Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal/Crohn's Disease.
Treatment: Pharmacy/Prescription Drugs.
The health plan denied the requested medication, Remicade as not medically necessary. 
The health plan's determination is overturned.

This is a review for the continued use of Remicade (Infliximab) versus an Infliximab biosimilar to treat Crohn's disease. This is a patient who has severe Crohn's disease and has had a prior bowel resection. She has been stable on Remicade infusions. The patient has previously tried and failed Humira and Stelara. She was switched from Remicade to Inflectra (Infliximab) by her insurance company but did not respond to this medication. She was hence switched back to Remicade and her Crohn's disease is in remission at an escalated dose of 10 milligrams per kilogram (mg/kg) of Infliximab every 6 weeks with the addition of Methotrexate. The attending gastroenterologist is appealing the patient being switched from Remicade to an Infliximab biosimilar Avsola or Renfelexis.

The health plan's determination of medical necessity is overturned.

Yes, the requested treatment of Remicade is medically necessary for this patient. The use of biologics -anti-tumor necrosis factor (TNF) agents are standard of care in moderate to severe Crohn's Disease. Infliximab (Remicade) and Adalimumab (Humira) are Food and Drug Administration (FDA) approved for Induction and maintenance therapy in Crohn's disease. 
The FDA definition of a biosimilar is "a biologic product that is highly similar to the reference product notwithstanding minor differences in clinical interactive components and there are no clinical meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product." Biosimilars are not the same as generic medications as there are structural differences between biosimilars and the reference or "originator" drug. At this time, there are four FDA approved biosimilars to Infliximab (Infliximab-dyyb/Inflectra, Infliximab-abda/Renflexis, and Infliximab-qbtx/Ixifi and Infliximab-axxq/Avsola). These biosimilars were approved for all indications as the originator. Several studies have since shown similar safety of these biosimilars in the inflammatory bowel disease (IBD) population, however studies showing equivalent efficacy are limited. The other area concern with biosimilar medication is the idea of interchangeability, which means that the biosimilar can be expected to produce the same clinical result as the reference product in any given patient and the safety and efficacy of alternating or switching between the biosimilar and the reference product is not greater than the risk with continued use of the reference product. While some studies have shown that it may be safe to switch from Infliximab to an Infliximab biosimilar, changing treatment more than once has not been studied so the safety of multiple switches remains unknown.
If a patient did not respond to the reference anti-TNF, they will not respond to the biosimilar anti-TNF as these medications have the same mechanism of action. Additionally, if a patient had an adverse reaction or developed drug antibodies to a reference anti-TNF, that patient is likely to have a reaction to the biosimilar anti-TNF as well. If the patient had an adverse reaction or developed antibodies to an originator anti-TNF, that patient should not be treated with the biosimilar product. The Infliximab biosimilar drugs were FDA approved as alternative to Infliximab for new starts on biological therapy but were not designed to be substituted for patients who were already either on Infliximab or one of the biosimilars.
If a patient is doing well on a particular biological agent, they must be continued on the same agent.

The continued use of Remicade at the escalated dose of 10mg/kg every 6 weeks is appropriate and medically necessary.