Asset Publisher
Ustekinumab: Stelara®; Wezlana™; Selarsdi™
Policy Number: PH-0117
Intravenous/Subcutaneous
Last Review Date: 06/04/2024
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
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. |
- Length of Authorization 1-3,38-46
Crohn’s Disease and Ulcerative Colitis:
Coverage will be provided for 8 weeks initially and may be renewed in 6-month intervals thereafter.
- Dose escalation requests for Crohn’s Disease and Ulcerative Colitis: will be provided for 3 months with continued renewal every 6 months thereafter (See Section V for continuation details).
Immune Checkpoint Inhibitor Related Diarrhea/Colitis:
Coverage will be provided for 4 doses total and may not be renewed.
All other indications:
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
Subcutaneous
|
Intravenous
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B. Max Units (per dose and over time) [HCPCS Unit]:
Indication |
Max Units |
Plaque Psoriasis & Psoriatic Arthritis with co-existent moderate-severe Plaque Psoriasis |
Subcutaneous Loading (J3357, J3590, & Q5137):
Subcutaneous Maintenance (J3357, J3590, & Q5137):
|
Psoriatic Arthritis |
Subcutaneous Loading (J3357, J3590, & Q5137):
Subcutaneous Maintenance (J3357, J3590, & Q5137):
|
Crohn’s Disease & Ulcerative Colitis |
Intravenous Induction (J3358 & Q5138):
Subcutaneous Maintenance (J3357 & Q5137):
|
Immune Checkpoint Inhibitor Related Diarrhea/Colitis |
Intravenous Induction (J3358 & Q5138):
Subcutaneous Maintenance (J3357 & Q5137):
|
- Initial Approval Criteria 1-3
Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information. |
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 1-3
- 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 TNF-inhibitor, IL-inhibitor, biologic response modifier or other non-biologic agent (e.g., abrocitinib, apremilast, tofacitinib, baricitinib, upadacitinib, deucravacitinib, etc.); AND
Adult Plaque Psoriasis (PsO) † 1-3,32,47-50
- 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 (i.e., hands, feet, head and neck, genitalia, etc.) or with intractable pruritis; AND
- 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, tapinarof, 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)
Pediatric Plaque Psoriasis (PsO) † 1-3,32,47-51
- 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 (i.e., hands, feet, head and neck, genitalia, etc.) or with intractable pruritis; AND
- 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)
Adult Psoriatic Arthritis (PsA) † 1-3,11,35,52
- 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, a trial and failure of at least a 4 week trial of ONE non-steroidal anti-inflammatory agent (NSAID), unless use is contraindicated; OR
- For patients with peripheral arthritis, dactylitis, OR active enthesitis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.
Juvenile Psoriatic Arthritis (JPsA) † 1-3,53,54
- 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 an oral disease-modifying anti-rheumatic agent (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.)
Crohn’s Disease (Stelara and Wezlana ONLY) † 1,2,12-14,16,20,26
- 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)
Ulcerative Colitis (Stelara and Wezlana ONLY) † 1,2,15,21-25,31,60
- 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
Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis (Stelara and Wezlana ONLY) ‡ 37,38
- Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, tremelimumab, dostarlimab, retifanlimab, etc.); 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 that is refractory to infliximab and/or vedolizumab
*Examples of contraindications to phototherapy (PUVA or UVB) include the following: 33,34,51 |
|
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1-3
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
Adult Plaque Psoriasis (PsO) 47,55
- 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., a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and ≥ 4-point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started].
Pediatric Plaque Psoriasis (PsO) 51,55
- 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. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and ≥ 4-point reduction in the children's Dermatology Life Quality Index (cDLQI) from when treatment started.]
Adult Psoriatic Arthritis (PsA) 17,56
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts 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) 57,58
- 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, 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 and Wezlana ONLY) 15
- 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 compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g., an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score].
Ulcerative Colitis (Stelara and Wezlana ONLY) 21-25
- Disease response as indicated by improvement in signs and symptoms compared to baseline such as stool frequency, rectal bleeding, and/or 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 [e.g., an improvement on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score or the Mayo Score].
Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis (Stelara and Wezlana ONLY) ‡ 37,38
- May not be renewed
- Dosage/Administration 1-3,37-46
Indication |
Dose |
Plaque Psoriasis |
Adult Subcutaneous Loading Dose:
Adult Subcutaneous Maintenance Dose:
|
Pediatric Subcutaneous Loading Dose:
Pediatric Subcutaneous Maintenance Dose:
|
|
Psoriatic Arthritis |
Adult Subcutaneous Loading Dose:
Adult Subcutaneous Maintenance Dose:
|
Pediatric Subcutaneous Loading Dose:
Pediatric Subcutaneous Maintenance Dose:
|
|
Crohn’s Disease & Ulcerative Colitis/ Immune Checkpoint Inhibitor-Related Diarrhea/Colitis |
Stelara and Wezlana ONLY Intravenous Induction Dose (one-time only):
Subcutaneous Maintenance Dose:
(Note Immune Checkpoint Inhibitor Related Toxicity: 1 induction dose plus up to 3 maintenance doses only) |
*Note:
|
|
**ustekinumab trough levels must be obtained (if this is a covered test under the benefit).
|
- 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 (Selarsdi ONLY) (Discontinue use for Wezlana on 07/01/2024)
- Q5137 – Injection, ustekinumab-auub (Wezlana), biosimilar, subcutaneous, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2024)
- Q5138 – Injection, ustekinumab-auub (Wezlana), biosimilar, intravenous, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2024)
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
- 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
- References
- Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; March 2023. Accessed November 2023.
- Wezlana [package insert]. Thousand Oaks, CA; Amgen Inc.; October 2023. Accessed November 2023.
- Selarsdi [package insert]. Leesburg, VA; Alvotech USA Inc.; April 2024. Accessed May 2024.
- 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.
- 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.
- Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
- 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.
- 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.
- 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.
- 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.
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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 September 2023.
- 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.
- 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.
- 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
- 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.
- 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
- Paine ER. Colonoscopic evaluation in ulcerative colitis. Gastroenterol Rep (Oxf). 2014 Aug; 2(3): 161–168.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Richard EG. (2021). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UpToDate. Last updated: Dec 01, 2022. Accessed on: September 5, 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.
- Honigsman H. (2020). UVB therapy (broadband and narrowband). In Elmets CA, Corona R (Eds.), UpToDate. Last updated: Jan 18, 2023; Accessed on September 5, 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.
- 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.
- 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
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) ustekinumab. National Comprehensive Cancer Network, 2023. 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 September 2023.
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Consolaro A, Giancane G, Schiappapietra B, et al. Clinical outcome measures in juvenile idiopathic arthritis. Pediatric Rheumatology 18 April 2016 14:23.
- 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
Appendix 1 – Covered Diagnosis Codes
Stelara and Wezlana Subcutaneous (J3357, Q5137)
ICD-10 |
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 |
K52.1 |
Toxic gastroenteritis and colitis |
L40.0 |
Psoriasis vulgaris |
L40.50 |
Arthropathic psoriasis, unspecified |
L40.51 |
Distal interphalangeal psoriatic arthropathy |
L40.52 |
Psoriatic arthritis mutilans |
L40.53 |
Psoriatic spondylitis |
L40.59 |
Other psoriatic arthropathy |
M08.80 |
Other juvenile arthritis, unspecified site |
M08.811 |
Other juvenile arthritis, right shoulder |
M08.812 |
Other juvenile arthritis, left shoulder |
M08.819 |
Other juvenile arthritis, unspecified shoulder |
M08.821 |
Other juvenile arthritis, right elbow |
M08.822 |
Other juvenile arthritis, left elbow |
M08.829 |
Other juvenile arthritis, unspecified elbow |
M08.831 |
Other juvenile arthritis, right wrist |
M08.832 |
Other juvenile arthritis, left wrist |
M08.839 |
Other juvenile arthritis, unspecified wrist |
M08.841 |
Other juvenile arthritis, right hand |
M08.842 |
Other juvenile arthritis, left hand |
M08.849 |
Other juvenile arthritis, unspecified hand |
M08.851 |
Other juvenile arthritis, right hip |
M08.852 |
Other juvenile arthritis, left hip |
M08.859 |
Other juvenile arthritis, unspecified hip |
M08.861 |
Other juvenile arthritis, right knee |
M08.862 |
Other juvenile arthritis, left knee |
M08.869 |
Other juvenile arthritis, unspecified knee |
M08.871 |
Other juvenile arthritis, right ankle and foot |
M08.872 |
Other juvenile arthritis, left ankle and foot |
M08.879 |
Other juvenile arthritis, unspecified ankle and foot |
M08.88 |
Other juvenile arthritis, other specified site |
M08.89 |
Other juvenile arthritis, multiple sites |
M08.9A |
Juvenile arthritis, unspecified, other specified site |
M08.911 |
Juvenile arthritis, unspecified, right shoulder |
M08.912 |
Juvenile arthritis, unspecified, left shoulder |
M08.919 |
Juvenile arthritis, unspecified, unspecified shoulder |
M08.921 |
Juvenile arthritis, unspecified, right elbow |
M08.922 |
Juvenile arthritis, unspecified, left elbow |
M08.929 |
Juvenile arthritis, unspecified, unspecified elbow |
M08.931 |
Juvenile arthritis, unspecified, right wrist |
M08.932 |
Juvenile arthritis, unspecified, left wrist |
M08.939 |
Juvenile arthritis, unspecified, unspecified wrist |
M08.941 |
Juvenile arthritis, unspecified, right hand |
M08.942 |
Juvenile arthritis, unspecified, left hand |
M08.949 |
Juvenile arthritis, unspecified, unspecified hand |
M08.951 |
Juvenile arthritis, unspecified, right hip |
M08.952 |
Juvenile arthritis, unspecified, left hip |
M08.959 |
Juvenile arthritis, unspecified, unspecified hip |
M08.961 |
Juvenile arthritis, unspecified, right knee |
M08.962 |
Juvenile arthritis, unspecified, left knee |
M08.969 |
Juvenile arthritis, unspecified, unspecified knee |
M08.971 |
Juvenile arthritis, unspecified, right ankle and foot |
M08.972 |
Juvenile arthritis, unspecified, left ankle and foot |
M08.979 |
Juvenile arthritis, unspecified, unspecified ankle and foot |
M08.98 |
Juvenile arthritis, unspecified, vertebrae |
M08.99 |
Juvenile arthritis, unspecified, multiple sites |
R19.7 |
Diarrhea, unspecified |
Stelara and Wezlana Intravenous (J3358, Q5138)
ICD-10 |
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 |
K52.1 |
Toxic gastroenteritis and colitis |
R19.7 |
Diarrhea, unspecified |
Selarsdi Subcutaneous (J3590)
ICD-10 |
ICD-10 Description |
L40.0 |
Psoriasis vulgaris |
L40.50 |
Arthropathic psoriasis, unspecified |
L40.51 |
Distal interphalangeal psoriatic arthropathy |
L40.52 |
Psoriatic arthritis mutilans |
L40.53 |
Psoriatic spondylitis |
L40.59 |
Other psoriatic arthropathy |
M08.80 |
Other juvenile arthritis, unspecified site |
M08.811 |
Other juvenile arthritis, right shoulder |
M08.812 |
Other juvenile arthritis, left shoulder |
M08.819 |
Other juvenile arthritis, unspecified shoulder |
M08.821 |
Other juvenile arthritis, right elbow |
M08.822 |
Other juvenile arthritis, left elbow |
M08.829 |
Other juvenile arthritis, unspecified elbow |
M08.831 |
Other juvenile arthritis, right wrist |
M08.832 |
Other juvenile arthritis, left wrist |
M08.839 |
Other juvenile arthritis, unspecified wrist |
M08.841 |
Other juvenile arthritis, right hand |
M08.842 |
Other juvenile arthritis, left hand |
M08.849 |
Other juvenile arthritis, unspecified hand |
M08.851 |
Other juvenile arthritis, right hip |
M08.852 |
Other juvenile arthritis, left hip |
M08.859 |
Other juvenile arthritis, unspecified hip |
M08.861 |
Other juvenile arthritis, right knee |
M08.862 |
Other juvenile arthritis, left knee |
M08.869 |
Other juvenile arthritis, unspecified knee |
M08.871 |
Other juvenile arthritis, right ankle and foot |
M08.872 |
Other juvenile arthritis, left ankle and foot |
M08.879 |
Other juvenile arthritis, unspecified ankle and foot |
M08.88 |
Other juvenile arthritis, other specified site |
M08.89 |
Other juvenile arthritis, multiple sites |
M08.9A |
Juvenile arthritis, unspecified, other specified site |
M08.911 |
Juvenile arthritis, unspecified, right shoulder |
M08.912 |
Juvenile arthritis, unspecified, left shoulder |
M08.919 |
Juvenile arthritis, unspecified, unspecified shoulder |
M08.921 |
Juvenile arthritis, unspecified, right elbow |
M08.922 |
Juvenile arthritis, unspecified, left elbow |
M08.929 |
Juvenile arthritis, unspecified, unspecified elbow |
M08.931 |
Juvenile arthritis, unspecified, right wrist |
M08.932 |
Juvenile arthritis, unspecified, left wrist |
M08.939 |
Juvenile arthritis, unspecified, unspecified wrist |
M08.941 |
Juvenile arthritis, unspecified, right hand |
M08.942 |
Juvenile arthritis, unspecified, left hand |
M08.949 |
Juvenile arthritis, unspecified, unspecified hand |
M08.951 |
Juvenile arthritis, unspecified, right hip |
M08.952 |
Juvenile arthritis, unspecified, left hip |
M08.959 |
Juvenile arthritis, unspecified, unspecified hip |
M08.961 |
Juvenile arthritis, unspecified, right knee |
M08.962 |
Juvenile arthritis, unspecified, left knee |
M08.969 |
Juvenile arthritis, unspecified, unspecified knee |
M08.971 |
Juvenile arthritis, unspecified, right ankle and foot |
M08.972 |
Juvenile arthritis, unspecified, left ankle and foot |
M08.979 |
Juvenile arthritis, unspecified, unspecified ankle and foot |
M08.98 |
Juvenile arthritis, unspecified, vertebrae |
M08.99 |
Juvenile arthritis, unspecified, multiple sites |
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 |
USTEKINUMAB (Stelara®; Wezlana™; Selarsdi™) Prior Auth Criteria |
|