Diagnosis: Crohn's Disease.
Treatment: Stelara subcutaneous (SQ) 90 mg (milligrams).

The insurer denied Stelara subcutaneous (SQ) 90mg. The denial is overturned.

The patient is a female with severe refractory Crohn's disease status post diverting ileostomy. She has failed Remicade, Humira, and Entyvio. She started Stelara. She has had gradual dose escalation of Stelara to the current dose of 90 mg every 4 weeks. She has had disease exacerbations and hospitalizations while on the increased dose of Stelara 90mg every 4 weeks.

At issue is the medical necessity of Stelara SQ 90mg.

The health plan's determination of medical necessity is overturned in whole.

The requested health service/treatment of Stelara SQ 90mg is medically necessary for this patient.

The request to continue Stelara 90mg every 4 weeks is supported as medically necessary in this case. Stelara is United States Food and Drug Administration (FDA) approved for the treatment of Crohn's disease, and a large randomized controlled trial demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohn's disease. [1-3] Guidelines for the treatment of Crohn's disease recommend the use of Stelara. [4] A study showed dosing intensification (90mg every 4 weeks) was used frequently to address loss of response, and a large proportion of patients were able to maintain response. [5-7] One study showed that dose escalation was required in approximately half of patients, and successful in 61.1% of dose escalation attempts. [5] Another study showed efficacy of dose escalation to recover lost response in 73% of patients in whom it was attempted. [7] Additionally, the American College of Gastroenterology guidelines for the treatment of Crohn's disease state that "Those with continued symptoms should be treated with an alternative therapy for mild to moderate disease, have their medication dose adjusted in order to attempt to optimize therapy." [4]

In this case, the patient has failed the other biologic medication classes recommended by guidelines for the treatment of Crohn's disease (Entyvio, and the anti-tumor necrosis factor medications Remicade and Humira), failed Stelara every 8 weeks, and had active disease despite the use of Stelara 90mg every 4 weeks. Decrease of Stelara dosing, or discontinuation of Stelara (even if an alternative therapy is attempted immediately) may result in complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for further surgery, or other complications of Crohn's disease. For all of these reasons, the request to continue Stelara 90mg every 4 weeks is supported as medically necessary for the treatment of Crohn's disease in this case.

Therefore, the requested health service/treatment of Stelara SQ 90mg is medically necessary for this patient.