Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Atopic Dermatitis. 
Treatment: Rinvoq ER (extended release). 

The insurer denied: Rinvoq ER (extended release). 
The denial is upheld. 

The patient is an adult female with atopic dermatitis, treated with topical steroids, prednisone, emollients, anti-histamines, antibiotics, and Otezla.  The provider is requesting Rinvoq.  The health plan requires a trial and failure to Dupixent or Adbry, as well as topical calcineurin inhibitors and Eucrisa.  The patient was in a trial involving Baricitinib with good success.  She has a needle phobia. 

The proposed treatment is not medically necessary. 

The Janus kinase (JAK)-signal transducers and activators of transcription pathway are involved in downstream signaling of many proinflammatory cytokines, including those within the Th2 axis (e.g., interleukin [IL]-4, IL-5, and IL-13), and oral Janus kinase inhibitors have emerged as a promising therapeutic class for atopic dermatitis (AD). Several recent clinical trials have investigated selective Janus kinase-one inhibitors as monotherapy for moderate-to-severe atopic dermatitis, including recent promising results from a phase III study of abrocitinib and a phase II study of upadacitinib (Rinvoq).  The first generation of Janus kinase inhibitors include tofacitinib, ruxolitinib, baricitinib, and oclacitinib, all of which are approved by the Food and Drug Administration (FDA) for use in humans, except for oclacitinib, which is approved for veterinary use. Second-generation agents have an increased selectivity to certain Janus kinase isoforms; abrocitinib and upadacitinib are commonly referred to as 'selective JAK1 inhibitors' as they have greater selectivity to Janus kinase-one (JAK1) compared to the other isoforms. 

Rinvoq (upadacitinib) was evaluated in a 16-week, double-blind, placebo-controlled, parallel-group, dose-ranging portion of this 88-week trial in eight countries.  Adults with moderate to severe disease and inadequate control by topical treatment were randomized 1:1:1:1, using an interactive response system and stratified geographically, to once-daily upadacitinib oral monotherapy 7.5, 15, or 30 milligrams (mg) or placebo.  The trial showed a 74% improvement (achievement of primary end point) at the 30 milligram dose.  Half of the patients receiving the 30 milligram dose of upadacitinib achieved clear or almost clear skin based on the Investigator Global Assessment (IGA) score and an improvement of at least 90% in Eczema Area and Severity Index (EASI) at week 16. Improvements in signs and symptoms of atopic dermatitis were shown after the first week in those receiving upadacitinib (7.5, 15, 30 milligrams), with a significant reduction in pruritus as well as clinical efficacy end points. There was no correlation between the occurrence of adverse events and dose of upadacitinib. Therefore, there were no safety concerns to preclude further investigation of upadacitinib for atopic dermatitis, and phase III trials are currently under way.  These agents offer a solution for patients who do not respond to Dupilumab or cannot tolerate Dupilumab side effects. 

Therefore, although Rinvoq is an appropriate therapy, a trial of Dupixent and appropriate topicals is within standard of care.