Last Review Date: 08/01/2024

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

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

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.

2. Dosing Limits

1. 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 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) † ^1-4,33,48-51

• 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) † ^1-4,33,48-52

• 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 (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) † ^1-4,12,36,53

• 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) † ^1-4,54,55

• 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 an oral disease-modifying anti-rheumatic agent (DMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.)

Crohn’s Disease (Stelara, Pyzchiva, and Wezlana ONLY) † ^{1,2,4,13-15,17,21,27}

• 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, Pyzchiva, and Wezlana ONLY)  † ^{1,2,4,16,22-26,32,61}

• 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, 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, 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

† 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

Adult Plaque Psoriasis (PsO) ^48,56

• 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) ^52,56

• 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) ^18,57

• 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) ^58,59

• 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, Pyzchiva, and Wezlana ONLY) ¹⁶

• 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, Pyzchiva, and Wezlana ONLY) ^22-26

• 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, Pyzchiva, and Wezlana ONLY) ‡ ^38,39

• 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

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3. Selarsdi [package insert]. Leesburg, VA; Alvotech USA Inc.; April 2024. Accessed May 2024.
4. Pyzchiva [package insert]. Yeonsu-gu, Incheon; Samsung Bioepis Co., Ltd.; June 2024. Accessed July 2024.
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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