Diagnosis: Chronic Constipation
Treatment: Trulance (plecanatide)
The insurer denied coverage for Trulance (plecanatide).
The denial is upheld.

The patient was having rectal bleeding that was attributed to hemorrhoids. The bleeding had stopped since starting a high fiber diet. The patient was being treated for constipation with Linzess but was not tolerating it. They had previously been treated with Miralax and Lactulose. The physician's office writes that the patient is "unable to try any other alternatives due to a severe reaction of Penicillin/Percocet and certain dyes involved with it."

UpToDate has an article titled "Management of chronic constipation in adults." The article discusses pharmacological therapy for severe constipation. Among the recommended treatments are Linaclotide, Plecanatide, Lubiprostone, and Prucalopride. Lubiprostone is a Food and Drug Administration (FDA) approved treatment based on two placebo-controlled trials that included a total of 479 patients with chronic idiopathic constipation. Significantly more patients receiving Lubiprostone achieved the primary endpoint with an increase in spontaneous bowel movements.

The FDA lists contraindications and drug interactions for Amitiza (lubiprostone). Mechanical bowel obstruction is a contraindication. Concomitant use of opioids such as methadone may interfere with the efficacy of Amitiza. The FDA prescribing information states that there is a low likelihood of pharmacologic drug-drug interactions.

This patient has chronic constipation and has not tolerated Linzess. It is appropriate to change medications. The insurance company is offering a formulary alternative Amitiza. The physician's statement that the patient cannot take alternatives such as Amitiza due to a reaction to Penicillin, Percocet, and intravenous (IV) dyes is not consistent with the FDA prescribing information for Amitiza. Therefore, it has not been shown that the formulary drug Amitiza is likely to cause an adverse reaction. Amitiza has not been shown to be ineffective in this patient. It is not known that Trulance would be more effective than Amitiza. The formulary exception for Trulance is denied since Amitiza is a reasonable alternative.

The carrier's denial of request for formulary exception for Trulance (plecanatide) to treat chronic constipation is upheld.