Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Rheumatoid Arthritis.
Treatment: Rinvoq 15mg (milligrams).
The insurer denied: Rinvoq 15mg (milligrams).
The denial is overturned.

The patient is an adult female with a diagnosis of Rheumatoid arthritis and Sjogren's syndrome. She was started on treatment with methotrexate discussed increased incidence of migraine headaches and it was discontinued. She is on hydroxychloroquine. She has sulfa allergies and cannot take sulfasalazine. The patient had a Prisma RA (rheumatoid arthritis) test, molecular signature test which showed that she has 10% chance of responding to a TNF (tumor necrosis factor) inhibitor. She was recently seen in clinic with active disease and synovitis on exam. Her rheumatologist wants to start her on Rinvoq.
Rinvoq was denied coverage by the health plan, as it was not considered medically necessary as the plan approved criteria only allow coverage of Rinvoq for rheumatoid arthritis if one of the following conditions is met: a) the patient has tried at least 1 TNF (tuor necrosis factor) inhibitor and it did not work well or the patient had a bad side effect, or b) the patient has received a biologic other than a TNF (tumor necrosis factor) inhibitor or targeted synthetic drug that is intended for rheumatoid 
arthritis treatment before. The denial is being appealed.

The requested Rinvoq is medically necessary.

The patient has seropositive rheumatoid arthritis. She has active disease and has failed conventional DMARD (disease-modifying antirheumatic drug) therapy. Her treatment needs to be escalated to a biologic or targeted synthetic drug. Since her molecular signature test showed 10% response to TNF (tumor necrosis factor) inhibitor, it is reasonable to avoid using TNF (tumor necrosis factor) inhibitor in this patient.
Clinical studies have shown that RA (rheumatoid arthritis) treatment selection informed by MSRC (molecular signature response classifier) test results improves clinical outcomes in real-world care and offers improvements in efficiency of healthcare spending. Reference 2 below: Predicted TNFi (tumor necrosis factor inhibitor) non-responders who received a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) with an alternative mechanism of action (altMOA) experienced up to 1.8-fold greater improvements in CDAI (Clinical Disease Activity Index) scores than those treated with a TNFi (tumor necrosis factor inhibitor) (12 weeks: 12.2 versus 
8.0; p-value = 0.083; 24 weeks: 14.2 vs 7.8 p-value = 0.009). In patients with a molecular signature of non-response to TNFi (tumor necrosis factor inhibitor) in high disease activity at baseline, this corresponded to 43.2% relative improvement in achieving a lower CDAI (Clinical Disease Activity Index) disease activity level when likely TNFi (tumor necrosis factor inhibitor) non-responders were treated with a non-TNFi (tumor necrosis factor inhibitor) therapy (38.9% vs 55.7%). Commensurate 
improvements in efficiency of spend are expected when TNFi (tumor necrosis factor inhibitor) are avoided in favor of altMOA (alternative mechanism of action).
Therefore, it is medically necessary for this patient to avoid TNF (tumor necrosis factor) inhibitor and start on a different mechanism of action drug, so that the disease can be controlled in an efficient manner and not delay treatment with an agent that is more likely to show benefit.