Background

Tildrakizumab-asmn (Ilumya) is a recombinant humanized IgG1Κ monoclonal antibody that inhibits the interleukin-23 (IL-23) receptor that specifically binds to the p19 subunit of interleukin-23, thereby blocking the release of proinflammatory cytokines and chemokines during the inflammatory response.

Psoriasis is a chronic, immune-related disease of the skin that primarily affects adults. Plaque psoriasis is the most common form, characterized by scaling and inflammation. Individuals diagnosed with psoriasis may experience pain and itching, restricted range of motion in their joints, and emotional distress. The course of psoriasis is marked by chronic and acute phases with a wide variety in relapse and clearance rates. Disease severity and clinical response to biologics may be measured with either the Psoriasis Area and Severity Index (PASI) or the Physician Global Assessment (PGA) scale.

The treatment of psoriasis consists of controlling inflammation and preventing discomfort through methods such as light therapy, stress reduction, and medications that suppress the immune response (e.g., topical corticosteroids or nonsteroidals, oral methotrexate, retinoids, cyclosporine).

Tildrakizumab-asmn is a biologic treatment for adults with moderate-to severe plaque psoriasis. Tildrakizumab binds specifically to IL-23p19 and binds to IL-23 molecules and prevents its interaction with the IL-23R, blocking the downstream signaling cascade. IL-23 is a naturally occurring cytokine known to be involved with multiple inflammatory pathways. This block initiates a downstream signaling cascade to induce a transcription of the inflammatory cytokines, IL-17. IL-17 activates inflammatory pathways associated with psoriasis.

Policy  

Ilumya may be considered MEDICALLY NECESSARY when the following criteria has been met:

1. Diagnosis of moderate-to-severe plaque psoriasis
2. One of the following:
   • Greater than or equal to 3% body surface area involvement
   • Severe scalp psoriasis
   • Palmoplantar (i.e., palms, soles), facial, or genital involvement
3. Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies:
   • Corticosteroids (e.g., betamethasone, clobetasol)
   • Vitamin D analogs (e.g., calcitriol, calcipotriene)
   • Tazarotene
   • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
   • Anthralin
   • Coal tar
4. Prescribed by or in consultation with a dermatologist

Continuation

Continuation of Ilumya may be considered MEDICALLY NECESSARY when documentation of positive clinical response to therapy as evidenced by ONE of the following:

• Reduction the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

References

1. American Hospital Formulary Service (AHFS). Drug Information2023.Tildrakizumab-asmn (Ilumya). [Lexicomp Online Web site]. 08/29/2022. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed March 15, 2023.
2. Armstrong AW, Siegel MP, Bagel P. From the Medical Board of the National Psoriasis Foundation: treatment targets for plaque psoriasis. J Am Acad Dermatol. 2017;76(2):290-298.
3. Elsevier Gold's Clinical Pharmacology Compendium. Tildrakizumab-asmn (Ilumya™). [Clinical Key Web site]. 07/13/2020. Available at: https://www.clinicalkey.com/pharmacology/monograph/5017.[via subscription only]. Accessed March 15, 2023.
4. Lexi-Drugs Compendium. Tildrakizumab-asmn (Ilumya™). [Lexicomp Online Web site]. 03/09/2023. Available at: http://online.lexi.com/lco/action/home[via subscription only]. Accessed March 15, 2023.
5. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826-850.
6. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis withbiologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
7. Papp K, Thaçi D, Reich K. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIbrandomized placebo-controlled trial. Br J Dermatol. 2015;173(4):930-939.
8. Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 andreSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017;390(10091):276-288.
9. Tildrakizumab-asmn (Ilumya). [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 07/2020. Available at: Plaque Psoriasis Treatment | ILUMYA® (tildrakizumab-asmn). Accessed March 15, 2023.
10. Truven Health Analytics. Micromedex® DrugDex® Compendium. DrugDex®. Tildrakizumab-asmn (Ilumya™). [Micromedex® SolutionsWeb site]. 08/15/2022. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed March 15, 2023.
11. US Food and Drug Administration. Center for Drug Evaluation and Research. Tildrakizumab-asmn (Ilumya™) Product Labeling and Approval Letter. 12/19/2022. [FDA Web site] Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed March 15,2023.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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