Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Crohn's Disease
Treatment: Stelara 90 mg (milligram) syringe every 4 weeks
The insurer denied coverage for Stelara 90 mg syringe every 4 weeks.
The denial is upheld.

The medical records indicate that the patient has as history of Crohn's Disease. The patient presented to the Gastroenterologist's (GI) office for a follow up due to Crohn's Disease. The patient has tried and failed Humira and Stelara 90 mg every eight (8) and six (6) weeks. He was doing well with every six (6) weeks; however, a colonoscopy, completed recently showed ulcers and active disease. At this time, the provider is requesting approval of Stelara every four (4) weeks.

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome.

The provider has requested Stelara at a dosing not approved by the FDA (Food and Drug Administration) or the plan guidelines. 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 four (4) weeks in Crohn's 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 Crohn's disease requires further study and would not be considered effective. 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 four (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 eight (8) weeks for maintenance, is as effective and without more adverse side effects than the requested non-formulary medication.

"A subset of patients with Crohn's disease (CD) do not respond to ustekinumab at the standard dose of 90 mg every 8 weeks. Little is known about the efficacy of shortening the interval between doses." (Ollech, et al., 2021).

The Stelara 90 milligram (mg) syringe every four (4) weeks does not need/have final approval from the appropriate regulatory bodies for this diagnosis.

The Food and Drug Administration (FDA) has approved this medication for 90mg every eight (8) weeks as maintenance.

According to the FDA Prescribing Label For Stelara, "Crohn's Disease Recommended Maintenance Adult Subcutaneous Dosage (2.3): A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter."

The patient is not a good candidate for Stelara 90 milligram (mg) syringe every four (4) weeks.

Stelara 90 milligram (mg) syringe every four (4) weeks is not the best available treatment for this patient at this time. This is unknown as Stelara every four (4) weeks has not been studied effectively. The requested service is not likely to be more beneficial than any of the standard treatments/procedure for this patient.

As such, this frequency of Stelara dosing is not generally accepted by the medical community as it is not well supported in the medical literature. It is not appropriate for the patient's condition.                                                    

In summary, the denial of Stelara 90 milligram (mg) syringe every 4 weeks and coverage for the requested treatment should be upheld. This treatment is not likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.