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

Physician 1The patient is a 34-year-old female first diagnosed with Lyme disease in 2001. She subsequently received multiple courses of antibiotic with minimal long-term results. She had one six-month course of antibiotic with minimal change in her condition. She reports experiencing fatigue, paresthesia, arthralgias, fever, photophobia and headaches. These symptoms have persisted for several years. The patient feels the symptoms are increasing in severity. Physical exam findings include peripheral neuropathy with no effusions or erosion of large joints. Laboratory data include a positive IgG Western blot, normal brain MRI, and abnormal nerve conduction studies. No CSF analysis has been provided. A request has been made for continued intravenous antibiotic therapy. The Health Plan has denied the request on the basis that extended antibiotic therapy is considered experimental.There are no double blind, placebo-controlled trials in peer-reviewed journals, which demonstrate the efficacy of antibiotic therapy beyond four weeks for the treatment of any form of Lyme disease (neuroborreliosis, third degree heart block or Lyme arthritis). A study by Klempner, et al., shows no efficacy to longer-term therapy and significant potential side effects. A study by Krupp, et al., revealed a slight improvement in fatigue at six months with longer-term therapy but no improvement in neurologic findings. The authors advised against long-term therapy due to the incidence of severe adverse events. The protocols submitted by the patients physician are not based on the known biology of the spirochete and are untested in a double blind, placebo-controlled trial. As such, there is insufficient evidence that extended antibiotic therapy is likely to benefit the patient.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. The Health Plans denial should be upheld.Physician 2The patient is a 34-year-old female with poorly documented history. She is said to have Lyme disease diagnosed in 2001 following a tick bite in early 2000, though the details of that diagnosis are not stated (i.e., clinical findings, presence of erythema migrans, serologic findings).  It is stated the patient had facial nerve palsy, peripheral neuropathy, temporomandibular joint dysfunction (which appears unrelated given its onset 20 years earlier), and various non-specific constitutional symptoms. She was treated with intramuscular penicillin without significant benefit, and then received six months of intravenous ceftriaxone with reported modest clinical gains. Since that time she has had non-specific symptoms including arthralgias (not frank arthritis), myalgias, neurogenic-type pain, fatigue, photophobia, headaches, and fibromyalgia component.More recent lab studies performed in 2004 were extensive and non-diagnostic, as the markers for systemic inflammation were normal, screens for Lyme-associated infection were all negative, and while IgG Western blot was positive, IgM Western blot was equivocal, and Lyme PCR was negative. The patients provider has requested two additional months of IV antibiotic treatment. The Health Plan has denied the request on the basis that the requested therapy is considered investigational.The diagnosis of Lyme disease in this patient is uncertain, and unsupported by the records provided. If we accept the diagnosis of Lyme disease on the basis of later clinical events, and the later positive IgG Western blot, then the patient has already been treated beyond adequately with a six-month and later two-month course of IV antibiotics (plus apparently interspersed courses of oral antibiotics) that far exceed established treatment recommendations. There is no accepted evidence that Lyme borrelia are resistant to standard protocol antibiotics.It is well recognized that non-specific symptoms can persist long-term after effective eradication of the Lyme organism and that further antibiotic treatment is both ineffective and inappropriate. In many patients these symptoms present as fibromyalgia, while in others a reactive mechanism may be responsible; neither of these conditions would be treated with further antibiotics. It appears the patients current condition is more suggestive of fibromyalgia and a chronic pain syndrome, with no evidence to suggest ongoing active infection with Lyme borrelia. There is no accepted evidence that further antibiotic treatment would be of benefit to this patient. 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 3The patient is a 34-year-old woman with an illness characterized by a multiplicity of symptoms that have occurred since a tick bite in 2000. She has a history of multiple tick bites while growing up and in her work as an ecologist. Symptoms and findings have included temporomandibular joint arthritis, Bells palsy, diffuse myalgias and arthralgias, and a nerve conduction study, which revealed a bilateral peroneal neuropathy. She also has fatigue, frequent headaches, and episodes of anxiety. The patients pain symptoms have been managed by a pain specialist with antidepressants and oral narcotics.Except for diffuse tenderness of her posterior thorax to palpation, a physical examination in July 2003 was not remarkable. The patient has a positive Lyme IgG Western Blot denoting past Lyme infection and a negative IgM, which indicates the infection was not recent. Laboratory studies for other parasites are negative. The patient has had extensive antibiotic therapy. She has received benzathine penicillin, doxycycline, intramuscular penicillin for a six-month period, and intravenous ceftriaxone (Rocephin) for a similar period of time. Additional antibiotic therapy has been recommended. The Health Plan has denied authorization for additional antibiotic therapy on the basis that it is investigational in nature.The patients history of a tick bite in 2000 was apparently associated with a localized eruption consistent with Lyme disease infection. She has a variety of medical symptoms that have been ascribed to ongoing Lyme disease. There is serological evidence that she had Lyme disease at some point in the past.Several studies have addressed the necessary duration of therapy for chronic Lyme disease. A study by Krupp, et al., demonstrated that a month of therapy with ceftriaxone (versus placebo) reduced perceived fatigue in a group of 55 patients with chronic Lyme disease. There are two controlled trials of long-term antibiotic therapy that do not show benefit from this treatment (Klempner, et al.). There is no scientific evidence that more than thirty days of antibiotic therapy has any beneficial