Pharmacy Prior Authorization Criteria

IBS - Diarrhea

Indications for Prior Authorization

Lotronex (alosetron hydrochloride)

• For diagnosis of Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS) in Women
  Indicated only for women with severe diarrhea-predominant IBS who have: • chronic IBS symptoms (generally lasting 6 months or longer) • had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and • not responded adequately to conventional therapy.

  Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following: • frequent and severe abdominal pain/discomfort • frequent bowel urgency or fecal incontinence • disability or restriction of daily activities due to IBS.

  Because of infrequent but serious gastrointestinal adverse reactions associated with Lotronex, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.

  Clinical studies have not been performed to adequately confirm the benefits of Lotronex in men.

Viberzi (eluxadoline)

• For diagnosis of Irritable bowel syndrome with diarrhea (IBS-D)
  Indicated in adults for the treatment of IBS-D.

Criteria

Brand Lotronex, Generic alosetron

Prior Authorization (Initial Authorization)

Length of Approval: 12 Week(s)

• Diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS)
AND
• Symptoms for at least 6 months [A]
AND
• Patient is female
AND
• Patient is 18 years of age or older
AND
• Trial and failure, contraindication, or intolerance to both of the following:
• antispasmodic agent [eg, Bentyl (dicyclomine)] [2, 6, B]
• antidiarrheal agent [eg, loperamide] [2, 3, 6]

Brand Lotronex, Generic alosetron

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)

• Symptoms of IBS continue to persist
AND
• Patient demonstrates positive clinical response to therapy as evidenced by one of the following: [1]
• Relief of IBS abdominal pain and discomfort
• Improvement in stool consistency
• Decrease in daily stool frequency
• Moderate or substantial improvement as measured by the Global Improvement Scale [C]

Viberzi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of irritable bowel syndrome with diarrhea
AND
• Trial and failure, contraindication, or intolerance to both of the following:
• antispasmodic agent [eg, Bentyl (dicyclomine)] [2, 6]
• antidiarrheal agent [eg, Lomotil (diphenoxylate and atropine)] [2, 3, 6]

Viberzi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Symptoms of IBS continue to persist
AND
• Patient demonstrates positive clinical response to therapy as evidenced by both of the following: [D]
• Improvement in the daily worst abdominal pain score
• Reduction in the Bristol Stool Scale

P & T Revisions

2024-05-20, 2023-12-06, 2023-03-23, 2022-03-25, 2021-09-28, 2021-05-19, 2021-03-18, 2020-03-06

References

1. Lotronex Prescribing Information. Sebela Pharmaceuticals Inc. Roswell, Georgia, CA. July 2016.
2. Lembo A, Sultan S, Chang L, Heidelbaugh JJ, Smalley W, Verne GN. AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Diarrhea. Gastroenterology. 2022;163(1):137-151. doi:https://doi.org/10.1053/j.gastro.2022.04.017
3. Wilkins T, Pepitone C, Alex B, Schade RR. Diagnosis and management of IBS in adults. Am Fam Physician. 2012;86(5):419-26.
4. Camiller M, Mayer EA, Drossman DA, et al. Improvement in the pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 antagonist. Aliment Pharmacol Ther 1999;13(9):1149-5.
5. Chey WD, Chey WY, Health AT, et al. Long-term Safety and Efficacy of Alosetron in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome. Am J of Gastroenterol 2004;99:2195-2203.
6. American College of Gastroenterology IBS Task Force. Evidence-based position statement on the management of irritable bowel syndrome in North America. Am J Gastroenterol. 2009;104(suppl 1):S1-S35.
7. Viberzi Prescribing Information. Allergan USA, Inc. Madison, NJ. June 2020.
8. Alosetron Prescribing Information. Actavis Pharma, Inc. Parsippany, NJ. January 2016
9. Ford AC, Moayyedi P, Chey WD, Harris LA, Lacy BE, Saito YA, Quigley EMM; ACG Task Force on Management of Irritable Bowel Syndrome. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018 Jun;113(Suppl 2):1-18.

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End Notes

1. Lotronex was removed from the market in late 2000 due to reports of ischemic colitis and severe constipation but has since been re-released with a “black box” warning for use in select cases. [1, 3, 4, 5]
2. Lotronex should be used with caution in debilitated patients, elderly patients, patients with hepatic impairment, and patients taking medications that decrease gastrointestinal motility. [1]
3. The Global Improvement Scale (GIS) assesses multiple symptoms of Irritable Bowel Syndrome (IBS) using a 7-point Likert scale which ranges from symptoms substantially worse to substantially improved. GIS responders were defined as having moderate or substantial improvement in IBS symptoms. [1]
4. The primary endpoint in Studies 1 and 2 to assess the efficacy of Viberzi was defined by both the simultaneous improvement in the daily worse abdominal pain score by ≥30% as compared to the baseline weekly average AND a reduction in the BSS to <5 on at least 50% of the days within a 12-week time interval. [7]

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Revision History

• 2024-05-20: 2024 UM Annual Review. No criteria changes
• 2023-12-06: Update reauth verbiage
• 2023-03-23: 2023 UM Annual Review. No criteria changes. Updated references
• 2022-03-25: 2022 UM Annual Review.
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-18: 2021 UM Annual Review.
• 2020-03-06: 2020 UM Annual Review. Removed drug name (i.e., Lotronex, Viberzi) from reauthorization criteria for operational clean up.

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