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

Physician 1: The patient is a 53-year-old female with Lyme disease. She has received nine months of treatment with Mepron and Zithromax. She has received intravenous Rocephin on a 2-3 times per week schedule for several months. The patient has symptoms of fatigue, irritability, and headaches. She has no significant physical exam findings based upon the medical records provided. No laboratory evidence (e.g., a Lyme Western blot or CSF analysis) or imaging studies have been submitted. The patient has been diagnosed with Lyme and Babesia with treatment duration based on subjective patient evaluation. It has been recommended the patient receive continued treatment with Rocephin. The Health Plan has denied coverage for the requested therapy on the basis it is considered investigational.There is no clinically proven evidence for antibiotic therapy for Lyme disease beyond thirty days. Furthermore, there does not appear to be sufficient diagnostic evidence for Neuroborreliosis or Lyme arthritis in this patient. An article by Klemper, et al. demonstrates no benefit to extended antibiotic therapy. The submitted literature includes a table of Studies Supporting Treatment for Longer Than 30 Days. These studies have no journal references and are unclear as to the study design. The submitted article by Johnson and Stricker does not reference any double blind, placebo-controlled trials of extended therapy. The other submitted article (Expert Review of AntiInfective Therapy) similarly does not reference studies of properly controlled trials. This patient has had extended, multi-drug regimens with minimal subjective improvement. It is not clinically warranted to continue such therapy with minimal evidence of disease and no objective parameters of efficacy. 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 53-year-old woman who was bitten by ticks regularly during 1986. The submitted notes also document a history of thyroid cancer in this patient in 1995. A note from July 2004 noted worsening pain, fatigue, and cognitive decline. The patient was treated with two antibiotics and an antimalarial at that time. A note from October 2004 reported poor exercise tolerance, fatigue, and joint and muscle pain and tenderness. The patient was apparently initially given Rocephin after this visit. A note from 11/2/04 documents an apparent reaction to Rocephin. When the patient was seen on 1/10/05 she was on three antibiotics (including Rocephin) and an antimalarial. The patients provider noted that the patient had less fatigue, pain and irritability on this regimen. There is no documentation in the records provided of the evidence for Lyme disease or for Babesia infection. A request has been made for continued use of Rocephin in the management of this patients condition. The Health Plan has denied this request on the basis the requested therapy is considered experimental. 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 this patients 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 3: The patient is a 53-year-old female stated to have Lyme disease. No history regarding the criteria used for diagnosis has been presented, nor is the duration of illness stated. Progress notes indicate that as of 1/10/05 the patient had already received approximately nine months of aggressive antibiotic therapy, including Zithromax, Omnicef, Rocephin, and Mepron. The patients provider described improvement in symptoms including fatigue, pain, and irritability, with no GI problems. The patient experienced some itching in her fingers, which was worse after eating sugar products, headaches on occasion, and tightness in her right shoulder. The patients provider has recommended that antibiotic therapy be continued. The Health Plan indicates the efficacy of the requested therapy for treatment of Lyme disease has not been shown. The diagnosis of Lyme disease in this patient is uncertain, and unsupported by the records provided. If we accept the diagnosis of Lyme disease, then the patient has already been treated with a nine-month course of therapy that far exceeded established treatment recommendations. There is no accepted evidence that prolonged treatment for Lyme disease beyond thirty days has any medical value. 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. The IDSA guidelines for treatment of Lyme disease clearly advise against ongoing empiric therapy with antibiotics beyond thirty days. Therefore, there is no indication for further antibiotic therapy in this patient. Accordingly, 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.