Currentmedical mutual - ohioPolicy N/A

Ilumya (tildrakizumab-asmn) — Coverage Criteria (Plaque Psoriasis)

Defines prior authorization, coverage criteria, dosing, and documentation for Ilumya (tildrakizumab-asmn) for adults with moderate to severe plaque psoriasis under Medical Mutual of Ohio; applies to medical benefit requests and site-of-care management.

Policy Summary

Payermedical mutual - ohio

PolicyIlumya (tildrakizumab-asmn) — Coverage Criteria (Plaque Psoriasis)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateAug 21, 2025

Key ActionSubmit prior authorization with documentation of prior therapies and clinical benefit; initial therapy requires trial of ≥1 traditional systemic agent for ≥3 months unless intolerant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 mgsingle-use syringe strength

Wk0,4 then Q12Wdosing schedule

90d / 1yrapproval durations

TB screeningpre-initiation test

≥18minimum age

Policy Summary

Payermedical mutual - ohio

PolicyIlumya (tildrakizumab-asmn) — Coverage Criteria (Plaque Psoriasis)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateAug 21, 2025

Key ActionSubmit prior authorization with documentation of prior therapies and clinical benefit; initial therapy requires trial of ≥1 traditional systemic agent for ≥3 months unless intolerant.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

FDA-Approved Indication — Plaque Psoriasis

Covered when ONE of the following is met:

Root: Patient meets A (Initial Therapy) OR B (Currently Receiving Ilumya)

A. Initial Therapy: Patient meets ALL of the following (i, ii, iii)

A.i Age: Patient is ≥ 18 years of age

A.ii Prior therapies: One of: (a) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; a 3-month PUVA trial counts) OR (b) patient has a contraindication to methotrexate as determined by the prescriber

Exception: a prior 3-month trial or intolerance to at least one biologic other than the requested drug can substitute for the traditional systemic agent requirement; a biosimilar of the requested biologic does not count.

A.iii Prescriber: Medication is prescribed by or in consultation with a dermatologist

B. Patient Currently Receiving Ilumya: Patient meets ALL of the following (i, ii, iii)

B.i Established therapy: Patient has been established on Ilumya therapy for at least 90 days

Patients with <90 days or who are restarting are reviewed under Initial Therapy (A).

B.ii 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

B.iii Symptom improvement: Patient experienced improvement in at least one symptom (e.g., decreased pain, itching, and/or burning) compared with baseline

Dosing and Approval Duration

Dosing must meet the following:

Dosing: 100 mg subcutaneously at Weeks 0 and 4, then once every 12 weeks (Q12W) thereafter; should be administered by a healthcare professional

Initial Approval: Initial approval duration = 3 months (90 days)

Extended Approval: Extended approval duration = 1 year (365 days)

Duration of Therapy: Indefinite

Ilumya should not be administered concurrently with other biologic therapies or with targeted synthetic DMARDs for the treatment of inflammatory conditions. Combination therapy with multiple biologic or targeted synthetic agents is generally discouraged because studies do not demonstrate additive efficacy and there is a potential for a higher rate of adverse effects when agents are combined. The policy does note an exception for use with methotrexate (MTX), which may be used in combination with Ilumya when clinically indicated.

Coverage is not recommended for indications or circumstances that are not explicitly listed in the Recommended Authorization Criteria. The policy will be updated as new published data become available; requests for uses outside the listed criteria are not supported by the current evidence and therefore are not approved under this policy.

Use of Ilumya in combination with other biologics or targeted synthetic DMARDs for inflammatory conditions is considered inappropriate. Combination regimens (other than with methotrexate) are not recommended because of the lack of demonstrated additive benefit and the increased potential for adverse events when multiple immunomodulatory agents are used concurrently.

Provider Actions, Prior Authorization, and Site-of-Care

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ilumya (HCPCS J3245). Requests that meet the criteria in this policy may be approved; requests that do not meet criteria will be forwarded for physician review. Claims submitted with HCPCS J3245 will pend with Remark Code M3M or M4M and be adjudicated per the Corporate Medical Policy.

Prior authorization required for Ilumya (HCPCS J3245).
Claims with HCPCS J3245 will pend with Remark Code M3M or M4M.

Billing Rule

Site-of-Care and Medication Sourcing

Initial and renewal requests for the medication listed in this policy are subject to site-of-care management and medication sourcing. When billed under the medical benefit, administration is restricted to non-hospital facility-based locations unless the member meets site-of-care exception criteria.

Administration restricted to non-hospital facility-based locations unless exception criteria met.
Applies to both initial and renewal requests.

Step Therapy

Step Therapy Requirement

Initial therapy requires a trial of at least one traditional systemic agent for psoriasis for a minimum of 3 months unless the patient is intolerant or has other exceptions (e.g., contraindication to methotrexate or prior biologic trial as specified). Examples of traditional systemic agents include methotrexate, cyclosporine, or acitretin; a 3-month trial of PUVA also counts.

Step requirement: ≥ 1 traditional systemic agent for ≥ 3 months (e.g., methotrexate, cyclosporine, acitretin, or PUVA).
Exceptions: intolerance, contraindication to methotrexate, or prior 3-month trial/intolerance to a biologic (biosimilars do not count).

Documentation Required

Documentation and Denial Conditions

The Company may request additional documentation to support medical necessity and reserves the right to deny reimbursement when services are not medically necessary, investigational/experimental, or outside the member's benefits. Requested documentation may include patient records, test results, and provider credentials.

Additional documentation supporting medical necessity must be provided upon request (e.g., records, test results, provider credentials).
Denial may result if services are not medically necessary, investigational/experimental, or not within member benefits.

Documentation Required

Renewal Documentation Requirements

For continuation or renewal of Ilumya, documentation must show the patient has been established on therapy for at least 90 days and has experienced a beneficial clinical response compared with baseline. Clinical benefit should include improvement in at least one of: estimated body surface area, erythema, induration/thickness, scale, or symptoms (e.g., decreased pain, itching, burning).

Documentation must confirm ≥ 90 days on therapy for continuation requests.
Provide objective or documented clinical improvement in BSA, erythema, induration/thickness, scale, or symptoms versus baseline.

J3245	Ilumya prior approval HCPCS (listed)
J3590	HCPCS J-code mentioned in header
C9399	HCPCS C-code mentioned in header

OpenPayer

Ilumya (tildrakizumab-asmn) — Coverage Criteria (Plaque Psoriasis)

Coverage Criteria for Ilumya (tildrakizumab-asmn)

Coding and Billing Codes

Provider Actions, Prior Authorization, and Site-of-Care

Background

Definitions