COVERED USES:

FDA Approved Indications:

1. Women with diarrhea-predominant Irritable Bowel Syndrome (IBS) who have:
   • Chronic IBS symptoms (generally lasting 6 months or longer)
   • Had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
   • Not responded adequately to conventional therapy
2. Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
   • Frequent and severe abdominal pain/discomfort
   • Frequent bowel urgency or fecal incontinence
   • Disability or restriction of daily activities due to IBS

Because of infrequent but serious gastrointestinal adverse events associated with Lotronex®, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.

Requests for a non-FDA approved ("off-label") indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

Only physicians who have enrolled in GlaxoSmithKline's Prescribing Program for Lotronex® based on their attestation of qualifications and acceptance of responsibilities, should prescribe Lotronex®.

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

Must have documented evidence of trial and failure of or intolerance to conventional therapy including:

• Dietary Modification
• Screen for diarrhea-inducing medications
• Opiod mu receptor agonists (loperamide (Imodium®), diphenoxylate (Lomotil®))
• Smooth muscle relaxants (dicyclomine (Bentyl®), hyoscyamine (Levsin®, Nu-Lev®, Levbid®))
• Tricyclic antidepressants (amitriptyline, desipramine)
• Bulking agents (psyllium (Metamucil®), polycarbophil (Konsyl® Fiber), methylcellulose (Citrocel®))

Initial Therapy:

1. The starting dose must be 1mg once daily for 4 weeks and authorization will be approved only for a 30-day treatment course.

Continued Therapy:

1. Documentation of a clinical response in the last 90 days must be provided to continue therapy and the authorization will be for 90 days at a time.
2. If the request is to increase therapy to 1mg twice daily then authorization will only occur for a 30-day treatment course.
3. Per recommendation of the FDA, Lotronex®should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1mg twice-a-day.

Rechallenge:

Medical rationale from a gastroenterologist must be provided for another trial of Lotronex® for a member with a history of inadequate control of IBS on Lotronex® 1 mg twice-a-day and will only be approved for an initial 30-day treatment course and then revevaluated as continued therapy

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization will be for up to 30 days. Reauthorization will be for up to 90 days.