Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Crohn's Disease.
Treatment: Stelara 90mg every 4 weeks, Pre-service.
The insurer denied the Stelara 90mg every 4 weeks, Pre-service.
The denial is upheld. 

The patient is a female with moderate to severe fistulizing Crohn's disease, status post resection. She has failed Pentasa, Remicade and Humira, and started Stelara 90 mg every 8 weeks last year. She has had some, but not a complete response, with evidence of ongoing disease on CTE (computed tomography enterography) three months ago, which revealed persistent fistula and inflamed loop of bowel, that were no worse than previous. Her provider requesting to increase Stelara to 90 mg (milligrams) every 4 weeks.

No, the health plan should not cover the Stelara 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, 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) 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, 90 mg (milligrams) SC (subcutaneous) 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) SC (subcutaneous) 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 had some, but not a complete response to Stelara 90 mg (milligrams) every 8 weeks, with evidence of ongoing active disease on CTE (computed tomography enterography), and needs dose intensification. As the patient has not tried and failed Stelara 90 mg (milligrams) every 6 weeks, which may result in improvement, the health plan should not cover the requested health service of Stelara every 4 weeks.

No, Stelara every 4 weeks is not likely to be more beneficial.
As Stelara 90 mg (milligrams) every 6 weeks may be just as beneficial for the patient, as per the rationale to question 1,  the requested health service would not necessarily be more beneficial than any standard treatment for the insured's condition, in this case, Stelara 90 mg (milligrams) every 6 weeks.