Diagnosis: Rheumatoid Arthritis
Treatment: Actemra ACTPen 162mg/0.9ml SC (subcutaneous) SOAJ (solution auto-injector)
The insurer denied the Actemra ACTPen 162mg/0.9ml SC SOAJ.
The determination is upheld.

The patient has seropositive rheumatoid arthritis (RA) and lupus overlap as well as mixed connective tissue disease (MCTD). The patient is currently on by mouth (PO) methotrexate (MTX) 20 milligrams (mg) weekly, Prednisone 10 mg daily and Plaquenil 200 mg twice daily (BID). The issue in this case is the medical necessity of subcutaneous (SQ) Actemra 162 mg every other week. The patient has not tried and failed the formulary drugs, including Rinvoq, Xeljanz and Xeljanz extended release (XR).

SQ Actemra is not medically necessary for this patient. There is no medical reason the patient cannot try Rinvoq, Xeljanz, Xeljanz XR, all of which are indicated for the treatment of RA. These drugs are equally in efficacy to SQ Actemra and all of these drugs have potential side effects, such as infection, lab abnormality, allergic reaction, etc. The provider states that the formulary drugs also have an increased risk of thrombosis and malignancy, which is accurate; however, the patient does not have a personal history of thrombosis or malignancy, therefore, they are not contraindicated in this case. A paper in the New England Journal of Medicine in 2014 concluded that 'in patients who had not previously received methotrexate or therapeutic doses of methotrexate, tofacitinib (Xeljanz) monotherapy was superior to methotrexate in reducing signs and symptoms of rheumatoid arthritis and inhibiting the progression of structural joint damage. The benefits of tofacitinib need to be considered in the context of the risks of adverse events'. Most patients with RA will try methotrexate (MTX) at some point and either have a partial response, fail it entirely or have an adverse event before moving on to a biologic. The point of the trial is to show that Xeljanz is superior to MTX in a head-to-head trial. The trial does not specify whether being on MTX prior to Xeljanz is salient in terms of the patient's response to the medication. In clinical practice most patients with RA will have tried MTX at some point before graduating to a biologic. That said, there is also data proving Xeljanz in combination with a disease modifying anti-rheumatic drug (DMARD) improves disease activity in patients with active RA. A study in Ann Intern Med in 2013 found that 'tofacitinib improved disease control in patients with active RA despite treatment with nonbiologic DMARDs, primarily methotrexate'.