Coverage is provided in the following conditions:
• Patient is at least 18 years of age; AND
• Patient is up to date with all vaccinations, in accordance with current immunization guidelines, prior to initiating therapy; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
Universal Criteria
• Must be prescribed by, or in consultation with, a specialist in gastroenterology; AND
• Patient does not have an active infection, including clinically important localized infections; 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 is not on concurrent treatment with another TNF-inhibitor, biologic response modifier or other non-biologic agent (i.e., apremilast, tofacitinib, baricitinib, upadacitinib, etc.); AND
Crohn’s Disease
• 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, etc.); OR
• Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum (3) month trial on previous therapy with a TNF modifier such as adalimumab, certolizumab, or infliximab.
Management of Immune Checkpoint Inhibitor-Related Diarrhea/Colitis
• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, etc.); AND
• Patient has moderate (grade 2) to severe (grade 3-4) diarrhea or colitis related to their immunotherapy
