CurrentCignaPolicy IP0659

Ilumya Prior Authorization Policy

Defines Cigna's prior authorization, coverage criteria, dosing, and coding for Ilumya (tildrakizumab-asmn) for treatment of moderate to severe plaque psoriasis in adults.

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; initial approvals are 3 months and continuation approvals up to 1 year when criteria for ongoing benefit are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age for coverage

3 moinitial approval

1 yrmaintenance approval

100 mgdose per injection

J3245billing code

Coverage Criteria for Ilumya (tildrakizumab-asmn)

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FDA-Approved Indication — Plaque Psoriasis

Approve when ONE of the following is met:

Overall options

A) Initial Therapy
- Age: Patient is ≥ 18 years of age
- Prior therapy: Patient meets ONE of: a) tried ≥ 1 traditional systemic agent for psoriasis for ≥ 3 months (examples: methotrexate, cyclosporine, acitretin; a 3-month trial of psoralen plus ultraviolet A light [PUVA] also counts) OR exception if patient had a 3-month trial or intolerance to at least one biologic other than the requested drug (a biosimilar does not count); OR b) contraindication to methotrexate as determined by the prescriber
- Prescriber specialty: Medication is prescribed by or in consultation with a dermatologist
B) Currently Receiving Ilumya
- Established therapy: Patient has been established on therapy for at least 3 months
  Patients with <3 months or restarting are reviewed under Initial Therapy
- Clinical response: 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
- Symptom improvement: Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, and/or burning)
Dosing: Dose is 100 mg given as a subcutaneous injection; doses administered at Weeks 0 and 4, then not more frequently than once every 12 weeks
Requests for doses outside established dosing considered case-by-case

Supplemental Appendix — Related therapies

Appendix reference: Lists related therapies, mechanisms, formulations, and indication acronyms that supplement the main policy's coverage criteria.

Not an all-inclusive list; refer to prescribing information for FDA-approved indications.

Ilumya (tildrakizumab) is not covered for indications other than plaque psoriasis. The policy specifically states that Ilumya for any other use is considered not medically necessary. In addition, the policy prohibits concurrent administration of Ilumya with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition; conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) may be used in combination and are not excluded by this statement.

The appendix provides examples of related biologic and targeted oral agents but is not an all‑inclusive list of indications or products. For authoritative information on approved indications, dosing, and formulation, refer to each agent's prescribing information as noted in the appendix.

Concurrent use of Ilumya with another biologic agent or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary. The rationale provided is that combination therapy is generally not recommended because of a potentially higher rate of adverse events and a lack of controlled clinical data demonstrating additive efficacy; the policy therefore disallows such combinations while allowing concomitant use of conventional synthetic DMARDs.

The appendix material does not contain additional, separate explicit "Not Medically Necessary" statements beyond those in the main exclusions section; it serves to list related agents, mechanisms, formulations, and indication acronyms and directs readers to prescribing information for FDA‑approved uses.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Preferred Product / Step Requirements

Prior Authorization is required. Initial approvals are time-limited (see policy header) and extensions may be granted when continuation criteria are met. Providers must follow referenced Inflammatory Conditions Preferred Specialty Management Policies (PSM001, PSM002, PSM017) — preferred product and step-therapy requirements in those policies must be met before approval of non-preferred products will be considered.

Prior authorization required
Initial approval: 3 months (per indication criteria)
Continuation approvals: up to 1 year when continuation criteria met
Refer to Inflammatory Conditions Preferred Specialty Management Policies (PSM001, PSM002, PSM017) for preferred product and step requirements

Documentation Required

Required Clinical Documentation

Document the clinical rationale and attach supporting records. At a minimum, include patient age, diagnosis, specialty of the prescribing clinician (or documentation of consultation), prior therapies tried (including dates, durations, and reasons for discontinuation or intolerance), and objective evidence of clinical response for continuation requests.

Required documentation: patient age and diagnosis
Prescriber specialty or consultation note
Prior therapy details: agents, formulation, dates, duration, and intolerance/contraindication
For continuation: documentation of clinical response or ongoing benefit

Note

Appendix: Related Therapies and How to Use It

Appendix lists related biologic and oral immunomodulatory therapies by agent name, formulation (SC, IV, oral), mechanism of action, and common abbreviated indications to inform prior therapy and step determinations. Use the appendix to identify prior biologics or oral agents when documenting treatment history or meeting step/biologic-failure requirements.

Appendix enumerates agents, formulations (SC, IV, oral), mechanisms (e.g., IL inhibitors, JAK/TYK2 inhibitors, S1P modulators, PDE4 inhibitors, integrin antagonists), and indication acronyms (PsO, PsA, RA, CD, UC, AD, etc.)
Appendix groups multiple agents by mechanism and indication which may inform step therapy or prior biologic failure requirements
Appendix is not an all-inclusive list; refer to prescribing information for FDA-approved indications

Denial Risk

Denial Triggers and Billing Risks

There are no explicit denial triggers listed in the appendix. However, claims submitted without covered diagnosis/procedure codes or without appropriate HCPCS/CPT codes will be denied as not medically necessary per Coding Information and Instructions for Use.

No appendix-specific denial triggers provided
Claims lacking covered diagnosis/procedure or appropriate billing codes will be denied as not covered/not medically necessary

Definitions and Key Terms

Ilumya (tildrakizumab-asmn) — drug descriptor

ClassInterleukin-23 (IL-23) blocker

FDA‑approved indicationTreatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Dosing schedule100 mg subcutaneous (SC) injection at Weeks 0 and 4, then every 12 weeks thereafter

AdministrationAdministered by a healthcare professional; safety and efficacy not established in patients < 18 years

Policy referenceCoverage Policy Number: IP0659

Beneficial clinical response (continuation therapy) — criteria

Required duration on therapy for continuationPatient has been established on Ilumya for at least 3 months

Objective clinical improvementImprovement from baseline in at least one of: estimated body surface area (BSA), erythema, induration/thickness, and/or scale

Symptom improvementCompared with baseline, improvement in at least one symptom (e.g., decreased pain, itching, and/or burning)

Approval duration when continuation criteria metApprove for up to 1 year

Acronym glossary

SCSubcutaneous

IVIntravenous

TNFTumor necrosis factor

PsOPlaque psoriasis

JAKJanus kinase

DMARDDisease-modifying antirheumatic drug

OpenPayer

Ilumya Prior Authorization Policy

Coverage Criteria for Ilumya (tildrakizumab-asmn)

Billing and Coding

Provider Actions, Authorization, and Documentation

Background

Definitions and Key Terms