Medical Drug Criteria

Policy Num:       P1.002.007
Policy Name:     Stelara® (ustekinumab)
Policy ID:          [P1.002.007]  [Ac / Mg / M+ / P+]  [0.00.00]

Last Review:       December 17, 2024
Next Review:      December 20, 2025
 

Related MDC:

Stelara® (ustekinumab)

Summary

Stelara is a human IgG1κ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit used by both the interleukin (IL)-12 and IL-23 naturally occurring cytokines. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). 

Policy Statements

Stelara® (ustekinumab) may be considered medically necessary if the following conditions are met:

• 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
• 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

Universal Criteria  

• 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

Policy Guidelines

Renewal Criteria ¹

• Patient continues to meet the universal and other indication-specific relevant criteria identified above; 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

DOSAGE/ADMINISTRATION

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 o Received the initial intravenous loading dose as specified above; AND o 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 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.

REQUIRED MEDICAL INFORMATION

As stated above.

EXCLUSION CRITERIA

N/A

BENEFIT APPLICATION

As stated in the insurer's policy.

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.

Other criteria

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.

References

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