Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's disease. 
Treatment: Rinvoq ER (extended release) 45mg (milligram) tablet. 

The insurer denied coverage for Rinvoq ER 45mg tablet. 

The denial is upheld. 

The patient is a teenager with a past medical history notable for asthma, atopic dermatitis, arthritis (ANA (antinuclear antibody) positive), latent tuberculosis (status post rifampin and INH (Isoniazid)) and moderate non-stricturing Crohn's disease diagnosed two years ago. Her presenting symptoms included abdominal pain, diarrhea and weight loss (125 to 89 pounds). An esophagogastroduodenoscopy (EGD) and colonoscopy showed linear erosions in the esophagus, gastritis (some granulomas noted), duodenitis and scattered colonic ulcers confirmed by wireless capsule endoscopy. The calprotectin level was 3939. The patient was notably vitamin D and iron deficient. She was treated with infliximab in escalating doses (5 milligrams per kilogram (mg/kg) eventually to 10mg/kg) to address poor levels without detectable antibodies. She did seem to have a partial clinical response when levels were finally achieved. Reassessment with magnetic resonance (MR) enterography showed moderate segmental ileitis and mild colonic wall thickening. Repeat EGD/colonoscopy showed esophageal ulceration (no granulomas), gastritis, severe terminal ileitis and moderate colonic chronic inflammation. She was treated with steroids and tube feeds for six months with marked clinical response (weight gain to 118 pounds). She started Stelara 260 mg on subsequent dosing with improvement in diarrhea. Recently she obtained a second opinion and was treated with prednisone 40mg. The Harvey-Bradshaw index = 6 (mild disease). Her treating team is now recommending Rinvoq 24 mg daily (weight 53.9kg, height 64.8 inches) to hopefully treat her Crohn's disease, atopic dermatitis (no rash noted on physical exam and her non-specific arthritis (not recommended by the rheumatologist that evaluated the patient in the past). 

These 2 reviews of the treatment Crohn's disease in children do not advocate for the use of Rinvoq and the drug is not Food and Drug Administration (FDA) approved or standard of care for the treatment of Crohn's disease in adults or children. For this particular patient, the literature would support the use of a combination of steroids, an immunomodulator (would treat the arthritis and mild atopic dermatitis as well) with/without a TNF (Tumor necrosis factor) - inhibitor at doses to achieve adequate levels. In addition, this patient appeared to have an excellent response to enteral nutrition that could address both her bowel inflammation and her nutritional support. Other second line agents like tacrolimus have not been tried either. The denial for Rinvoq by the insurer is appropriate and the agent is not considered medically necessary for this patient at this time. This review was based on the information submitted for review and the two reviews from UpToDate cited above. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Rinvoq ER 45mg tablet services is not substantiated.