CurrentAvMedPolicy N/A

Pharmacy Prior Authorization / Step-Edit: alosetron (Lotronex) and eluxadoline (Viberzi) Coverage Criteria

Form and clinical criteria used by AvMed to authorize pharmacy coverage for alosetron (Lotronex) and eluxadoline (Viberzi) for members, including initial and reauthorization requirements and quantity/dosing guidance. Applies to prescribers submitting PA requests for these drugs.

Policy Summary

PayerAvMed

PolicyPharmacy Prior Authorization / Step-Edit: alosetron (Lotronex) and eluxadoline (Viberzi) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the PA form with prescriber hand signature and required clinical documentation; fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3required prior therapies before approval

6 moinitial approval duration

12 moreauthorization duration

18+minimum member age

Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria: Member is 18 years of age or older18 years

Initial approval = 6 months

Diagnosis of irritable bowel syndrome with diarrhea (IBS-D) with chronic symptoms persisting for 6 months or longer (chart notes required)>= 6 months

Constipation exclusion: Member does NOT have constipation, history of chronic or severe constipation, or complications resulting from constipation

Policy Summary

PayerAvMed

PolicyPharmacy Prior Authorization / Step-Edit: alosetron (Lotronex) and eluxadoline (Viberzi) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the PA form with prescriber hand signature and required clinical documentation; fax to 1-305-671-0200.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prior therapy requirement: History of failure, contraindication or intolerance to THREE of the following: antispasmodic agent (e.g., dicyclomine); antidiarrheal agent (e.g., diphenoxylate/atropine); tricyclic antidepressant (e.g., amitriptyline); dietary changes (e.g., low FODMAP, fiber supplementation, gluten-free)3 agents/approaches

Verified by pharmacy paid claims or chart notes

inv-02: Reauthorization / Continuation Therapy

Reauthorization when ALL of the following are met:

Reauthorization criteria: Member has had a positive clinical response to therapy demonstrated by improvement in abdominal cramping/pain or in stool frequency and consistencyclinical improvement

Reauthorization = 12 months

Therapy is NOT appropriate for members who currently have constipation or who have a history of chronic or severe constipation, or who have experienced complications resulting from constipation. This exclusion must be confirmed on the prior authorization form and supported by chart notes as applicable.

Coding and Diagnosis

Diagnosis codes to be providedICD-10

ICD Code

ICD Code, if applicable (blank on form — provider to supply)

Symptom duration requirement

Required symptom duration>= 6 months

DocumentationChart notes must be submitted to confirm diagnosis and duration

Applies toIrritable bowel syndrome with diarrhea (IBS-D)

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Prescribers must complete and sign the AvMed pharmacy prior authorization form and fax to 1-305-671-0200. Preprinted signature stamps are not acceptable. If the form or required information is incomplete, incorrect, or illegible, the authorization process may be delayed or the request may be denied.

Fax prior authorization form to 1-305-671-0200
Prescriber signature required (hand-signed; stamps not valid)
Ensure phone and fax numbers on form are correct to avoid follow-up

Step Therapy

Step Therapy Requirement

Step therapy: approval requires documented failure, contraindication, or intolerance to THREE different therapy types prior to initiation of alosetron (Lotronex) or eluxadoline (Viberzi). Verification may be performed via pharmacy paid claims and/or submitted chart notes. Use of samples to initiate therapy does not satisfy step therapy or preauthorization requirements.

Required failures: antispasmodic agent (e.g., dicyclomine), antidiarrheal agent (e.g., diphenoxylate/atropine), tricyclic antidepressant (e.g., amitriptyline), or documented dietary changes (e.g., low FODMAP, fiber, gluten-free).
Document treatment failure, intolerance, or contraindication for three therapy types
Previous therapies will be verified through pharmacy paid claims or chart notes

Documentation Required

Required Documentation

Complete documentation required on the PA form. Authorization may be delayed or denied if member and drug information, prescriber signature, or supporting documentation are missing or illegible. Provide all relevant clinical records to support each checked criterion.

Member and prescriber information: member name, AvMed ID, DOB, prescriber name, prescriber signature, date, office contact, phone, fax, DEA or NPI
Drug information: drug name/formulation/strength, dosing schedule, length of therapy, diagnosis, ICD code (if applicable), weight, date
Clinical documentation: chart notes, lab results, diagnostics to support diagnosis and prior therapy failures or clinical response

Denial Risk

Triggers for Delay or Denial

Incomplete, incorrect, or illegible forms or missing supporting documentation may delay processing or result in denial. Failure to include required signatures or to verify prior therapies via claims/chart notes are common denial triggers.

Illegible or unsigned forms
Missing member or prescriber contact information (phone/fax)
Absence of supporting chart notes or pharmacy paid claims to document prior therapies or clinical response

Background

Irritable bowel syndrome with diarrhea (IBS-D) is a chronic functional gastrointestinal disorder characterized by abdominal pain and diarrhea. This policy targets adults with chronic IBS-D symptoms that have persisted for ≥ 6 months and requires documentation (chart notes) to confirm the diagnosis and symptom duration. Prior authorization supports coverage for alosetron (Lotronex) and eluxadoline (Viberzi) when the clinical criteria are met.

Definitions

Irritable bowel syndrome with diarrhea (IBS-D) — definition

Definition (term)Irritable bowel syndrome with diarrhea (IBS-D)

Chronicity threshold>= 6 months (symptoms persisted for 6 months or longer)

ExclusionMember must NOT have constipation, history of chronic or severe constipation, or complications resulting from constipation

Supporting evidenceChart notes required to confirm diagnosis

Initial Therapy Dosing and Criteria

inv-12: Initial dosing and limits

Dosing and quantity guidance plus initial approval criteria

Alosetron dosing guidance: Initial: 0.5 mg twice daily for 4 weeks; if tolerated but response inadequate, may increase after 4 weeks to 1 mg twice daily (maximum 2 mg/day). If inadequate after 4 weeks of 1 mg twice-daily dosing, discontinue treatment.per dosing text

See quantity limits

Eluxadoline dosing guidance: Eluxadoline (Viberzi): 100 mg twice daily; may decrease to 75 mg twice daily in patients unable to tolerate the 100 mg dose.per dosing text

See quantity limits

Continuation / Reauthorization Criteria

inv-13: Reauthorization

Reauthorization requirements

Continuation: Positive clinical response to therapy demonstrated by improvement in abdominal cramping/pain or in stool frequency and consistencyclinical improvement

Reauthorization period = 12 months

Step Therapy Documentation

Step	Requirement
1
Provider must document failure, contraindication, or intolerance to THREE of the following: antispasmodic agent (e.g., dicyclomine); antidiarrheal agent (e.g., diphenoxylate/atropine); tricyclic antidepressant (e.g., amitriptyline); dietary changes (e.g., low FODMAP, fiber supplementation, gluten-free). Prior therapies may be verified via pharmacy paid claims or chart notes.

Quantity Limits and Dosing

Alosetron (Lotronex) — initial dosing and limits

Initial dosing0.5 mg twice daily for 4 weeks

Dose escalationIf tolerated but response inadequate, may increase after 4 weeks to 1 mg twice daily

Maximum daily dose2 mg/day

Discontinuation ruleIf inadequate response after 4 weeks of 1 mg twice-daily dosing, discontinue treatment

Eluxadoline (Viberzi) — dosing

Standard dosing100 mg twice daily

Dose adjustment if not toleratedMay decrease to 75 mg twice daily if unable to tolerate the 100 mg dose