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 seeking coverage under the payer's pharmacy benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLotronex (alosetron) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document female sex or self-identification as female, diagnosis of severe diarrhea-predominant IBS, symptoms ≥6 months, exclusion of GI abnormalities, and inadequate response to conventional therapy.

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POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

female-onlypatients eligible

>= 6 monthsmin symptom duration

severe diarrhea-predominant IBSindication required

prior auth requiredcoverage type

Coverage Criteria for Lotronex (alosetron)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLotronex (alosetron) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Initial Therapy Criteria

Patient is a biological female or self-identifies as female with a diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS).
Indication restricted to females due to safety profile; benefits in men not established.
IBS symptoms are chronic, with symptom duration of at least 6 months.>= 6 months
Anatomic or biochemical gastrointestinal tract abnormalities have been excluded.
Patient has had an inadequate response to conventional therapy.
Prior inadequate response to conventional therapies is required before approval.

Severe diarrhea-predominant IBS definition (supporting): Diarrhea-predominant IBS is considered severe if it includes diarrhea plus one or more of: frequent and severe abdominal pain/discomfort; frequent bowel urgency or fecal incontinence; or disability/restriction of daily activities due to IBS.

Provider Requirements, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is limited to biological females or those who self-identify as female with a diagnosis of severe diarrhea‑predominant irritable bowel syndrome (IBS).

Request must include prior authorization request form and clinical rationale
Approval restricted to females or those who self-identify as female

Step Therapy

Step Therapy Requirement

Step therapy: member must have had an inadequate response to conventional therapy before approval will be granted.

Document prior trials of conventional therapies (e.g., dietary modification, antidiarrheals, fiber, antispasmodics, antidepressants) and reason for failure (lack of efficacy or intolerance)
Specify duration and outcomes of each prior therapy trial

Documentation Required

Required Supporting Documentation

Provide supporting documentation to confirm eligibility and medical necessity.

Evidence of biological sex or self-identified sex (as applicable)
Diagnosis of severe diarrhea‑predominant IBS with documentation of symptoms and severity
Documentation confirming chronicity (symptoms ≥ 6 months)
Evidence that anatomic or biochemical gastrointestinal abnormalities have been excluded (relevant test results or specialist evaluation)

Denial Risk

Grounds for Denial

Requests may be denied if the patient is not female, diagnosis is not severe diarrhea‑predominant IBS, or supporting documentation is incomplete or insufficient.

Denial reasons include: not a biological female / does not self‑identify as female; diagnosis does not meet severe diarrhea‑predominant IBS criteria; chronicity (< 6 months) not demonstrated; anatomic/biochemical exclusions not documented; insufficient evidence of prior inadequate response to conventional therapy

Background on Lotronex (alosetron)

Lotronex (alosetron) is indicated for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who meet all of the following: chronic IBS symptoms generally lasting six months or longer; exclusion of anatomic or biochemical gastrointestinal abnormalities; and inadequate response to conventional therapy. Severe diarrhea-predominant IBS is defined as diarrhea plus one or more of: frequent and severe abdominal pain/discomfort, frequent bowel urgency or fecal incontinence, or disability/restriction of daily activities due to IBS. Because of infrequent but serious gastrointestinal adverse reactions, the indication is restricted to patients for whom the benefit-to-risk balance is most favorable.

OpenPayer

Lotronex (alosetron) prior authorization

Coverage Criteria for Lotronex (alosetron)

Key Coding & Clinical Thresholds

Provider Requirements, Documentation, and Denial Risks

Background on Lotronex (alosetron)

Definitions