinumab.

Prior authorization for provider-administered Ilumya requires submission of medical records documenting the diagnosis of chronic moderate to severe plaque psoriasis and disease extent (≥3% body surface area involvement or palmoplantar, facial, genital, or severe scalp involvement).

If required prior trials are not documented, coverage may be considered not medically necessary. The record should show history of failure, contraindication, or intolerance to at least one topical therapy (for example: corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, or coal tar) and a three-month trial of methotrexate at maximally indicated dose unless contraindicated or not tolerated.

Documentation must also include evidence of prior biologic therapy trials per policy (history of failure, contraindication, or intolerance to three biologic products where applicable), dosing consistent with FDA labeling, and that Ilumya will be provider-administered as a subcutaneous injection prescribed by or in consultation with a dermatologist.

When the patient cannot self-administer, a physician attestation explaining the inability to self-administer or lack of a competent caregiver must be submitted.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J3245

Injection, tildrakizumab, 1 mg

Diagnosis CodesICD-10

L40.0

Psoriasis vulgaris

Body Surface Area (BSA) and special-site eligibility

Minimum BSA for eligibility>= 3% body surface area

Special-site involvement qualifiesPalmoplantar, facial, or genital involvement qualifies regardless of BSA

Severe scalp psoriasis qualifiesSevere scalp psoriasis qualifies regardless of BSA

Documentation requiredSubmission of medical records (chart notes, labs) documenting BSA or special-site involvement

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for provider-administered Ilumya (tildrakizumab) for treatment of moderate to severe plaque psoriasis. Initial and reauthorization requests for provider administration will be approved for no longer than 12 months per authorization.

Initial and reauthorization duration: ≤ 12 months
Prescribed by or in consultation with a dermatologist
Dosing must follow FDA-approved labeling

Denial Risk

Denial Risk — Incomplete or Insufficient Documentation

Prior authorization may be denied if medical records do not clearly document chronic moderate to severe plaque psoriasis, the required extent of disease (≥ 3% body surface area involvement or special-site involvement such as palmoplantar, facial, genital, or severe scalp psoriasis), inability to self-administer (with physician explanation), or if the patient is receiving Ilumya in combination with another systemic targeted immunomodulator for the same indication.

Background

Ilumya (tildrakizumab) is a humanized IgG1/k monoclonal antibody that selectively binds the p19 subunit of interleukin-23 (IL-23). It inhibits downstream pro-inflammatory cytokine activity implicated in the pathophysiology of plaque psoriasis.

Ilumya is indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and is administered by subcutaneous injection; provider-administered use is covered when policy criteria are met.

Definitions

Ilumya (tildrakizumab) — key facts

Mechanism of actionHumanized IgG1/k monoclonal antibody that selectively binds the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor

Therapeutic classInterleukin-23 (IL-23) p19 subunit antagonist

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

Pharmacologic effectInhibits release of pro-inflammatory cytokines and chemokines involved in psoriasis pathophysiology