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

Physician 1: The patient is a 44-year-old man who is requesting additional therapy for Lyme disease. He has previously received a month of treatment with intravenous ceftriaxone and is now requesting a longer course of therapy. The patients physician has indicated the ongoing IV therapy is needed to prevent a relapse. The Health Plan has denied this request indicating there is no evidence from peer-reviewed studies that more than four weeks of intravenous therapy is of benefit in the treatment of Lyme disease.In addition to the intravenous ceftriaxone, the patient has also received oral azithromycin, clarithromycin, minocycline and metronidazole.Laboratory assessment has shown elevated liver function tests of unclear origin. The patient has had a single positive IgG antibody test for human monocytic Ehrlichia, which by itself, is not of significance. The IgM is negative. Both IgM and IgG Western Blot tests for Lyme disease are negative by CDC criteria.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. Furthermore, in the case of this patient the definitive tests for Lyme disease (IgM and IgG) are both negative. Thus, there is no seriological evidence that the patient has Lyme disease. For these reasons, 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 44-year-old male with a presumed diagnosis of Lyme disease. The patients symptoms include fatigue, diarrhea, memory loss, paresthesia and blurry vision. No history of tick bite or ECM rash is noted. No physical examination findings of joint effusions or abnormal neurologic exam are included in the information provided. Laboratory findings include an IgG positive Western Blot. Other lab work is unremarkable. PCR testing for Borrelia is negative. No CSF analysis has been submitted.The patients provider has recommended continuation of IV antibiotic therapy. The Health Plan has denied the request on the basis the requested therapy is considered experimental.Presuming the patient has Neuroborreliosis, the standard treatment is four weeks of intravenous ceftriaxone or penicillin. The patient has received this therapy to date. Extended or repeat courses of antibiotic therapy have not been proven efficacious in the treatment of Lyme disease. A study by Klemper M, et al. demonstrated no benefit to extended therapy. To date, there is no data to support extended or repeated therapy for Lyme disease. If the patients diagnosis is Neuroborreliosis, then the administered four-week course of antibiotic is adequate therapy. Continuing treatment until symptoms are relieved is not scientifically proven as efficacious. The proposed treatment has not been shown to be beneficial in the current body of knowledge. 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 44-year-old man reported to have Lyme disease, though the provided records are not conclusive. The patients self-described symptoms are nonspecific; no objective physical findings are noted. Furthermore, laboratory results presented to support a diagnosis of Lyme disease are equivocal at best and both IgG and IgM are negative by CDC and New York criteria. Lyme PCR was also negative.The patient has already been treated with multiple oral antibiotics for 2-3 months, followed by 5-6 weeks of IV Rocephin. The patient continues to note nonspecific symptoms. The patients physician has requested authorization for continuing IV Rocephin to avoid relapse.The mainstream literature and the recommendation of the IDSA conclude there is no accepted evidence that prolonged intravenous antibiotic treatment for Lyme disease beyond 30 days has any medical value. In addition, there is no evidence of B. burgdorferi having antibiotic resistance in the United States. Furthermore, 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 fibromyalgia and other ongoing nonspecific syndromes not amenable to antibiotic treatment.For these reasons, the IDSA guidelines for treatment of Lyme disease clearly advise against ongoing empiric treatment with antibiotics 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.