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Skyrizi® (risankizumab-rzaa)

Policy Number: PH-0671

 

Intravenous

 

Last Review Date: 07/02/2024

Date of Origin: 07/05/2022

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

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

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

  1. 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
  1. 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

  1. Renewal Criteria 1

Coverage cannot be renewed.

  1. 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)

  2. 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
  1. References
  1. Skyrizi [package insert]. North Chicago, IL; AbbVie, Inc.; June 2024. Accessed June 2024.
  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. (2022). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UptoDate. Lasted updated: Dec 01, 2022; Accessed on: July 20, 2023. 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. Hoönigsmann H. (2023). UVB therapy (broadband and narrowband). In Elmets CA, Corona R (Eds.), UptoDate. Last updated: Jan 18, 2023; Accessed on July 20, 2023. 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.
  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.
  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.
  30. 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.
  31. 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.
  32. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
  33. 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.
  34. 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.
  35. 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.
  36. 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
  37. 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

Appendix 1 – Covered Diagnosis Codes

ICD-10 Codes

ICD-10 Description

K50.00

Crohn's disease of small intestine without complications

K50.011

Crohn's disease of small intestine with rectal bleeding

K50.012

Crohn's disease of small intestine with intestinal obstruction

K50.013

Crohn's disease of small intestine with fistula

K50.014

Crohn's disease of small intestine with abscess

K50.018

Crohn's disease of small intestine with other complication

K50.019

Crohn's disease of small intestine with unspecified complications

K50.10

Crohn's disease of large intestine without complications

K50.111

Crohn's disease of large intestine with rectal bleeding

K50.112

Crohn's disease of large intestine with intestinal obstruction

K50.113

Crohn's disease of large intestine with fistula

K50.114

Crohn's disease of large intestine with abscess

K50.118

Crohn's disease of large intestine with other complication

K50.119

Crohn's disease of large intestine with unspecified complications

K50.80

Crohn's disease of both small and large intestine without complications

K50.811

Crohn's disease of both small and large intestine with rectal bleeding

K50.812

Crohn's disease of both small and large intestine with intestinal obstruction

K50.813

Crohn's disease of both small and large intestine with fistula

K50.814

Crohn's disease of both small and large intestine with abscess

K50.818

Crohn's disease of both small and large intestine with other complication

K50.819

Crohn's disease of both small and large intestine with unspecified complications

K50.90

Crohn's disease, unspecified, without complications

K50.911

Crohn's disease, unspecified, with rectal bleeding

K50.912

Crohn's disease, unspecified, with intestinal obstruction

K50.913

Crohn's disease, unspecified, with fistula

K50.914

Crohn's disease, unspecified, with abscess

K50.918

Crohn's disease, unspecified, with other complication

K50.919

Crohn's disease, unspecified, with unspecified complications

K51.00

Ulcerative (chronic) pancolitis without complications

K51.011

Ulcerative (chronic) pancolitis with rectal bleeding

K51.012

Ulcerative (chronic) pancolitis with intestinal obstruction

K51.013

Ulcerative (chronic) pancolitis with fistula

K51.014

Ulcerative (chronic) pancolitis with abscess

K51.018

Ulcerative (chronic) pancolitis with other complication

K51.019

Ulcerative (chronic) pancolitis with unspecified complications

K51.20

Ulcerative (chronic) proctitis without complications

K51.211

Ulcerative (chronic) proctitis with rectal bleeding

K51.212

Ulcerative (chronic) proctitis with intestinal obstruction

K51.213

Ulcerative (chronic) proctitis with fistula

K51.214

Ulcerative (chronic) proctitis with abscess

K51.218

Ulcerative (chronic) proctitis with other complication

K51.219

Ulcerative (chronic) proctitis with unspecified complications

K51.30

Ulcerative (chronic) rectosigmoiditis without complications

K51.311

Ulcerative (chronic) rectosigmoiditis with rectal bleeding

K51.312

Ulcerative (chronic) rectosigmoiditis with intestinal obstruction

K51.313

Ulcerative (chronic) rectosigmoiditis with fistula

K51.314

Ulcerative (chronic) rectosigmoiditis with abscess

K51.318

Ulcerative (chronic) rectosigmoiditis with other complication

K51.319

Ulcerative (chronic) rectosigmoiditis with unspecified complications

K51.50

Left sided colitis without complications

K51.511

Left sided colitis with rectal bleeding

K51.512

Left sided colitis with intestinal obstruction

K51.513

Left sided colitis with fistula

K51.514

Left sided colitis with abscess

K51.518

Left sided colitis with other complication

K51.519

Left sided colitis with unspecified complications

K51.80

Other ulcerative colitis without complications

K51.811

Other ulcerative colitis with rectal bleeding

K51.812

Other ulcerative colitis with intestinal obstruction

K51.813

Other ulcerative colitis with fistula

K51.814

Other ulcerative colitis with abscess

K51.818

Other ulcerative colitis with other complication

K51.819

Other ulcerative colitis with unspecified complications

K51.90

Ulcerative colitis, unspecified, without complications

K51.911

Ulcerative colitis, unspecified with rectal bleeding

K51.912

Ulcerative colitis, unspecified with intestinal obstruction

K51.913

Ulcerative colitis, unspecified with fistula

K51.914

Ulcerative colitis, unspecified with abscess

K51.918

Ulcerative colitis, unspecified with other complication

K51.919

Ulcerative colitis, unspecified with unspecified complications

R19.7

Diarrhea, unspecified

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC