Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ulcerative colitis.
Treatment: Stelara (dosed every 6 weeks).
The insurer denied the Stelara (dosed every 6 weeks).
The denial is overturned.

The patient is a male with moderate to severe ulcerative colitis. He has failed Humira Remicade, Entyvio, 6-MP (mercaptopurine) and steroids. He started Stelara 90 mg (milligrams) every 8 weeks. He did well until earlier this year, when due to breakthrough symptoms before his next dose, and low serum drug levels, Stelara was increased to 90 mg (milligrams) every 6 weeks. He has done well since that time. The provider is requesting to continue Stelara at 90 mg (milligrams) every 6 weeks.

Yes, the Stelara every 6 weeks is medically necessary.
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 weeks 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 nonresponders 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 reinduction 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 reinduction 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.

While the studies were all done in patients with Crohn's disease, as Stelara is FDA (United States Food and Drug Administration) approved for use in ulcerative colitis, the premise is the same, and such dose intensification of Stelara in ulcerative colitis is widely used and accepted by gastroenterologists. Therefore, as the patient has lost response to Stelara 90 mg (milligrams) every 8 weeks, with low serum drug levels, and has improved on Stelara 90 mg (milligrams) every 6 weeks,  the requested Stelara 90 mg (milligrams) every 6 weeks is clinically appropriate, accepted standard of care, and medically necessary