CurrentViva HealthPolicy IC-0358

Ilumya (tildrakizumab-asmn) for plaque psoriasis

Criteria and coverage rules for Ilumya (tildrakizumab-asmn) subcutaneous injections for adults with moderate-to-severe plaque psoriasis under Viva Health.

Policy Summary

PayerViva Health

PolicyIlumya (tildrakizumab-asmn) for plaque psoriasis

Policy CodePolicy IC-0358

Change TypeNo material changes

Effective Date

Next Review DateMar 4, 2025

Key ActionObtain prior authorization with documentation of indication, age ≥18, baseline severity, TB screen, vaccination status, and prior therapy trials when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization length

100 mgper dose (billable units)

every 12 weeksmaintenance dosing interval

≥18minimum patient age

L40.0covered diagnosis

Coverage Criteria for Ilumya (tildrakizumab)

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Initial Therapy - Plaque Psoriasis

Covered when ALL of the following are met

Age and baseline: Patient is at least 18 years of age; physician has assessed baseline disease severity using an objective measure/tool; patient is up to date with age-appropriate vaccinations prior to initiating therapy.

Infection and screening: Patient has been evaluated and screened for latent tuberculosis prior to initiating treatment and will receive ongoing TB monitoring; patient does not have an active infection; patient will not receive live vaccines during therapy.

Concomitant therapy: Patient is not on concurrent treatment with another biologic therapy or targeted synthetic therapy.

Disease severity for PsO: Documented moderate-to-severe plaque psoriasis for at least 6 months with at least one: involvement of at least 3% body surface area (BSA) OR PASI ≥ 10 OR incapacitation/serious emotional consequences due to plaque location or intractable pruritus.

Prior therapy trials for PsO: Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of topical agents; AND did not respond adequately (or is not a candidate) to a 3-month minimum trial of at least one non-biologic systemic agent; AND did not respond adequately (or is not a candidate) to a 3-month minimum trial of phototherapy.

For patients already established on biologic therapy, targeted synthetic therapy, or those with > 10% BSA involvement, trials of topical agents, non-biologic systemic agents, and phototherapy are not required.

Renewal Criteria - Plaque Psoriasis

Renewal covered when ALL of the following are met

Ongoing criteria: Patient continues to meet the universal and indication-specific criteria; absence of unacceptable toxicity (e.g., severe infections, severe hypersensitivity reactions).

Demonstrated response: Disease response demonstrated by improvement compared to baseline in signs and symptoms (e.g., redness, thickness, scaliness, and/or surface area involvement such as total BSA ≤ 1%) and/or improvement on disease activity scoring tools (e.g., PASI ≤ 3, PGA ≤ 1).

Dosage/Administration

Dose and administration

Dosing schedule: Administer 100 mg subcutaneously at Week 0 and Week 4, then 100 mg every 12 weeks thereafter; Ilumya should be administered by a health care provider only.

Loading = 100 billable units (100 mg) at Weeks 0 and 4; Maintenance = 100 billable units (100 mg) every 12 weeks. Ilumya billed as J3245 (Injection, tildrakizumab, 1 mg; 1 billable unit = 1 mg; 100 mg = 100 units).

Patients who do not have access to phototherapy are not automatically excluded. Lack of access will be evaluated on a case-by-case basis; the policy lists examples of contraindications and situations that may make phototherapy inappropriate (e.g., xeroderma pigmentosum, other photosensitive genodermatoses, pregnancy for PUVA, history of photosensitivity disorders, melanoma or extensive solar damage, immunosuppression, photosensitizing medications, severe organ disease, young age for PUVA, or anatomical ineligibility such as face, genital, scalp, or nail).

This appendix is intended for non‑Medicare coverage determinations. For Medicare beneficiaries, coverage for outpatient (Part B) drugs is governed by the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15 §50, and by any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Providers should follow those Medicare documents where they apply; the CMS Medicare Coverage Database may be searched for NCD/LCD/LCA documents at https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications or requirements may be applied at the discretion of the health plan.

Concurrent use of Ilumya with another biologic therapy or a targeted synthetic therapy is not allowed. The policy requires that the patient is not on concurrent treatment with another biologic or targeted synthetic agent as part of the universal criteria for initiation; such combination therapy would be considered not medically necessary and will prevent approval.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document the indication, patient age (≥18 years), baseline disease severity using an objective measure/tool, TB screening prior to initiation and ongoing monitoring plans, up-to-date vaccination status, and prior therapies (topical, non-biologic systemic, and phototherapy) including duration and reason for inadequate response or ineligibility.

Age: patient ≥ 18 years
Baseline severity: BSA, PASI, PGA, or other objective tool documented
TB: screen for latent TB before starting and have plan for ongoing monitoring
Vaccinations: patient up to date with age-appropriate vaccines before initiation
Prior therapies: documentation of trials and inadequate response or contraindication to topical (≥4 weeks), non-biologic systemic (≥3 months), and phototherapy (≥3 months) unless exempt (established biologic user or >10% BSA)

Documentation Required

Required Documentation and Exclusion Criteria

Providers must ensure documentation supports the diagnosis code L40.0 (psoriasis vulgaris), confirm absence of active infection, and verify patient will not receive concurrent biologic or targeted synthetic therapy or live vaccines during treatment.

Covered diagnosis: L40.0 (Psoriasis vulgaris)
Active infection: presence of active infection will preclude initiation
Concurrent therapy: concurrent biologic/targeted therapy will prevent approval
Vaccination during therapy: live vaccines must not be administered during treatment

Step Therapy

Step Therapy Requirements

Step therapy requirements apply for plaque psoriasis: document inadequate response or ineligibility to specified topical agents, at least one non-biologic systemic agent, and phototherapy as outlined; exemptions include patients already established on biologic/targeted therapy or those with >10% BSA.

Topical agents: ≥4-week trial required unless not a candidate
Non-biologic systemic: ≥3-month trial of at least one agent required unless not a candidate
Phototherapy: ≥3-month trial required unless not a candidate
Exemptions: established biologic users or >10% BSA — trials not required

Billing Rule

Billing and Administration

Billing/coding information: use HCPCS J3245 (injection, tildrakizumab, 1 mg). Dosage regimen: 100 mg subcutaneously at Week 0 and Week 4, then 100 mg every 12 weeks; administration by a health care provider is required.

HCPCS: J3245 — Injection, tildrakizumab, 1 mg (1 billable unit = 1 mg)
Dose: 100 mg SC at Week 0 and 4, then every 12 weeks
Administration: must be administered by a health care provider

Note

Medicare Policy Compliance

Medicare requirements may differ. Where applicable, follow Medicare Benefit Policy Manual Chapter 15 §50 and any relevant NCDs, LCDs, or LCAs. Consult the CMS coverage database for applicable Medicare coverage rules.

Medicare Part B: see Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50
Check NCDs/LCDs/LCAs for local Medicare coverage rules: https://www.cms.gov/medicare-coverage-database/search.aspx

Background

Ilumya (tildrakizumab-asmn) is an interleukin‑23 p19 monoclonal antibody indicated for adults with moderate‑to‑severe plaque psoriasis. Coverage is limited to patients aged ≥ 18 years who have had baseline disease assessment and TB screening prior to initiation, are up to date with age‑appropriate vaccinations, and do not have active infection or concurrent biologic/targeted synthetic therapy. The policy defines moderate‑to‑severe disease as documented plaque psoriasis for at least 6 months with criteria such as BSA ≥3%, PASI ≥10, or incapacitating disease by location, and it requires prior trials of topical therapy, at least one non‑biologic systemic agent, and phototherapy unless the patient is already on biologic/targeted therapy or has >10% BSA involvement. Ilumya dosing per the policy is 100 mg subcutaneously at Week 0 and Week 4, then 100 mg every 12 weeks thereafter; administration should be by a health care provider.

Definitions and Contraindications

Moderate-to-severe plaque psoriasis — definition

Minimum disease durationDocumented plaque psoriasis for at least 6 months

Objective severity criteria (any one)BSA ≥ 3% OR PASI ≥ 10 OR incapacitating/serious emotional consequences due to lesion location or intractable pruritus

Prior therapy requirementsFailed or is not a candidate for a 4‑week trial of topical agents, a 3‑month trial of at least one non‑biologic systemic agent, and a 3‑month trial of phototherapy (unless already on biologic/targeted therapy or >10% BSA)

Contraindications to phototherapy (PUVA or UVB)

Genetic photosensitivity disordersXeroderma pigmentosum and other rare photosensitive genodermatoses (e.g., trichothiodystrophy, Cockayne, Bloom, Rothmund‑Thomson)

Pregnancy/lactation (PUVA)Pregnancy or lactation contraindicates PUVA

History of photosensitivity or skin cancerPrior photosensitivity diseases, melanoma, non‑melanoma skin cancer, extensive solar damage, or prior arsenic/ionizing radiation exposure

Immunosuppression or genetic cancer riskImmunosuppression post‑organ transplant (UVB only) and genetic disorders increasing skin cancer risk (e.g., Gorlin syndrome, oculocutaneous albinism) (UVB only)

Photosensitizing medications and severe organ diseaseUse of photosensitizing medications (PUVA only) and severe liver, renal, or cardiac disease (PUVA only)

Age and anatomical limitationsYoung age < 12 years (PUVA only) and anatomical locations deemed ineligible for phototherapy (face, genital, scalp, or nail)

OpenPayer

Ilumya (tildrakizumab-asmn) for plaque psoriasis

Coverage Criteria for Ilumya (tildrakizumab)

Coding and Diagnosis Codes

Provider Requirements and Authorization Rules

Background

Definitions and Contraindications