Diagnosis: Crohn's disease.
Treatment: Pentasa.
The insurer denied the Pentasa.
The determination is overturned.


This is a patient with a history of Crohn's disease. Pentasa is under review for medical necessity.

Pentasa is Food and Drug Administration (FDA) approved for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis. Despite the lack of FDA approval in Crohn's disease, the clinical practice guidelines do support the use of mesalamine products (such as Pentasa) in treating mild Crohn's disease with small bowel and colonic inflammation.
Per the guidelines "5- aminosalicylic acid (ASA) might be used for induction of remission in children with mild colonic inflammation" (Ruemmele FM et al).
According to Hanauer, Stephen B:"The meta-analysis of 3 large, double-blind, randomized studies in the treatment of active Crohn's disease confirms that Pentasa 4 grams (g)/day is superior to placebo in reducing the Crohn's disease activity index (CDAI)."
Per Coward, Stephanie, et al: "High-dose mesalamine is an option among patients preferring to avoid steroids."
This child has proximal small bowel and colonic disease. Therefore, the use of Pentasa in this case is appropriate.
The available formulary alternatives are intended for colonic disease only and have no small bowel release. Pentasa is the only mesalamine formulation that has small bowel release, making it superior in this case with duodenal and ileal Crohn's disease.
Therefore, the requested Pentasa is medically necessary.