When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
The safety and effectiveness of tildrakizumab-asmn (Ilumya™) have not been established in pediatric individuals.
Armstrong, AW, Siegel, MP, Bagel, P. From the medical board of the national psoriasis foundation: treatment targets for plaque psoriasis. J Am Acad Dermatol. Feb. 2017;76(2):290–298.
Elsevier Gold's Clinical Pharmacology Compendium. Tildrakizumab-asmn (Ilumya™). [Clinical Key Web site]. 03/24/2018. Available athttps://www.clinicalkey.com/pharmacology/monograph/5017. [via subscription only]. Accessed January 10, 2020.
Lexi-Drugs Compendium. Tildrakizumab-asmn (Ilumya™). [Lexicomp Online Web site]. 12/07/2019. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed January 10, 2020.
Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB,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 May;58(5):826-50.
National Psoriasis Foundation. Systemic treatments: biologics and oral treatments. 2017. Available at: https://www.psoriasis.org/sites/default/files/systemic_treatments_-_biologics_and_oral_treatments.pdf. Accessed January 10, 2020.
Papp K, Thaçi D, Reich K. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol.2015 Oct;173(4):930-9.
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 randomised controlled, phase 3 trials. Lancet 2017; 390(10091):276-288.
Truven Health Analytics. Micromedex® DrugDex® Compendium. DrugDex®. tildrakizumab-asmn (Ilumya™). [Micromedex® Solutions Web site]. 11/05/2019. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed January 10, 2020.
US Food and Drug Administration. Center for Drug Evaluation and Research. tildrakizumab-asmn (Ilumya™) Product Labeling. 03/2018. [FDA Web site] Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed January 10, 2020.
US Food and Drug Administration.Center for Drug Evaluation and Research. tildrakizumab-asmn (Ilumya™) Approval Letter. [FDA Web site]. Available at:https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761067Orig1s000Approv.pdf. Accessed January 10, 2020.
Policy: 08.00.15e:Off-label Coverage for Prescription Drugs and/or Biologics
Policy: 08.00.34m:Infliximab and Related Biosimilars
Policy: 08.00.82k:Ustekinumab (Stelara®)