Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Crohn's disease and refractory atopic dermatitis.  
Treatment:  Rinvoq.

The insurer denied coverage for Rinvoq.  The denial is overturned.
 
The patient has a history of Crohn's disease, eosinophilic esophagitis, and atopic dermatitis. He has been on treatment with Stelara. A colonoscopy showed active colitis. A colonoscopy a year later showed active ileitis. A wireless capsule endoscopy showed small aphthous ulcers in the small intestine. He was treated with budesonide but remained with active disease. His physician would like to treat him with a combination of Rinvoq and Stelara. It is reported that the patient has already started on this combination regimen, and both his Crohn's symptoms and atopic dermatitis have improved. 

Inflammatory Bowel Disease Volume 27 Issue 8 July 2021 has an article titled 
"Dual Biologic and Small Molecule Therapy For the Treatment of Refractory Pediatric Inflammatory Bowel Disease." In this study 75% (percent) of patients achieved steroid free clinical remission in 6 months in an extremely refractory group. 

Clinical Gastroenterology and Hepatology March 2022; 20(3):e361-379 has an article titled "Dual Biologic or Small Molecule Therapy of Inflammatory Bowel Disease: A Systematic Review and Meta analysis." It was advised that in patients with very refractory disease one should consider this option. 

Alimentary Pharmacology and Therapeutics 2020 Jun;51(11):1031-1038 has an article titled "Efficacy and Safety of Simultaneous Treatment with Two Biologic Medications in Refractory Crohn's Disease." The conclusion was that in this study dual biologic therapy was associated with clinical, biomarker, and endoscopic improvement in selected patients with refractory Crohn's disease. 

The World Journal of Clinical Cases 2023 April 26;11(12):2621-2630 has an article titled "Emerging role of dual biologic therapy for the treatment of inflammatory bowel disease." The conclusion is that the increasing use of dual biologics, alongside small molecule therapies, particularly in earlier disease, may help to improve cost effectiveness and reduce morbidity experienced by patients. 

Gastroenterology February 2022 Volume 162 Issue 3, Supplement S1 has an article titled "Dual Biologic or Small Molecule Treatment in Inflammatory Bowel Disease: Data for Clinical Practice." The conclusion is that dual therapy proved to be a feasible option that can be employed without significant safety concerns in carefully selected groups of patients. 

Inflammatory Bowel Disease 2021 October 27(10): 1698-1702 has an article titled "Effectiveness and Safety of Combining Tofacitinib with a Biologic in Patients with Refractory Inflammatory Bowel Disease." The conclusion was that combination of tofacitinib with a biologic agent induced a significant clinical response and endoscopic response without any new safety signals in a subset of IBD patients with active clinical symptoms despite biologic monotherapy. 

This patient has remained with active Crohn's disease on an increased dose of Stelara. His doctor feels that giving a combination of Stelara and Rinvoq will help the patient avoid surgery. Each of these drugs acts with different mechanisms to treat Crohn's disease. The medical literature has multiple articles that have shown a benefit of dual biologic therapy in refractory Crohn's patients. 

The health care plan did not act in the best interest of the patient. Rinvoq is a medically necessary treatment. The denial is overturned.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Rinvoq is substantiated.