CurrentUnitedHealthcarePolicy 2025 P 3109-11

Ilumya (tildrakizumab) step therapy for plaque psoriasis

Defines UnitedHealthcare's step therapy requiring members to try preferred self-administered injectable alternatives (three agents) before Ilumya approval; applies to commercial plan benefit designs where Ilumya coverage is available. Infused products are excluded.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) step therapy for plaque psoriasis

Policy CodePolicy 2025 P 3109-11

Change TypeStep requirement increasedpreferred product references revised

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain and document trials of three preferred self-administered injectable products (drug name, dates, duration) showing failure, contraindication, or intolerance prior to requesting authorization for Ilumya.

SourceLink

POLICY UPDATE CHANGES

Requires a member to try three preferred self-administered injectable products before providing coverage for Ilumya (tildrakizumab).

Preferred adalimumab examples were removed and step now references 'one of the preferred adalimumab products' and preferred ustekinumab products.

Ilumya is excluded from coverage for the majority of UnitedHealthcare benefits.

3required preferred self-administered injectable trials before Ilumya

12 monthsauthorization duration on approval

Ilumya excludedcoverage exclusion for majority of benefits

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Coverage Criteria for Ilumya (tildrakizumab)

Initial Therapy — Covered when ALL of the following are met for plaque psoriasis

Covered when ALL of the following are met for plaque psoriasis:

Plaque Psoriasis Initial Approval

Preferred products list: One of the preferred adalimumab products OR Cimzia (certolizumab) OR Cosentyx (secukinumab) OR Enbrel (etanercept) OR Skyrizi (risankizumab) OR Sotyktu (deucravacitinib) OR One of the preferred ustekinumab products OR Tremfya (guselkumab)select 3 distinct agents
List comes from policy; see drug coverage tools for specific preferred product names.

Infused medications are explicitly excluded from the step therapy criteria and are not considered when assessing trials required prior to coverage of Ilumya. UnitedHealthcare requires members to try preferred self‑administered injectable products; infusion therapies should not be used to meet that requirement. Additionally, Ilumya is excluded from coverage for the majority of UnitedHealthcare benefits, which limits the applicability of the criteria to benefit designs where Ilumya coverage is available.

The policy does not provide separate "not medically necessary" language, but the explicit exclusion — Ilumya is excluded from coverage for the majority of our benefits — indicates the criteria apply only in benefit designs that permit Ilumya coverage. Where the exclusion applies, the step therapy requirements will not be relevant because Ilumya is not covered.

Claims and Authorization Coding

Claims/diagnosis codes referencedmixed

ICD-10

diagnosis codes may be used for automated approval/re-approval processes

inv-05: Authorization duration

Authorization durationApprovals are issued for 12 months

Impacting factorsState mandates, federal requirements, and member-specific benefit plans may affect coverage

Related programsOther policies and utilization management programs may apply to approvals

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Approvals will be issued for 12 months. State mandates, federal requirements, and the member-specific benefit plan may affect coverage criteria.

Approval duration: 12 months
State/federal mandates and member benefit plans may modify requirements

Step Therapy

Step Therapy Requirement

Member must have a documented history of failure, contraindication, or intolerance to three preferred self-administered injectable products prior to coverage for Ilumya (tildrakizumab). Trials must include drug name, dates, and duration.

Required trials: three preferred self-administered injectable products
Preferred products include (but are not limited to): one preferred adalimumab product, Cimzia (certolizumab), Cosentyx (secukinumab), Enbrel (etanercept), Skyrizi (risankizumab), Sotyktu (deucravacitinib), one preferred ustekinumab product, Tremfya (guselkumab)

Initial Therapy

Initial therapy — Initial coverage criteria for Ilumya

Initial coverage criteria for Ilumya

Initial approval for Ilumya: History of failure, contraindication, or intolerance to three preferred self-administered injectable products from the specified list with documentation of drug, date, and duration of trial.3 agents

Preferred lists referenced in drug coverage tools.

Re-authorization / Continuation Criteria

Re-authorization — Re-authorization rules for ongoing approval

Re-authorization rules

Re-authorization: Authorization will be issued for 12 months; UnitedHealthcare may approve initial and re-authorization based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.12 months

State mandates, federal requirements, and member-specific benefit plans may impact coverage; automated approval processes may vary by program.

Step Therapy Requirement Details

Step	Required prior agents (self-administered injectables from preferred list)	Documentation required	Coverage status
1	Member must have a history of failure, contraindication, or intolerance to three distinct preferred self-administered injectable products selected from: one of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Skyrizi (risankizumab); Sotyktu (deucravacitinib); one of the preferred ustekinumab products; Tremfya (guselkumab).	Document drug name, date, and duration of each trial demonstrating failure, contraindication, or intolerance for each of the three preferred products.	Coverage allowed with criteria

Site of Care and Administration

Note

Site‑of‑care: infused meds excluded from step

Infused medications are excluded from the step therapy requirement; only self‑administered injectable preferred products count toward the three required trials.

Background

Ilumya (tildrakizumab) is an interleukin‑23 (IL‑23) antagonist indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. UnitedHealthcare's step therapy program requires a documented history of failure, contraindication, or intolerance to three preferred self‑administered injectable products before Ilumya will be approved; infused medications are not counted toward that requirement.

Definitions

inv-11: Step therapy definition

DefinitionStep therapy requires a member to try and document failure, contraindication, or intolerance to three preferred self‑administered injectable products before Ilumya (tildrakizumab) will be approved

Excluded productsInfused medications are excluded from the step therapy requirement

Documentation neededDocument drug name, dates, and duration of each trial demonstrating failure, contraindication, or intolerance

Preferred product listPreferred products referenced in the drug coverage tools — examples include preferred adalimumab products, ustekinumab products, Cimzia, Cosentyx, Enbrel, Skyrizi, Sotyktu, Tremfya