CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ilumya (tildrakizumab) — Coverage Criteria for Moderate to Severe Plaque Psoriasis

Covers medical necessity and utilization requirements for Ilumya (tildrakizumab) prescribed for adults with moderate to severe plaque psoriasis, including initial and continuation authorization, dosing, quantity limits, and prior-treatment requirements for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIlumya (tildrakizumab) — Coverage Criteria for moderate to severe plaque psoriasis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, age ≥18, pretreatment TB screening, specialist prescription/consultation, and required prior treatment history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum patient age for coverage

12 moauthorization duration

100 mgstandard dose

J3245applicable HCPCS/CPT code

100 mg/12 wks

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Coverage Criteria for Ilumya (tildrakizumab)

Initial Therapy

Covered when ALL of the following are met:

Initial coverage criteria: Patient has a diagnosis of moderate to severe plaque psoriasis.

Initial coverage criteria: Patient is 18 years of age or older.

Initial coverage criteria: Pretreatment tuberculosis (TB) screening performed with a TB skin test or an interferon gamma release assay (e.g., QFT-GIT, T‑SPOT TB).

Initial coverage criteria: Prescribed by, or in consultation with, a specialist in dermatology or rheumatology.

Initial coverage criteria: Psoriasis affects relevant areas (e.g., genitals/groin, intertriginous areas).

Prior systemic or phototherapy treatment: Member has had an inadequate response to at least a 3-month trial of methotrexate, cyclosporine, or acitretin OR has experienced clinically significant adverse effects from these agents.

See Appendix A for examples of adverse effects or contraindications.

Prior systemic or phototherapy treatment: Member has had an inadequate response to at least a 3-month trial of phototherapy (e.g., UVB, PUVA), unless phototherapy intolerance is documented.

Prior biologic therapy when applicable: When applicable, member has had inadequate response, intolerance, or contraindication to at least a 3-month trial of adalimumab and at least a 6-month trial of ustekinumab biosimilar at maximum tolerated doses.

Continuation of Therapy

Authorization of 12 months may be granted for members using Ilumya who achieve or maintain positive clinical response when ANY of the following are met:

Continuation criteria: Improvement in signs and symptoms from baseline (e.g., itching, redness, scaling, burning, cracking, pain, flaking).

Documentation of clinical improvement required for continuation (e.g., symptom improvement).

Continuation criteria: Reduction in body surface area (BSA) affected from baseline.

Documentation of reduced BSA or low disease activity required for continuation.

Use of tildrakizumab (Ilumya) for dosing regimens or indications that are not recognized as medically accepted per standard compendia is excluded from coverage. Therapies used at doses or for conditions outside recognized indications in compendia such as AHFS, Micromedex DrugDex/Clinical Pharmacology, or Lexi-Drugs are considered investigational and are not covered.

Requests for Ilumya that propose use not supported by recognized compendia or peer‑reviewed medical literature will be considered investigational and are not covered. Coverage is limited to indications and dosing supported by standard reference compendia or sufficient peer‑reviewed evidence.

Coding and Dosing Information

Applicable HCPCS/CPT CodesHCPCSCovered

J3245

Injection, tildrakizumab, 1 mg

Dose and quantity limits — Ilumya (tildrakizumab)

Standard loading and maintenance dosing100 mg subcutaneously at Week 0 and Week 4 (loading), then 100 mg every 12 weeks (maintenance)

Administrative quantity limitQuantity limit: 100 mg per 12 weeks

Post‑limit allowance for loading dosePost‑limit allowance: loading dose of 200 mg (2 mL) per month

Billing/unit noteMaximum dosing billable unit = 1 mg; loading recorded as 100 units (100 mg) at Week 0 & 4; maintenance recorded as 100 units (100 mg) every 12 weeks

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals and continuation authorizations are typically granted for 12 months when all clinical criteria are met.

Initial coverage duration: 12 months
Continuation coverage duration: 12 months

Documentation Required

Requests must include complete documentation to avoid denial or delay. Required documentation includes: diagnosis of moderate to severe plaque psoriasis, patient age (≥18 years), pretreatment TB screening results (TB skin test or interferon-gamma release assay such as QFT‑GIT or T‑SPOT TB), and prescription or consult from a dermatology or rheumatology specialist.

Diagnosis and patient age (≥18)
Pretreatment TB screening (TB skin test or IGRA)

Definitions

Moderate to severe plaque psoriasis — diagnostic and severity criteria

Required diagnosisDocumented diagnosis of moderate to severe plaque psoriasis

Minimum agePatient is 18 years of age or older

Affected areas notedInvolvement may include genitals/groin and intertriginous areas

Pretreatment screeningPretreatment TB screening required (TB skin test or interferon gamma release assay)

Prescriber requirementPrescribed by, or in consultation with, a dermatology or rheumatology specialist

Prior treatment requirementsInadequate response to ≥3‑month trial of methotrexate, cyclosporine, or acitretin OR ≥3‑month trial of phototherapy (unless intolerant); additional requirements apply for prior biologics per policy

Background

This policy addresses use of tildrakizumab (Ilumya), an IL‑23p19 inhibitor, for adults with moderate to severe plaque psoriasis. Coverage is limited to members meeting the policy’s medical necessity criteria (including age ≥18, pretreatment TB screening, specialist involvement, and prior-treatment requirements). The recommended dosing is a loading regimen of 100 mg at Week 0 and Week 4 followed by 100 mg every 12 weeks, with administrative quantity limits applied; investigational or off‑label uses not supported by standard compendia or peer‑reviewed literature are not covered.