CurrentCignaPolicy N/A

Inflammatory Conditions - Ilumya Prior Authorization Policy

Defines Cigna prior authorization requirements, coverage criteria, and limitations for Ilumya (tildrakizumab-asmn) for adults with plaque psoriasis, and specifies prescriber and documentation expectations for plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ilumya Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised criteria and clarifications

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with specialist prescription/consultation and document prior therapies or contraindications to support approval.

SourceLink

POLICY UPDATE CHANGES

For initial therapy, a 3-month trial or prior intolerance to Otezla/Otezla XR or Sotyktu was added as an exception to the requirement for a trial of one traditional systemic agent.

The wording allowing a prescriber-determined contraindication to methotrexate was modified to 'according to the prescriber, the patient has a contraindication to methotrexate'.

For patients currently receiving Ilumya, the timeframe 'established on therapy' is specified as at least 3 months.

≥18minimum age for initiation

3 monthsinitial approval

1 yearcontinuation approval

0,4,q12w

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ilumya Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised criteria and clarifications

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with specialist prescription/consultation and document prior therapies or contraindications to support approval.

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.

Coverage Criteria for Ilumya (tildrakizumab-asmn)

FDA-Approved Indication — Plaque Psoriasis

Ilumya is covered as medically necessary when the following criteria are met for plaque psoriasis.

Main paths: Approve when ONE of the following is met: A) Initial Therapy or B) Currently Receiving Ilumya

Top-level branching

A) Initial Therapy

i: Patient is >= 18 years of age>= 18 years
ii
- 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). Exception if patient already had a 3-month trial or intolerance to at least one biologic (other than the requested drug), Otezla/Otezla XR, or Sotyktu; a biosimilar of the requested biologic does not count>= 3 months
  Traditional systemic agents examples and exceptions per policy
- b: According to the prescriber, the patient has a contraindication to methotrexate
  Prescriber-determined contraindication
iii: Medication is prescribed by or in consultation with a dermatologist
Specialist requirement for initial therapy

B) Currently Receiving Ilumya

i: Patient has been established on therapy for at least 3 months>= 3 months
Defined timeframe for 'established on therapy'
ii: 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
Clinical response measure
iii: Compared with baseline, patient experienced improvement in at least one symptom (eg decreased pain, itching, and/or burning)
Symptom improvement requirement

Concurrent administration of Ilumya with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not supported by this policy. Combination therapy is generally not recommended because it may increase the risk of adverse events and there is a lack of controlled clinical data demonstrating additive benefit. Note that this policy does not prohibit use of conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine) in combination with Ilumya.

Use of Ilumya in combination with another biologic or a targeted synthetic oral small molecule agent for inflammatory conditions is considered not medically necessary under this policy. The policy cites safety concerns (potentially higher rates of adverse events) and insufficient controlled clinical evidence to support combination regimens. This restriction does not apply to conventional synthetic DMARDs.

Billing and Coding

No explicit CPT/HCPCS/NDC codes listedmixed

No codes listed

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization (PA) is required for coverage of Ilumya. Initial approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., dermatologist for plaque psoriasis). All approvals are for the duration specified in the policy; when expressed in months, 1 month = 30 days.

Prescriber: specialist or consultation required (e.g., dermatologist for plaque psoriasis).
All approvals routed per PA process and issued for the duration noted.

Step Therapy

Step-Therapy Requirement Before Biologic

Step requirement before biologic: For initial therapy of plaque psoriasis, patients must generally have tried at least one traditional systemic agent for ≥3 months (examples: methotrexate, cyclosporine, acitretin, or a 3-month PUVA trial) unless intolerant or contraindicated. An exception permits patients who have already had a 3-month trial or intolerance to at least one biologic (other than the requested drug), apremilast (Otezla/Otezla XR), or Sotyktu (deucravacitinib) to proceed without the traditional systemic agent. A biosimilar of the requested biologic does not satisfy the exception. Patients who previously tried a biologic, Otezla/Otezla XR, or Sotyktu are not required to 'step back' to a traditional systemic agent.

Background

Ilumya (tildrakizumab-asmn) is an interleukin-23 (IL-23) blocker approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is administered by subcutaneous injection according to the prescribing schedule (initial doses at Weeks 0 and 4, then every 12 weeks).

Because safety and efficacy of combination biologic or targeted synthetic therapy have not been established and combination use may increase adverse events, this policy restricts concurrent use with other biologic or targeted synthetic agents; conventional synthetic DMARDs remain an exception.

Drug and Term Definitions

Ilumya (tildrakizumab-asmn)

Drug classInterleukin‑23 (IL‑23) blocker

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

Route of administrationSubcutaneous injection

Dosing schedule (per PI)Administer at Weeks 0 and 4, then once every 12 weeks

Administration settingShould be administered by a healthcare professional

Pediatric useSafety and efficacy not established in patients < 18 years of age

Required trial: ≥1 traditional systemic agent for ≥3 months (methotrexate, cyclosporine, acitretin, or PUVA).
Exception: prior 3‑month trial or intolerance to ≥1 biologic (not including biosimilars), or prior trial/intolerance to Otezla/Otezla XR or Sotyktu.
If prescriber documents contraindication to methotrexate, the step requirement may be waived.

Documentation Required

Required Clinical Documentation

Required clinical documentation: Documentation must demonstrate prescriber specialty or consultation, evidence of prior therapies or documented contraindication/intolerance, and for continuation requests evidence of clinical benefit (improvement in body surface area, erythema, induration/thickness, scale, or symptoms such as pain/itching/burning compared with baseline). Baseline status and follow-up response measures should be available in the medical record for review.

Prescriber specialty or consultation note (e.g., dermatologist).
Documentation of prior systemic therapy trials (agents, durations) or documented intolerance/contraindication.
For continuation: record of at least 3 months on therapy and measurable clinical improvement versus baseline.

Denial Risk

Concurrent Biologic/Targeted Synthetic Use — Denial Risk

Concurrent use with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition is considered not medically necessary and may be denied. This does not apply to concomitant use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

Concurrent administration with another biologic is not allowed.
Concurrent administration with a targeted synthetic oral small molecule (e.g., JAK inhibitors, other targeted orals used for inflammatory conditions) is not allowed.
Concomitant use of conventional synthetic DMARDs is permitted.

Billing Rule

Billing/Coding and Plan Terms — Denial Risk

Billing and coding guidance: Claims for Ilumya must be submitted with appropriate covered diagnosis and procedure codes per the benefit plan. Failure to submit services with covered codes or to follow applicable benefit plan terms may result in claim denial. Use the most appropriate codes as of the date of service.

Submit services with covered diagnosis/procedure codes aligned to the member's benefit plan.
Claims lacking covered codes under the applicable coverage policy will be denied as not covered.
Follow any additional payer-specific billing instructions and the member's benefit plan terms.