Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Colitis
Treatment: Pentasa 250mg Capsule Sustained Action (SA)

The insurer denied the Pentasa 250mg Capsule Sustained Action (SA).
The denial is overturned.

The patient is a male with Crohn's disease diagnosed.  The request is for Pentasa, which is preferred over other mesalamines, per provider, as the patient is unable to swallow capsules or tablets.  Pentasa may be opened up and sprinkled.

Yes, the health plan should cover the requested Pentasa.
The 5-aminosalicylic acid (5-ASA) derivatives available in oral formulations include balsalazide, mesalamine, olsalazine and sulfasalazine.

Asacol, Asacol HD 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.

Based on older literature, Pentasa has efficacy in Crohn's disease. In a study by Hanauer SB et al, a multicenter trial enrolled patients with either active Crohn's disease (CDAI (Crohn's Disease Activity Index) > (greater than) or = 150) or disease in remission (CDAI (Crohn's Disease Activity Index) < (less than) 150). The primary measure of therapeutic response was mean change in CDAI (Crohn's Disease Activity Index) from baseline to final visit. All patients began treatment with a dosage of < (less than) or = 4 g/day (grams per day) of mesalamine that ranged from 3.7 g (grams) at baseline to 3.4 g (grams) at final visit. Overall, 467 patients were enrolled: 333 (active disease) and 134 (remission). The median study participation time was 14 months. For patients entering with active disease, the mean reduction in CDAI (Crohn's Disease Activity Index) was 77 points, with 42% (122/289) achieving remission by their final visit. For patients entering in remission, there was an increase in mean CDAI (Crohn's Disease Activity Index) from 90 at baseline to 96 at final visit, with 79% (95/120) of patients in remission at final visit and 72% (31/43) in remission continuously after 12 months of therapy (Hanauer SB, et al. Am J Gastroenterol.).

In a meta-analysis of 3 studies, compared with placebo, Pentasa at 4-g/day was associated with a statistically significant overall improvement in the CDAI (Crohn's Disease Activity Index) from baseline to the final visit (Hanauer SB, Stromberg U. Clin Gastroenterol Hepatol.).

Yes, the requested Pentasa is more beneficial than any standard treatment for the patient's condition.
Given the release mechanism, Pentasa would be more appropriate compared to alternative mesalamine drugs for the treatment of Crohn's disease.

As the patient is unable to swallow, Pentasa would be more appropriate compared to alternative mesalamine drugs.