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IL-23 Inhibitors MEDICATION POLICY: IL-23 Inhibitors Generic Name: Preferred: Risankizumab (Skyrizi®) Therapeutic Class or Brand Name: IL-23 Non-preferred: Guselkumab (Tremfya®), Inhibitors Tildrakizumab (Ilumya®) Applicable Drugs (if Therapeutic Class): Date of Origin: 5/15/2019 Guselkumab (Tremfya®), Risankizumab Date Last Reviewed / Revised: 7/16/2021 (Skyrizi®), Tildrakizumab (Ilumya®) GPI Code: 90250542, 90250570, 90250580 PRIOR AUTHORIZATION CRITERIA (May be considered medically necessary when criteria I - IV are met) I. Documented diagnosis of one of the following conditions A through B AND must meet criteria listed under applicable diagnosis: A. Moderate to Severe Chronic Plaque Psoriasis and criteria 1 through 4 are met: 1. History of treatment failure, intolerance, or contraindications with phototherapy or photochemotherapy. 2. History of treatment failure, intolerance, or contraindication with at least one appropriate systemic agent (i.e. cyclosporine, methotrexate, acitretin, etc.). 3. Diagnosis must be established by a dermatologist. 4. Minimum age requirement: 18 years old. B. Active Psoriatic Arthritis (PsA) and criteria 1 through 5 are met: 1. The request is for Tremfya®. 2. History of treatment failure, intolerance to, or contraindication to methotrexate or a second line DMARD. 3. Patient has severe PsA and severe psoriasis. See Table 1 under Appendix. 4. Diagnosis must be established by a rheumatologist or dermatologist. 5. Minimum age requirement: 18 years old. II. Absence of active serious infection. III. Negative TB skin test within the previous 12 months or history of treatment for latent TB infection. IV. Refer to plan document for the list of preferred products. If requested agent is not listed as a preferred product, must have a documented failure, intolerance, or contraindication to preferred product(s). EXCLUSION CRITERIA Avoid use of Live vaccines. CONFIDENTIAL & PROPRIETARY, VENTEGRA, INC. WWW.VENTEGRA.COM MEDICATION POLICY: IL-23 Inhibitors Coadministration with another targeted immune modulator. Examples of targeted immune modulators include the following: o Actemra® (tocilizumab) o Cosentyx® (secukinumab) o Dupixent® (dupilumab) o Entyvio® (vedolizumab) o Ilaris® (canakinumab) o IlumyaTM (tildrakizumab-asmn) o Kevzara® (sarilumab) o Kineret® (anakinra) o Olumiant® (baricitinib) o Orencia® (abatacept) o Otezla® (apremilast) o RiabniTM (rituximab-arrx) o RinvoqTM (upadacitinib) o Rituxan® (rituximab) o Ruxience® (rituximab-pvvr) o Siliq™ (brodalumab) o Stelara® (ustekinumab) o Skyrizi® (risankizumab) o Taltz® (Ixekizumab) o TNF inhibitors [Avsola® (infliximab-axxq), Cimzia® (certolizumab pegol), Enbrel® (etanercept), Humira® (adalimumab), Inflectra® (infliximab-dyyb), Remicade® (infliximab), Renflexis® (infliximab-abda), Simponi®/Simponi® Aria® (golimumab)] o Tremfya™ (guselkumab) o Truxima® (rituximab-abbs) o Tysabri® (natalizumab) o Xeljanz®/XR (tofacitinib) OTHER CRITERIA NA CONFIDENTIAL & PROPRIETARY, VENTEGRA, INC. WWW.VENTEGRA.COM MEDICATION POLICY: IL-23 Inhibitors QUANTITY / DAYS SUPPLY RESTRICTIONS Tremfya® o Quantities up to 2 x 100 mg prefilled syringes for the first 28 days, then in quantities up to one prefilled 100 mg syringe every 56 days (8 weeks). Skyrizi® o Quantities up to 4 x 75 mg prefilled syringes for the first 28 days, then in quantities up to two prefilled 75 mg syringes every 84 days (12 weeks). o Quantities up to 2 x 150mg Prefilled / Autoinjector for the first 28 days, then in quantities up to 1 prefilled/ autoinjector 150mg syringe every 84 days (12 weeks). Ilumya® o Quantities up to 2 x 100 mg prefilled syringes for the first 28 days, then in quantities up to one prefilled 100 mg syringe every 84 days (12 weeks). APPROVAL LENGTH Authorization: 4 months. Re-Authorization: 1 year, with an updated letter of medical necessity or progress notes showing improvement or maintenance with medication. APPENDIX Table 1 - Examples of severe psoriatic arthritis and severe psoriasis: CONFIDENTIAL & PROPRIETARY, VENTEGRA, INC. WWW.VENTEGRA.COM MEDICATION POLICY: IL-23 Inhibitors REFERENCES 1. American Academy of Dermatology Psoriasis Clinical Guideline. Available at: https://www.aad.org/practicecenter/quality/clinical-guidelines/psoriasis 2. Menter A.,et. al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019 Apr;80(4):1029-1072. doi: 10.1016/j.jaad.2018.11.057. Epub 2019 Feb 13. 3. Singh, JA, et. al., Special Article: 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019 Jan;71(1):5-32. doi: 10.1002/art.40726. Epub 2018 Nov 30. Available at: https://www.rheumatology.org/Portals/0/Files/PsA-Guideline-2018.pdf 4. Ilumya® [Package Insert]. Cranbury, NJ: Sun Pharma. July 2020. Available at: https://ypd57my3oo168lx16fbexdxu-wpengine.netdna-ssl.com/wp-content/uploads/Sun- Pharma_ILUMYA_US_Prescribing-Information-and-Med-Guide_2020.pdf. 5. Tremfya® [Package Insert]. Horsham, PA: Janssen Biotech. July 2020. Available at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing- information/TREMFYA-pi.pdf 6. Skyrizi® [Package Insert]. North Chicago, IL: Abbvie. April 2021. Available at: https://www.rxabbvie.com/pdf/skyrizi_pi.pdf 7. Medispan® DISCLAIMER: Medication Policies are developed to help ensure safe, effective and appropriate use of selected medications. They offer a guide to coverage and are not intended to dictate to providers how to practice medicine. Refer to Plan for individual adoption of specific Medication Policies. Providers are expected to exercise their medical judgement in providing the most appropriate care for their patients. CONFIDENTIAL & PROPRIETARY, VENTEGRA, INC. WWW.VENTEGRA.COM .
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