Diagnosis: Ulcerative colitis and severe dermatitis.
Treatment: Rinvoq 45MG (milligrams) ER (extended release) Tablet.

The insurer denied Rinvoq 45MG (milligrams) ER (extended release) Tablet. The denial is upheld.

The patient is an adolescent female. She has been diagnosed with ulcerative colitis and severe dermatitis. She failed steroids and Stelara. Her doctor requested Rinvoq 45 mg (milligrams) daily. The health plan denied coverage of the request because the patient is under the plan approved age for Rinvoq. The denial is being appealed.

The requested Rinvoq is not medically necessary.

Upadactinib (Rinvoq) was recently studied in a phase 3, multicentre, randomised, double-blind, placebo-controlled clinical programme (1). This study found that "Upadacitinib demonstrated a positive efficacy and safety profile and could be an effective treatment option for patients with moderately to severely active ulcerative colitis." Another recently published systematic review and network meta-analysis showed that "upadacitinib 45 mg [milligrams] once daily ranked first for clinical remission in all patients, patients naïve to anti-TNF [tumor necrosis factor] drugs and patients previously exposed." (2)
In the appeal letter, Crohn's disease was mentioned. Published clinical studies showed the safety and effectiveness of upadacitinib in adult patients with Crohn's disease (3-4).
This patient also has severe dermatitis. The appeal letter mentioned about a phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis. This study included 272 patients with only 29 children (9 placebo, 10 in low dose and 10 in high dose group). This study reported the safety data and did not report its effectiveness. The pediatric patient number is very small. There has been no large pediatric study yet.

In summary, all published clinical studies were performed in adult patients with ulcerative colitis or Crohn's disease. There have been no clinical studies of upadacitinib in children with ulcerative colitis or Crohn's disease. There have been no adequate clinical studies of upadacitinib in children with atopic dermatitis. This patient is an adolescent. Thus, there has been no medical literature or SOC (standard of care) to support the safety and effectiveness of upadacitinib in children with ulcerative
colitis, Crohn's disease or atopic dermatitis. Therefore, given the above, the requested Rinvoq is not medically necessary.