Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 36-year-old woman with biopsy-documented dermatomyositis. Her disease has progressed despite treatment over the past four years under prednisone, methotrexate, and CellCept. She has been diagnosed by her neurologist as having refractory dermatomyositis. She is now backing on prednisone and methotrexate. Based on the information provided, neither CellCept nor methotrexate spared the use of prednisone. A request has been made for authorization and coverage for Rituxan. The Health Plan has denied the request. Dermatomyositis is an autoimmune disease affecting the skin and muscles. It is a rare disease and randomized, controlled treatment trials are either lacking or based on small patient numbers. However, based on the pathogenesis of dermatomyositis and our understanding of the mechanism of action of the drugs currently available in our armamentarium that might be useful in interrupting the disease process, it is reasonable to conclude that Rituxan may be of potential benefit. Studies show that B-cells near the blood vessels, which make antibodies play an important role in the pathogenesis of dermatomyositis. An article in the May 2004 issue of Current Opinion in Rheumatology states, the success of Rituxan in a well-controlled trial confirms previous preliminary reports indicating that B-cell depletion can treat established autoimmune disease. Based on these findings, and given the failure of conservative treatment of this patients disease, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Physician 2: The patient is a 36-year-old female who carries the diagnosis of dermatomyositis. She has been examined by a neurologist and has been treated with CellCept as well as methotrexate and prednisone. Her physician has recommended a trial of Rituxan. The Health Plan has denied coverage for the requested medication indicating it is considered experimental for treatment of the patients medical condition. Review of the submitted records indicates the patient has not been treated with intravenous immunoglobulin therapy (IVIG). Double-blinded placebo-controlled studies in dermatomyositis have demonstrated improvement in strength with IVIG. There is insufficient data to support the use of Rituxan for treatment of dermatomyositis at this time. As such, standard therapies are likely to be more beneficial than Rituxan for treatment of this patients dermatomyositis. Therefore, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld. Physician 3: The patient is a 36-year-old female who was diagnosed with dermatomyositis in 2000-2001 at the Mayo Clinic on the basis of muscle weakness, rash, EMG, and muscle biopsy. She has been treated with a series of appropriate agents including prednisone, Plaquenil, methotrexate, and CellCept. However, the patient has been found to have continuing active disease and refractory dermatomyositis. The patient wishes to pursue treatment with Rituxan. The Health Plan has denied authorization and coverage for Rituxan on the basis it is considered investigational for treatment of patients such as this patient.This patient has a presumably well-documented history of dermatomyositis and has been found to have an inadequate response to a number of appropriate therapies, including methotrexate and CellCept. She has consulted a provider with a special interest in the use of Rituxan for treatment of dermatomyositis. The patients provider has completed a small observational treatment trial of seven patients. His described results are markedly positive, and he has requested authorization to treat this patient with Rituxan. His enclosed paper clearly describes the rationale for anti-B cell therapy in dermatomyositis. While the data on Rituxan appears promising, the efficacy of the drug for treatment of dermatomyositis has not been established at this time. In addition, it appears the patient has not yet been treated with certain major therapies that are already accepted for use in dermatomyositis. Given her inadequate benefit with methotrexate and with CellCept, it would seem unlikely that a course of azathioprine would be of benefit. However, IVIG has produced major responses in many refractory dermatomyositis patients, with a fairly long safety record in this and other illnesses. There is a strong likelihood that intermittent IVIG would produce significant improvement in this patients medical condition. Thus, at this time IVIG is likely to be the most beneficial treatment for the patients medical condition. Based upon this information, I have determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.