1. Aetna considers Enbrel (etanercept) medically necessary for any of the following indications:

   1. Adult Rheumatoid Arthritis:

      Etanercept is considered medically necessary for members with moderate to severe active adult rheumatoid arthritis, as indicated by both of the following:

      1. At least 6 swollen or painful joints; and

      2. An erythrocyte sedimentation rate (ESR) of greater than 28 mm/hr, or a C-reactive protein (CRP) greater than 2.0 mg/dL, or morning stiffness more than 45 minutes;

   2. Juvenile Rheumatoid Arthritis:

      Etanercept is considered medically necessary for members with active polyarticular-course juvenile arthritis who meet all of the following selection criteria:

      1. Active polyarticular-course juvenile rheumatoid arthritis, as indicated by both of the following:

         1. At least 5 swollen joints; and

         2. Three or more joints with limitation of motion and pain, tenderness, or both;

      2. Member has failed to respond to an adequate trial† (see chart below) of at least one of the following disease-modifying anti-rheumatic drugs (DMARDs):

         1. Hydroxychloroquine
         2. Oral or injectable gold
         3. Methotrexate
         4. Azathioprine
         5. Penicillamine

         6. Sulfasalazine;

   3. Active Psoriatic Arthritis:

      Etanercept is considered medically necessary for members with active psoriatic arthritis, as indicated by both of the following:

      1. At least 3 swollen joints; and

      2. At least 3 tender joints.

   4. Ankylosing Spondylitis:

      Etanercept is considered medically necessary for members with moderate to severe ankylosing spondylitis who have failed physiotherapy and are resistant to treatment with non-steroidal anti-inflammatory drugs and intra-articular corticosteroid injection.

   5. Reactive Arthritis:

      Etanercept is considered medically necessary for members with refractory reactive arthritis who have failed non-steroidal anti-inflammatory drugs, sulfasalazine, steroids and methotrexate.

   6. Behcet's disease:

      Etanercept is considered medically necessary for treatment of mucocutaneous manifestations (oral ulcers, nodular skin lesions) of Behcet's disease refractory to glucocorticoids and azathioprine.

   7. Chronic Moderate to Severe Psoriasis

      For medical necessity criteria, see CPB 658 - Psoriasis: Biological Therapies.

2. Aetna considers Enbrel (etanercept) experimental and investigational for all other indications, including inflammatory bowel disease (e.g., Crohn's disease) arthritis, Churg-Strauss syndrome, chronic heart failure, Sjogren's syndrome, Wegener's granulomatosis, asthma, sarcoidosis, graft-versus-host disease, idiopathic pulmonary fibrosis, inclusion-body myositis, and hidradenitis suppurativa.

See also CPB 205 - Phototherapy and Photochemotherapy (PUVA) for Skin Conditions, CPB 341 - Remicade (infliximab), CPB 577 - Psoriasis: Laser Treatment, CPB 595 - Kineret (Anakinra), and CPB 655 - Adalimumab (Humira).

†Note: The table below lists the duration of adequate trials of DMARDs:

The patient selection criteria were adapted from the FDA-approved labeling of Enbrel, off-label indications for etanercept accepted by the U.S. Pharmacopoeial Convention, and from published studies of etanercept’s effectiveness.  Although there is evidence of the effectiveness of both tumor necrosis factor inhibitors etanercept and infliximab (Remicade) in Crohn’s disease arthritis, only infliximab has been shown to also improve the underlying Crohn’s disease.