MedImpact, an independent, trend-focused pharmacy benefit manager (PBM), is the nation’s largest privately held PBM, serving health plans, self-funded employers and government entities. A letter from that company addressed to me about one of my patients included the above headline as a reason for denying coverage of drug therapy of Lyme disease beyond a dose of 200 mg per day for 5-7 days.
Is the pharmacy benefit manager (i.e. the representative of your insurance company) just confused? Or is this a blatant mis-statement of the FDA’s recommendation for treatment of Lyme disease?
I would have to say that both are correct.
Current “standard of care” recommendations for the treatment of early Lyme disease do not appear to exist – when I put in a Google search for “FDA recommendations for treatment of Lyme disease” I get reviews of Lyme disease, clinical management (from both IDSA and ILADS camps), a (locked) version in the American Academy of Pediatrics Red Book from 2015, several articles on Lyme disease testing, and an article entitled.
When I changed the search terms to “FDA approved treatment of Lyme disease” the results were no more enlightening. Apparently, the FDA does not approve treatments of Lyme disease. If we read the FDA’s website – we see that the FDA regulates food safety and drug safety. It approves specific drugs for treatment of specific diseases. It does not prohibit the use of “off-label” doses or drugs. It does not approve therapy initiated by physicians. It does not approve surgical procedures. It does approve medical and health-related devices.
The FDA page about doxycycline can be found here.
Here is the “indications and usage” section:
DORYX is a tetracycline-class antimicrobial indicated for:
Here is the “Dosage and Administration” section:
• Adults: the usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours) followed by a maintenance dose of 100 mg/day. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended. (2.1)
Here is the section on “specific bacterial infections”:
1.4 Specific bacterial infections Relapsing fever due to Borrelia recurrentis. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis.
Apparently Borrelia burgdorferi, the organism originally described by Willi Burgdorfer as the causative agent of Lyme disease, is not even on the list.
As to the proper duration of treatment of Lyme disease, the “experts” vary widely in their opinions. But even Gary Wormser, MD, one of the most vocal of “chronic Lyme disease” deniers, recommends a dose of 200 – 400 mg per day for at least 6 weeks for neuroborreliosis.
There are many published articles on treatment of Lyme disease, case reports, in vitro studies, animal studies – not a lot of people studies, unfortunately – but who would want to be in the placebo arm of a clinical trial with a disease as devastating as Lyme disease?
We have treatment recommendations put forth by both the IDSA and ILADS. Both agree that treatment with doxycycline is the initial treatment of choice. They do not agree on duration of treatment, based on large numbers of theoretically adequately treated patients continuing to have symptoms despite the theoretically adequate treatment.
Of the few peer-reviewed published articles I found online that discussed dosage of doxycycline and duration of treatment, all seemed to agree that a daily dose of 200 to 400 mg was appropriate.
Even more importantly, as the 2014 revision of the ILADS Practice Guidelines for the Treatment of Lyme Disease states:
This panel has placed a high value on the ability of the clinician to exercise clinical judgment. In the view of the panel, guidelines should not constrain the treating clinician from exercising clinical judgment in the absence of strong and compelling evidence to the contrary.
A summary version of the guidelines published on the website of ILADS stated:
Since there is currently no definitive test for Lyme disease, laboratory results should not be used to exclude an individual from treatment.
Lyme disease is a clinical diagnosis, and tests should be used to support rather than to supersede the physician’s judgment.
The early use of antibiotics can prevent persistent, recurrent, and refractory Lyme disease.
The duration of therapy should be guided by clinical response, rather than by an arbitrary (ie, 30 day) treatment course.
The practice of stopping antibiotics to allow for delayed recovery is not recommended for persistent Lyme disease. In these cases, it is reasonable to continue treatment for several months after clinical and laboratory abnormalities have begun to resolve and symptoms have disappeared.
So, once again I pose the question: Is your insurance company representative just confused? Or is this a blatant mis-statement of the FDA’s (apparently non-existent) recommendation for treatment of Lyme disease?
Dotevall, Leif, and Lars Hagberg. “Successful oral doxycycline treatment of Lyme disease-associated facial palsy and meningitis.” Clinical infectious diseases 28.3 (1999): 569-574.
Wormser, Gary P., et al. “Practice guidelines for the treatment of Lyme disease.” Clinical infectious diseases31.Supplement_1 (2000): S1-S14.
Cameron, Daniel J., Lorraine B. Johnson, and Elizabeth L. Maloney. “Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease.” Expert review of anti-infective therapy 12.9 (2014): 1103-1135.
Source: FDA Recommends 200MG Doxycycline