ModifiedUnitedHealthcarePolicy 2025 P 3109-11

Ilumya® (tildrakizumab-asmn) - Step Therapy - UnitedHealthcare Commercial Plans

UnitedHealthcare commercial plans step therapy program requiring trial of three preferred self-administered injectable products before coverage of Ilumya for plaque psoriasis; excludes infused medications and notes Ilumya is excluded for the majority of benefits. Authorization issued for 12 months.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya® (tildrakizumab-asmn) - Step Therapy - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 3109-11

Change TypeModified (step therapy updates)

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionPrior authorization requires documentation that the member has failed, has a contraindication to, or is intolerant of three preferred self-administered injectable products (document drug, date, and duration of trial); authorization will be issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Effective 6/1/2025 the program requires members to try three preferred self-administered injectable products before coverage for Ilumya.

Ilumya is explicitly noted as excluded from coverage for the majority of benefits.

Infused medications are excluded from step therapy options.

Authorization duration set to 12 months.

3Required prior preferred agents

12 moAuthorization duration

Coverage exclusion prevalence (Ilumya)

2025-06-01Effective date

Summary of Material Changes

Effective 2025-06-01, the step therapy program requires members to trial three preferred self-administered injectable products before Ilumya (tildrakizumab-asmn) coverage for plaque psoriasis. Sotyktu was added as a step therapy agent in 10/2024 and, per 4/2025 updates, adalimumab examples were removed and wording for preferred ustekinumab was updated; Ilumya is explicitly noted as excluded from coverage for the majority of benefits. Authorization will be issued for 12 months.

Key program stats

Required prior preferred agents3

Authorization duration12 months

Coverage exclusion prevalence (Ilumya)majority

Effective date2025-06-01

Initial Approval Criteria — Plaque Psoriasis

Plaque Psoriasis - Initial approval criteria

Ilumya will be approved when ALL of the following are met:

ALL of the following

Indication: adult with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy (per Ilumya indication)
ALL of the following
- Preferred products list (each counts toward the required three)
  - One of the preferred adalimumab products
    For a list of preferred products please reference drug coverage tools.
  - Cimzia (certolizumab)

Diagnosis Codes & Automated Logic

ICD-10 diagnoses referenced for automated approval/reauthorizationICD-10

No codes listed

UnitedHealthcare may approve initial or re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; the use of these automated approval processes varies by program. Provider actions: Automated approval note.

What Providers Must Do

Prior Authorization

Step therapy prior authorization requirement

Prior authorization is required. The member must have failed, be contraindicated to, or be intolerant of three preferred self-administered injectable products; authorization will be issued for 12 months.

Documentation Required

Documentation of trials

Providers must document the drug name, date, and duration of trial for each of the three preferred products tried.

Key Definitions

Preferred products: Designated formulary agents (for lists of preferred products reference drug coverage tools).

Document Changes Timeline

2024-10modified

Added Sotyktu as a step therapy agent and updated step to three agents; Cosentyx moved to preferred step agent and adalimumab examples adjusted (no change to clinical intent).

2025-04modified

Removed adalimumab example products from the step therapy list and changed wording to 'One of the preferred ustekinumab products' with a footnote to reference preferred product lists.

2025-06-01addedLatest

Effective 6/1/2025 the program requires members to try three preferred self-administered injectable products before coverage for Ilumya (tildrakizumab); infused medications are excluded from step options and Ilumya is excluded from coverage for the majority of benefits.

Program Scope & Notes

Background: The step therapy program encourages use of lower cost alternatives and requires trial of three preferred self-administered injectable products before Ilumya coverage for plaque psoriasis. Ilumya is indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Infused medications are excluded from the step options. Authorization duration is 12 months. Applicability may vary by member benefit and Ilumya is excluded for the majority of benefits.

Policy Summary

PayerUnitedHealthcare

PolicyIlumya® (tildrakizumab-asmn) - Step Therapy - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 3109-11

Change TypeModified (step therapy updates)

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

Cosentyx (secukinumab)

Skyrizi (risankizumab)

Sotyktu (deucravacitinib)

One of the preferred ustekinumab products

For a list of preferred products please reference drug coverage tools.

Tremfya (guselkumab)

Infused medications for any of the conditions referenced are not part of the criteria (i.e., excluded from step options)

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Infused medications are excluded from step therapy options and do not count toward the required preferred product trials; only self-administered injectable products may satisfy the step requirement.

Billing Rule

Infused medications excluded from step options

Infused medications are excluded from the step therapy options and must not be used to satisfy the required three preferred self-administered injectable products.

Denial Risk

Coverage exclusion risk

Ilumya is excluded from coverage for the majority of benefits; claims may be denied if the member's benefit excludes Ilumya or if the step therapy criteria are not met.

Documentation Required

Automated approval note

Approvals and reauthorizations may be granted solely based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic through automated processes, which vary by program.