Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic Idiopathic Constipation

Treatment: Amitiza (lubiprostone) 8 micrograms (mcg) 

The insurer is denied coverage for Amitiza (lubiprostone) 8 micrograms (mcg) 

The denial is upheld. 

This child has a past medical history notable for aspiration, recurrent pneumonia, laryngeal cleft (status post repair) gastroparesis (90% [percent] retention at 1 hour - gastric emptying study), possible constipation and small intestinal bacterial overgrowth (SIBO) that has developed fecal incontinence averaging ~ 4 times per day. Incontinence occurs at various times during the day and appears inconsistent. Work-up for incontinence included a Sitz marker study that showed all markers present on day 4 and no markers retained on day 7. An abdominal x-ray suggested a dilated rectum. Besides incontinence his symptoms include abdominal distention, discomfort and bloating that responds to SIBO treatment. According to his history and pharmacy records he has received treatment at various times with Botox (pylorus), Reglan, erythromycin, Periactin, bowel clean outs, rifaximin, lactulose, Miralax, senna, and bisacodyl. To address his incontinence, he was evaluated. His weight was 35.7 kilograms and his height was 124.6 centimeters. His history suggests that he does not feel the passage of stool during accidents and his parents report 1 soft normal stool per day. His physical exam including rectal exam was normal. The impression was that he was not constipated but rather had non-retentive fecal incontinence. The treating team recommended lubiprostone 8 mcg [microgram] BID [twice per day] to "improve physiologic stooling and increase bulk of stool". Anorectal manometry has not been performed.   

This patient suffers from a number of chronic medical conditions including gastroparesis and SIBO [small intestine bacterial overgrowth] that now manifests with fecal incontinence. It is unclear from the studies done to date that he truly suffers from constipation or withholding stool. There is no imaging suggesting a large retained stool burden, his rectal exam is normal and he passes one normal soft stool per day by report. Anorectal manometry has not been done. Despite the impression that he is not constipated the appeal requests lubiprotone for the treatment of chronic idiopathic constipation.

Regarding the use of lubiprotone in children, in a review of the treatment of chronic functional constipation and fecal incontinence in infants, children and adolescents from UptoDate  the authors conclude the following:
 
The justification for the use of lubiprostone in the office notes and the appeal are not the same. Even though the use of lubiprostone is off label at this age it seems to be safe to use for chronic idiopathic constipation; however, constipation seems not be the cause of this patient's incontinence and therefore unnecessary.  
 
Regarding the use of Metamucil and the prior use of Benefiber, these are not identical products.  Both contain soluble fiber and are bulk-forming laxatives. Either would be considered first line agents for chronic constipation should the patient actual have this issue. Bulking the stools may permit him to better control the passage of stool and help him sense that he needs to evacuate before incontinence occurs.

Based on the above, lubiprotone is not medically necessary for this patient and other more traditional first line treatments could achieve efficacy as suggested by the insurer. Further assessment as to the direct cause of his symptoms seems prudent.

Based on the above, the medical necessity for the Amitiza (lubiprostone) 8 micrograms (mcg) for the treatment of chronic idiopathic constipation is not substantiated. The insurer's denial is upheld.