Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Ankylosing Spondylitis.
Treatment: Rinvoq.
The insurer denied: Rinvoq.
The denial is overturned.

The patient is an adult female with a diagnosis of ankylosing spondylitis and Crohn's disease. The patient is followed by rheumatology as well as gastroenterology. The patient was recently seen in clinic with worsening back pain and stiffness as well as some peripheral joint symptoms. She is currently on methotrexate, sulfasalazine, prednisone and Skyrizi. There is no report of enthesitis, dactylitis or uveitis on exam. The patient does have erythema nodosum reported. Her rheumatologist 
wants to add Rinvoq to her current treatment. Her rheumatologist plans to stop methotrexate and sulfasalazine after Rinvoq is approved and continue Rinvoq along with Skyrizi which was prescribed by GI (gastroenterology).
Rinvoq was denied coverage by the health plan as it will be used in combination with Skyrizi.
The patient's rheumatologist is appealing the determination, as the patient has active joint disease and has tried and failed Humira, Remicade, Stelara, Xeljanz, methotrexate, sulfasalazine, prednisone and diclofenac. The patient also has Crohn's disease on Skyrizi and follows with IBD (inflammatory 
bowel disease) clinic. Rinvoq is being prescribed for her spondylarthritis.

The requested Rinvoq is medically necessary.

The patient has diagnosis of resistant spondyloarthropathy and Crohn's disease. The patient has tried and failed several DMARDs (disease-modifying anti-rheumatic drugs) and Biologics. The patient has also failed Xeljanz monotherapy in the past. Currently her Crohn's disease is being treated with Skyrizi, and she follows in IBD (inflammatory bowel disease) clinic. The patient continues to have active joint disease. Rinvoq is not a biologic defined as small molecule agent which inhibits JAK (Janus kinase). There is an emerging strategy with combination of two Biologics or a biologic and JAKi (Janus kinase inhibitor) in patients with refractory disease. The effect of dual therapies acting on different inflammatory pathways may be the optimal treatment approach, particularly for refractory individuals or those with EIM (extraintestinal manifestations). Additionally, there may be a "ceiling effect" of biologic monotherapy, as no therapy to date has demonstrated consistently higher rates of clinical and endoscopic remission following the registration trials for TNF (tumor necrosis factor) antagonists.
A recent publication (1) conducted a systematic review and meta-analysis to summarize emerging data on the safety and effectiveness of dual biologic therapy in combination or with tofacitinib, which is another JAKi (Janus kinase inhibitor) like Rinvoq, in patients with refractory inflammatory bowel disease. 30 studies reporting 288 trials of dual biologic or small molecule therapy in 279 patients (76% Crohn's disease; median duration of treatment 24 weeks). The main indications for dual therapy included medically refractory IBD (inflammatory bowel disease) (81%) and concurrent extra-intestinal manifestations or rheumatologic disease (12%). The most common combinations of dual therapy included tumor necrosis factor- antagonists & anti-integrins (48%), ustekinumab and anti-integrins (19%); 61% of patients had previously failed at least one of the two therapies used in combination. Over a median follow-up of 32 weeks, pooled rates of adverse and serious adverse events were 31%; pooled rates of clinical and endoscopic remission were 59%, and 34%, respectively. 12% of patients required surgery. Rates of success were higher in patients on dual therapy due to EIM (extraintestinal manifestations). Heterogeneity was not significant for endoscopic response, endoscopic remission, and malignancy.
Therefore, given the above, in this patient, Rinvoq can be added to Skyrizi to manage active arthritis safely in combination. Therefore, it is medically necessary as supported by current medical literature and practice guidelines.