Appeal type: Formulary Exception
Decision: Overturned


Diagnosis: Digestive System/Gastrointestinal/Irritable Bowel Syndrome
Treatment: Prescription Drugs-Viberzi
The health plan denied the requested prescription medication, Viberzi as not medically necessary. The health plan's determination is overturned.

This is a review of the medical necessity for Viberzi (Eluxadoline) to treat irritable bowel syndrome with diarrhea (IBS-D) in a patient. A letter from the patient's gastroenterologist states that the patient has tried and failed probiotics, antispasmodics, and Rifaxamin. He was started on Viberzi to relieve his symptoms of diarrhea. Therefore, the attending provider would like to continue Viberzi to treat this patient's IBS-D.
At issue is the medical necessity for the requested medication, Viberzi.

I overturn, in whole, the health plan's determination.

The patient has tried and failed antispasmodics (Dicyclomine, Hyoscyamine). He has also tried and failed Xifaxan. He has not tried and failed Amitriptyline or Nortriptyline. He has not tried and failed Loperamide.
However, the evidence of treating IBS-D with Loperamide is very low according to current (2022) American Gastroenterological Association (AGA) guidelines for the pharmacological management of IBS-D, and it is also low for Tricyclic antidepressants.
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 -opioid receptor agonist and d-opioid receptor antagonist Eluxadoline were approved in May 2015 for the treatment of IBS-D. Patients with IBS-D receiving Eluxadoline in the phase II dose-ranging study had greater efficacy compared with patients receiving a placebo after 12 weeks. A significantly greater percentage of patients receiving Eluxadoline 25 mg (milligrams) or 200 mg twice daily achieved clinical response (i.e. decrease from baseline in mean worst abdominal pain >=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; p (level of statistical significance) = 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 < 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. Constipation was most common in the Eluxadoline 100 mg group (6%); however, no patients in this group discontinued 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. The current AGA guidelines for the pharmacological management of IBS-D, also recommend Eluxadoline.