Last Review Date: 07/02/2024

Date of Origin: 07/05/2022

Dates Reviewed: 07/2022, 10/2022, 08/2023, 07/2024

1. Length of Authorization

Coverage will be provided for 11 weeks (3 doses) and cannot be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Skyrizi carton containing one 600 mg/10 mL single-dose vial: 2 vials at Weeks 0, 4 & 8 (6 vials total)

2. Max Units (per dose and over time) [HCPCS Unit]:

• Crohn’s Disease
  • Induction dose: 600 billable units (600 mg) at Week 0, 4, & 8
• Ulcerative Colitis
  • Induction dose: 1200 billable units (1200 mg) at Week 0, 4, & 8

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for the presence of TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will not receive live vaccines during therapy; AND
• Patient is not on concurrent treatment with another IL-inhibitor, TNF-inhibitor, biologic response modifier or other non-biologic immunomodulating agent (e.g., apremilast, tofacitinib, baricitinib, upadacitinib, abrocitinib, deucravacitinib, etc.); AND
• Baseline liver enzymes and bilirubin levels have been obtained prior to initiating therapy; AND

Crohn’s Disease (CD) † ^1,25-29

• Documented moderate to severe active disease; AND
• Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate, etc.)

Ulcerative Colitis † ^1,30-37

• Documented moderate to severe active disease; AND
  • Documented failure or ineffective response to a minimum 3-month trial of conventional therapy [aminosalicylates, corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate, etc.] at maximum tolerated doses, unless there is a contraindication or intolerance to use; OR
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier such as adalimumab, golimumab, or infliximab

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage cannot be renewed.

5. Dosage/Administration ¹

   Indication	Dose
   Crohn’s Disease	Induction: Administer 600 mg intravenously at Week 0, Week 4, and Week 8. Maintenance: Administer 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter (*NOTE: refer to criteria for self-administration under applicable benefit)
   Ulcerative Colitis	Induction: Administer 1200 mg intravenously at Week 0, Week 4, and Week 8. Maintenance: Administer 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter (*NOTE: refer to criteria for self-administration under applicable benefit)

6. Billing Code/Availability Information

HCPCS Code:

• J2327 – Injection, risankizumab-rzaa, intravenous, 1 mg; 1 billable unit = 1 mg

NDC(s):

• Skyrizi carton containing one 600 mg/10 mL single-dose vial: 00074-5015-xx

7. References

1. Skyrizi [package insert]. North Chicago, IL; AbbVie, Inc.; June 2024. Accessed June 2024.
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14. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019; 80:1029. https://doi.org/10.1016/j.jaad.2018.11.057.
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17. Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol 2020; 82:1445.
18. National Institute for Health and Care Excellence (NICE). Risankizumab for treating moderate to severe plaque psoriasis. Technology appraisal guidance. Published: 21 August 2019. www.nice.org.uk/guidance/ta596.
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20. Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712. doi: 10.1136/annrheumdis-2020-217159.
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Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A