Diagnosis: Crohn's disease
Treatment: Infliximab (Remicade)
The insurer denied the Infliximab (Remicade).
The determination is overturned.

This is a female patient with Crohn's disease. She started on Remicade and the dose was escalated. She had abdominal pain and hematochezia starting at week 7 after infusions; she was changed from Remicade 12.5 milligrams per kilogram (mg/kg) every 8 weeks to 10 mg/kg every 6 weeks. She had abdominal pain, diarrhea, and hematochezia, and was changed to Remicade 10 mg/kg (500 milligrams (mg)) every 4 weeks. She was in remission on Remicade 10 mg/kg every 4 weeks but reported that her infusion was delayed for a few days, and she had severe Crohn's disease flare symptoms including nausea, vomiting, and unintentional weight loss. At issue is the medical necessity of Infliximab (Remicade).

Yes, the continued use of Remicade is medically necessary for this patient. At issue in this case is a change from Remicade to a biosimilar form of infliximab in this patient with Crohn's disease. Inflectra, Avsola, and Renflexis are Food and Drug Administration (FDA)-approved biosimilars to Remicade (infliximab) for the treatment of Crohn's disease and Ulcerative Colitis. Support for the safety and efficacy of biosimilar medications in inflammatory bowel disease is provided by studies which either extrapolated safety and efficacy from patients with other diseases (such as rheumatoid arthritis), or from studies in patients who had controlled inflammatory bowel disease; many of these trials are underpowered to assess for noninferiority in inflammatory bowel disease patients [1]. Although there is support for initiation of therapy with an infliximab biosimilar rather than Remicade, there is a lack of high-quality data or large studies to support the safety of a switch from one biosimilar to another in Crohn's disease in remission [7,8]. For these reasons, the request for continuation of Remicade is supported in this patient currently stabilized on Remicade.