ModifiedUnitedHealthcarePolicy 2025D0074N

Ilumya (tildrakizumab) for plaque psoriasis (provider-administered)

Policy governing medical-benefit, provider‑administered use of Ilumya (tildrakizumab) for adults with moderate to severe plaque psoriasis, including initial and continuation authorization criteria and documentation requirements for UnitedHealthcare commercial and community plans.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) for plaque psoriasis (provider-administered)

Policy CodePolicy 2025D0074N

Change TypeClarification of benefit routingarchival of prior version

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization for provider‑administered Ilumya with documentation of diagnosis, inability to self‑administer (physician attestation), prior therapy history, and dosing consistent with FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Ilumya as a self‑administered subcutaneous injection for treatment of plaque psoriasis should be obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan documents.

Archived previous policy version 2025D0074M.

12 monthsmaximum initial or reauthorization period

>= 3% BSAminimum disease extent

J3245HCPCS code

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Californiabenefit routing exception

Coverage Criteria for Ilumya (tildrakizumab)

Initial therapy — provider-administered (general commercial/community)

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

Initial commercial provider-administered criteria: Diagnosis of moderate to severe plaque psoriasis; physician attestation that the patient is unable to self‑administer or there is no competent caregiver to administer the drug (physician must submit explanation); patient is not receiving Ilumya in combination with another targeted immunomodulator; dosing is in accordance with United States FDA‑approved labeling; initial authorization will be for no longer than 12 months.

Initial therapy — medical necessity disease and prior therapy requirements

Covered when ALL of the following are met:

Disease extent: Documentation of chronic moderate to severe plaque psoriasis with greater than or equal to 3% body surface area involvement, or palmoplantar, facial, genital involvement, or severe scalp psoriasis.>=3% BSA or specified site involvement

Prior therapy pathways: Either: (1) Both: history of failure, contraindication, or intolerance to one of the specified topical therapies (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) AND history of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated or significant adverse effects occurred; OR (2) prior treatment with a biologic or targeted synthetic DMARD FDA‑approved for plaque psoriasis.

Preferred biologic failures (alternate path): When referenced in pathways requiring preferred product step criteria: history of failure, contraindication, or intolerance to three of the listed preferred biologic products is required (see preferred product list).

For Medicare reviews, refer to CMS section; preferred product list referenced separately.

Continuation/reauthorization criteria

Covered when ALL of the following are met for continuation:

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

Self‑administered Ilumya (tildrakizumab) for the treatment of plaque psoriasis is generally procured under the pharmacy benefit unless the member’s benefit plan specifies otherwise.

Exception: for members enrolled in UnitedHealthcare of California plans where a delegated provider group conducts the prior authorization review, self‑administered Ilumya may be obtained under the medical benefit. Always follow the member‑specific benefit plan when determining benefit routing.

Ilumya must not be used concurrently with another targeted immunomodulator; combination therapy with other biologic or targeted immunomodulatory agents is considered not allowed under these criteria.

Applicable Codes and Disease Metrics

Applicable HCPCS CodesHCPCS

J3245

Injection, tildrakizumab, 1 mg

Applicable Diagnosis CodesICD-10

L40.0

Psoriasis vulgaris

inv-09: Body surface area — disease extent threshold and special site involvement

Disease extent threshold>= 3% body surface area (BSA)

Special site involvement qualifies regardless of BSAPalmoplantar, facial, or genital involvement

Severe scalp disease qualifies regardless of BSASevere scalp psoriasis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required for provider-administered Ilumya (tildrakizumab). Initial and continuation requests require prior authorization; initial authorization limited to 12 months and reauthorization limited to 12 months.

Ilumya (tildrakizumab) — provider-administered
Initial authorization: ≤ 12 months
Reauthorization: ≤ 12 months

Prior Authorization

Prior Authorization and Benefit Routing

For members in UnitedHealthcare of California plans where a delegated provider group performs the prior authorization review, self-administered Ilumya may be obtained under the medical benefit. In all cases, the member-specific benefit plan document governs; check the member's benefit plan for pharmacy vs medical routing prior to submitting a request. Benefit routing that conflicts with the member plan may result in denial.

California delegated exception: self-administered Ilumya may be routed to medical benefit for delegated reviews

Background

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

Definitions and Drug Information

inv-19: Ilumya (tildrakizumab) — product summary per label

Generic nameTildrakizumab

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

Indication (per label)Treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Source (label)Ilumya [package insert], Sun Pharmaceutical Industries, Inc.; December 2022

inv-20: Moderate to severe plaque psoriasis (disease extent definition)

Definition (disease extent)Chronic plaque psoriasis with >= 3% body surface area involvement

Revision History and Policy Changes

2025-10-01coverage_rationale_updatedLatest

Added language clarifying that self‑administered Ilumya for plaque psoriasis should be obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise; for UnitedHealthcare of California plans with a delegated provider group, self‑administered Ilumya may be obtained under the medical benefit.

2025-10-01archived_prior_version

Archived previous policy version 2025D0074M.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) for plaque psoriasis (provider-administered)

Policy CodePolicy 2025D0074N

Change TypeClarification of benefit routingarchival of prior version

Effective DateOct 1, 2025

Next Review Date

SourceLink

On This Page

Always verify member-specific benefit plan for pharmacy vs medical routing

Documentation Required

Initial Therapy — Required Medical Records and Prior Therapy Documentation

For initial therapy, submit medical records (e.g., chart notes, laboratory values) documenting diagnosis and required trials and findings. Records must include documentation of: BSA or special-site involvement, prior topical therapy trial(s), methotrexate trial or rationale for not using methotrexate, or prior biologic/targeted synthetic DMARD use, as applicable.

Diagnosis of chronic moderate to severe plaque psoriasis
Document ≥ 3% BSA involvement or palmoplantar, facial, genital, or severe scalp psoriasis
Document history of failure/contraindication/intolerance to required topical therapies
Document 3-month methotrexate trial at maximally indicated dose or contraindication/adverse effects, unless exception applies
Or documentation of prior biologic/targeted synthetic DMARD use

Step Therapy

Initial Therapy — Topical and Methotrexate Trial Requirements

Initial therapy requires trials of topical therapies and a 3-month methotrexate trial at maximally indicated dose unless contraindicated or clinically significant adverse effects occur. Alternatively, prior treatment with an FDA‑approved biologic/targeted synthetic DMARD for plaque psoriasis may satisfy prior therapy requirements. For some cases, failure to three preferred biologic products is required; include documentation of these trials where applicable.

Topical therapies trial (history of failure, contraindication, or intolerance): corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar
Methotrexate: ≥ 3 months at maximally indicated dose, unless contraindicated or intolerant
Alternatively: prior biologic/targeted synthetic DMARD use (examples provided)
When required: documentation of failure/contraindication/intolerance to three preferred biologics (list provided in policy)

Denial Risk

Physician Attestation for Ability to Self-Administer

Physician attestation is required confirming the patient is unable to self-administer or has no competent caregiver to administer the drug; the attestation must include an explanation. Initial requests may be denied if this attestation and explanation are not provided. For continuation, re-attestation is required.

Attestation that patient cannot self-administer or lacks competent caregiver — include explanation
Lack of attestation may result in denial of initial request
Re-attestation required for continuation requests

Documentation Required

Member Benefit Documentation Requirement

Member benefit documentation must be provided when there is any conflict between this policy and the member-specific plan. The member-specific benefit plan document governs; check and submit that documentation with the request if benefit routing or coverage differs.

Submit member-specific benefit plan documentation when routing or coverage conflicts exist
Member-specific plan governs over standard policy

Denial Risk

Benefit Routing Denial Risk

Benefit routing may trigger denial when the member's plan specifies pharmacy coverage for self-administered Ilumya. Verify coverage routing before submission and include justification if requesting medical benefit coverage for self-administered administration.

If member plan specifies pharmacy benefit for self-administered Ilumya, medical benefit requests may be denied
Include justification and member plan documentation if requesting medical benefit coverage despite pharmacy routing

Alternate qualifying sitesPalmoplantar, facial, genital involvement

Severe scalpSevere scalp psoriasis qualifies regardless of %BSA

inv-21: Ilumya referenced as the biologic agent (package insert and trials)

Agent referencedIlumya (tildrakizumab)

Clinical trial evidence citedreSURFACE 1 and reSURFACE 2 phase 3 trials (Reich et al.)

Package insert referenceIlumya [package insert], December 2022