Last Review Date: 10/03/2024

Date of Origin: 07/05/2022

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

1. Length of Authorization

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

2. Dosing Limits

A. 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)

B. 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 biologic therapy (e.g., IL-inhibitor, TNF-inhibitor, integrin receptor antagonist, T cell costimulation modulator, etc.) or targeted synthetic therapy (e.g., apremilast, tofacitinib, baricitinib, upadacitinib, abrocitinib, deucravacitinib, ritlecitinib, ruxolitinib, etrasimod, ozanimod, etc.); AND
• Baseline liver enzymes and bilirubin levels have been obtained prior to initiating therapy; AND

Crohn’s Disease (CD) † ^1,2-6,15,16

• 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, methotrexate, etc.); OR
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier (e.g., adalimumab, certolizumab, or infliximab); OR
  • Patient has evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary; OR
  • Patient is already established on a biologic or targeted synthetic therapy for the treatment of CD

Ulcerative Colitis † ^1,11-14

• 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; OR
  • Patient is already established on a biologic or targeted synthetic therapy for the treatment of UC

† 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: for maintenance therapy, refer to criteria for the subcutaneous formulation 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: for maintenance therapy, refer to the criteria for the subcutaneous formulation 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:

• 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 September 2024.
2. D'Haens G, Panaccione R, Baert F, et al. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
3. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27.
4. Torres J, Bonovas S, Doherty G, et al. European Crohn’s and Colitis Organisation [ECCO] Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. Journal of Crohn's and Colitis, 2020, 4–22 doi:10.1093/ecco-jcc/jjz180.
5. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute Guideline on the use of Thiopurines, Methotrexate, and Anti-TNF-α Biologic Drugs for the Induction and Maintenance of Remission in Inflammatory Crohn’s Disease.  Gastroenterology 2013;145:1459-1463.
6. National Institute for Health and Care Excellence. NICE 2019. Crohn’s Disease: Management. Published 03 May 2019. NICE Guideline [NG129]. https://www.nice.org.uk/guidance/ng129.
7. Harbord M, Eliakim R, Bettenworth D, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis. 2017 Jan 28. doi: 10.1093/ecco-jcc/jjx009.
8. Lewis JD, Chuai S, Nessel L, et al. Use of the Non-invasive Components of the Mayo Score to Assess Clinical Response in Ulcerative Colitis. Inflamm Bowel Dis. 2008 Dec; 14(12): 1660–1666. doi:  10.1002/ibd.20520.
9. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
10. Walsh AJ, Bryant RV, Travis SPL. Current best practice for disease activity assessment in IBD. Nature Reviews Gastroenterology & Hepatology 13, 567–579 (2016) doi:10.1038/nrgastro.2016.128.
11. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology. 2020;158(5):1450-1461. doi:10.1053/j.gastro.2020.01.006.
12. Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis. 2022 Jan 28. 16 (1):2-17. Doi: 10.1093/ecco-jcc/jjab178.
13. Louis E, Panaccione R, Parkes G, et al. S4 Risankizumab Induction Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomized Phase 3 INSPIRE Study. The American Journal of Gastroenterology 118(12S):p S2, December 2023. | DOI: 10.14309/01.ajg.0000995752.19097.c8
14. Louis E, Panaccione R, Parkes G, et al. OP06 Risankizumab Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis: Efficacy and Safety in the Randomised Phase 3 COMMAND Study, Journal of Crohn's and Colitis, Volume 18, Issue Supplement_1, January 2024, Pages i10–i12, https://doi.org/10.1093/ecco-jcc/jjad212.0006
15. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021 Jun;160(7):2496-2508. doi: 10.1053/j.gastro.2021.04.022. PMID: 34051983; PMCID: PMC8988893.
16. Gordon H, Minozzi S, Kopylov U, et al. ECCO Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment, Journal of Crohn's and Colitis, 2024;  https://doi.org/10.1093/ecco-jcc/jjae091

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