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Ustekinumab: Stelara®; Wezlana™

Policy Number: PH-90117

Intravenous/Subcutaneous

Last Review Date: 12/07/2023

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

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 1,2,37-45

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.

  1. Dosing Limits

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

Subcutaneous

  • Stelara 45 mg/0.5 mL single-dose vial/prefilled syringe:
    • Loading: 1 vial/syringe at weeks 0 & 4
    • Maintenance: 1 vial/syringe every 12 weeks
  • Stelara 90 mg/mL single-dose prefilled syringe:
    • Loading: 1 syringe at weeks 0 & 4
  • Maintenance: 1 syringe every 4 weeks
  • Wezlana 45 mg/0.5 mL single-dose vial/prefilled syringe:
    • Loading: 1 vial/syringe at weeks 0 & 4
    • Maintenance: 1 vial/syringe every 12 weeks
  • Wezlana 90 mg/mL single-dose prefilled syringe:
    • Loading: 1 syringe at weeks 0 & 4
    • Maintenance: 1 syringe every 4 weeks

Intravenous

  • Stelara 130 mg/26 mL (5 mg/mL) single-dose vial: 4 vials
  • Wezlana 130 mg/26 mL (5 mg/mL) single-dose vial: 4 vials

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):

  • 90 billable units (90 mg) at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

  • 90 billable units (90 mg) every 12 weeks

Psoriatic Arthritis

Subcutaneous Loading (J3357):

  • 45 billable units (45mg) at weeks 0 & 4; maintenance dosing 12 weeks later

Subcutaneous Maintenance (J3357):

  • 45 billable units (45 mg) every 12 weeks

Crohn’s Disease & Ulcerative Colitis

Intravenous Induction (J3358):

  • 520 billable units (520 mg) x 1 dose

Subcutaneous Maintenance (J3357):

  • 90 billable units (90 mg) 8 weeks after induction & every 4 weeks thereafter

Immune Checkpoint Inhibitor Related Diarrhea/Colitis

Intravenous Induction (J3358):

  • 520 billable units (520 mg) x 1 dose

Subcutaneous Maintenance (J3357):

  • 90 billable units (90 mg) 8 weeks after induction & every 8 weeks thereafter x 3 doses
  1. Initial Approval Criteria 1,2

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 1,2

  • 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) † 1,2,31,46-49

  • 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) † 1,2,31,46-50

  • 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) † 1,2,10,34,51

  • 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) † 1,2,52,53

  • 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 † 1,2,11-13,15,19,25

  • 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 † 1,2,14,20-24,30,59

  • Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
  • Documented moderate to severe active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of conventional therapy (aminosalicylates, corticosteroids or immunomodulators [e.g., azathioprine, 6-mercaptopurine, or methotrexate])

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis 36,37

  • 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: 32,33,50

  • Xeroderma pigmentosum
  • Other rare photosensitive genodermatoses (e.g., trichothiodystrophy, Cockayne syndrome, Bloom syndrome, Rothmund-Thomson syndrome) (UVB only)
  • Genetic disorders associated with increased risk of skin cancer (e.g., Gorlin syndrome, oculocutaneous albinism) (UVB only)
  • Pregnancy or lactation (PUVA only)
  • Lupus Erythematosus
  • History of one of the following: photosensitivity diseases (e.g., chronic actinic dermatitis, solar urticaria), melanoma, non-melanoma skin cancer, extensive solar damage (PUVA only), treatment with arsenic or ionizing radiation
  • Immunosuppression in an organ transplant patient (UVB only)
  • Photosensitizing medications (PUVA only)
  • Severe liver, renal, or cardiac disease (PUVA only)
  • Young age < 12 years old (PUVA only)

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

  1. Renewal Criteria 1,2

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) 46,54

  • 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) 50,54

  • 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) 16,55

  • 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) 56,57

  • 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 14

  • 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 20-24

  • 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 36,37

  • May not be renewed
  1. Dosage/Administration 1,2,36-45

Indication

Dose

Plaque Psoriasis

Adult Subcutaneous Loading Dose:

  • ≤100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Adult Subcutaneous Maintenance Dose:

  • ≤100 kg: 45 mg every 12 weeks
  • >100 kg: 90 mg every 12 weeks

Pediatric Subcutaneous Loading Dose:

  • <60 kg: 0.75 mg/kg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • 60 – 100 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Pediatric Subcutaneous Maintenance Dose:

  • <60 kg: 0.75 mg/kg every 12 weeks
  • 60 – 100 kg: 45 mg every 12 weeks
  • >100 kg: 90 mg every 12 weeks

Psoriatic Arthritis

Adult Subcutaneous Loading Dose:

  • 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • Co-existing moderate to severe plaque psoriasis AND weighing >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Adult Subcutaneous Maintenance Dose:

  • 45 mg every 12 weeks
  • Co-existing moderate to severe plaque psoriasis AND weighing >100 kg: 90 mg every 12 weeks

Pediatric Subcutaneous Loading Dose:

  • <60 kg: 0.75 mg/kg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • ≥60 kg: 45 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later
  • Co-existing moderate to severe plaque psoriasis AND weighing >100 kg: 90 mg at weeks 0 & 4, then begin maintenance dosing 12 weeks later

Pediatric Subcutaneous Maintenance Dose:

  • <60 kg: 0.75 mg/kg every 12 weeks
  • ≥60 kg: 45 mg every 12 weeks
  • Co-existing moderate to severe plaque psoriasis AND weighing >100 kg: 90 mg every 12 weeks

Crohn’s Disease & Ulcerative Colitis/

 Immune Checkpoint Inhibitor-Related Diarrhea/Colitis

Intravenous Induction Dose (one-time only):

  • ≤ 55 kg: 260 mg
  • > 55 kg to 85 kg: 390 mg
  • > 85 kg: 520 mg

Subcutaneous Maintenance Dose:

  • 90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter

(Note Immune Checkpoint Inhibitor Related Toxicity: 1 induction dose plus up to 3 maintenance doses only)

  • Crohn’s Disease & Ulcerative Colitis dose escalation37-44 (up to the maximum dose and frequency specified below) may occur upon clinical review on a case-by-case basis provided that the patient has:
  • Shown an initial response to therapy; AND
  • Received the initial intravenous loading dose as specified above; AND
  • Received a minimum of one subcutaneous maintenance dose as specified above; AND
  • Responded to therapy (by treatment week 16*) with subsequent loss of response; AND
  • Dose escalation must not exceed the following limits:
  • 90 mg every 4 weeks (certain patients may benefit from a smaller reduction in interval if they become symptomatic 5, 6, or 7 weeks after the prior administration)
  • Coverage will be provided for 3 months with continued approval (as specified in Sections I & IV) contingent upon demonstration of clinical improvement and ustekinumab levels (if available)**
    • Patients who do not regain response at a 4-week interval should discontinue therapy
    • Patients who are responding to therapy may continue with their current dosing**

*Note:

  • Request for dose escalation prior to week 16 will be evaluated considering the patient’s clinical picture regarding severity of inflammation, factors which may result in subtherapeutic response to standard dosing (e.g., hypoalbuminemia, prior TNF-I failure), timing of response and breakthrough/loss of response, presence of perianal fistula; AND
  • ustekinumab trough (if available)** is <4.5 micrograms/mL

**ustekinumab trough levels must be obtained (if this is a covered test under the benefit).

  • Patients who are well-controlled with a trough >4.5 micrograms/mL may be candidates to increase the interval between administrations from 4 weeks to 6 weeks. Response should be assessed after 3 months at this every 6-week interval. Those patients demonstrating loss of response may decrease the interval back to 90 mg every 4 weeks.
  • Patients whose trough is <4.5 micrograms/mL are candidates to decrease the interval between administrations from 8 weeks to as frequently as 4 weeks. Some patients may benefit from one additional IV loading dose in conjunction with this more frequent maintenance dosing interval.
  1. 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 (Wezlana Only)

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
  • 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
  1. References
  1. Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; March 2023. Accessed November 2023.
  2. Wezlana [package insert]. Thousand Oaks, CA; Amgen Inc.; October 2023. Accessed November 2023.
  3. 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.
  4. 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.
  5. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
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  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
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  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
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  20. 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.
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  25. 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. 
  26. 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.
  27. 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.
  28. 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.
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  30. 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.
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  55. 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.
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  57. Consolaro A, Giancane G, Schiappapietra B, et al. Clinical outcome measures in juvenile idiopathic arthritis. Pediatric Rheumatology 18 April 2016 14:23.
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Appendix 1 – Covered Diagnosis Codes

Subcutaneous (J3357, J3590)

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

Intravenous (J3358, J3590)

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

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

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

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

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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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

 

 

 

 

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