Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriatic Arthritis
Treatment: Remicade
The insurer denied: Remicade
The denial is overturned.

The patient is an adult female with history of the psoriatic arthritis and Crohn's disease. The patient previously was on Remicade, and overall, she was doing very well. However, with biosimilar medication Inflectra, she experienced side effects such as GI (gastrointestinal) bleeds and blood clots requiring hospital admission. The request for Remicade was initially denied coverage by the health plan due to the patient not having tried and failed Renflexis, Avsola or infliximab. The reason the provider is appealing the determination is because the patient previously did very well on Remicade and had side effects when switch to a biosimilar. The request is for going back to Remicade, as the patient was stable on this treatment.

The requested Remicade is medically necessary.

The request for Remicade was initially denied due to the patient not having tried and failed Renflexis, Avsola or infliximab.
Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF (tumor necrosis factor) biosimilars has 
introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reported consequences of non-medical 
switching remain largely unknown, as much of the evidence comes from poorly controlled or uncontrolled real-world evidence studies that often have an element of bias and non-standardized outcome measures. Experts and authors of studies have stated that to appropriately evaluate the safety, efficacy, and immunogenicity of non-medical switching from an originator to its 
biosimilar, there should be seven key study design elements when assessing the existing evidence: studies should be (1) randomized and double-blind, (2) adequately controlled, and (3) 
adequately powered; include (4) multiple switching, (5) an assessment of immunogenicity, and (6) adequate follow-up duration; and (7) report individual patient-level outcomes.
A systematic review assessed the robustness and consistency of the current non-medical switching evidence, with a focus on TNF (tumor necrosis factor) inhibitors. A comprehensive literature search identified 98 publications corresponding to 91 studies (17 randomized controlled trials and 74 real world evidence studies) describing non-medical switching from a TNF (tumor necrosis factor) inhibitor originator to its biosimilar. When assessing the totality of this evidence, none of the non-medical switching studies conducted to date were found to use all seven of the key design elements, and the absence of these elements dilutes the robustness of the data. Therefore, experts suggest that patients should not be indiscriminately switched from an originator TNF (tumor necrosis factor) inhibitor to its biosimilar for non-medical reasons. Switching decisions should remain between the treating physicians and their patients and be made on a case-by-case basis, relying upon robust scientific evidence. While there are studies that showed that non-medical switching can be safe, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable inflammatory bowel disease or inflammatory arthritis patients to biosimilars. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of 
appropriate controls; and scarcity of research on biosimilar switch long-term effects. Therefore, at this time enough solid evidence is not found in the literature to suggest that switching a patient from the stable parent drug to the biosimilar would have equal evidence and would not promote flaring and worsening of patient's disease which could cause long term consequences. Therefore, the requested drug Remicade is medically necessary.