CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lotronex (alosetron) prior authorization

Defines prior authorization requirements for Lotronex (alosetron) for treatment of severe diarrhea-predominant irritable bowel syndrome in females; applies to prescribers and pharmacy benefit administrators at Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLotronex (alosetron) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization only for biological females or persons identifying as female who have severe diarrhea‑predominant IBS with ≥6 months of symptoms, excluded anatomic/biochemical causes, and inadequate response to conventional therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

women onlyFDA-indicated population

>=6 monthsSymptom duration

severe diarrhea-predominant IBSIndication required

conventional failurePrior therapy

Coverage Criteria for Lotronex (alosetron)

Initial Prior Authorization

Covered when ALL of the following are met:

Initial authorization criteria: Patient is a biological female or a person self-identifying as female with a diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS).

Symptom duration: Chronic IBS symptoms lasting at least 6 months.>= 6 months

Anatomic/biochemical exclusion: Gastrointestinal tract anatomic or biochemical abnormalities have been excluded (no alternative anatomic/biochemical explanation for symptoms).

Prior therapy requirement:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLotronex (alosetron) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Inadequate response to conventional therapy for diarrhea-predominant IBS prior to initiation of Lotronex (alosetron).

Severity definition: IBS is severe diarrhea-predominant if diarrhea is present plus one or more of: frequent bowel urgency or fecal incontinence; frequent and severe abdominal pain/discomfort; or disability or restriction of daily activities due to IBS.

Restricted to women due to limited data in men and risk of serious GI adverse reactions.

Use of Lotronex (alosetron) is restricted to women. Clinical studies have not adequately confirmed benefits in men, and the FDA-approved indication specifies use only in females with severe diarrhea‑predominant irritable bowel syndrome who meet the outlined clinical criteria.

Key Coding & Symptom Duration

Symptom duration

Required duration of symptoms>= 6 months (chronic IBS symptoms generally lasting six months or longer)

Supporting detailFDA‑approved indication specifies chronic IBS symptoms generally lasting six months or longer

Usage in criteria setIncluded as an AND requirement for initial authorization: symptoms >= 6 months

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lotronex (alosetron). The requested drug must be prescribed for a biological female or a person who self-identifies as female with a diagnosis of severe diarrhea‑predominant irritable bowel syndrome (IBS).

Prior authorization required for biological females or persons who self-identify as female with severe diarrhea‑predominant IBS.

Step Therapy

Conventional Therapy Requirement

The patient must have an inadequate response to conventional therapy before Lotronex will be authorized.

Documentation of trial and inadequate response to conventional therapies (e.g., dietary modification, antidiarrheals, antispasmodics) is required.

Documentation Required

Required Documentation

Submit documentation supporting medical necessity with the prior authorization request.

Diagnosis of severe diarrhea‑predominant IBS.
Duration of symptoms: chronic IBS symptoms lasting ≥ 6 months.
Evidence that anatomic or biochemical gastrointestinal tract abnormalities have been excluded.
Documentation of inadequate response to conventional therapy, including treatments tried, dates, and outcomes.

Denial Risk

Grounds for Denial

Requests will be denied if the criteria below are not met.

Patient is not a biological female and does not self‑identify as female.
Diagnosis is not severe diarrhea‑predominant IBS.
Insufficient documentation of chronicity (≥ 6 months) or exclusion of anatomic/biochemical GI causes.
No documentation of inadequate response to conventional therapy.
Clinical justification does not address the severe‑disease features (e.g., frequent bowel urgency or fecal incontinence; frequent and severe abdominal pain/discomfort; disability or restriction of daily activities).

Background on Lotronex (alosetron)

Lotronex (alosetron) is indicated for women with severe diarrhea‑predominant irritable bowel syndrome (IBS) after exclusion of anatomic or biochemical gastrointestinal abnormalities and failure to respond adequately to conventional therapy. Severe diarrhea‑predominant IBS is defined as diarrhea plus one or more of: frequent bowel urgency or fecal incontinence; frequent and severe abdominal pain/discomfort; or disability or restriction of daily activities due to IBS. Chronic symptoms generally last six months or longer.

Definitions — Severe Diarrhea‑Predominant IBS

Severe diarrhea‑predominant IBS (severity criteria)

DefinitionDiarrhea‑predominant IBS is severe if it includes diarrhea plus one or more of: frequent bowel urgency or fecal incontinence; frequent and severe abdominal pain/discomfort; disability or restriction of daily activities due to IBS.

Component 1Frequent bowel urgency or fecal incontinence

Component 2Frequent and severe abdominal pain/discomfort

Component 3Disability or restriction of daily activities due to IBS