(risankizumab-rzaa)

Last Review Date: 07/05/2022

Date of Origin: 07/05/2022

Dates Reviewed: 07/2022

1. Length of Authorization

Crohn’s Disease:

Coverage will be provided for 8 weeks 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: 3 for Weeks 0, 4 & 8

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

• Crohn’s Disease
  • Induction dose: 600 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 TNF inhibitor, biologic response modifier or other non-biologic immunomodulating agent (i.e., apremilast, tofacitinib, baricitinib, upadacitinib, etc.); AND

Crohn’s Disease

• 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.); AND
• 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)

† 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: 600 mg administered intravenously at Week 0, Week 4, and Week 8. Maintenance: 360 mg administered subcutaneously at Week 12 and every 8 weeks thereafter (refer to criteria for self-administration under the applicable benefit).

6. Billing Code/Availability Information

HCPCS Code:

• J3590 – Unclassified biologics
• C9399 – Unclassified drugs or biologicals (for hospital outpatient use ONLY)

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 2022. Accessed June 2022.
2. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
3. Menter A, Gottlieb A, Feldman SR, 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.
4. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.
5. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
6. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. Doi: 10.1111/bjd.15665.
7. Armstrong AW, Siegel MP, Bagel J, et al.  From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis.  J Am Acad Dermatol. 2017 Feb; 76(2):290-298. Doi: 10.1016/j.jaad.2016.10.017.
8. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018 Aug 25;392(10148):650-661. Doi: 10.1016/S0140-6736(18)31713-6. Epub 2018 Aug 7.
9. Langley R, Blauvelt A, Gooderham M, et al. Efficacy and safety of continuous Q12W risankizumab versus treatment withdrawal: results from the phase 3 IMMhance trial [poster no. 10093]. In: AAD Annual Meeting. 2019.
10. Reich K, Gooderham M, Thaçi D, et al. Efficacy and safety of continuous risankizumab or switching from adalimumab to risankizumab treatment in patients with moderate-to-severe plaque psoriasis: results from the phase 3 IMMvent trial [poster no. 10218]. In: AAD Annual Meeting. 2019.
11. Richard EG. (2021). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UptoDate. Lasted updated: June 28, 2021; Accessed on: June 20, 2022. Available from https://www.uptodate.com/contents/psoralen-plus-ultraviolet-a-puva-photochemotherapy?search=Psoralen%20plus%20ultraviolet%20A%20(PUVA)%20photochemotherapy&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.  
12. Honigsman H. (2020). UVB therapy (broadband and narrowband). In Elmets CA, Corona R (Eds.), UptoDate. Last updated: August 19, 2022; Accessed on June 20, 2022. Available from https://www.uptodate.com/contents/uvb-therapy-broadband-and-narrowband?search=UVB%20therapy%20(broadband%20and%20narrowband&source=search_result&selectedTitle=1~80&usage_type=default&display_rank=1.  
13. American Academy of Dermatology Work Group. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.
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.
15. Smith CH, Yiu ZZN, Bale T, et al; British Association of Dermatologists’ Clinical Standards Unit. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020 Oct;183(4):628-637. doi: 10.1111/bjd.19039.
16. National Institute for Health and Care Excellence. NICE 2017. Psoriasis: assessment and management. Published 24 October 2012. Clinical guideline [CG153]. https://www.nice.org.uk/guidance/CG153. Accessed June 2022.
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.
19. American Academy of Dermatology Work Group. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.
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.
21. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445].
22. Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022 Feb;81(2):225-231. doi: 10.1136/annrheumdis-2021-221019.
23. Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2021 Nov 23:annrheumdis-2021-221048. doi: 10.1136/annrheumdis-2021-221048.
24. National Institute for Health and Care Excellence. NICE 2013. Psoriasis. Published 06 August 2013. Quality standard [QS40]. https://www.nice.org.uk/guidance/qs40. Accessed June 2022.
25. 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.
26. 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.
27. 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.
28. 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.
29. 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.

Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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