CurrentColorado Rocky Mountain Health PlansPolicy N/A

Lotronex (alosetron) prior authorization

Prior authorization requirements and coverage criteria for Lotronex (alosetron) for management of severe diarrhea-predominant IBS, applying to members covered under the UnitedHealthcare Pharmacy Clinical Pharmacy Programs used by Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLotronex (alosetron) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of severe diarrhea‑predominant IBS ≥6 months, failure of conventional therapy, and exclusion of anatomic/biochemical GI causes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

women onlyindication

must fail conventional therapytreatment requirement

≥6 monthssymptom duration

Coverage Criteria

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inv-01: Initial Authorization

Covered when ALL of the following are met:

Initial Authorization for Lotronex: Member has a diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS) with symptoms for at least six months; AND member has not responded adequately to conventional therapy (e.g., loperamide, antispasmodics); AND anatomic or biochemical abnormalities of the gastrointestinal (GI) tract have been excluded; AND patient was female at birth.>= 6 months

Authorization issued for 12 months

inv-02: Reauthorization

Covered when ALL of the following are met:

Reauthorization for Lotronex: Documentation of positive clinical response to Lotronex (alosetron) therapy; AND patient was female at birth.

Authorization issued for 12 months

Brand Lotronex (alosetron) is noted in the program materials as commonly subject to plan-specific coverage restrictions. Brand Lotronex is typically excluded from coverage, and some member benefit plans or state mandates may impose additional limits; tried-and-failed criteria for obtaining coverage of the brand product may be required. Providers should check the member-specific benefit plan and any applicable state or federal requirements to determine whether the branded product is covered for an individual member.

Initial Therapy Criteria

inv-11: Initial therapy

Initial approval is granted when ALL of the following are satisfied (nested criteria preserved):

Initial therapy

Diagnostic and duration criteria: Diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS) with symptoms for at least six months>= 6 months
Prior treatment and exclusion criteria
- Prior therapy: Has not responded adequately to conventional therapy (e.g., loperamide, antispasmodics)
- Exclusion of other causes: Anatomic or biochemical abnormalities of the GI tract have been excluded
Demographic requirement: Patient was female at birth

Continuation / Reauthorization Criteria

inv-12: Reauthorization

Reauthorization for ongoing therapy is covered when ALL of the following are met:

Continuation/Reauthorization: Documentation of positive clinical response to Lotronex (alosetron) therapy; AND patient was female at birth.

Authorization issued for 12 months

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization and Duration

Prior authorization is required. Initial approvals are issued for 12 months when all criteria are met. Reauthorizations are also issued for 12 months when there is documentation of positive clinical response.

Initial authorization: approval requires documented diagnosis of severe diarrhea‑predominant IBS with symptoms ≥ 6 months; exclusion of anatomic or biochemical GI abnormalities; and inadequate response to conventional therapy (e.g., loperamide, antispasmodics).
Reauthorization: documentation of positive clinical response to therapy.
Approval duration: 12 months for both initial authorization and reauthorization.

Step Therapy

Step Therapy Requirement

Step therapy must be documented prior to approval. The prescriber must show inadequate response to conventional therapies before Lotronex will be authorized.

Documented inadequate response to loperamide and/or antispasmodics and other conventional therapies.
If plan-specific step edits exist (e.g., trials of specific agents or durations), those must be met — consult member’s benefit plan.

Documentation Required

Required Documentation

Provide complete clinical documentation to support the request. Missing or insufficient documentation is a common reason for denial.

Diagnosis and symptom duration (≥ 6 months).
Documentation that anatomic/biochemical causes were excluded.
Records showing trials and inadequate response to conventional therapies (medication names, doses, dates, and outcomes).
For reauthorization, documentation of positive clinical response to Lotronex.

Denial Risk

Potential Reasons for Denial

Requests may be denied if required criteria or documentation are missing or not met.

Missing key documentation (diagnosis, symptom duration, exclusion of other causes, trial history).
Insufficient trial or incomplete documentation of step therapy (no evidence of loperamide/antispasmodic failure).
Anatomic or biochemical causes not adequately excluded.
Use in patients not meeting demographic or safety criteria per plan or manufacturer guidance (e.g., male patients when plan limits to females as noted by some plans).
Coverage exclusions for brand product may apply per member’s benefit plan.

Step	Requirement	Examples / Notes
1	Trial and inadequate response to conventional therapy is required prior to approval.	Examples of conventional therapy include loperamide and antispasmodics; documentation of inadequate response must be provided. Authorization issued for 12 months when criteria met.

Background

Alosetron (Lotronex) is approved only for a narrowly defined population: women with severe diarrhea‑predominant irritable bowel syndrome (IBS) who have chronic symptoms. Use is limited to patients who meet the program’s diagnostic and safety safeguards, including documentation that anatomic or biochemical causes of symptoms have been excluded and that the patient has had an inadequate response to conventional therapies.

The policy requires that the member have symptoms for at least 6 months and have not responded adequately to conventional therapy (examples include loperamide and antispasmodics) before initial approval will be granted. Prior authorization is required, and initial approvals are issued for 12 months when all criteria are met. Reauthorization likewise requires documentation of a positive clinical response and is issued for 12 months.

Because the indication is restricted to patients who were female at birth, and because of safety and utilization-management concerns, clinicians must provide documentation of diagnosis, duration of symptoms, exclusion of other GI causes, and prior treatment history when requesting authorization for Lotronex.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLotronex (alosetron) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis of severe diarrhea‑predominant IBS ≥6 months, failure of conventional therapy, and exclusion of anatomic/biochemical GI causes.

SourceLink

On This Page

OpenPayer

Lotronex (alosetron) prior authorization

Coverage Criteria

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Coding & Clinical Thresholds

Provider Actions and Billing Guidance

Step Therapy Requirements

Definitions

Background