Dr Jones Kids - Cost Per Patient

COST PER PATIENT

By Dr. Daniel Cameron on 12 November, 2007 11:05:00

"It is possible to estimate the cost of Lyme disease from a 2006 study by Zhang and colleagues based on collaboration between the CDC, University of Maryland, and a managed health care program in Maryland, USA.

The average cost per Lyme disease patient in Maryland Eastern Shore was $1,310 for early Lyme disease and $16,199 for chronic Lyme disease."

The approximate annual economic impact of Lyme disease in Pennsylvania could be ≈$29 million based on average of 3,655 cases reported to the CDC. The approximate annual economic impact of Lyme disease in Pennsylvania is more likely to be ≈$290 million based on an actual average of 36,550 cases every year. The annual cost of ≈$290 million for Pennsylvania does not include the lifetime costs of chronic Lyme disease for patients described in the Klempner and Fallon trials. Neither does the annual cost of ≈$290 million for Pennsylvania include the lifetime pain and suffering for chronic Lyme disease patients, families, and loved ones."

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Lyme Project: Pennsylvania Testimony by Dr. Cameron By Dr. Daniel Cameron on 12 November, 2007 11:05:00 I have been trained at the University of Minnesota, Beth Israel Medical Center and Mt. Sinai in medicine and epidemiology. I have treated thousands of Lyme disease patients in my Mt. Kisco, New York office. I am the chief author of the International Lyme and Associated Diseases Society (ILADS) treatment guidelines, president of ILADS, as well as being a member of the Infectious Diseases Society of America (IDSA) and Council of State and Territorial Epidemiologist (CSTE).

I thank you for the opportunity to discuss this important issue. I have been treating Lyme disease patients for over 20 years using evidence-based medicine. Early in my career, Drs. Logigian and Steere published a paper in the 1990 New England Journal of Medicine (NEJM) describing many of the patients I was seeing in my practice. Drs. Logigian and Steere described neurologic Lyme disease patients with symptoms of memory loss, mood changes, sleep disturbances, fatigue, headaches, and arthritis that began up to 14 years after the onset of the disease. Two-thirds of these neurologic Lyme disease patients improved with antibiotic treatment. I remain convinced that physicians can justify treating chronic Lyme disease patients based on the evidence.

I was surprised to read that an IDSA panel’s review of the evidence concluded that there was no evidence that chronic Lyme disease exists. The IDSA concluded that “In many patients, post-treatment symptoms appear to be more related to the aches and pains of daily living rather than to either Lyme disease or a tickborne coinfection.”

In 2004, a panel selected by ILADS reviewing the same published evidence available to the IDSA reached the opposite conclusion. The number of Lyme disease patients who later go on to develop the chronic form of the disease has been estimated to be as high as 34% and 62%, according to studies done in Massachusetts and New York. A study by Dr. Klempner from the New England Medical Center and Tufts University School of Medicine demonstrated that the quality of life for chronic Lyme disease patients is lower than for patients who have Type 2 diabetes or a recent heart attack, and equivalent to that of patients with congestive heart failure.

How did the IDSA and ILADS reach opposite conclusions for the treatment of chronic Lyme disease? The IDSA guideline relied on 3 placebo-controlled randomized clinical trials (RCT): one by Dr. Krupp, and two by Dr. Klempner. The Krupp trial revealed a significant treatment effect at 6 months with 4 week of intravenous antibiotics for the primary endpoint, fatigue – (64% vs 18.5%, p < 0.001). The two Klempner trials did not show any benefit from long-term treatment.

ILADS raised the concern that the total number of subjects enrolled in the three published RCTs cited by IDSA amounted to only 184 subjects-- a sample so small that these patients may not be representative of the chronic Lyme disease population as a whole.

ILADS also does not agree with the IDSA panel’s decision to dismiss success rates of 79 to 92% for the more than 1000 patients treated for chronic Lyme in previous non-placebo, randomized trials and case series. ILADS considered the successful treatment outcomes seen in those studies as more reflective of actual practice.

The IDSA authors never addressed the drawbacks of enrolling Lyme disease patients who had already been ill an average of 4.7 years, and had already had an average of three courses of previous treatment without success, by the time they enrolled in the Klempner study. I have attached a published analytic review of the generalizability of the Klempner RCTs, which concluded that “Applying the findings to target populations with characteristics that differ from those included in these trials is inappropriate and may limit options for chronic Lyme disease patients who might benefit from antibiotic treatment.” The same concerns with generalizability can be raised for the 37 Lyme disease patients enrolling in the Fallon RCT who were ill for a total of 9 years.

ILADS remains concerned that IDSA’s decision to dismiss chronic Lyme disease will only worsen the problem of delayed treatment for Lyme disease patients. The average onset of symptoms before diagnosis was 1.7 years in the Fallon RCT and 1.9 years in a Cameron cohort study. These are three examples of delayed diagnosis from the Cameron cohort. A 42-year-old woman who had Bell’s Palsy went undiagnosed for 8 years because her spinal tap was “negative” for Lyme-- even though Bell’s Palsy is a typical symptom of Lyme disease, and a spinal tap is a notoriously unreliable test for Lyme. A 57-year-old woman went undiagnosed for 6 years following a tick bite and a swollen knee, after having been told by her doctor that the knee swelling was due to a meniscus tear. A 16- year-old boy went undiagnosed for 6 years, despite having initially being diagnosed with Bell’s palsy-- and experiencing a sudden, seemingly inexplicable decline in his mental acuity, which resulted in his grade’s dropping precipitously in school. In all these cases and others, treatment delays were strongly associated with treatment failure.

ILADS has raised the concern that insurance companies are using the IDSA guidelines to withhold necessary treatment. In an analytic review, two health insurance companies cited the Klempner trials as justification for not covering Lyme treatment with intravenous antibiotics. One insurer’s policy states that they "will not cover IV therapy beyond 28 days for Lyme Disease without review and input from a trained Infectious Disease Specialist approved by GHI-HMO." Citing the Klempner trials, Cigna does not cover a course of intravenous antibiotics lasting longer than 28 days because longer treatment is “considered experimental, investigational or unproven for this indication.”

ILADS remains concerned that the IDSA guidelines will be used to restrict a physician’s ability to practice medicine for chronic Lyme disease patients. For example, the NEJM recently issued a recommendation that doctors discuss with their patients, in “clear and empathetic language”, the “evidence” against the concept of chronic Lyme disease.

But there is nothing “empathetic” about dismissing patients’ symptoms as a figment of their imagination, and nothing “clear” about withholding important medical information that would allow patients to make informed decisions about their treatment. ILADS has advised that instead of presenting only one side of the story, doctors should tell their patients what they are entitled to know: that there are two different perspectives on this issue within the medical community, and that equally competent doctors recommend antibiotics for chronic Lyme disease. Patients should be permitted to make their own decisions, in consultation with their doctors and their families.

The IDSA did not weigh the economic cost of chronic Lyme disease treatment and adverse treatment-related events against the cost of not treating a patient who has a persistent chronic Lyme disease. The IDSA did not consider the medical and non-medical costs associated with failing to treat chronic Lyme disease patients.

It is possible to estimate the cost of Lyme disease from a 2006 study by Zhang and colleagues based on collaboration between the CDC, University of Maryland, and a managed health care program in Maryland, USA. The average cost per Lyme disease patient in Maryland Eastern Shore was $1,310 for early Lyme disease and $16,199 for chronic Lyme disease. The approximate annual economic impact of Lyme disease in Pennsylvania could be ≈$29 million based on average of 3,655 cases reported to the CDC. The approximate annual economic impact of Lyme disease in Pennsylvania is more likely to be ≈$290 million based on an actual average of 36,550 cases every year. The annual cost of ≈$290 million for Pennsylvania does not include the lifetime costs of chronic Lyme disease for patients described in the Klempner and Fallon trials. Neither does the annual cost of ≈$290 million for Pennsylvania include the lifetime pain and suffering for chronic Lyme disease patients, families, and loved ones.

Why do we need legislation for a problem we usually work out in medicine? There are several obstacles to medicine working this out. 1) ILADS physicians experienced in the treatment of chronic Lyme disease and citizens of the Pennsylvania have been excluded from the process of developing resources to educate the public about the prevention of chronic Lyme and tick-related diseases, including the long-term effects of misdiagnosis, 2) Chronic Lyme disease patients have been denied access to care based only on the IDSA view, and 3) Physicians have been reluctant to treat Lyme disease patients based on reports that surrounding states have subjected physicians who treat Lyme disease to professional misconduct proceedings.

ILADS advises passage of Bill No: HB0798 to improve the Commonwealth of Pennsylvania’s ability to prevent chronic Lyme disease, improve the chronic Lyme disease patients access to care, and offer some protection for physicians who use their own clinical judgment when treating a chronic Lyme disease patient.

I appreciate the opportunity to testify to the Committee today.

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