Diagnosis: Abdominal Pain
Treatment: Amitiza 8 micrograms (MCG) Capsule, 60 for 30 days
The insurer denied the Amitiza 8 micrograms (MCG) Capsule, 60 for 30 days.
The denial is upheld.

The patient is a female with Henoch Schönlein purpura that has required corticosteroid treatment.

Pertinent to this review, the patient's provider attests to "diarrhea all day long" with stool retention, abdominal pain, and gastroesophageal reflux disease (GERD). Treatment has included Levsin for cramping, and a laxative combination of Miralax, senna, bisacodyl, and as needed (PRN) "colon clean outs."

Motility studies have not yet been pursued, but referral to a "motility specialist" is under consideration. The patient's provider proposes a trial of Amitiza at this time.

No, the health plan should not cover the treatment with Amitiza.

No, the treatment with Amitiza is not likely to be more beneficial.

Constipation in childhood is common, and usually responds to anticipatory guidance regarding diet, toilet training, and toileting behaviors.

Treatment may involve education, dietary changes, behavior modification, and pharmacotherapy. The patient's records suggest there may be some accompanying stool withholding, rectal impaction, and encopresis with overflow incontinence.

Functional constipation may be of concern here, but the patient's available record provides no objective data that addresses primary anatomic or neurologic causation, what precipitating events may be at play, nor what dietary changes and behavior modification have in this case been tried and failed. Studies that have been done show an unremarkable gastrointestinal (GI) tract aside for fatty liver. There is neither evidence provided for advanced gastroesophageal reflux disease (GERD) nor for gastrointestinal (GI) hypomotility.

No formal motility testing has been performed to warrant this treatment as medically necessary. Pending objective evaluation, the standard-of-care for the patient is a maintenance regimen of laxatives if the stools is hard, large in diameter, or causes pain, as describes "chronic constipation" in her age group. Although there is literature support for the contention that lubiprostone (Amitiza) may be efficacious and well tolerated were the patient objectively found to have functional constipation, its empiric use in her case prior to appropriate evaluation is premature, off-label, and not without risk.