Initial Approval Criteria
• Patient is at least 18 years of age; AND Universal Criteria 1,13
• Prescriber and patient must be enrolled in and meet the conditions of the TOUCH program; AND
• Not used in combination with antineoplastic, immunosuppressant, or immunomodulating agents; AND
• Patient must not have a systemic medical condition resulting in significantly compromised immune system function; AND
Multiple Sclerosis
• Patient has been diagnosed with a relapsing form of multiple sclerosis [i.e. relapsingremitting disease (RRMS)*, active secondary progressive disease (SPMS)**, or clinically isolated syndrome (CIS)***]; AND
• Confirmed diagnosis of MS as documented by laboratory report (i.e. MRI); AND • Used as single agent therapy Crohn’s Disease † 1,13
• Patient has moderate to severe active disease; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Documented trial and failure on ONE oral immunosuppressive therapy for at least 3 months, unless use is contraindicated, such as corticosteroids, methotrexate, azathioprine, and/or 6-mercaptopurine; AND
• Documented trial and failure on ONE TNF-Inhibitor therapy for at least 3 months, unless contraindicated, such as infliximab, certolizumab, or adalimumab; AND
• Used as single agent therapy [Not used concurrently with another biologic drug or immunosuppressant (e.g., 6-mercaptopurine, azathioprine, cyclosporine, methotrexate, etc.) used for Crohn’s Disease] † FDA Approved Indication(s)
