CurrentCignaPolicy IP0659

Ilumya Prior Authorization Policy

Defines Cigna's prior authorization, coverage criteria, dosing, and coding for Ilumya (tildrakizumab-asmn) for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Applies to benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyIlumya Prior Authorization Policy

Policy CodePolicy IP0659

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and document age, prior therapies (≥1 traditional systemic agent trial ≥3 months or prior biologic intolerance), dermatologist involvement or consultation, baseline disease measures, and clinical response for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18Minimum age for coverage

3 monthsInitial auth duration

1 yearRenewal duration

100 mgDose per injection

Weeks 0,4, q12wDosing schedule

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Coverage Criteria for Ilumya (tildrakizumab)

Coverage criteria for plaque psoriasis (Initial and Continuation Therapy)

Ilumya is considered medically necessary for plaque psoriasis when the following criteria are met.

FDA-Approved Indication

A) Initial Therapy
- i: Patient is >= 18 years of age
- ii: Either: a) tried >=1 traditional systemic agent for >=3 months (e.g., methotrexate, cyclosporine, acitretin, or 3-month PUVA) unless intolerant; OR b) contraindication to methotrexate as determined by prescriber; note: exception if prior 3-month trial or intolerance to at least one biologic other than the requested drug
  A biosimilar of the requested biologic does not count; a patient who has tried a biologic is not required to 'step back' to a traditional systemic agent.
- iii: Medication is prescribed by or in consultation with a dermatologist
B) Patient Currently Receiving Ilumya
- i: Patient has been established on therapy for at least 3 months
  <3 months or restarting therapy is reviewed as Initial Therapy (A).
- ii: Patient experienced a beneficial clinical response defined as improvement from baseline in at least one of: estimated body surface area, erythema, induration/thickness, and/or scale
- iii: Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, and/or burning)

Dosing Requirements: Dose 100 mg subcutaneous injection at Weeks 0 and 4, then not more frequently than once every 12 weeks

The policy clarifies that concurrent use with conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) is not excluded and may be used in combination with Ilumya when clinically appropriate. However, the policy considers Ilumya for any other use outside plaque psoriasis — and concurrent administration with other biologics or with targeted synthetic oral small molecule drugs for inflammatory conditions — to be not medically necessary (see separate guidance on combination biologic or targeted therapy).

The appendix content does not list discrete exclusion conditions beyond the main policy statements. No additional, separate exclusion entries are provided in the appendix chunks for Ilumya.

The policy explicitly states that concurrent administration of Ilumya with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is considered not medically necessary due to potential for higher adverse events and lack of data supporting additive efficacy. The appendix lists examples of biologic and oral targeted agents (IL‑17 and IL‑23 inhibitors, JAK/TYK2 inhibitors, PDE4 inhibitors, etc.) to illustrate agents in those classes but does not alter the policy position that combination biologic/targeted therapy is not supported.

There are no standalone statements in the appendix labeling any uses of Ilumya or listed agents as explicitly labeled 'not medically necessary.' The policy’s not‑medically‑necessary determination regarding combination with other biologics or targeted small molecules is contained in the main Conditions Not Covered section rather than the appendix listings.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J3245

Injection, tildrakizumab, 1 mg

No codes listed in appendixmixed

No codes listed

Provider Actions, Prior Authorization, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Ilumya (tildrakizumab) requires prior authorization for benefit coverage. Initial approvals are typically for 3 months; continuation (patients currently receiving Ilumya) may be approved for up to 1 year when continuation criteria are met. Prescriptions should be by or in consultation with a specialist in the treated condition (e.g., dermatologist). Requests for doses outside the dosing documented in policy will be reviewed case-by-case by a clinician.

Initial approval: 3 months
Continuation approval: 1 year
Prescriber: specialist or in consultation with specialist
Dosing per policy: 100 mg SC at Weeks 0 and 4, then every 12 weeks

Step Therapy

Step Therapy / Preferred Product Requirement

Step therapy / preferred product requirement applies. This product requires use of preferred products before approval of the requested product per the Inflammatory Conditions Preferred Specialty Management Policy for the appropriate benefit/PBM formulary (PSM001, PSM002, or PSM017). Refer to the applicable preferred specialty management policy for required preferred agents and any exception rules.

Background

Ilumya (tildrakizumab-asmn) is an interleukin‑23 (IL‑23) inhibitor indicated for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is administered as a 100 mg subcutaneous injection at Weeks 0 and 4, then every 12 weeks thereafter. The policy requires prior authorization and specifies that therapy should be prescribed by or in consultation with a dermatologist. Safety and efficacy in patients <18 years have not been established. The appendix lists Ilumya among other biologic and oral agents by mechanism and indication to provide context for related therapies.

Definitions and Dosing

Ilumya dosing schedule — key facts

Dose per injection100 mg subcutaneous injection

Initial dosing scheduleWeeks 0 and 4

Maintenance frequencyThen not more frequently than once every 12 weeks (q12w)

RouteSubcutaneous (SC) administration by healthcare professional

Traditional systemic agent — examples and trial requirements

Examples of traditional systemic agentsMethotrexate, cyclosporine, acitretin

PUVA counts as a traditional systemic trial

Policy Summary

PayerCigna

PolicyIlumya Prior Authorization Policy

Policy CodePolicy IP0659

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

See: Inflammatory Conditions Preferred Specialty Management Policy (PSM001, PSM002, PSM017)
Preferred product requirement applies before Ilumya approval

Documentation Required

Required Documentation

Documentation requirements. Prescriber must document the patient’s age, prior therapies (including trials of traditional systemic agents or prior biologics), trial durations (e.g., 3-month trial of a traditional systemic agent unless intolerant), clinical response measures from baseline for continuation requests, and that the medication is prescribed by or in consultation with an appropriate specialist. Receipt of sample product does not satisfy criteria.

Document age (≥ 18 years for initial therapy)
Document prior therapy trials and durations (e.g., ≥ 3 months for traditional systemic agents) or contraindication to methotrexate
For continuation: document ≥ 3 months on therapy and clinical improvement vs baseline
Document specialist prescriber or consultation

Note

Ilumya Listing and Appendix Notes

Appendix listing: Ilumya is listed in the appendix as tildrakizumab (Ilumya) with mechanism noted as inhibition of IL-23 and indication of plaque psoriasis. The appendix provides examples of biologics and oral targeted agents but does not itself add step therapy or procedural prior authorization requirements beyond the main policy.

Ilumya (tildrakizumab) — Inhibition of IL-23; Indication: PsO (plaque psoriasis)
Appendix contains examples of other biologics and oral therapies but no additional step-therapy rules specific to Ilumya
No specific procedural prior authorization steps are specified in the appendix

Denial Risk

Denial Triggers

Denial triggers / risks. Requests will be denied or not medically necessary if: indication is other than plaque psoriasis, dosing or administration schedule does not match policy without supportive justification, concurrent use with another biologic or targeted synthetic oral small molecule therapy (combination therapy) is requested, or required preferred product/step therapy requirements have not been met.

Non‑approved indications (any use other than plaque psoriasis) are not covered
Concurrent use with other biologics or targeted synthetic oral small molecule drugs is not covered
Requests with dosing more frequent or otherwise outside documented dosing may be denied without clinical justification
Failure to meet preferred product / step therapy requirements may result in denial

A 3-month trial of psoralen plus ultraviolet A light (PUVA) also counts

Required trial durationAt least 3 months of a traditional systemic agent unless intolerant

Exception to trial requirementException if patient had a 3-month trial or intolerance to at least one biologic other than the requested drug

PsO — definition / abbreviation

AbbreviationPsO = plaque psoriasis

Usage in appendixAppendix lists PsO as indication for multiple agents (e.g., Ilumya)

ContextTerm used throughout appendices to denote plaque psoriasis in agent listings

Mechanism classes referenced in appendices

IL-23 inhibitorsListed for biologic therapies (e.g., Ilumya, Skyrizi, Tremfya)

IL-17 inhibitorsListed for biologic therapies (e.g., brodalumab, secukinumab, ixekizumab)

JAK inhibitorsListed for oral targeted synthetic therapies (e.g., tofacitinib, upadacitinib)

TYK2 inhibitorsListed for oral targeted synthetic therapies (e.g., deucravacitinib)

PDE4 inhibitorsListed for oral therapies (e.g., apremilast/Otezla)