Eluxadoline (Viberzi) Form

Eluxadoline (Viberzi™) is a mu-opioid receptor agonist. FDA Approved Indication(s) Viberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS- D). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Viberzi is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Irritable Bowel Syndrome with Diarrhea (must meet all):

1. Diagnosis of IBS-D;
   2. Age ≥ 18 years;
   3. Failure of an anti-diarrheal agent (e.g., loperamide) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
2. Failure of an antispasmodic (e.g., dicyclomine) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
3. Dose does not exceed 200 mg (2 tablets) per day. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 6

   CLINICAL POLICY Eluxadoline b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Irritable Bowel Syndrome with Diarrhea (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed 200 mg (2 tablets) per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less
      B. Other diagnoses/indications (must meet 1 or 2):
7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – Page 2 of 6

   CLINICAL POLICY Eluxadoline CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration IBS-D: irritable bowel syndrome with diarrhea Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen loperamide (Imodium A-D) Adults: 4 mg PO followed by 2 mg after each unformed stool until diarrhea is resolved; then individualize dose. Administer optimal daily dose (4-8 mg) as single or divided doses. Dose Limit/ Maximum Dose If no clinical improvement after treatment with 16 mg/day for at least 10 days, symptoms are unlikely to be controlled by further use. diphenoxylate/atropine (Lomotil)
   Initially, 5 mg (2 tablets) PO QID; Discontinue after 10 days if clinical improvement is not observed dicyclomine (Bentyl) Adults: 20 mg PO QID up to 1 week, hyoscyamine (Levsin, Levbid) then increase to 40 mg PO QID Adults: Levsin: 0.125 – 0.25 mg PO Q 4h Levbid: 0.375 – 0.75 mg PO Q 12h 20 mg/day (of diphenoxylate)
   160 mg/day (40 mg PO QID) 1.5 mg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
   o Patients without a gallbladder o Known or suspected biliary duct obstruction; or sphincter of Oddi disease or dysfunction o Alcoholism, alcohol abuse or alcohol addiction, or in patients who drink more than 3 alcoholic beverages per day o A history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction o Known hypersensitivity reaction to Viberzi
   o Severe hepatic impairment (Child-Pugh Class C) o History of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction Page 3 of 6

   CLINICAL POLICY Eluxadoline • Boxed warning(s): none reported V. Dosage and Administration
   Indication IBS-D Maximum Dose 200 mg/day Dosing Regimen 100 mg PO BID or
   75 mg PO BID in patients who:
   • Are unable to tolerate the 100 mg dose of Viberzi
   • Are receiving concomitant OATP1B1 inhibitors
   • Have mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment
   • Have moderate or severe renal impairment (eGFR less than 60 mL/min/1.73m2; and in patients with end stage renal disease (eGFR less than 15 mL/min/1.73m2 not yet on dialysis
   VI. Product Availability
   Tablets: 75 mg, 100 mg VII.