Diagnosis: Ulcerative Colitis.
Treatment: Mesalamine DR 800MG DR TAB.

The insurer denied the Mesalamine DR 800MG DR TAB.
The denial is overturned.

The patient is a male with ulcerative colitis. The patient started mesalamine and noticed a small amount of blood in the stools. He started balsalazide and had blood stools. The patient had an allergic reaction to sulfasalazine.

Yes, the requested Mesalamine is medically necessary.

The 5-aminosalicylic acid (5-ASA) derivatives available in oral formulations include balsalazide, mesalamine, olsalazine and sulfasalazine.

Asacol, Asacol HD (delayed release) and Delzicol tablets contain a pH-sensitive film that dissolves at a higher pH, thereby delivering mesalamine to the terminal ileum and proximal colon. Lialda and Apriso are formulated in a matrix that delays mesalamine release until it reaches the distal ileum and colon. Balsalazide, olsalazine and sulfasalazine are prodrugs that are cleaved in the colon following bacterial reduction to form mesalamine. Pentasa is formed by packaging mesalamine in permeable microgranules. Permeable microgranules allow for mesalamine release throughout the intestinal tract. Pentasa is more appropriate for Crohn's Disease because of its diffuse intestinal tract distribution.

For ulcerative colitis, a Cochrane review showed no significant differences in the efficacy and safety of different formulations of Oral 5-ASA (5-aminosalicylic acid) used for induction and maintenance of UC (ulcerative colitis).

As the patient had failed or had allergic reactions to formulary alternatives to all of the formulary alternatives (generic Apriso, balsalazide, and sulfasalazine), the requested Mesalamine is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.

As the patient had failed or had allergic reactions to formulary alternatives to all of the formulary alternatives (generic Apriso, balsalazide, and sulfasalazine), the requested Mesalamine is medically necessary.