Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative Colitis
Treatment: Entyvio
The insurer denied the request or Entyvio.
The health plan's determination is overturned in whole. 

The patient is a female who has a history of ulcerative colitis. She tried and failed numerous therapies, including Infliximab, Stelara and Mesalamine. She was started on Xeljanz and had a partial response.

Medical necessity of dual therapy with Entyvio and Xeljanz cannot be established based on the available literature. There is no sufficient scientific evidence supporting the concurrent use of Xeljanz and Entyvio in treating pediatric ulcerative colitis. The available literature is mainly from case reports and does not allow a well-supported conclusion regarding the long term safety or efficacy of this combination. The clinical practice guidelines have not yet adopted concurrent use of biologics in treating pediatric inflammatory bowel disease.
Per Ribaldone, Davide Giuseppe, et al. "The use of dual biological therapy is an attractive therapeutic option and may be an opportunity to better tailor and personalize the therapies for patients. Further studies, such as randomized control trials, to provide comparative efficacy and safety endpoints of combination therapies, and to clarify potential advantages of combined biological therapies, are needed."
According to Ahmed, Waseem, et al. "Dual biologic or small molecule therapy may be a possible option in highly selected, refractory inflammatory bowel disease (IBD) patients at specialized centers. Higher quality combination of therapies with a significant improvement in the quality of data is required prior to more widespread use.
Finally, and according to Haider, Mahnur et al. "The majority of studies on dual targeted therapy (DTT) are case reports and case series on the combination of dual biologic therapy. From the limited evidence available in patients with IBD, dual biologic therapy may be a safe option for patients with refractory IBD who have failed multiple biologic therapies and to manage extraintestinal manifestation of IBD. Further studies and randomized control trials are required to comprehensively evaluate the safety and efficacy of DTT in IBD." Therefore, the requested dual therapy is not well supported by scientific evidence and not consistent with the generally accepted practices. The records do not indicate that the patient has tried and failed monotherapy with Entyvio.

However, using Entyvio as a monotherapy in this case is appropriate and can be allowed as medically necessary. 
Entyvio is FDA approved for the use in the treatment of inflammatory bowel disease in adults. There are many peer reviewed literature reports supporting the use of Entyvio in pediatric patients with inflammatory bowel disease. Despite the lack of FDA approval in pediatric patients, Entyvio is being widely used for the treatment of children with Crohn's disease and ulcerative colitis. The safety and efficacy of Entyvio are well established in pediatric patients with inflammatory bowel disease.
Per Ledder O et al, "Vedolizumab was safe and effective in this cohort of paediatric refractory IBD". Similar findings were reported by Singh N et al and Anna-Maria Schneider et al.
Therefore, Entyvio is requested for a medically appropriate indication. 
The member has already failed the available FDA approved alternatives. Therefore, Entyvio is appropriate and medically necessary in this case.