Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 65-year-old man who is said to have a history of Lyme disease. There is no evidence in the provided materials that the patient actually had this disease. The results of the definitive serological tests (Western Blots) included in the records are not conclusive.  No other laboratory data of consequence is provided. There is a CD57 count that is slightly low and a non-specific SPECT brain scan performed in 2003; these are not diagnostic of Lyme disease.There is no mention in the submitted information of tick exposure or the characteristic rash seen in early Lyme disease. The medical records provided are from the patients primary care physician. The records note the patient is being treated with intravenous Rocephin and a quinolone antibiotic. He was given intravenous Rocephin for 10.5 months. Additionally, the patient received Biaxin, Plaquenil, Augmentin, Bicillin, Zithromax and Ketek during this period of time. The patients oral thrush is an obvious complication from this therapy. Skin rash, leukopenia and right upper quadrant pain are also likely to represent antibiotic toxicity.A request has been made for authorization and coverage for continued antibiotic therapy.The patient has received a large number of antibiotics over an extended period of time for treatment of non-specific symptoms without clear evidence that he has Lyme disease. He has been given a variety of oral antibiotics and apparently also has received intravenous Rocephin for a period of 10.5 months. Even if there was clear documentation of this diagnosis, the therapy is not clinically indicated.Several studies have addressed the necessary duration of therapy for chronic Lyme disease. There is no peer-reviewed data supporting more than 30 days of treatment for Lyme disease in any form. The submitted materials do not include substantial data supporting use of an extended period of antibiotic therapy. An article by Steere, et al. notes that antibiotic treatment for 14-28 days is adequate in most cases. A study published in 2001 in the New England Journal of Medicine found that a month of Rocephin followed by 60 days of an oral antibiotic was no more effective than a placebo. Thus, there is no support for an extended period of antibiotic therapy for management of Lyme 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 2: The patient is a 65-year-old male who states he has late stage Lyme disease or Neuroborreliosis. He attributes his memory and cognitive dysfunction to this condition. He also has symptoms of fatigue, weight loss, paresthesias, and gastroesophageal reflux disease. The patient has been treated for 10.5 months with intravenous antibiotic therapy. The patient reports subjective improvement with this treatment. The records do not demonstrate any abnormal physical findings. A technetium scan of the brain indicates moderate, global hypoperfusion with heterogeneity. The IgG Western Blot for Lyme is negative and the IgM is equivocal. The complete blood count is within normal limits. A CD57 test is not standard testing and its significance has not been shown in the peer-reviewed literature. The imaging findings are non-specific and do not confirm the diagnosis of Neuroborreliosis. The patients provider has recommended the patient continue to receive antibiotic therapy, which has been denied by the Health Plan.The diagnosis of Neuroborreliosis has not been clearly established. The patient has already received prolonged therapy with no objective improvement cited. There are no double-blind placebo-controlled trials in peer-reviewed literature, which demonstrate the efficacy of antibiotic therapy beyond four weeks for late stage Lyme disease. Similarly, there are no studies, which show efficacy in repeated courses of antibiotics. A study by Klemper M, et al. demonstrated no benefit to extended antibiotic treatment. In addition, there can be risk with potential site infection, allergic reaction or thrombophlebitis from intravenous therapy.Based upon the information set forth above, 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. Therefore, the Health Plans denial should be upheld.Physician 3: The patient is a 65-year-old male with a stated history of Lyme disease, for which no clear documentation is provided other than equivocal Western Blot results. Records also include a SPECT scan result describing a non-specific encephalopathy. The patient describes non-specific symptoms, including fatigue, weight loss, and paresthesias. He has received more than 10 months of IV Rocephin therapy with reported improvement in these non-specific symptoms, which apparently still persist. The patient has requested coverage for continued antibiotic therapy. The Health Plan has denied this request.If we accept the diagnosis of Lyme disease, despite the lack of definitive evidence in the records provided, there is still no medical justification for prolonged IV antibiotic treatment. There is no accepted medical evidence that prolonged IV antibiotic treatment beyond 30 days for Lyme disease has any medical value. There is no evidence of B. burgdorferi having antibiotic resistance in the United States. Persistence of non-specific symptoms after appropriate treatment of documented Lyme disease should not be treated with further long-term antibiotics, as there is no objective evidence of benefit, and these patients often have other non-specific syndromes not amenable to antibiotic treatment.For these reasons, the IDSA guidelines for treatment of Lyme disease clearly advise against ongoing empiric IV antibiotic treatment beyond thirty days. 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.