Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: diarrhea.
Treatment: Pharmacy/Prescription Drugs-Viberzi.
The insurer denied Viberzi. 
The denial is overturned.

The patient is a female seeking treatment with Viberzi (Eluxadoline) for irritable bowel syndrome with diarrhea (IBS-D). This patient has been on Viberzi for several years after having tried and failed antidiarrheals, antispasmodics and Xifaxan. She has relief of the symptoms of diarrhea with Viberzi. Therefore, the attending provider would like to continue Viberzi to treat this patient's IBS-D. The subject under review is whether the non-formulary Viberzi would be more effective than the formulary alternatives.

The patient should be continued on Viberzi. 
Per the medical records provided, the patient has tried and failed loperamide and Xifaxan. Alosetron is restricted for use in women with severe IBS-D under a risk-management program. Alosetron was originally approved by the Food and Drug Administration (FDA) in 2000 for the treatment of IBS-D in women; however, it was voluntarily withdrawn due to serious adverse events, namely ischemic colitis and serious complications of constipation. In 2002, the FDA approved the reintroduction of alosetron but restricted its use to the treatment of severe IBS-D in women under a risk-management program.
Irritable bowel syndrome is a functional bowel disorder with gastrointestinal symptoms (e.g., abdominal pain, straining, urgency, incomplete evacuation, nausea, and bloating) that occur alongside bowel function alterations (i.e., constipation, diarrhea, or both). Patients with irritable bowel syndrome may also experience comorbid anxiety and depression. Irritable bowel syndrome is common, with a prevalence estimated between 3% and 28%, affecting patient health and quality of life. Management of irritable bowel syndrome can include lifestyle changes, dietary interventions, counseling, psychologic medication, and agents that affect gastrointestinal motility. The mixed MU opioid peptide (-opioid) receptor agonist and d-opioid receptor antagonist eluxadoline was approved in May 2015 for the treatment of IBS-D. Patients with IBS-D receiving eluxadoline in a phase II dose-ranging study had greater efficacy compared with patients receiving placebo after 12 weeks .
A significantly greater percentage of patients receiving eluxadoline 25 milligrams (mg) or 200 mg twice daily achieved clinical response (i.e. decrease from baseline in mean worst abdominal pain greater than (>)=30% and >=2 points, with a daily Bristol Stool Scale score of 3 or 4 on >=66% of daily diary entries within a week) after 4 weeks of treatment compared with placebo (12% or 13.8% versus 5.7%, respectively; probability [p] = 0.04 for 25 mg and p = 0.02 for 200 mg versus placebo). Clinical response was also significantly greater in patients receiving eluxadoline 100 mg twice daily after 12 weeks of treatment compared with placebo (20.2% versus 11.3%, respectively; p less than [<] 0.05). Eluxadoline improved the number of daily bowel movements and decreased the episodes of urgency and incontinence experienced by patients during the 3-month treatment period. Eluxadoline had an overall favorable safety profile, with nausea, abdominal pain, vomiting, and constipation the most commonly reported adverse events (AEs). Constipation was most common in the eluxadoline 100 mg group (6%); however, no patients in this group discontinued from the study or rated the intensity of constipation as severe. According to current American College of Gastroenterology (ACG) guidelines for the management of IBS-D, the authors suggest that mixed opioid agonists/antagonists be used to treat global IBS-D symptoms.
Since this patient is stable on Viberzi, she should be continued on this medication.