47335-0177-XX ILUMYA 100MG/ML SYRINGE (SUN PHARMA GLOB)
47335-0177-9X ILUMYA 100MG/ML Solution Prefilled Syringe (SUN PHARMACEUTICALS)
Tildrakizumab is a humanized IgG1/k monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.
Tildrakizumab-asmnfor the treatment of moderate-to-severe plaque psoriasis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Tildrakizumab-asmn for the treatment of other conditions/diseases is considered investigational.
Tildrakizumab-asmn for the treatment of moderate-to-severe plaque psoriasis is considered medically appropriate if ALL of the following criteria are met:
BCBST requirement: Prior trial and failure of ANY ONE of the following agents is required:
Individual is 18 years of age or older
Individual is up to date with all vaccinations, in accordance with current vaccination guidelines
Individual has been evaluated and screened for the presence of ALL of the following prior to initiating treatment:
Latent tuberculosis (TB) infection and will receive ongoing monitoring for presence of TB during treatment
Presence of active infection, including clinically important localized infections
Individual will not receive ANY ONE of the following:
Live vaccine(s) during the administration of Tildrakizumab-asmn
Concurrent treatment with another TNF inhibitor, biologic response modifier, or other non-biologicimmunomodulating agent (i.e., apremilast, tofacitinib, baricitinib, etc.)
Physician has assessed baseline disease severity utilizing an objective measure/tool
Individual diagnosed with documented moderately to severely active plaque psoriasis for 6 months or longer and ANY ONE of the following:
Involvement of at least 3% of body surface area (BSA)
Psoriasis Area and Severity Index (PASI) score of 10 or greater
Incapacitation or serious emotional consequences due to plaque location (e.g., hands, feet, head and neck or genitalia) or with intractable pruritus
Individual did not respond adequately to or is not a candidate for a 3 month minimum trial of topical agents (e.g. Anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, retinoic acid derivatives, and/or Vitamin D analogues)
Individual did not respond adequately to or is not a candidate for a 3 month minimum trial of at least one systemic agent (e.g. immunosuppressives, retinoic acid derivatives, and/or methotrexate)
Individual did not respond adequately to or is not a candidate for a 3 month minimum trial of phototherapy (i.e. Psoralens with UVA light [PUVA] OR UVB with coal tar or dithranol), Note: contraindications to phototherapy (PUVA or UVB) may include ANY ONE of the following:
Pregnancy or lactation (PUVA only)
History of one of the following: ANY ONE of the following:
Photosensitivity diseases (e.g., chronic actinic dermatitis, solar urticaria)
Non-melanoma skin cancer
Treatment with arsenic or ionizing radiation
Immunosuppression in an organ transplant patient
Tildrakizumab-asmn is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria, not including prior treatments
Absence of unacceptable toxicity from the agent, e.g. serious infections, severe hypersensitivity reactions including angioedema and urticaria, etc.
Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, or the amount of surface area involvement (a total BSA involvement <1%), or an improvement on a disease activity scoring tool (e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started)
Ongoing monitoring for tuberculosis (TB) and active infections
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Plaque Psoriasis||100 mg subcutaneously at Weeks 0 and 4, then 100 mg every 12 weeks thereafter. Ilumya™ should be administered by a health care provider only.|
LENGTH OF AUTHORIZATION
Coverage will be provided 6 months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Elmets, C.A., Korman, N.J., Prater, E.F., Wong, E.B., Rupani, R.N., Kivelevitch, D. et al. (2020, July). Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. Journal of the American Academy of Dermatology (2020). Retrieved August 18, 2020 from https://doi.org/10.1016/j.jaad.2020.07.087.
Lexicomp Online. (2020). AHFS DI. Tildrakizumab-asmn. Retrieved August 18, 2020 from Lexicomp Online with AHFS.
Medical Advisory Secretariat. (2009, June). Ultraviolet phototherapy management of moderate-to-severe plaque psoriasis, an evidence based analysis. Ontario Health Technology Assessment Series. 9(27), 1-66. Retrieved July 24, 2020 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3377497/.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, November). Tildrakizumab-asmn. Retrieved August 18, 2020 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, March). Center for Drug Evaluation and Research. Ilumya™ (Tildrakizumab-asmn) injection, for subcutaneous use. Retrieved August 18, 2020 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761067s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 4/30/2018
MOST RECENT REVIEW DATE: 12/31/2020
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg