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.

All FDA-approved indications not otherwise excluded form Part D.

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:

1. Women with chronic severe diarrhea-predominant irritable bowel syndrome, AND
2. Have had a screen for diarrhea-inducing medications, AND
3. Must have documentation of dietary modification, AND

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 re-evaluated for continued therapy.

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization will be for up to 30 days; reauthorization will be for up to 90 days.