Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Takayasu's arteritis
Treatment:  Actemra ACTPen 162 MG (milligrams) / 0.9 ML (milliliter) Subcutaneous Solution Auto-Injector (SOAJ) (Pre-Service)
The insurer denied the Actemra ACTPen 162 MG (milligrams) / 0.9 ML (milliliter) Subcutaneous Solution Auto-Injector (SOAJ) (Pre-Service)
The denial is upheld

The patient is a female with Takayasu's arteritis diagnosed, involving the ascending aorta, subclavian, carotid, celiac and renal arteries.  She was initially treated with steroids and cyclophosphamide.  Her course was complicated by renal artery stenosis, hypertension, carotid aneurysm and mesenteric arteritis.  She was intermittently lost to follow-up.  She was treated with CellCept, with occasional breakthrough flares.  A renal artery stent was placed.  There is no history of treatment with methotrexate, azathioprine or leflunomide.  

At the patient's office visit, there was concern for ongoing vasculitis with fatigue and morning stiffness.  A computed tomography (CT) angiogram was stable.  Inflammatory markers were not reported.  The patient wished to avoid treatment with prednisone or CellCept.  The attending physician prescribed Actemra, which was denied by the Plan as she failed to try plan-preferred tumor necrosis factor (TNF) inhibitor alternatives (i.e., Enbrel or infliximab). The attending physician asserted that he did not wish to try plan-preferred tumor necrosis factor (TNF) inhibitors due to increased risk of malignancy, infection and cardiovascular risk.  The appeal is for Actemra for the treatment of Takayasu's arteritis.

No, the proposed Actemra for the treatment of Takayasu's arteritis is not medically necessary.
The proposed Actemra for the treatment of Takayasu's arteritis is not medically necessary over the health plan's preferred alternatives. This patient with longstanding Takayasu's arteritis and inconsistent follow-up has been treated with cyclophosphamide, steroids and CellCept.  The patient had been lost to follow-up and did not wish to be treated again with steroids or CellCept.  There is no history of treatment with methotrexate, azathioprine or leflunomide.  The attending physician prescribed Actemra and asserted that he did not wish to try plan-preferred tumor necrosis factor (TNF) inhibitors (i.e., Enbrel, infliximab) due to increased risk of malignancy, infection and cardiovascular risk. Of note, per prior adverse determination, Actemra also carries an increased risk of malignancies and infection. Studies for tumor necrosis factor (TNF) inhibitors show safety and efficacy for Takayasu's arteritis and the risk of an adverse event is not a rationale to bypass plan-preferred tumor necrosis factor (TNF) inhibitors. 

Furthermore, per the American College of Rheumatology guidelines for the management of giant cell arteritis and Takayasu's arteritis, "Methotrexate is often used as the initial nonglucocorticoid immunosuppressive agent, but other therapies such as tumor necrosis factor inhibitors and azathioprine can be considered as well.  For patients with active Takayasu's arteritis, we conditionally recommend the use of other nonglucocorticoid immunosuppressive therapy over Actemra as initial therapy," since "the efficacy of Actemra in Takayasu's arteritis is not established at this time. While Actemra has been shown to be efficacious for giant cell arteritis, the primary efficacy end point was not achieved in the only randomized trial of Actemra in Takayasu's arteritis conducted thus far. Actemra may be considered for patients with inadequate response to other immunosuppressive therapies."  

Although a recent open-label extension trial suggested long-term efficacy and safety of Actemra in the treatment of Takayasu's arteritis, Actemra was not compared with plan-preferred tumor necrosis factor (TNF) inhibitors in this study.  Therefore, treatment with Actemra in this patient with Takayasu's arteritis who did not fail other disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF) inhibitors is not clinically appropriate or in accordance with standard of care, and thus not medically necessary over plan-preferred Enbrel or infliximab at this time.

Yes, the health plan did act reasonably, with sound medical judgment and in the best interest of the patient.