Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Crohn's Disease.
Treatment: Pharmacy/Prescription Drugs- Stelara subcutaneous (SQ) 90 milligrams (mg)
The insurer denied Pharmacy/Prescription Drugs- Stelara subcutaneous (SQ) 90 milligrams (mg).
The determination is overturned.

The patient has anatomically extensive Crohn's disease diagnosed several years ago. They failed Remicade despite a therapeutic drug level. They started Stelara last year, with improvement. They have been on Stelara 90 milligrams (mg) every 8 weeks. The patient's Stelara level was low at 2.9 microgram/milliliter. Magnetic resonance enterography showed a long segment of ileal disease, left-sided colonic disease, and a midline upper gluteal abscess. They were started on Entyvio, and are now on 300 milligrams (mg) every 4 weeks. They had continued abdominal pain, diarrhea, and rectal bleeding, with elevated fecal calprotectin of 1,642 microgram/gram (ug/g). A physical examination showed a perianal skin tag with pus. At issue is the medical necessity of the requested health service/treatment of Stelara subcutaneous (SQ) 90 milligrams (mg).

The requested health service/treatment of Stelara subcutaneous (SQ) 90 milligrams (mg) is medically necessary for this patient. For example, current medical literature supports the request for Stelara 90 milligrams (mg) every 4 weeks (to be used as dual biologic therapy with high-dose Entyvio) for the treatment of Crohn's disease. The patient's disease is severe and anatomically extensive, and they failed all recommended primary therapeutic medication classes recommended by guidelines for the treatment of Crohn's disease; they are already on dose-escalated Entyvio [1,2].

Several studies have assessed the use of Stelara with Entyvio, including both used at dosing every 4 weeks [2-7]. In aggregate, no significant safety issues were attributed to dual biologic therapy, and the therapy was broadly successful in improving response in patients who had failed biologic therapy [3-7]. Additionally, there is prospective study data which supports the greater efficacy of Stelara compared with Entyvio when used for the treatment of Crohn's disease [8]. Another larger study concurred [9].

Although the patient had a magnetic resonance enterography, elevated fecal calprotectin, ongoing symptoms and a low Stelara level, they did have some improvement with Stelara. A study showed dosing at 90 milligrams (mg) every 4 weeks was used frequently to address inadequate disease control, and a large proportion of patients were able to maintain response with dose escalation to 90 milligrams (mg) every 4 weeks [10]. Multiple studies have shown that a majority of patients in whom Stelara dosing every 8 weeks failed to control symptoms responded to dosing every 4 weeks [11-13]. In this case, the patient has had disease symptoms while taking Stelara every 8 weeks, with a low Stelara level of 2.9 microgram/milliliter (ug/mL). A Stelara level of at least 4.5 microgram/milliliter (ug/mL) is associated with effective disease control. American College of Gastroenterology guidelines for the treatment of Crohn's disease stated that, "Those with continued symptoms should...have their medication dose adjusted in order to attempt to optimize therapy" [1,12].

A continuation of the current Stelara dose could result in additional complications of uncontrolled disease, flare, hospitalization, need for surgery, fistula, and stricture. Alternative options are limited. Therefore, the request for Stelara 90 milligrams (mg) every 4 weeks (with Entyvio) is supported as medically necessary for the treatment of this patient's Crohn's disease.