Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Digestive System/Gastrointestinal. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Rinvoq 45 milligrams (MG) oral (OR) tablets 24 (TB24). 
The denial is overturned. 

This patient is a female who has severe ulcerative colitis. She had previously tried and failed two anti-tumor necrosis factor (TNF) agents (adalimumab and infliximab) an interleukin (IL)12-23 inhibitor, Stelara (ustekinumab) and an anti-integrin inhibitor Entyvio (vedolizumab). She has required courses of steroids (budesonide) to treat flares of her Crohn's disease and is now steroids dependent. Given her failure of every class of biological agent used to treat ulcerative colitis including anti TNF agents (adalimumab and infliximab), interleukin IL-12-23 inhibitor and an anti-integrin agent, her gastroenterologist would like to use a biological agent with a different mechanism of action and is hence requesting the use of the Rinvoq (upadacitinib) which is a Janus kinase (JAK) inhibitor that was recently United States Food and Drug Administration (FDA) approved for ulcerative colitis.
At issue is the medical necessity of Rinvoq 45 milligrams (MG) oral (OR) tablets 24 (TB24).

The health plan's determination of medical necessity is overturned in whole.

Yes, the requested health service/treatment of Rinvoq 45MG OR TB24 is medically necessary for this patient.
This patient has medically refractory ulcerative colitis (UC) and has failed every other class of biological agent used to treat UC. Early biologic therapy is recommended in patients with inflammatory bowel disease and poor prognostic factors and in those refractory to conventional medications. Anti-tumor necrosis factor (anti-TNF) agents infliximab and adalimumab currently constitute the major biological therapy in inflammatory bowel disease (IBD). Additional anti-TNFs such as golimumab and other new biologics are currently being developed for both anti-TNF-naive and resistant patients. These include anti-integrins (vedolizumab and etrolizumab), a JAK inhibitor (tofacitinib and upadacitinib) and an anti-anti-interleukin (IL)-23 and IL-12 antibody (ustekinumab). The FDA approved upadacitinib (Rinvoq, AbbVie) for the treatment of adults with moderately to severely active ulcerative colitis (UC) in March 2022, in cases in which intolerance or poor responses to one or more tumor necrosis factor blockers were recorded.
 
Investigators assessed the efficacy of upadacitinib in three phase 3 randomized, multicenter, double-blind, placebo-controlled studies (ClinicalTrials.gov Identifiers: NCT03006068, NCT03653026, NCT02819635). In two induction studies, U-ACHIEVE and U-ACCOMPLISH, patients received 45 milligrams (mg) of upadacitinib or placebo once daily for eight weeks. In the third study, U-ACHIEVE Maintenance, patients received 15 or 30 mg of upadacitinib or placebo once daily for 52 weeks. Significantly more patients in the upadacitinib group than in the placebo group achieved the primary end point of clinical remission at approximately weeks eight and 52. In U-ACHIEVE and U-ACCOMPLISH, 26% (percent) and 33% of patients, respectively, achieved clinical remission; only 5% and 4% of placebo patients, respectively, achieved clinical remission. In the maintenance trial, 42% and 52% of patients treated with 15 or 30 mg of upadacitinib, respectively, versus 12% of the placebo group, achieved clinical remission. The overall safety profile of upadacitinib in the UC trials was similar to that seen in trials of patients with rheumatoid arthritis and atopic dermatitis.
Therefore, the requested health service/treatment of Rinvoq 45MG OR TB24 is medically necessary.