Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Stelara at a dose of 90mg every 4 weeks.
The insurer denied the Stelara at a dose of 90mg every 4 weeks.
The denial is overturned. 

The patient is a male with severe fistulizing Crohn's. He has failed 5-ASA [(5-aminosalicylic acid)] (mesalamine), MTX (methotrexate), Remicade and Humira, and has had some but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, with improvement in luminal disease, but worsening of his fistula. His provider is requesting to increase Stelara to 90 mg (milligrams) every 4 weeks.

Yes, the health plan should cover the Stelara at a dose of 90mg every 4 weeks.

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 [n (number) =11], every 6 weeks [n (number) =5], or a combination of IV [intravenous] booster and frequency increase to every 6 weeks or every 4 weeks [n=5]). A total of 11 patients (52%) had clinical response after dose escalation (2 [18%] were primary nonresponders to induction while nine [82%] had poor initial clinical response).

The most common escalated maintenance dosing was 90 mg (milligrams) SC (subcutaneous) 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] SC [subcutaneous] every 8 weeks to every 4 weeks [n=8], 90 mg [milligrams] SC [subcutaneous] every 8 weeks to every 6 weeks [n=1]), 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) SC (subcutaneous) every 8 weeks.

Therefore, as the patient has lost response to Stelara 90 mg (milligrams) every 8 weeks, the health plan should cover Stelara 90 mg (milligrams) every 4 weeks.

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.

Yes, Stelara 90 mg (milligrams) every 4 weeks is likely to be more beneficial.

Medical literature supports dose intensification of biologics, as noted above. The patient has already failed two anti-TNFs (tumor necrosis factors), and has had improvement with Stelara. Therefore, medical literature supports continuation of Stelara at a higher dose as being more effective and beneficial than changing to Entyvio, or another anti-TNF (tumor necrosis factor) Cimzia, the only FDA (United States Food and Drug Administration)-approved biologics that the patient has not tried. Therefore, the requested Stelara 90 mg (milligrams) every 4 weeks is likely to be more beneficial for the enrollee than any available standard therapy.