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Prior Authorization Protocol
VIBERZITM (eluxadoline)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Treatment of irritable bowel syndrome with diarrhea
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of irritable bowel syndrome with diarrhea

    AND

    • Failure of or clinically significant adverse effects to two of the following:
      • Bulk forming agent (e.g., psyllium)
      • Anti-diarrhea agent (e.g., bismuth subsalicylate, loperamide)
      • Antispasmodic agent (e.g., diphenoxylate-atropine, dicyclomine, hyoscyamine, hyoscyamine/atropine/scopolamine/phenobarbital)

  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
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  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    XifaxanR (rifaximin)
    550 mg PO TID x 14 days

    Total three courses of therapy, 14 days each, separated by 10 weeks between each course.

    loperamide (ImodiumR)**
    **Available by prescription and over the counter (OTC). Coverage of OTC agents may vary with plan formulary and benefit design.

    4  8 mg PO per day as a single dose or divided doses

    16 mg per day

    diphenoxylate-atropine (LomotilR)

    2 tablets or 10 mL solution PO QID until initial control achieved, then reduce dosage to amount necessary to maintain bowel control

    20 mg per day of diphenoxylate component (8 tablets or 40 mLs per day)

    psyllium**

    **Available by over the counter (OTC). Coverage of OTC agents may vary with plan formulary and benefit design.

    2.5-30 g PO per day in divided doses

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    bismuth subsalicylate (Pepto-Bismol)**

    **Available by prescription and over the counter (OTC). Coverage of OTC agents may vary with plan formulary and benefit design.

    525 mg every 30 to 60 minutes or 1,050 mg every 60 minutes as needed for up to 2 days

    4,200 mg per day

    dicyclomine (Bentyl)

    Adults: 80mg/day PO divided QID then increase to 160 mg/day. If efficacy not achieved in 2 weeks, therapy should be discontinued

    160 mg per day

    hyoscyamine (Levsin, Levbid, Hyosyne, Anaspaz)

    Levsin, Hyosyne, Anaspaz: 0.125 to 0.25 mg PO q4h

    Levbid: 0.375  0.75 mg PO q12h

    1.5 mg per day

    hyoscyamine/atropine/scopolamine/phenobarbital (Donnatal, Phenogytro)

    Immediate release: 1 to 2 tablets or 5 to 10 mL of elixir TID to QID

    2 tablets or 10 mL per day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Viberzi

    100 mg PO BID

    Length of Benefit

  7. Product Availability:
    Tablets: 75 mg, 100 mg
  8. References:
    1. Viberzi [Prescribing Information]. Cincinnati, OH: Forest Pharmaceuticals, Inc.; May 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.