Last Review Date: 10/03/2024

Date of Origin: 02/15/2011

Dates Reviewed: 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 9/2016, 10/2016, 11/2016, 03/2017, 06/2017, 09/2017, 10/2017, 03/2018, 06/2018, 10/2018, 10/2019, 12/2019, 07/2020, 08/2020, 10/2021, 04/2022, 06/2022, 09/2022, 08/2023, 10/2023, 12/2023, 06/2024, 08/2024, 10/2024

1. Length of Authorization ^1-4,39-47

Crohn’s Disease and Ulcerative Colitis:

Initial coverage will be provided for 8 weeks and may be renewed annually thereafter.

• Dose escalation requests for Crohn’s Disease and Ulcerative Colitis: will be provided for 3 months with continued renewal annually thereafter (See Section V for continuation details).

Immune Checkpoint Inhibitor Related Diarrhea/Colitis:

Coverage will be provided for a one-time intravenous induction dose plus up to 3 subcutaneous maintenance doses and may not be renewed.

All other indications:

Initial coverage will be provided for 6 months and may be renewed annually thereafter.

2. Dosing Limits

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

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

3. Initial Approval Criteria ^1-4

Coverage is provided in the following conditions:

• Patient is at least 18 years of age (unless otherwise specified); AND
• Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

Universal Criteria ^1-4

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for 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, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib, ritlecitinib, ruxolitinib, etrasimod, ozanimod, etc.); AND

Plaque Psoriasis (PsO) † ^1-4,33,48-52

• Patient is at least 6 years of age; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe plaque psoriasis for at least 6 months with at least one of the following:

• Involvement of at least 3% of body surface area (BSA); OR
• Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
• Incapacitation or serious emotional consequences due to plaque location (e.g., hands, feet, head and neck, genitalia, etc.) or with intractable pruritis; AND

• Patient meets ALL of the following ¥:
  • Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, roflumilast, retinoic acid derivatives, and/or vitamin D analogues); AND
  • Patient did not respond adequately (or is not a candidate) to a 3-month minimum trial of at least one non-biologic systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
  • Patient did not respond adequately (or is not a candidate*) to a 3-month minimum trial of phototherapy (i.e., psoralens with UVA light [PUVA] or UVB with coal tar or dithranol)

¥ Note: For patients already established on biologic therapy, targeted synthetic therapy, or those with > 10% BSA involvement, trial and failure of topical agents, non-biologic systemic agents, and phototherapy is not required.

Adult Psoriatic Arthritis (PsA) † ^{1-4,12,,53,63}

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe active disease; AND

• For patients with predominantly axial disease OR enthesitis, a failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory drug (NSAID), unless use is contraindicated; OR
• For patients with peripheral arthritis OR dactylitis, a failure of at least a 3 month trial of ONE conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, azathioprine, sulfasalazine, leflunomide, hydroxychloroquine, etc.); OR
• Patient is already established on biologic or targeted synthetic therapy for the treatment of PsA

Juvenile Psoriatic Arthritis (JPsA) † ^1-4,54,55

• Patient is at least 6 years of age; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severe active polyarticular disease; AND
• May be used as a single agent or in combination with methotrexate; AND
  • Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (e.g., methotrexate, leflunomide, sulfasalazine, etc.); OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of JPsA

Crohn’s Disease (Stelara, Pyzchiva, and Wezlana ONLY) † ^{1,2,4, ,21,27,65,68}

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented moderate to severely 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); 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 biologic or targeted synthetic therapy for the treatment of CD

Ulcerative Colitis (Stelara, Pyzchiva, and Wezlana ONLY) † ^{1,2,4,22,60,69}

• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• 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

 Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis (Stelara, Pyzchiva, and Wezlana ONLY) ‡ ^38,39

• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, tremelimumab, dostarlimab, retifanlimab, nivolumab/relatlimab, tislelizumab, toripalimab, etc.); AND
  • Patient has diarrhea or colitis that is refractory to infliximab and/or vedolizumab; AND
    • Patient has mild (G1) diarrhea or colitis with persistent or progressive symptoms and is lactoferrin/calprotectin positive; OR
    • Patient has moderate (G2) to severe (G3-4) diarrhea or colitis

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

4. Renewal Criteria ^1-4

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious infections, malignancy, severe hypersensitivity reactions, posterior reversible encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS), non-infectious pneumonia, etc.; AND

Plaque Psoriasis (PsO) ^{48,52,56,61,62}

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤ 1%), and/or an improvement on a disease activity scoring tool [e.g., Psoriasis Area and Severity Index (PASI) score ≤ 3, physician’s global assessment (PGA) score ≤ 1, etc.].

Adult Psoriatic Arthritis (PsA) ^18,57,64

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, improvement on imaging (X-ray, ultrasound, or MRI),  and/or an improvement on a disease activity scoring tool [e.g., defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria].

Juvenile Psoriatic Arthritis (JPsA) ^58,59,64

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, improvement on imaging (X-ray, ultrasound, or MRI), and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].

Crohn’s Disease (Stelara, Pyzchiva, and Wezlana ONLY) ^37,66,67

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight regain, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, improvement in biomarker levels [i.e., fecal calprotectin or serum C-reactive protein (CRP)], and/or an improvement on a disease activity scoring tool (e.g., Harvey-Bradshaw Index score, etc.).

Ulcerative Colitis (Stelara, Pyzchiva, and Wezlana ONLY) ^22-26,70

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, endoscopic activity, tapering or discontinuation of corticosteroid therapy, normalization of C-reactive protein (CRP) or fecal calprotectin (FC), and/or an improvement on a disease activity scoring tool.

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis (Stelara, Pyzchiva, and Wezlana ONLY) ‡ ^38,39

• Coverage may not be renewed

5. Dosage/Administration ^1-4,38-47

6. Billing Code/Availability Information

HCPCS Code(s):

• J3357 – Ustekinumab, for subcutaneous injection, 1 mg; 1 billable unit = 1 mg (Stelara SQ Only)
• J3358 – Ustekinumab, for intravenous injection, 1 mg; 1 billable unit = 1 mg (Stelara IV Only)
• J3590 – Unclassified biologics (Pyzchiva and Selarsdi ONLY)
• Q5137 – Injection, ustekinumab-auub (Wezlana), biosimilar, subcutaneous, 1 mg; 1 billable unit = 1 mg
• Q5138 – Injection, ustekinumab-auub (Wezlana), biosimilar, intravenous, 1 mg; 1 billable unit = 1 mg

NDC(s):

• Subcutaneous

• Stelara 45 mg/0.5 mL single-dose prefilled syringe: 57894-0060-xx
• Stelara 90 mg/mL single-dose prefilled syringe: 57894-0061-xx
• Stelara 45 mg/0.5 mL single-dose vial: 57894-0060-xx
• Wezlana 45 mg/0.5 mL single-dose prefilled syringe: 55513-0076-xx and 72511-0076-xx
• Wezlana 90 mg/mL single-dose prefilled syringe: 55513-0089-xx and 72511-0089-xx
• Wezlana 45 mg/0.5 mL single-dose vial: 55513-0055-xx and 72511-0055-xx
• Pyzchiva 45 mg/0.5 mL single-dose prefilled syringe: 61314-0651-xx
• Pyzchiva 90 mg/mL single-dose prefilled syringe: 61314-0652-xx
• Selarsdi 45 mg/0.5 mL single-dose prefilled syringe: 51759-0505-xx
• Selarsdi 90 mg/mL single-dose prefilled syringe: 51759-0607-xx

• Intravenous

• Stelara 130 mg/26 mL (5 mg/mL) single-dose vial: 57894-0054-xx
• Wezlana 130 mg/26 mL (5 mg/mL) single-dose vial: 55513-0066-xx
• Pyzchiva 130 mg/26 mL (5 mg/mL) single-dose vial: 61314-0654-xx

7. References

1. Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; March 2024. Accessed August 2024.
2. Wezlana [package insert]. Thousand Oaks, CA; Amgen Inc.; October 2023. Accessed August 2024.
3. Selarsdi [package insert]. Leesburg, VA; Alvotech USA Inc.; April 2024. Accessed August 2024.
4. Pyzchiva [package insert]. Yeonsu-gu, Incheon; Samsung Bioepis Co., Ltd.; June 2024. Accessed August 2024.
5. Leonardi CL, Kimball AB, Papp KA, et al, “Efficacy and Safety of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 76-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 1),” Lancet, 2008, 371(9625): 1665-74.
6. Papp KA, Langley RG, Lebwohl M, et al, “Efficacy and Safety of Ustekinumab, a Human Interleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 52-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 2),” Lancet, 2008, 371(9625): 1675-84.
7. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
8. Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients with moderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013 Apr;168(4):844-54.
9. 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. doi: 10.1016/j.jaad.2008.02.039.
10. 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.
11. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi: 10.1136/annrheumdis-2015-208337.
12. Singh JA, Guyatt G, Ogdie A, et al. 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.
13. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104(2):465.
14. 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 Dec;145(6):1459-63. doi: 10.1053/j.gastro.2013.10.047.
15. Gomollón F, Dignass A, Annese V, et al. EUROPEAN Evidence-based consensus on the diagnosis and management of Crohn's disease 2016: Part 1: Diagnosis and medical management. J Crohns Colitis. 2016 Sep 22. pii: jjw168.
16. 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.
17. National Institute for Health and Care Excellence. NICE 2012. Crohn’s Disease: Management. Published 10 October 2012. Clinical Guideline [CG152]. https://www.nice.org.uk/guidance/cg152/resources/crohns-disease-management-pdf-35109627942085.
18. 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]. https://www.nice.org.uk/guidance/ta445. Accessed August 2024.
19. 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.
20. 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.
21. 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
22. Sands BE, Sandborn WJ, Panaccione R, et al. UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.
23. 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
24. Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
25. 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
26. Kornbluth, A, Sachar, DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23.
27. Feagan BG, Sandborn WJ, Gasink C, UNITI–IM-UNITI Study Group et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.  doi: 10.1056/NEJMoa1602773. 
28. Leonardi CL, Kimball AB, Papp KA, PHOENIX 1 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet. 2008;371(9625):1665.
29. Papp KA, Langley RG, Lebwohl M, PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008;371(9625):1675.
30. Landells I, Marano C, Hsu MC, et al. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study.  J Am Acad Dermatol. 2015;73(4):594.
31. McInnes IB, Kavanaugh A, Gottlieb AB, PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet. 2013;382(9894):780. Epub 2013 Jun 13.
32. Ritchlin C, Rahman P, Kavanaugh A, PSUMMIT 2 Study Group. Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990. Epub 2014 Jan 30.
33. 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 Feb 13. pii: S0190-9622(18)33001-9. https://doi.org/10.1016/j.jaad.2018.11.057.
34. Richard EG. (2022). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UpToDate. Last updated: Dec 01, 2022. Accessed on: August 20, 2024. 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.
35. Elments, CA. (2024). UVB phototherapy (broadband and narrowband). In Callen J, Corona R (Eds.), UptoDate. Last updated: March 27,2024; Accessed on August 20, 2024. 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.
36. 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.
37. National Institute for Health and Care Excellence. NICE 2019. Crohn’s Disease: Management. Published 03 May 2019. Clinical Guideline [NG129]. https://www.nice.org.uk/guidance/ng129/resources/crohns-disease-management-pdf-66141667282885
38. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) ustekinumab. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2024.
39. Thomas AS, Ma W, Wang Y. Ustekinumab for Refractory Colitis Associated with Immune Checkpoint Inhibitors. N Engl J Med 2021;384:581-583.
40. Mathurin Fumery M, Laurent Peyrin-Biroulet L, Stéphane Nancey S, et al. Effectiveness and safety of ustekinumab intensification at 90 Mg every four weeks In Crohn's disease: a multicenter study. Journal of Crohn's and Colitis, Elsevier - Oxford University Press, 2021, 15 (2), pp.222-227.
41. Haider, S., et al. Ustekinumab dose escalation improves clinical responses in refractory Crohn's disease Therap Adv Gastroenterol. 2020; 13: 1756284820959245.Published online 2020 Oct 13.
42. Ollech JE et al, Effectiveness of Ustekinumab Dose Escalation in Patients with Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Feb 26.
43. Kopylov U, Hanzel J, Liefferinckx C, et al. Effectiveness of ustekinumab dose escalation in Crohn's disease patients with insufficient response to standard-dose subcutaneous maintenance therapy. Aliment Pharmacol Ther 2020;52:135-42.
44. Ma C, Fedorak RN, Kaplan GG, et al. Long-term Maintenance of Clinical, Endoscopic, and Radiographic Response to Ustekinumab in Moderate-to-Severe Crohn's Disease: Real-world Experience from a Multicenter Cohort Study. Inflamm Bowel Dis 2017;23:833-9.
45. Dalal R, Njie C, Gupta S, Allegretti JR. Predictors of Ustekinumab Failure After Dose Intensification Among Patients With Crohn’s Disease American College of Gastroenterology; 2020. p. S0646.
46. Battat R, Kopylov U, Bessissow T, et al. Association between ustekinumab trough concentrations and clinical, biomarker, and endoscopic outcomes in patients with Crohn's disease. Clin Gastroenterol Hepatol, 15 (2017), pp. 1427-1434,
47. Cheifetz AS, Abreu MT,Afif W, et al. A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease. Am J Gastroenterol 2021  Accession Number: 34388143 DOI: 10.14309/ajg.0000000000001396.
48. 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.
49. 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 August 2024.
50. 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 August 2024.
51. Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019 Sep;81(3):775-804. Doi: 10.1016/j.jaad.2019.04.042.
52. Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020 Jan;82(1):161-201. Doi: 10.1016/j.jaad.2019.08.049.
53. 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. Doi: 10.1016/j.jaad.2010.11.055.
54. Ringold S, Angeles‐Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care & Research, Vol. 71, No. 6, June 2019, pp 717–734 DOI 10.1002/acr.23870.
55. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications.   Arthritis Rheum. 2013 Oct;65(10):2499-512.
56. 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.
57. Mease PJ. Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S64-85. Doi: 10.1002/acr.20577.
58. Ringold S, Bittner R, Neggi T, et al. Performance of rheumatoid arthritis disease activity measures and juvenile arthritis disease activity scores in polyarticular-course juvenile idiopathic arthritis: Analysis of their ability to classify the American College of Rheumatology pediatric measures of response and the preliminary criteria for flare and inactive disease. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1095-102.
59. Consolaro A, Giancane G, Schiappapietra B, et al. Clinical outcome measures in juvenile idiopathic arthritis. Pediatric Rheumatology 18 April 2016 14:23.
60. 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
61. Foley P, Mahar PD, Smith SD, et al. Australian consensus: Treatment goals for moderate to severe psoriasis in the era of targeted therapies – Considerations for paediatric patients. Australas J Dermatol. 2024 May 13. doi:10.1111/ajd.14303
62. Foley P, Gebaur K, Sullivan J, et al. Australian consensus: Treatment goals for moderate to severe psoriasis in the era of targeted therapies – Adult patients. Australas J Dermatol. 2023 Nov;64(4):467-487. doi:10.1111/ajd.14138
63. Gossec L, Kerschbaumer A, Ferreira RJO, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024 May 15;83(6):706-719. doi: 10.1136/ard-2024-225531. PMID: 38499325
64. Tiwari V, Brent LH. Psoriatic Arthritis. [Updated 2024 Jan 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024. https://www.ncbi.nlm.nih.gov/books/NBK547710/. Accessed August 20, 2024.
65. 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
66. Ranasinghe IR, Tian C, Hsu R. Crohn Disease. [Updated 2024 Feb 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024.  https://www.ncbi.nlm.nih.gov/books/NBK436021/. Accessed August 22, 2024.
67. Ananthakrishnan AN, Alder J, Chachu KA, et al. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Crohn’s Disease. Gastroenterology. 2023 Dec;165(6):1367-1399. doi: 10.1053/j.gastro.2023.09.029. PMID: 37981354.
68. 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.
69. 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.
70. Singh S, Ananthakrishnan AN, Nguyen NH, et al.. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007. PMID: 36822736.

Appendix 1 – Covered Diagnosis Codes

Stelara (J3357), Pyzchiva (J3590), and Wezlana (Q5137) Subcutaneous

Stelara (J3358), Pyzchiva (J3590), and Wezlana (Q5138) Intravenous

Selarsdi Subcutaneous (J3590)

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