Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative Colitis. 
Treatment: Vedolizumab x 12oo Units At OP LOC, Pre-service. 

The insurer denied the Vedolizumab x 12oo Units At OP LOC. 
The denial is upheld. 

This patient is a male with ulcerative colitis.  The patient failed Remicade. The patient was on Entyvio (Vedolizumab) and Xeljanz. 

The prior denial reason was: Use of Xeljanz and Entyvio (Vedolizumab) is not supported.  The reason for appeal is: The patient is doing well on the requested regimen. 

No, the proposed treatment is not medically necessary. 

Xeljanz (Tofacitinib) is an oral inhibitor of Janus kinases 1, 2, and 3, that FDA (Food Drug Administration) approved for the treatment of adults with moderately to severely active ulcerative colitis. In a double-blind, placebo-controlled, phase 2 trial, 194 adults with moderately to severely active ulcerative colitis were randomly assigned to receive tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, or 15 mg or placebo twice daily for 8 weeks. The primary outcome, clinical response at 8 weeks, occurred in 32%, 48%, 61%, and 78% of patients receiving tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg , and 15 mg, respectively, as compared with 42% of patients receiving placebo (Sandborn WJ, et al. N Engl J Med.). 

OCTAVE Induction 1 and 2 trials, were phase 3, randomized, double-blind, placebo-controlled trial in adults with ulcerative colitis. In the OCTAVE Induction 1 and 2 trials, 598 and 541 patients, respectively, who had moderately to severely active ulcerative colitis despite previous conventional therapy or therapy with a tumor necrosis factor antagonist were randomly assigned to receive induction therapy with tofacitinib (10 mg twice daily) or placebo for 8 weeks. The OCTAVE Sustain trial, was a phase 3, randomized, double-blind, placebo-controlled which included 593 patients who had a clinical response to induction therapy. Patients were randomly assigned to receive maintenance therapy with tofacitinib (either 5 mg or 10 mg twice daily) or placebo for 52 weeks. In the OCTAVE Induction 1 trial, remission at 8 weeks occurred in 18.5% of the patients in the tofacitinib group versus 8.2% in the placebo group; in the OCTAVE Induction 2 trial, remission occurred in 16.6% versus 3.6%. In the OCTAVE Sustain trial, remission at 52 weeks occurred in 34.3% of the patients in the 5-mg tofacitinib group and 40.6% in the 10-mg tofacitinib group versus 11.1% in the placebo group (Sandborn WJ, et al. N Engl J Med.). 

Vedolizumab is a drug that specifically targets the alpha 4 beta 7 integrin that is selectively expressed on gut-homing T lymphocytes. Vedolizumab, by selectively targeting the alpha 4 beta 7 integrin heterodimer is thought to specifically inhibit lymphocyte migration within the gut and may not cross the blood brain barrier. 

The U.S. Food and Drug Administration (FDA) approved Entyvio (Vedolizumab) to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn's disease. Vedolizumab's use in ulcerative colitis has been studied in a randomized, double-blind, placebo-controlled Phase III trial (GEMINI I trial). 47% of the Vedolizumab group versus 26% in the placebo group achieved clinical response, 17% in the Vedolizumab group versus 5% in the placebo group achieved clinical remission, and 41% in the Vedolizumab versus 25% in the placebo group achieved mucosal healing. 

Literature does not support the safety / efficacy of using both Xeljanz and Entyvio (Vedolizumab) together.