Diagnosis: Irritable Bowel Syndrome

Treatment Trulance 3mg (milligrams) tablet

The insurer denied coverage for Trulance 3mg tablet

The denial is upheld

The patient has a history of chronic constipation. She also complains about bloating. Supplemental fiber and MiraLAX have not worked. She has a diagnosis of irritable bowel syndrome and small intestinal bacteria overgrowth.

Up-To-Date article "Management of chronic constipation in adults" discusses pharmacologic therapy. Plecanatide has been approved by the FDA (Food and Drug Administration) for chronic idiopathic constipation. 20 percent of patients experienced improvement in the frequency of complete spontaneous bowel movements versus 13 percent in the placebo group. lubiprostone is also an FDA approved drug for constipation. Patients treated with lubiprostone had an increase in spontaneous bowel movements. Corresponding improvement was observed for abdominal bloating, discomfort, stool frequency and straining.

This patient has chronic constipation and requires pharmacologic therapy. The insurance company has offered lubiprostone as a formulary alternative. There are no head to head trials involving these agents. Zhang et al in a metanalysis of published trials involving 8 different drugs found that the increase in frequency of bowel movements was similar for lubiprostone and plecanatide. In view of this, it is reasonable to first try the lubiprostone and if it is not successful, Trulance would be appropriate. Since lubiprostone has not been tried the request for Trulance is denied.

The healthcare plan acted reasonably and with sound medical Judgement. Trulance is not medically necessary at this time.

The insurer's denial of coverage for Trulance 3mg tablet once per day is upheld. Medical Necessity is not substantiated.