Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Formulary exception for Stelara SQ  90mg (every 4 weeks).
The insurer denied the Formulary exception for Stelara SQ  90mg (every 4 weeks).
The denial is overturned.

The patient is a female with moderate to severe Crohn's with perianal involvement. She has failed Pentasa, Entocort, 6-MP (mercaptopurine), Prednisone, Remicade, Entyvio and Humira. She had some, but not a complete, response to Stelara 90 mg (milligrams) every 8 weeks. She was increased to Stelara 90 mg every 4 weeks, with improvement in symptoms, decrease in inflammatory markers, and she has a therapeutic Stelara level of 6. Her provider is requesting to continue Stelara at 90 mg (milligrams) every 4 weeks.

Yes, the health plan should cover the Formulary exception for Stelara at 90 mg (milligrams) every 4 weeks.
The patient has failed two anti-TNFs (tumor necrosis factors), Remicade and Humira. She has also failed Entyvio. She has failed Stelara at FDA (United States Food and Drug Administration)-approved dosing.

Medical literature supports dose intensification of biologics in patients who lose response to FDA (United States Food and Drug Administration) approved dosing. Stelara has been found to be safe and effective at doses as high as 90 mg (milligrams) every 4 weeks.

Results from a retrospective cohort study of patients with CD (Crohn's disease) reported that among 122 patients on ustekinumab, 21 (17%) patients on every 8 week maintenance dosing required dose intensification (frequency increased to every 4 weeks, every 6 weeks, or a combination of IV [intravenous] booster and frequency increase to every 6 weeks or every 4 weeks). A total of 11 patients (52%) had clinical response after dose escalation (2 [18%] were primary non-responders to induction while 9 [82%] had poor initial clinical response).

A multicenter, retrospective, open-label cohort study of adults with moderate to severe CD (Crohn's disease) was conducted to evaluate the long-term maintenance efficacy of ustekinumab therapy. During the maintenance therapy, dose escalation was required in 16.3% (17/104) patients and a combination strategy of re-induction and dose escalation was required in 6.7% (7/104) of patients. The most common escalated maintenance dosing was 90 mg (milligrams) every 4 or 6 weeks. Clinical response was regained in 52.9% (9/17) of patients who had dose escalation, and 57.1% (4/7) of patients who had combined re-induction and dose escalation.

Results from a retrospective, multicenter, open-label study of patients with refractory CD (Crohn's disease) receiving ustekinumab, demonstrated that, among 11 patients who required a dosing interval reduction (includes 90 mg (milligrams) every 8 weeks to every 4 weeks, 90 mg (milligrams) every 8 weeks to every 6 weeks), clinical improvement was seen in 73% (8/11) of patients.

Results from a retrospective, open-label, observational study of ustekinumab for the treatment of anti-tumor necrosis factor (anti-TNF) resistant CD (Crohn's disease) patients, demonstrated that, among patients who achieved clinical response at the last followup, dose escalation was required in 35% (7/20) of patients who received ustekinumab 90 mg (milligrams) every 8 weeks.

Dose intensification of Stelara in patients with IBD (inflammatory bowel disease) has been found to be safe and effective at doses as high as 90 mg (milligrams) every 4 weeks. This patient has failed 2 anti-TNFs (tumor necrosis factors) and Entyvio, and had some, but lost response to Stelara 90 mg (milligrams) every 8 weeks and is doing well on 90 mg (milligrams) every 4 weeks with good drug levels. Therefore, the requested formulary exception for Stelara 90 mg (milligrams) every 4 weeks is clinically appropriate, accepted standard of medical care, is medically necessary, and should be covered by the health plan. While the question asks about formulary alternatives, none are listed, however the patient has failed Remicade, Humira and Entyvio, and the only other biologic FDA (United States Food and Drug Administration) approved for Crohn's that the patient has not failed, Cimzia, is an anti-TNF (tumor necrosis factor), which would not be indicated as the patient has already failed two anti-TNFs (tumor necrosis factors).