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202203-147359

2022

CVS Caremark

Self-Funded

Digestive System/ Gastrointestinal

Pharmacy/ Prescription Drugs

Formulary Exception

Upheld

Case Summary

Diagnosis: constipation.
Treatment: Trulance.
The insurer denied Trulance.
The health plan's determination is upheld.

The patient is a female with chronic idiopathic constipation. She has attempted Metamucil and Miralax with ongoing constipation, incomplete bowel movements, and abdominal cramping. She failed Linzess 72 mcg (micrograms) daily, which caused diarrhea.

A formulary exception is not indicated in this case.
Trulance is not supported over the formulary alternative Amitiza (lubiprostone). The patient has had chronic constipation, and failed fiber and osmotic laxatives, and an advanced agent (Linzess). The American Gastroenterological Association Medical Position Statement on Constipation states that newer agents such as Amitiza or Trulance should be used if non-pharmaceutical laxatives fail. Amitiza has shown safety and efficacy for the treatment of constipation and associated symptoms including bloating and abdominal pain. Trulance has not demonstrated higher safety or efficacy than Amitiza in a direct controlled comparison. For these reasons, the use of Trulance is not indicated in this case.

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