Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's Disease
Treatment:  Stelara (J3358)
The insurer denied the Stelara (J3358)
The denial is upheld. 

The patient is a female with Crohn's disease, steroid dependent, with perianal involvement. She has had multiple hospitalizations for her disease, and has not achieved remission with optimized dosing of her anti-TNF (tumor necrosis factor) medication (Infliximab).  She is on Remicade every four weeks, and Prednisone 25 mg (milligrams) daily.  The request is for the addition of Stelara to the patient's Infliximab.

Following two initial doses of Remicade induction, there was excellent then waning response (increased diarrhea, nighttime awakenings) at week five, necessitating earlier infusions at increased dose with resultant sub therapeutic level at week five infusion (third dose). Despite increasing therapeutic levels, the patient required infusions at every 2.5 to 3 weeks.

The patient presented to the ED (emergency department) with low grade fever 100.4 to 101, eight BM (bowel movements) in 24 hours, three nighttime awakenings, and some visible blood in stool. There was decreased appetite, intermittent abdominal pain. Her last Remicade infusion earlier in the month. Repeat EGD (esophagogastroduodenoscopy)/Colonoscopy was consistent with severe chronic colitis. MR (magnetic resonance) enterography showed no fistula or small bowel disease.  She was discharged on prednisone 25 mg (milligrams) and Remicade infusion at increased dose 600 mg (milligrams).

No, the treatment with Stelara is not medically necessary.
The safety of combination biologic therapy has not been established, and it should only be considered in patients that have failed all alternatives, which is not the case in this patient.

There is some literature to support use of dual biologic therapy. In a study by Yang E, et al, the authors retrospectively reviewed data on patients with refractory CD (Crohn's disease) receiving DBT (dual biologic therapy) with TNF- (tumor necrosis factor alpha) antagonists, vedolizumab, natalizumab, and/or ustekinumab at two centers in North America. The authors identified 22 patients with CD (Crohn's disease) who had undergone a total of 24 dual biologic therapy (DBT) therapeutic trials. Most of the patients had a history of CD (Crohn's disease) complications, including prior surgery (91%), stricturing (59%), penetrating disease (36%), and/or fistulas (55%). The median number of failed biologic treatments was 4, and there was a total of 94 failed single biologic trials among the patient cohort. The most common reasons for failure were secondary non-response without immunogenicity, primary non-response, immunogenicity and AE (adverse events). Prior to starting DBT (dual biologic therapy) treating, 79% of patients were receiving immunodulators, 33% receiving steroids, and 33% receiving antibiotics. The three most common DBT (dual biologic therapy) combinations included vedolizumab with either ustekinumab, infliximab or adalimumab. The authors found endoscopic improvement in 43% of DBT (dual biologic therapy) trials and endoscopic remission in 26% of trials.

However, this patient has not been given sufficient time to assess response to Remicade.  Furthermore, the patient has not tried/failed Stelara monotherapy. Therefore, treatment with Stelara as requested is not medically necessary.