Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Ulcerative Colitis

Treatment: Uceris (2 mg [milligrams] foam/applicator, insert 2 mg in rectum at bedtime as needed)

The insurer denied coverage for Uceris (2 mg foam/applicator, insert 2 mg in rectum at bedtime as needed).

The denial is upheld.

This is a patient with a history of ulcerative colitis. His symptoms include blood in the stool, urgency, tenesmus, increase bowel frequency, nocturnal awakening, and occasional soiling. His extent of disease includes his rectum, sigmoid, and cecum. His initial calprotectin was 442 that subsequently decreased to 147 with ASA (aminosalicylic acids) treatment. He has been treated with Delizicol transitioned to Pentasa, sulfasalazine (severe allergic reaction), Flagyl, and Canasa suppository. His most recent laboratories show a calprotectin 683, CRP (C-Reactive Protein) 0.4, hemoglobin 12.5, and platelet count 348. He underwent a second (actually third) opinion regarding treatment given persistent symptoms and was prescribed temporary rectal therapy with Uceris foam to provide immediate relief of urgency as a bridge to other systemic therapy.

This patient suffers from mild to moderate ulcerative colitis with most of his symptoms related to focal disease of the rectosigmoid region. In a review of the management of mild to moderate ulcerative colitis in children and adolescents from UpToDate, the authors state the following regarding proctitis treatment: 

Proctitis Patients with disease limited to the rectum (i.e. [that is], inflammation that extends no more than 15 cm [centimeters] proximal to the anal verge) are good candidates for receiving topical therapy. Moderately active inflammation is treated best initially with a topical 5-aminosalicylate (5-ASA, e.g., mesalamine) enema or suppository preparation, a topical (rectal) hydrocortisone enema, foam, or suppository, or budesonide enema. A combination of topical and oral mesalamine is also useful in inducing remission and may be necessary if topical therapy alone is ineffective. In patients who have not responded to topical aminosalicylates, topical corticosteroid preparations can be utilized for induction of remission, although evidence from pediatric studies is lacking. Topical budesonide can treat proctosigmoiditis effectively and may have fewer side effects than conventional glucocorticoids. If topical administration of medication is not possible due to parent or child refusal, oral administration of a 5-ASA medication is a reasonable alternative, although oral 5-ASA usually requires more frequent dosing and is probably less effective than topical 5-ASA for proctitis.

In a second review comparing budesonide foam with hydrocortisone acetate foam from Dis Colon Rectum 2003 - https://pubmed.ncbi.nlm.nih.gov/12847368/ the authors demonstrated similar efficacy and safety of the two foams in patients with proctosigmoiditis. These 2 references support the insurer's policy regarding the lack of medical necessity for Uceris foam and there seems to be no distinct advantage to deviating from the preferred agents as supported by the literature. In this particular case, either foam would be expected to be effective as temporary local treatments before proceeding with more definitive therapy such as Entyvio.

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

The insurer's denial of coverage for the Uceris (2 mg [milligrams] foam/applicator, insert 2 mg in rectum at bedtime as needed) is upheld. Medical necessity is not substantiated.