Diagnosis: Crohn's Disease.
Treatment: Entyvio (vedolizumab).

The health plan denied the requested medication, Entyvio (vedolizumab) as not medically necessary.

The health plan's determination is upheld.

The patient is a male with Crohn's sigmoid colitis along with ileitis on the most recent colonoscopy. The patient has previously tried and failed therapy with Mesalamine and corticosteroids. More recently, the patient underwent robotic sigmoidectomy for diverticulitis and the surgery was complicated by an anastomotic leak. He now has a diverting ileostomy. The patient was readmitted to the hospital with a new pre-sacral collection.

The patient's provider has recommended treatment with Entyvio. On a progress note it is listed that he is already on this therapy but a later in note says he needs to start medications for Crohn's. Per the provider, Entyvio is preferred due to the lower risk of infection in a patient of advanced age. This request was denied by the plan. The plan requires that first line therapy be an anti- tumor necrosis factor (TNF) agent, usually infliximab or adalimumab and that Entyvio is not medically necessary.

I recommend upholding, in whole, the health plan's determination of medical necessity.

No, there is no randomized data comparing Entyvio to anti-TNF therapy directly in Crohn's disease, only ulcerative colitis. However, a very comprehensive network meta-analysis by Singh et al. ultimately reviewed data from 31 trials.[1] On the basis of 15 of the randomized controlled trials including 2931 biologic-naive patients, infliximab monotherapy (odds ratio [OR] 4·53 [95% confidence interval (CI) 1·49-13·79]) and infliximab combined with azathioprine (7·49 [2·04-27·49]) were associated with significantly higher odds of inducing remission compared to vedolizumab (3·76 [1·01-14·03]). No differences between active interventions were observed in maintenance trials. Most trials were at low or uncertain risk of bias.

In a previous meta-analysis using some of the same trials, these same authors found that in biologic-naïve patients, infliximab and adalimumab were ranked highest for induction of clinical remission in Crohn's disease.

Although the safety profile is somewhat better for Entyvio, the clinical efficacy is likely to be significantly higher with anti-TNF agents. In my opinion, the plan is justified in this denial for Entyvio.