Clinical Policy Bulletin:Enbrel (Etanercept)


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

      Etanercept is considered medically necessary for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. 

    2. Juvenile Rheumatoid Arthritis:

      Entanercept is considered medically necessary for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

    3. Active Psoriatic Arthritis:

      Etanercept is considered medically necessary for members with active psoriatic arthritis who have had a failure of two or more nonbiologic disease-modifying antirheumatic drugs (DMARDs) (methotrexate, sulfasalazine, cyclosporine, leflunomide, gold compounds, or antimalarials).

    4. Ankylosing Spondylitis:

      Etanercept is considered medically necessary for members with moderate to severe ankylosing spondylitis who have failed treatment with two or more non-steroidal anti-inflammatory drugs (NSAIDS).

    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 any of the following (not an all inclusive list):
    1. Asthma
    2. Chronic heart failure
    3. Churg-Strauss syndrome
    4. Graft-versus-host disease
    5. Hidradenitis suppurativa
    6. Idiopathic pulmonary fibrosis
    7. Inclusion-body myositis
    8. Inflammatory bowel disease (e.g., Crohn’s disease) arthritis
    9. Lupus erythematosus
    10. Sarcoidosis
    11. Sjogren’s syndrome
    12. Tumor necrosis factor receptor-associated periodic syndrome (TRAPS), formerly known as Hibernian fever
    13. Wegener’s granulomatosis.

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

BackgroundThe 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.

Guidelines on rheumatoid arthritis (RA) from the American College of Rheumatology (Saag, et al., 2008) state that patients with early RA with low or moderate disease activity (in study) were not considered candidates for biologic therapy. The use of anti-TNF agents in combination with methotrexate was recommended if high disease activity was present for less than three months with features of a poor prognosis.

The FDA-approved labeling for Enbrel includes black-box warnings about the risk of infections with etanercept. The labeling states that, in post-marketing reports, serious infections and sepsis, including fatalities, have been reported with the use of etanercept. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. The labeling states that rare cases of tuberculosis (TB) have been observed in patients treated with tumor necrosis factor (TNF) antagonists, including etanercept. The labeling recommends that patients who develop a new infection while undergoing treatment with etanercept should be monitored closely. Administration of etanercept should be discontinued if a patient develops a serious infection or sepsis. The labeling states that treatment with etanercept should not be initiated in patients with active infections including chronic or localized infections. The labeling recommends that physicians should exercise caution when considering the use of etanercept in patients with a history of recurring infections or with underlying conditions which may predispose patients to infections, such as advanced or poorly controlled diabetes. The labeling notes that, in a 24-week study of concurrent etanercept and anakinra therapy, the rate of serious infections in the combination arm (7%) was higher than with etanercept alone (0%). The combination of etanercept and anakinra did not result in higher ACR response rates compared to etanercept alone. The labeling states that concurrent therapy with etancerpt and anakinra is not recommended.

In a Cochrane review, Jessop et al (2009) evluated the effects of drugs for discoid lupus erythematosus. In June 2009, these investigators updated their searches of the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 2, 2009), MEDLINE, EMBASE, LILACS, and online ongoing trials registers. The reference lists of relevant reviews were searched. Index Medicus (1956 to 1966) was hand-searched and authors were approached for information about unpublished trials. These researchers included all randomized trials of drugs to treat people with discoid lupus erythematosus. Drugs included in the search were azathioprine, chloroquine, clofazimine, corticosteroids, (oral and topical), dapsone, gold, interferon alpha-2a, methotrexate, phenytoin, retinoids, sulphasalazine, thalidomide, topical calcineurin blockers (pimecrolimus and tacrolimus), and biological agents (etanercept, efalizimab, infliximab, and rituximab). Two reviewers independently examined each retrieved study for eligibility. Two trials involving 136 participants were included. No new trials were included in this update. In a cross-over study of 12 weeks duration, fluocinonide 0.05 % cream (a potent topical corticosteroid), appeared to be better than hydrocortisone 1 % cream (a mild corticosteroid) when the first arm of the trial involving 78 participants was analyzed at 6 weeks. Clearing or excellent improvement was seen in 27 % of people using fluocinonide and in 10 % of those using hydrocortisone, giving a 17 % absolute benefit in favor of fluocinonide (95 % confidence interval [CI] 0.0 to 0.34, NNT (Number needed to treat) 6). In the second trial, acitretin (50 mg/day) was compared with hydroxychloroquine (400 mg/day) in 58 people in a parallel trial of 8 weeks duration. There was marked improvement or clearing in 46 % of people using acitretin and in 50 % of those on hydroxychloroquine, but there was no significant difference between the 2 interventions. The adverse effects were more frequent and more severe in the acitretin group. In this trial, clearing of erythema was measured and found to be better in the hydroxychloroquine group (RR 0.61, 95 % CI 0.36 to 1.06). The authors concluded that fluocinonide cream may be more effective than hydrocortisone in treating people with discoid lupus erythematosus. Hydroxychloroquine and acitretin appear to be of equal efficacy, although adverse effects are more frequent and more severe with acitretin. There is not enough reliable evidence about other drugs (including etanercept) used to treat discoid lupus erythematosus.

Schoindre and colleagues (2009) stated that TNF receptor-associated periodic syndrome (TRAPS) is a highly polymorphic auto-inflammatory syndrome related to mutations in the TNFRSF1A gene encoding the type 1 TNF receptor. Arthralgia and non-erosive synovitis are among the most common manifestations. These investigators reported the case of a 73-year-old woman who presented with chronic erosive joint disease that progressed by flare-ups. Moderate non-specific abdominal and cutaneous abnormalities were noted, suggesting TRAPS. This diagnosis was confirmed when genetic tests identified the R92Q mutation in the TNFRSF1A gene. Although steroid therapy was effective in alleviating the symptoms, combination therapy with methotrexate and etanercept neither decreased the frequency of the flare-ups nor slowed the pace of joint destruction. Treatment with anakinra is being considered. The authors noted that this is the first reported case of joint destruction related to TRAPS.

CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
20600 – 20610  
96401 – 96450  
HCPCS code covered if selection criteria are met:
J1438 Injection, etanercept, 25 mg
ICD-9 codes covered if selection criteria are met:
136.1 Behcet’s syndrome [mucocutaneous manifestations (oral ulcers, nodular skin lesions) of Behcet’s disease refractory to glucocorticoids and azathioprine]
696.0 Psoriatic arthropathy [active and failed two or more nonbiologic DMARDS]
696.1 Other psoriasis [chronic moderate to severe]
711.00 – 711.99 Arthropathy associated with infections [refractory reactive]
713.0 – 713.8 Arthropathy associated with other disorders classified elsewhere [refractory reactive]
714.0 – 714.9 Rheumatoid arthritis and other inflammatory polyarthropathies [moderate to severe active]
716.20 – 716.29 Allergic arthritis [refractory reactive]
720.0 Ankylosing spondylitis [moderate to severe and failed two or more NSAIDS]
720.81 – 720.9 Other and unspecified inflammatory spondylopathies [moderate to severe]
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
135 Sarcoidosis
428.0 – 428.9 Heart failure [chronic]
446.4 Wegener’s granulomatosis [Churg-Strauss syndrome]
493.00 – 493.92 Asthma
515 Postinflammatory pulmonary fibrosis [idiopathic]
555.0 – 555.9 Regional enteritis
556.0 – 556.9 Ulcerative colitis [Crohn’s disease arthritis]
695.4 Lupus erythematosus
705.83 Hidradenitis [suppurativa]
710.2 Sicca syndrome [Sjogren’s syndrome]
729.1 Myalgia and myositis [inclusion body]
996.85 Complication of bone marrow transplant [graft-versus-host disease]
Other ICD-9 codes related to the CPB:
719.00 – 719.09 Effusion of joint [swollen joints]
719.40 – 719.49 Pain in joint [tender joints]

The above policy is based on the following references:

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