Skip to main content
Shop Plans Learn more about our coverage options including health, Medicare, dental and vision options for you, your family or your employees. Get Started Individual & Family Medicare Employer Vision Dental International Travel Find Care FAQ Blog Members Stay on top of your health care with helpful member resources. Members Home Medicare Health Dental Vision Find Care Member Knowledge Center Member Forms Medicare Forms Library Make a Payment Federal Employees Student Blue Healthy Blue Providers Access tools, policies and the latest information to help you care for our members. Providers Home Network Participation Networks & Programs Claims, Appeals & Inquiries Prior Authorization Services & CPT codes Prescription Drug Search Forms and Documents Policies, Guidelines & Codes Provider News Provider FAQ Contact Us Employers Learn about our coverage options for small and large employers, and access tools and resources for your group. Employers Home Shop Employer Plans Employer Portal Support Member Forms & Resources Find Care Blog Agents Access the tools you need: rate quotes, applications, forms, the latest industry news, marketing materials and more. Agents Home Agent Services Check Eligibility Find Care Member Forms & Resources Medicare Forms Library
Contact Us
Log In
I am ... Please select A member A provider An employer An agent
Log in to Agent Services
Log in to Employer Services Register for Employer Services I'm registered but need portal access
Username Forgot username? Continue to Log In Register for Blue Connect Need help? Learn how to log in.
Log in to Blue e Register for Blue e Log in to Dental Blue
Back
Tildrakizumab-asmn (Ilumya®)
Commercial Utilization Management Policy
Version Date: September 2023

Restricted Product(s)

  • tildrakizumab-asmn (Ilumya®) subcutaneous injection for administration by a healthcare professional

FDA Approved Use

  • For adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Criteria for Medical Necessity

The restricted product(s) may be considered medically necessary when the following criteria are met:

  1. The patient has a diagnosis of moderate to severe plaque psoriasis (PS); AND
    1. The patient is 18 years of age or older; AND
    2. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months [medical record documentation required]; OR
    3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PS [medical record documentation required]; OR 
    4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PS [medical record documentation required]; OR
    5. The patient has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) [medical record documentation required]; OR
    6. The patient has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) [medical record documentation required]; AND
  2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist for PS) or has consulted with a specialist in the area of the patient’s diagnosis; AND
  3. The patient will NOT be using tildrakizumab-asmn (Ilumya®) in combination with another biologic immunomodulator agent or Otezla®; AND
  4. The patient does NOT have any FDA labeled contraindications to tildrakizumab-asmn (Ilumya®); AND
  5. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
  6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  7. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

    Duration of Approval: 365 days (1 year)

FDA Label Reference
Medication  Indication  Dosing  HCPCS  Maximum Units*

tildrakizumab-asmn (Ilumya®)

subcutaneous (SC) injection

PS in patients ≥ 18 years oldSC: 100 mg at weeks 0 and 4, then every 12 weeks thereafterJ3245600

*Maximum units allowed for duration of approval

*Site of Care Medical Necessity Criteria

  1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
  2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
    1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR
    2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR
    3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR
    4. Re-initiation of therapy, defined as ONE of the following:
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
    5. Requirement of a change in the requested restricted product formulation; AND
  3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References

All information referenced is from FDA package insert unless otherwise noted below.

  1. Menter A, Strober BE, Kaplan DH, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
  2. Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (resurface 1 and resurface 2): results from two randomized controlled, phase 3 trials. Lancet. 2017;390(10091):276-288.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

September 2023: Criteria change: Separated out intolerance/hypersensitivity criteria from FDA labeled contraindication criteria for clarity.
October 2021: Criteria change: Added Site of Care medical necessity criteria. Policy notification given 8/2/2021 for effective date 10/1/2021.
August 2021: Criteria change: Removed criterion point regarding medication history indicating use of another biologic immunomodulator agent FDA labeled for the treatment of the same condition. Policy notification given 6/1/2021 for effective date 8/1/2021.
June 2021: Criteria change: Medical record documentation required for all indications.
April 2021: Criteria change: Addition of criteria for history of use of another biologic immunomodulator agent (or Otezla) for the same indication; PS: BSA requirement changed to 10%, added option for concomitant severe PsA; added requirement that patient has no FDA labeled contraindications, and for TB testing; added maximum units; medical policy formatting change. Policy notification given 2/26/2021 for effective date 4/28/2021.
*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy
About Us Newsroom Blog Member Forms COVID-19 Transparency in Coverage Find Care Rights & Responsibilities Policies & Best Practices Privacy Policy Website User Agreement Fraud & Abuse Technical Information Contact Us Locations Careers

Disclosures:

BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. Blue Cross NC is an independent licensee of the Blue Cross and Blue Shield Association. All other marks are the property of their respective owners.

Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.

Information in other languages: Español   中文   Tiếng Việt   한국어   Français   العَرَبِيَّة   Hmoob   ру́сский   Tagalog   ગુજરાતી   ភាសាខ្មែរ   Deutsch   हिन्दी   ລາວ   日本語

© 2025 Blue Cross and Blue Shield of North Carolina. ®, SM Marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. All other marks and names are property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association.