CurrentmhnPolicy CP.PMN.153

Alosetron (Lotronex) — Coverage Criteria for Diarrhea‑Predominant IBS

Defines medical necessity and prior authorization criteria for alosetron (Lotronex) for treatment of diarrhea-predominant irritable bowel syndrome in members of the payer's Commercial and Medicaid lines of business.

Policy Summary

Payermhn

PolicyAlosetron (Lotronex) — Coverage Criteria for Diarrhea‑Predominant IBS

Policy CodePolicy CP.PMN.153

Change TypeNo material change

Effective DateNov 16, 2016

Next Review DateJul 14, 2025

Key ActionSubmit prior authorization with documentation showing diagnosis of diarrhea‑predominant IBS, age ≥18, required prior medication trials, and dosing not to exceed 2 mg/day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 mg/dayMaximum daily dose allowed

≥ 18Minimum age for coverage

12 monthsTypical approval duration

0.5 mg BIDStarting dose

Coverage Criteria for Alosetron (Lotronex)

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Initial approval - IBS-D: Member has a diagnosis of diarrhea‑predominant irritable bowel syndrome; age ≥ 18 years; failure of an anti‑diarrheal agent (e.g., loperamide) at up to maximally indicated doses unless contraindicated or not tolerated; failure of an antispasmodic agent (e.g., dicyclomine) at up to maximally indicated doses unless contraindicated or not tolerated; if request is for brand Lotronex, member must use generic alosetron unless contraindicated or has clinically significant adverse effects; dose does not exceed both: 2 mg per day and 2 tablets per day.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation therapy - IBS-D: Member is currently receiving the medication via the health plan benefit or previously met initial approval criteria; member is responding positively to therapy; if request is for brand Lotronex, member must use generic alosetron unless contraindicated or has clinically significant adverse effects; if request is for a dose increase, new dose does not exceed both: 2 mg per day and 2 tablets per day.

Other Indications

Other diagnoses/indications:

Other indications: If the drug has undergone a label change within the prior 6 months that is not yet reflected in this policy, refer to the applicable formulary/no coverage or non‑formulary policies for the relevant line of business (e.g., CP.CPA.190, CP.PMN.255, CP.PMN.16); OR if the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (e.g., CP.CPA.09 for commercial, CP.PMN.53 for Medicaid).

Requests for uses of alosetron that are Non‑FDA approved and are not specifically addressed in this clinical policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the payer’s off‑label use policies (CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.

Alosetron should not be initiated in patients with constipation. Contraindications include a history of chronic or severe constipation or sequelae from constipation (for example, intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions), ischemic colitis, impaired intestinal circulation, thrombophlebitis or hypercoagulable states, inflammatory bowel diseases (Crohn’s disease or ulcerative colitis), diverticulitis, severe hepatic impairment, and concomitant use of fluvoxamine. The drug carries a boxed warning for serious gastrointestinal adverse reactions, including ischemic colitis and severe complications of constipation that have led to hospitalization and, rarely, transfusion, surgery, or death.

Coding and Dosing Information

NDC / Product codesNDC

NDC not listed

No NDC codes provided in this part of the policy

Prior authorization affected codesmixed

affected codes

placeholder text in document indicating affected codes (no specific CPT/HCPCS/ICD-10 codes listed in these chunks)

Maximum daily dose

Maximum daily dose2 mg per day (maximum dose for IBS‑D); also limited to 2 tablets/day

Starting/titration dosingStart 0.5 mg orally twice daily; may increase to 1 mg twice daily after 4 weeks if tolerated

Discontinuation ruleDiscontinue if inadequate control after 4 weeks of treatment at 1 mg twice daily

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document diagnosis of diarrhea‑predominant irritable bowel syndrome (IBS-D) and that the member is age ≥ 18. Prior to approval, the provider must demonstrate failure of an anti‑diarrheal agent (e.g., loperamide) at up to maximally indicated doses and failure of an antispasmodic agent (e.g., dicyclomine) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects occurred. If request is for brand Lotronex, the member must have used generic alosetron unless contraindicated or significant adverse effects were experienced. Dose limits: does not exceed 2 mg per day and 2 tablets per day.

Prior authorization required
Diagnosis: diarrhea‑predominant IBS
Age ≥ 18 years
Failure of anti‑diarrheal (e.g., loperamide) at maximally indicated doses unless contraindicated
Failure of antispasmodic (e.g., dicyclomine) at maximally indicated doses unless contraindicated
Generic trial required prior to brand Lotronex unless contraindicated
Dose limit: ≤ 2 mg/day and ≤ 2 tablets/day

Note

Prior Authorization Duration

For Commercial line of business, approval duration is 12 months or the duration of the request, whichever is less.

Commercial: 12 months or duration of request, whichever is less

Denial Risk

Non‑FDA Indications

Requests for non‑FDA approved indications that are not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided in accordance with the applicable off‑label use policy (CP.CPA.09 for Commercial; CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Non‑FDA indications require documentation per off‑label use policies (CP.CPA.09 for Commercial; CP.PMN.53 for Medicaid)

Documentation Required

Submission of Clinical Documentation

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, medication history) demonstrating the member meets all approval criteria. Incomplete documentation may result in denial or delayed processing.

Submit office chart notes, lab results, medication history, and prior treatment details

Note

Provider Responsibilities and Compliance

Providers should follow the coverage document(s), applicable state and federal requirements, and Health Plan administrative policies. Documentation and claims submission imply agreement with and acceptance of this policy and its requirements. Coverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage document.

Follow coverage documents and state/federal requirements
Documentation/claims submission implies agreement to policy requirements
Coverage subject to terms, conditions, exclusions, and limitations of coverage documents

Step Therapy

Required Prior Medication Trials / Step Therapy

Therapeutic alternatives (e.g., loperamide, diphenoxylate/atropine, dicyclomine, hyoscyamine) should be used as appropriate per Appendix B dosing recommendations prior to approval. See Appendix B for dosing regimens and maximum doses.

Step therapy required: failure of an anti‑diarrheal (loperamide) and an antispasmodic (dicyclomine) at appropriate doses
See Appendix B for dosing regimens and maximum doses for therapeutic alternatives

Note

Coverage Decision Legalities

Providers are reminded that coverage decisions and the administration of benefits are made per the Health Plan and are governed by applicable laws and the member's coverage documents; this policy does not guarantee payment. Providers are expected to exercise professional medical judgment in patient care.

Policy is a guide to medical necessity and not a guarantee of payment
Providers are responsible for medical advice and treatment decisions

Background

Alosetron is a selective 5‑HT3 receptor antagonist approved for use in women with severe diarrhea‑predominant irritable bowel syndrome (IBS‑D) who have chronic symptoms, have had other causes excluded, and have not responded to conventional therapy. Use is limited by the risk of serious gastrointestinal adverse events, including ischemic colitis and severe constipation with complications; these risks underlie boxed‑warning language and restricted indication. Additionally, clinical trials have not sufficiently demonstrated benefit in men, so effectiveness in male patients remains unconfirmed.

Definitions

Severe diarrhea‑predominant IBS — definition and qualifying features

Definition termSevere diarrhea‑predominant irritable bowel syndrome (IBS‑D)

Required features (one or more)Frequent and severe abdominal pain/discomfort; frequent bowel urgency or fecal incontinence; or disability/restriction of daily activities due to IBS

Chronicity and exclusionsChronic symptoms generally lasting ≥6 months and other anatomic or biochemical GI abnormalities must be excluded

Population indicatedIndication limited to women with severe diarrhea‑predominant IBS who have not responded adequately to conventional therapy

Revision History and References

2021-10-18approval_duration_revision

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

2022-07-26annual_review_template_update

4Q 2022 annual review: added generic redirection; references reviewed and updated; template changes applied to other diagnoses/indications and continued therapy section.

2023-07-05annual_review

4Q 2023 annual review: no significant changes; references reviewed and updated.

2024-07-12annual_review

4Q 2024 annual review: no significant changes; references reviewed and updated.

2025-07-14annual_reviewLatest

4Q 2025 annual review: no significant changes; references reviewed and updated.

Policy Summary

Payermhn

PolicyAlosetron (Lotronex) — Coverage Criteria for Diarrhea‑Predominant IBS

Policy CodePolicy CP.PMN.153

Change TypeNo material change

Effective DateNov 16, 2016

Next Review DateJul 14, 2025

Key ActionSubmit prior authorization with documentation showing diagnosis of diarrhea‑predominant IBS, age ≥18, required prior medication trials, and dosing not to exceed 2 mg/day.

SourceLink

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