Enbrel denials in California external review

What the reviewers wrote

Where the denial was overturned

Physician 1: The patient is a 45-year-old male with longstanding nodulocystic acne and hidradenitis suppurativa. He has previously been prescribed numerous antibiotics without successful resolution of his symptoms. Accutane provided some benefit but had to be discontinued due to hypertriglyceridemia in spite of the concurrent administration of lipid lowering agents. Enbrel therapy has been recommended for the patient, but The Health Plan denied coverage due to the investigational nature of the therapy.The patient and his provider are without significant options other than tumor necrosis factor (TNF) inhibitors at this point in his treatment. The preliminary evidence does support the use of this therapy for the treatment of hidradenitis suppurativa, and it is a reasonable approach at this juncture.

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for the medication Enbrel. The enrollee has a diagnosis of rheumatoid arthritis. She has been off prednisone and does not use ibuprofen often. The enrollee was provided with a one-month supply of Enbrel samples. After using the medication, she reported an improvement of about 40-50 percent. She continues to have some mild shoulder pain, but she thinks this is due to her work. The enrollee’s physician reports the enrollee cannot use standard medications because she has liver problems. This reviewer found no study data that addresses the question of what the relative gastrointestinal risks, especially liver, and side-effects are among these four medications. All of them can affect the liver but the relative risks are different.

Where the denial was upheld

Physician 1The patient is a 69-year-old woman who has followed a typical course for Takayasu’s arteritis and has stenosis of the left subclavian artery, carotid arteries, right vertebral artery, left ulnar artery, and branches of the aorta supplying the kidneys. She has had numerous bypass surgeries to maintain blood flow to her upper extremities and stenting of her renal arteries. In September 2003, studies revealed 70% stenosis of her celiac axis and superior mesenteric artery. The patient’s disease continues to be very aggressive despite prednisone treatment and Plaquenil. The patient’s provider has recommended Enbrel. The Health Plan has denied authorization for Enbrel on the basis that it is considered investigational for treatment of Takayasu’s arteritis.The pathogenesis of Takayasu’s arteritis and temporal arteritis are very similar.

The patient is a 38-year-old female with a diagnosis of Behcet’s disease. She has had inadequate disease control despite treatment with various agents including azathioprine, cyclosporine, methotrexate, colchicines, and long-term steroids. The patient continues to have oral and genital ulcerations, joint inflammation, and rashes. A history of psoriasis is also noted, but there are no indications of GI symptoms in the records provided. The patient’s rheumatologist requested authorization for a trial of TNF inhibition to treat the patient’s Behcet’s disease and the Health Plan approved a three-month trial of Remicade. The patient and her provider have expressed a preference for Enbrel, and have requested authorization.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Enbrel, then check the rights and deadlines that apply to your plan.