Last Review Date: 09/01/2022

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

1. Length of Authorization

Crohn’s Disease and Ulcerative Colitis:

Coverage will be provided for 8 weeks initially and may be renewed in 6 month intervals thereafter.

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

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

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

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age (unless otherwise specified); AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

Universal Criteria ¹

• 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 a TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib, upadacitinib, etc.); AND

Adult Plaque Psoriasis (PsO) † ^1,30,45-48

• 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, 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) † ^1,30,45-49

• Patient is at least 6 years of age; 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, 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) † ^1,9,33,50

• Documented moderate to severe active disease; AND

• For patients with predominantly axial disease OR active enthesitis, a trial and failure of at least a 4 week trial of ONE (1) non-steroidal anti-inflammatory agent (NSAID), unless use is contraindicated; OR
• For patients with peripheral arthritis or dactylitis, a trial and failure of at least a 3 month trial of ONE (1) oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.

Juvenile Psoriatic Arthritis (PsA) † ^1,51,52

• Patient is at least 6 years of age; 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 † ^{1,10-12,14,18,24}

• 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 † ^{1,13,19-23,29}

• Documented moderate to severe active disease; AND
  • Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial of corticosteroids or immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate)

Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis ‡^35,36

• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, etc.); AND
  • Patient has mild (grade 1) diarrhea or colitis with persistent or progressive symptoms and is lactoferrin/calprotectin positive; OR
  • Patient has moderate (grade 2) to severe (grade 3-4) diarrhea or colitis related to their immunotherapy and is refractory to infliximab and/or vedolizumab

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

4. Renewal Criteria ¹

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) ^45,53

• 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) ^49,53

• 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) ^15,54

• 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 (PsA) ^55,56

• 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 ¹³

• 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 ^19-23

• 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 ‡

• May not be renewed

5. Dosage/Administration

6. Billing Code/Availability Information

HCPCS Code:

• J3357 – Ustekinumab, for subcutaneous injection, 1 mg; 1 billable unit = 1 mg
• J3358 – Ustekinumab, for intravenous injection, 1 mg; 1 billable unit = 1 mg

NDC:

• Subcutaneous
  • Stelara 45 mg single-dose vial (SDV) and prefilled (PF) syringe: 57894-0060-xx
  • Stelara 90 mg prefilled (PF) syringe: 57894-0061-xx
• Intravenous
  • Stelara 130 mg (5 mg/mL) single-dose vial (SDV): 57894-0054-xx

7. References

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Appendix 1 – Covered Diagnosis Codes

Subcutaneous (J3357)

Intravenous (J3358)

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