ModifiedmhnPolicy CP.PHAR.386

Tildrakizumab (Ilumya) for plaque psoriasis

Policy governing medical necessity criteria, dosing, and coverage limitations for tildrakizumab-asmn (Ilumya) for adults with moderate-to-severe plaque psoriasis under the payer's Medicaid line of business.

Policy Summary

Payermhn

PolicyTildrakizumab (Ilumya) for plaque psoriasis

Policy CodePolicy CP.PHAR.386

Change TypeCoding additionstep-therapy and duration updates

Effective DateMay 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets initial approval criteria, including prior drug trials and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J3245 (tildrakizumab) to coding section.

Reiterated requirement against combination use with a biologic DMARD or JAK inhibitor and moved that requirement to earlier sections.

Updated preferred adalimumab product list and added multiple biosimilars and alternative biologics to Section III.B over successive SDC and annual reviews.

Extended initial approval durations to 12 months for chronic conditions and allowed bypass of conventional therapies if member failed a biologic agent.

100 mgrecommended maintenance dose

12 monthsapproval duration

18+age requirement

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prohibitedcombination use

Coverage Criteria

Continuation Therapy

Covered for continuation when ALL of the following are met:

Plaque Psoriasis Continued

1. Member is currently receiving medication via the Health Plan benefit or previously met the Initial Approval criteria; OR member is receiving medication and is enrolled in continuity-of-care per state/product regulations.
2. Member is responding positively to therapy (clinical improvement documented).
3. No combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors.
4. If the request is for a dose increase, the new dose does not exceed 100 mg every 12 weeks.

General medical necessity

Covered when policy-defined criteria and prior authorization requirements are met

General coverage conditions: Coverage requires prior authorization and documentation of medical necessity per Health Plan policy; providers should reference current coding guidance and maintain supporting documentation.

Initial approval durations for chronic conditions have been extended to 12 months; preferred-product and step therapy rules (including allowed bypass of conventional therapies if the member has failed a biologic agent) apply as updated.

Restrictions

Prohibition of combination use with a biologic DMARD or a JAK inhibitor (combination therapy is not authorized/not medically necessary).
Coverage and coding determinations are subject to Health Plan benefit terms, state and federal requirements, and up-to-date professional coding guidance; inclusion of codes in the policy does not guarantee coverage (see HCPCS J3245 for tildrakizumab).

Prior authorization and approval duration

Non–FDA approved indications for tildrakizumab are not addressed by this policy unless an off‑label use is supported by the payer's off‑label use policy (CP.PMN.53) or other applicable evidence of coverage documentation. In addition, the policy prohibits combination use with other biologic disease‑modifying antirheumatic drugs or potent immunosuppressants because of the potential for additive immunosuppression, increased risk of neutropenia, and a higher risk of serious infections.

Combination use of tildrakizumab with a biologic DMARD or a JAK inhibitor is explicitly prohibited; this requirement has been reiterated and moved into the earlier sections of the policy to guide coverage determinations and prior authorization reviews.

Use of tildrakizumab in combination with other biologic DMARDs or JAK inhibitors is considered medically inappropriate and not authorized due to the risk of additive immunosuppression and associated increased risk of serious infections and neutropenia.

The policy reiterates that concurrent administration of tildrakizumab with other biologic therapies or JAK inhibitors is not permitted. This prohibition has been reaffirmed in coding and clinical sections to ensure prescribers and claims reviewers apply a consistent denial trigger when combination therapy is submitted.

Coding

HCPCS CodesHCPCS

J3245

Injection, tildrakizumab, 1 mg

Therapeutic alternatives / comparator agents (informational)mixed

Taltz (ixekizumab)	Example comparator biologic — dosing regimen and maintenance noted
Otezla (apremilast)	Oral comparator — dosing regimen and maintenance noted
Ustekinumab (various products)	Comparator biologic — weight-based dosing listed
Adalimumab products (various biosimilars/brands listed)	Comparator TNF inhibitor — dosing listed

HCPCS CodesHCPCS

J3245

Injection, tildrakizumab, 1 mg

BSA threshold

BSA threshold>= 3% total body surface area

Alternative special-site criterionInvolvement of hands, feet, scalp, face, or genital area qualifies as moderate-to-severe disease

Age applicability for BSA criterionApplies within initial approval criteria for adults (age >= 18 years)

Initial approval duration

Initial approval duration12 months for chronic conditions

Maintenance dosing interval referencedMaintenance dose: 100 mg SC every 12 weeks

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tildrakizumab (HCPCS J3245) and related biologic products listed in this policy. Submit PA requests prior to initiation of therapy to avoid claim denials or retrospective review.

Prior authorization required for tildrakizumab (J3245).
PA may also be required for comparator biologics and systemic agents listed in criteria.

Step Therapy

Step Therapy / Preferred Products

Step therapy applies for plaque psoriasis: members must have documented failure, intolerance, or contraindication to specified conventional systemic agents before approval of tildrakizumab, unless the member previously failed a biologic (bypass allowed). Preferred biologic products and bypass rules are described in the clinical criteria.

Step therapy requires trials of methotrexate and cyclosporine or acitretin (or phototherapy when appropriate) per Section I.
If member has not tried Taltz, failure of Taltz is required; if Taltz failed, additional requirement of trial/failure of an adalimumab product, Otezla/Otezla XR, and a ustekinumab product applies.

Background

Tildrakizumab‑asmn (Ilumya) is an interleukin‑23 (IL‑23) inhibitor indicated for adults with moderate‑to‑severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The policy defines moderate‑to‑severe disease as involvement of >= 3% total body surface area or involvement of special areas (hands, feet, scalp, face, or genital region). Recommended dosing is 100 mg subcutaneously at weeks 0 and 4, then 100 mg every 12 weeks, and prior authorization (HCPCS J3245) is required with initial approvals commonly extended to 12 months for chronic conditions.

Definitions

Moderate-to-severe plaque psoriasis — BSA and special-site definition

Definition of moderate-to-severe plaque psoriasis (BSA)>= 3% total body surface area

Special-site involvementDisease involving hands, feet, scalp, face, or genital area qualifies as moderate-to-severe

Age requirement for diagnosisApplies to adults aged >= 18 years as part of initial approval criteria

Clinical policy purpose — medical necessity guidance

Primary purposeProvide a guide to medical necessity to assist in making coverage decisions and administering benefits

Not a contractDoes not constitute a contract or guarantee regarding payment or results; coverage subject to plan terms and state/federal requirements

Policy Summary

Payermhn

PolicyTildrakizumab (Ilumya) for plaque psoriasis

Policy CodePolicy CP.PHAR.386

Change TypeCoding additionstep-therapy and duration updates

Effective DateMay 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets initial approval criteria, including prior drug trials and prescriber specialty.

SourceLink

On This Page

Prior authorization is required for tildrakizumab (HCPCS J3245) and may be required for listed comparator biologics; providers must demonstrate the member meets the applicable clinical criteria and submit supporting documentation.

Initial and continuation approvals for chronic conditions have an approval duration of 12 months unless otherwise specified.

Initial dosing schedule100 mg SC at weeks 0 and 4 (per dosing guidance)

Bypass of conventional therapies allowed if member previously failed a biologic agent.

Documentation Required

Provider Must Submit Supporting Documentation

Providers must submit documentation to support that the member meets all approval criteria. Include clinical evidence such as office chart notes, relevant laboratory results, prior treatment records, and dates/duration of prior therapy trials.

Include office visit notes documenting diagnosis, body surface area or involvement of critical areas (hands/feet/scalp/face/genital).
Provide records showing prescriber specialty (dermatologist or rheumatologist) and member age.
Document dates, doses, and durations of prior systemic therapies and biologics (e.g., methotrexate, cyclosporine, acitretin, Taltz, adalimumab products, Otezla, ustekinumab).

Documentation Required

Required Documentation & Coding

Maintain and make available medical records that demonstrate medical necessity for tildrakizumab. Coding guidance is informational only; include relevant HCPCS/CPT codes on claims and retain clinical documentation (office notes, labs, prior therapy history) to substantiate approval.

Reference coding guidance prior to claim submission.
Retain documentation of diagnosis, prior therapy trials, contraindications, or intolerances.
Document dosing regimen and monitoring per policy (100 mg at weeks 0 and 4, then 100 mg every 12 weeks).

Denial Risk

Lack of Documentation & Denial Triggers

Lack of required documentation or submission of unlisted/prohibited combination therapy information will likely result in denial. Missing elements include absence of diagnosis, missing prior therapy trials or dates, no prescriber specialty, or insufficient age verification.

Denial triggers include: missing diagnosis of moderate-to-severe plaque psoriasis (BSA or critical site involvement), no documentation of required prior conventional or biologic therapy trials, member age <18 for PsO, or prescriber not a dermatologist/rheumatologist.
Combination use with other bDMARDs or JAK inhibitors is not authorized and may trigger denial.
Use of unlisted codes without supporting clinical documentation may result in claim denial.

Clinical judgmentPolicy is not medical advice; providers are expected to exercise professional medical judgment