Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 49-year-old woman diagnosed with chronic fatigue syndrome attributed to Epstein-Barr virus (EBV) infection. The submitted information does not provide corroborating historical or serologic evidence supporting the infection. The patient has a 30-year history of arthritis without documented deformity or synovitis. She currently experiences diffuse body aches including all joints with 15 minutes of morning stiffness. In addition, the patient has photosensitivity, Raynauds and alopecia. Her exam apparently revealed four tender points with no evidence of inflammatory arthritis or systemic lupus erythematosus (SLE) features. She has a low normal C4 with negative ANA, Ro, La dsDNA, normal ESR and CBC with an elevated parvovirus B-19 IgG and negative IgM. The patient has been treated with NSAIDS, narcotic analgesics, and anxiolytics. She is followed by a psychiatrist for depression. At the patients follow-up visit, she had greater than 12 tender points and Neurontin was started. The patients provider has recommended IVIG therapy. The Health Plan has denied authorization for IVIG on the basis that it is considered experimental.There has not been convincing evidence that IVIG is efficacious for the entity known as chronic fatigue syndrome. The most recent placebo controlled, double-blinded study demonstrated no efficacy. A case series documented a clinical response in the three individuals with acute parvovirus B-19 associated chronic fatigue syndrome, which this patient does not have. There is extensive literature from the solid organ and bone marrow/stem cell transplant community on the efficacy of IVIG for treatment of EBV infection in the immunocompromised host. However, this is not the patients condition. Although there is clearly a lack of efficacious therapy for CFS, IVIG is not likely to be more beneficial than the optimal treatment of the patients affective disorder, fibromyalgia and possible undifferentiated connective tissue disease. Therefore, I have determined that the requested therapy 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 2The patient is a 49-year-old woman with arthralgias since age 20. The patient had no synovitis on exam. In addition, the patient has a history of Epstein-Barr virus infection, Raynauds, alopecia, photosensitivity, and chronic fatigue syndrome (CFS). The submitted records also indicate the patient has fibromyalgia, though only 4 of 18 tender points were noted. The patient also has a history of parvovirus B-19 infection. The patients chief complaint is joint pain in her hands, elbows and knees. Her rheumatologist has suggested treatment with IVIG. The Health Plan indicates the efficacy of IVIG for treatment of the patients diagnoses has not been established.The Health Plans denial should be upheld. The current prevailing notion is that chronic fatigue syndrome is not directly caused by an infectious agent. As a result, the article by Gantz supports the contention that antiviral drugs, antibacterial agents and high-dose intravenous immunoglobulin have no role in treating patients with CFS. Additionally, in the Strauss and Gluckman article referenced above, the authors indicate they do not believe there is a relationship between EBV infection and chronic fatigue syndrome. They also note that there is no true immune deficiency in CFS, although there may be a mild immune dysregulation. Furthermore, the Schur article indicates there is little evidence of immune deficiency in CFS and little evidence that IVIG decreases symptoms of CFS.Moreover, it is not clear that this 49-year-old patient has CFS from parvovirus infection. A study by CDC looked at 40 different infectious agents and failed to link them to CFS. Most people who are tested for parvovirus IgG will be positive, because most individuals are infected during childhood.As set forth above, the literature does not support the use of IVIG for treatment of patients with arthralgias and chronic fatigue syndrome. Therefore, I have determined that the requested therapy 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 49-year-old woman with chronic fatigue syndrome and fibromyalgia. The patient also has a history of Epstein-Barr virus and arthritis. The patients provider has recommended treatment with IVIG therapy. The Health Plan indicates IVIG is considered investigational for treatment of the patients diagnoses.There is not adequate evidence that off-label use of IVIG is effective in the treatment of chronic fatigue syndrome. The submitted articles show mixed results, involve small numbers, and rely on anecdotal data. Furthermore, review of the current medical literature does not demonstrate that IVIG has been shown to be effective for patients such as this patient. Thus, there is insufficient evidence that IVIG is beneficial for this indication. Therefore, I have determined that the requested therapy 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.