CurrentUnitedHealthcarePolicy N/A

Ilumya (tildrakizumab) prior authorization and medical necessity criteria

Defines UnitedHealthcare prior authorization, medical necessity, and reauthorization criteria for Ilumya (tildrakizumab) for adults with moderate to severe plaque psoriasis; affects providers seeking coverage for Ilumya under UnitedHealthcare benefits.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya (tildrakizumab) prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeRevised step therapy referencesclarified coverage exclusion

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionSubmit medical records documenting diagnosis, disease extent (e.g., >=3% BSA or special-site involvement), prior therapy trials including a 3-month methotrexate trial, and failures/intolerance to three preferred agents for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Removed examples for adalimumab in step therapy and changed Stelara step therapy language to 'One of the preferred ustekinumab products c'; added footnote to reference drug coverage tools for preferred products.

Updated step therapy requirements to specify one of the preferred adalimumab products and later removed the adalimumab examples while adding Sotyktu and moving Cosentyx to preferred step agent and changing step to three agents.

Noted that Ilumya is excluded from coverage for the majority of benefits.

12 moauthorization duration

>=3% BSAdisease extent threshold

3 agents

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Coverage Criteria for Ilumya (tildrakizumab)

Initial Authorization

Approved when ALL of the following criteria are met:

Disease extent: Greater than or equal to 3% body surface area involvement OR palmoplantar, facial, genital involvement OR severe scalp psoriasis>=3% BSA or special-site involvement
Prior topical therapy: History of failure to one of the following topical therapies unless contraindicated or intolerant: corticosteroids (e.g., betamethasone, clobetasol, desonide), vitamin D analogs (e.g., calcitriol, calcipotriene), tazarotene, calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar (document drug, date, and duration)
Methotrexate trial: History of failure to a 3-month trial of methotrexate at maximally indicated dose unless contraindicated or intolerant (document date and duration)3 months
Alternate pathway - prior targeted immunomodulator: Patient previously treated with a targeted immunomodulator FDA-approved for plaque psoriasis as documented by claims or medical records (document drug, date, and duration) (e.g., certolizumab, adalimumab, apremilast, risankizumab, ustekinumab, guselkumab)
Preferred product failures: History of failure, contraindication, or intolerance to three of the listed preferred products (document drug, date, and duration): one of the preferred adalimumab products; Cimzia (certolizumab); Cosentyx (secukinumab); Enbrel (etanercept); Skyrizi (risankizumab); Sotyktu (deucravacitinib); one of the preferred ustekinumab products; Tremfya (guselkumab)3 agents
Concomitant therapy: Patient is not receiving Ilumya in combination with another targeted immunomodulator

Ilumya (tildrakizumab) is excluded from coverage for the majority of UnitedHealthcare benefits. Providers should be aware that this exclusion is noted in the program listing and that supply limits may be in place when coverage is considered. Prior authorization language and program notes emphasize the exclusion status and reference potential quantity or supply restrictions.

Use of Ilumya in combination with another targeted immunomodulator is not permitted. The policy explicitly states that the patient must not be receiving Ilumya in combination with another targeted immunomodulator for both initial authorization and reauthorization, with examples provided of agents considered targeted immunomodulators (e.g., etanercept, certolizumab, adalimumab, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, and JAK inhibitors).

Clinical Thresholds and Coding-related Criteria

Body surface area or special-site involvement — Coverage Threshold

Disease extent threshold>= 3% body surface area (BSA) involvement OR palmoplantar, facial, genital involvement OR severe scalp psoriasis

Documentation requiredSubmit documentation of BSA or description of special-site involvement in medical records (chart notes, photos where available)

Related topical-therapy requirementAlso requires history of failure to at least one topical therapy unless contraindicated (document drug, dates, duration)

Methotrexate trial duration — Prior Therapy Requirement

Required methotrexate trial duration3 month trial at maximally indicated dose (unless contraindicated or intolerant)

Documentation specificsDocument drug name, start and end dates, and duration of methotrexate trial in medical records

What Providers Must Submit / Watch For

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit medical records (e.g., chart notes, laboratory values) documenting the diagnosis of chronic moderate to severe plaque psoriasis and all required clinical information.

Authorization issued for 12 months
Prescribed by or in consultation with a dermatologist

Step Therapy

Step Therapy / Preferred-Product Failures

Member must have history of failure, contraindication, or intolerance to three specified preferred systemic/biologic products before Ilumya is approved. Document the drug name, dates, and duration of each trial.

Examples of preferred products to document: preferred adalimumab product(s), certolizumab (Cimzia), secukinumab (Cosentyx), etanercept (Enbrel), risankizumab (Skyrizi), deucravacitinib (Sotyktu), preferred ustekinumab product(s), guselkumab (Tremfya)
For a current list of preferred products, reference drug coverage tools (see policy references)

Background on Ilumya

Ilumya (tildrakizumab) is an interleukin‑23 antagonist indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The policy background and prescribing information identify Ilumya by its mechanism and approved adult plaque psoriasis indication; program materials also note the drug’s formulary status and review history.

Key Definitions

Ilumya (tildrakizumab) — Definition and Indication

Drug class and indicationIlumya (tildrakizumab) — an interleukin-23 (IL-23) antagonist indicated for treatment of adults with moderate to severe plaque psoriasis

Patient populationAdults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Therapeutic roleSystemic biologic therapy targeting IL-23 pathway for plaque psoriasis management