Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Orthopedic/Musculoskeletal. 
Treatment: Lab Work/Blood Tests. 
The insurer denied Vectra DA testing. 
The denial is overturned in whole.

The patient is a male with Rheumatoid Arthritis (RA) for whom coverage of Vectra DA testing was requested. The initial request for coverage was denied by the health plan on the basis that Vectra DA was not medically necessary. The treating rheumatologist appealed the denial. He stated that Vectra was used to "objectively measure inflammation caused by RA" to assess the severity of the patient's disease. He also stated that it would "measure how well current therapy is working" and would predict future joint damage. The subject under review is the medical necessity for Vectra DA testing. 

The health plan's determination is overturned, in whole.

The Vectra DA test, a Multi-protein Biomarker Disease Activity (MBDA) test, is a composite score of Rheumatoid Arthritis (RA) disease activity that measures concentrations of 12 serum proteins. These proteins encompass adhesion molecules, cytokines, growth factors, matrix metalloproteases, hormones, and acute phase reactants that have each demonstrated to correlate with RA disease activity independently. According to the Vectra DA website, "an algorithm is then applied to calculate a single VECTRA DA score ranging from 1 to 100 that categorizes RA into low, moderate, or high disease activity. Vectra DA can provide a baseline assessment of RA disease activity and track it over time. Vectra DA is validated for use in adults diagnosed with RA." There are numerous studies in the peer-reviewed literature that have validated this concept of a composite score based upon multiple independent biomarkers in RA that correlates with RA disease activity (see references). This test has grown in use among Rheumatologists as a way to discern the effectiveness of current treatment in RA patients, particularly those who may have pain from other etiologies (e.g. Fibromyalgia, Osteoarthritis).

In this case, the documentation shows that the patient had active RA based upon the history/symptoms and physical examination. The patient had previously tried and failed numerous medications including Enbrel, Humira, Orencia, Actemra, Cimzia, and Xeljanz. The rheumatologist intended to initiate a new medication, Rinvoq, and ultimately prescribed this for the patient. Prior to initiation of Rinvoq, the rheumatologist stated that he ordered the Vectra DA to "objectively measure inflammation caused by RA" to assess the severity of the patient's disease. He also stated that it would predict future joint damage. Considering that the patient had failed numerous other treatments, it was important for the rheumatologist to obtain sufficient "baseline" information regarding the patient's disease activity to complement the patient's symptoms and examination findings prior to starting the next treatment. In addition, he intended the Vectra DA to help in the prediction of progression of joint damage. Current peer-reviewed medical literature evidence supports the clinical utility of Vectra DA as an adjunct in the assessment of RA disease activity, particularly when the rheumatologist may be uncertain if a patient's ongoing pain and stiffness are attributable to RA specifically and/or solely. Medical literature also supports the utility of Vectra DA in predicting future radiographic damage in RA. Hence, in this clinical scenario, Vectra DA is medically necessary for this patient as supported by current medical literature and standards of care in the United States.