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202110-142566

2021

Excellus

PPO

Digestive System/ Gastrointestinal

Pharmacy/ Prescription Drugs

Experimental/Investigational

Overturned

Case Summary

Diagnosis: Ulcerative Colitis.
Treatment: Stelara 90mg/ml syringe every 4 weeks.
The insurer denied the Stelara 90mg/ml syringe every 4 weeks.
The denial is upheld.

The patient is a male who has the diagnosis of inflammatory bowel disease. Specifically, the patient has ulcerative colitis. The patient received Stelara as treatment for this condition. As the patient evidenced increasing symptoms attributable to their condition, the provider has requested the provision of Stelara at a decreased dosing interval of every 4 weeks. This is the subject of this review.

No, the health plan should not cover the Stelara every 4 weeks.
The provider has requested Stelara at a dosing not approved by the FDA (United States Food and Drug Administration). A review of the literature indicates that there have been no significant studies to date demonstrating the safety and efficacy of Stelara dose escalation to every 4 weeks in Ulcerative Colitis disease. The reports are anecdotal and involve small numbers of patients. As such, the usefulness, efficacy and safety of dose escalation of Stelara in patients with refractory disease requires further study and would not be considered medically appropriate. Despite the patient's presentation and history, there is no cogent medical literature or society guidelines to recommend dosing Stelara at an interval of every 4 weeks for maintenance. There is no medical literature to show that this dosing frequency has a positive effect on healthcare outcomes. The formulary medications, including Stelara at a dosing of every 8 weeks for maintenance, is as effective and without more adverse side effects than the requested non-formulary medication.

Therefore, the request is denied and not medically appropriate for this patient.

No, the Stelara every 4 weeks is not more beneficial.

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