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
