Ulcerative Colitis Treatment with Infliximab
Medical Necessity Assessment
- The patient has a diagnosis of ulcerative colitis, unspecified, without complications, as evidenced by documented colonoscopy findings showing moderate-severe inflammation and subsequent improvement with treatment, according to the American Gastroenterological Association 1, 2
- The American Gastroenterological Association strongly recommends infliximab over no treatment for adult outpatients with moderate-to-severe ulcerative colitis, with a strong recommendation and moderate to high certainty of evidence 2
- The patient's prescriber, a gastroenterologist, meets the specialist requirement for prescribing infliximab, as recommended by the American Gastroenterological Association 2
- The patient had documented moderate-severe inflammation on sigmoidoscopy, which meets the criteria for "moderately to severely active ulcerative colitis" required for infliximab therapy, according to the American Gastroenterological Association 2
Treatment Considerations
- Patients should have documented negative tuberculosis testing within 12 months of initiating infliximab therapy, as recommended by the American Gastroenterological Association, due to the increased risk of tuberculosis with infliximab treatment 2
- Combining infliximab with immunomodulators is suggested over monotherapy, as it reduces antibody formation against infliximab and improves treatment durability, according to the American Gastroenterological Association 2
- Avsola (infliximab-axxq) is an FDA-approved biosimilar to Remicade (infliximab), and biosimilars are considered equivalent to their originator drug in efficacy, as stated by the American Gastroenterological Association 2