Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Irritable Bowel Syndrome with Diarrhea (IBS-D).
Treatment: Xifaxan 550 milligram (mg) tablets (42 per 14 days).
The insurer denied the request for Xifaxan 550 mg tablets (42 per 14 days).
The health plan's determination is overturned. 

The patient is a female who has a medical history of irritable bowel syndrome, diarrhea-predominant (IBS-D), as well as mast cell activation syndrome, chronic gas and bloating, abdominal pain, and diarrhea. She has failed treatments for IBS-D and diarrhea, including Iberogast, Sucraid, Linzess, and Motegrity. She has had multiple courses of Xifaxan, including daily use for 2 years. She has had recurrent abdominal pain and diarrhea between Xifaxan treatments. Endoscopic procedures and motility testing have not shown an alternative cause for her symptoms. The coverage is requested for Xifaxan 550 mg three times daily for 14 days (42 per 14 days) for the treatment of irritable bowel syndrome, diarrhea-predominant.

Xifaxan is supported as medically necessary. The patient has irritable bowel syndrome, diarrhea-predominant (IBS-D). Xifaxan has proven effective for the treatment of irritable bowel syndrome, diarrhea-predominant [1,2]. The U.S. Food and Drug Administration (FDA) has approved Xifaxan for the treatment of IBS-D, and the medication has proven safe and effective in randomized placebo-controlled trials for IBS-D [1-3]. In the TARGET-3 trial of over 1,000 patients, Xifaxan 550mg three times daily (the requested dose) proved effective with significant symptom improvement in irritable bowel syndrome [4]. The American College of Gastroenterology guidelines for the treatment of irritable bowel syndrome state that Xifaxan is effective; the patient has already attempted multiple alternatives without success [1,5,6]. There is data for safety and effectiveness of subsequent courses of Xifaxan, which continued to be effective - the subsequent courses were just as effective and the effect had a similar duration [4,7]. Without Xifaxan, the enrollee has recurrent symptoms which do not respond to therapy with alternatives. For these reasons, the request for Xifaxan 550 mg three times daily for 14 days is supported as medically necessary for the treatment of this patient's irritable bowel syndrome, diarrhea-predominant.

Per the plan definition:

Services will be deemed Medically Necessary only if:

- They are clinically appropriate in terms of type, frequency, extent, site, and duration, and considered effective for Your illness, injury, or disease;
- They are required for the direct care and treatment or management of that condition;
- Your condition would be adversely affected if the services were not provided;
- They are provided in accordance with generally accepted standards of medical practice;
- They are not primarily for the convenience of You, Your family, or Your Provider;
- They are not more costly than an alternative service or sequence of services, that is at least as likely to produce equivalent therapeutic or diagnostic results;
- When setting or place of service is part of the review, services that can be safely provided to You in a lower cost setting will not be Medically Necessary if they are performed in a higher cost setting. For example, We will not provide coverage for an inpatient admission for surgery if the surgery could have been performed on an outpatient basis or an infusion or injection of a specialty drug provided in the outpatient department of a Hospital if the drug could be provided in a Physician's office or the home setting.
 
The health plan's determination of medical necessity is overturned in whole.