Diagnosis: Ulcerative Colitis (UC).
Treatment: Humira Pen - CD [crohn disease]/UC/HS [hidradenitis suppurativa] 80 milligrams (mg)/0.8 milliliter (ml) subcutaneous (SC) pen injector kit (PNKT).

The insurer denied coverage for Humira Pen - CD/UC/HS 80 milligrams (mg)/0.8 milliliter (ml) subcutaneous (SC) pen injector kit (PNKT).

The denial is upheld.

The patient is an adolescent with a past medical history notable for ulcerative colitis involving the rectosigmoid region. The patient had blood in her stool and diarrhea (no details). An EGD (esophagogastroduodenoscopy) and colonoscopy was notable for moderate colitis extending from rectum to sigmoid. Pathology suggested moderate to severe chronic colitis. The patient was treated with mesalamine 2.4 mg (milligram) twice a day oral and topical treatment with alternating Cortenema and mesalamine enema. The patient was evaluated. Documentation suggests that the patient has 3-4 loose, mushy stools per day always with blood. She has no abdominal pain or fever. She feels lightheaded, interfering with some activity. These symptoms correspond to a pediatric ulcerative colitis activity index (PUCAI) score of 35, consistent with mild to moderate ulcerative colitis. Laboratories this day showed ESR (erythrocyte sedimentation rate) 17, CRP (C-reactive protein) 7, fecal calprotectin 493 and hemoglobin 11.1. The treating team is requesting the use of Humira.

According to a review of the management of mild to moderate ulcerative colitis in children and adolescents from UptoDate, the authors note the following:

Moderate disease - Patients with moderate disease (PUCAI score of 35 to 64) typically have more than four bloody bowel movements per day and intermittent abdominal pain but no tenesmus or fever. The most common approach for patients with moderate symptoms is a course of systemic glucocorticoids, especially if systemic symptoms such as fever or anorexia are present. However, for patients who are reluctant to use glucocorticoids, it is reasonable to offer a trial of 5-ASA, similar to patients with milder disease, using doses at the high end of the range. A third option that is used for selected patients at some centers is early use of a biologic agent (typically in hospitalized patients using infliximab or adalimumab, similar to the approach for patients with more severe disease.

This patient has mild to moderate ulcerative colitis (PUCAI score 35) involving her distal, left-sided colon. She has failed topical steroid therapy and topical/systemic mesalamine.

This patient has not been treated with any of the recommended agents.

Prednisone/budesonide are very effective in inducing remission in mild to moderate ulcerative colitis. Entocort EC (enteric coated) is for right sided colitis and would not be effective to treat this patient's rectosigmoid disease.

Methotrexate has no role in the treatment of this patient's ulcerative colitis.

In conclusion, systemic steroids are as effective as the biological agents in the setting of mild to moderate ulcerative colitis. The correct form of budesonide (Uceris, not Entocort EC) can reduce steroid side effects. In steroid refractory disease or severe ulcerative colitis, biologicals are indicated preferentially. Immunomodulators are effective for maintenance of remission and are unlikely to cause lymphoma is this patient. The durability of immunomodulators seems equal or better than biological agents (Humira). This decision was based on the materials submitted for review and the attached review cited above in pdf format.

The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.

The insurer's denial of coverage for Humira Pen - CD/UC/HS 80 milligrams (mg)/0.8 milliliter (ml) subcutaneous (SC) pen injector kit (PNKT) is upheld. Medical necessity is not substantiated.