Footnotes* Note: In general, Aetna does not cover immunizations required solely for the purpose of employment, or because of incarceration. O'Leary ST, Campbell JD, Kimberlin DW. However, the study suggests a possible benefit of post-exposure combination of antibiotics with vaccination. color: blue!important; 2009;361(2):135-144. Prescribing Information. On March 18, 2016, the FDA approved obiltoxaximab (Anthim) injection for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs. OL OL OL LI { The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria. Despite the paucity of human data, limited animal data suggested that adjunctive anti-toxin therapy may improve survival. Available at: http://www.cdc.gov/ncidod/dbmd/diseaseinfo/anthrax_g.htm.  11/20/2020 Injection anthrax has not been reported in the United States. The site is secure. Guidelines for the Surveillance and Control of Anthrax in Humans and Animals. In Scotland, the 2009 outbreak of Bacillus anthracis infection among persons who inject drugs resulted in a 28% death rate. Anthrax can be found globally. On March 18, 2016, the FDA approved obiltoxaximab (Anthim) injection for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Aetna considers post-exposure anthrax vaccination medically necessary according to the ACIP guidelines. For people who have been exposed to anthrax (but have no symptoms of the disease), providers may prescribe preventive antibiotics, such as ciprofloxacin, penicillin, or doxycycline, depending on the strain of anthrax. On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. The FDA concluded that the results of studies in research animals provided sufficient evidence that human anthrax immune globulin is reasonably likely to benefit humans with inhalational anthrax (FDA, 2015). Injection anthrax, has been identified among heroin-injecting drug users in northern Europe. Grabenstein JD. Drugs.com provides accurate and independent information on more than 24,000 … However, with proper treatment, 60% of patients survive. Evaluation of anthrax vaccine safety in 18 to 20 year olds: A first step towards age de-escalation studies in adolescents. Vaccine. Bush LM, Perez MT. Persons who work with imported animal hides or furs in areas where standards are insufficient to prevent exposure to anthrax spores. Last Review 11/20/2020. Which single antibiotic or combination of antibiotics will be most effective for you depends on how you were infected with anthrax, your age, your overall health and other factors. top: 0px; Treating providers are solely responsible for medical advice and treatment of members. Emerg Infect Dis. The ACIP guidelines state that AVA is contraindicated for persons who have experienced an anaphylactic reaction following a previous dose of AVA or any of the vaccine components. } Check contract language, limitations and exclusions for coverage details. The risk for persons who come in contact in the workplace with imported animal hides, furs, bone meal, wool, animal hair, or bristles has been reduced by changes in industry standards and import restrictions. In Scotland, there have been cases of injection anthrax from injecting illegal drugs (heroin). Swartz MN. Responder units engaged in response activities that might lead to exposure to aerosolized, Following cutaneous or gastrointestinal exposure to, Activities with a high potential for aerosol production. Clin Infect Dis. Prophylaxis and treatment of anthrax in pregnant women. Therefore, if subsequent exposures occur, additional vaccinations might be required. Pediatrics. People of any age may be affected. Antibiotics are effective against the germinated form of Bacillus anthracis but are not effective against the spore form of the organism. Evidence Report/Technology Assessment 141. According to the ACIP guidelines, in the context of the routine pre-exposure program, vaccination of persons with moderate or severe acute illness should be postponed until recovery. list-style-type : square !important; Preventive treatment consists of antibiotics and the anthrax vaccine. li.bullet { AIG-IV recipients had surgery more often and, among survivors, had longer hospital stays than did non-recipients; AIG-IV recipients were sicker than non-recipients. Anthim was developed by Elusys Therapeutics, Inc. of Pine Brook, New Jersey, in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. Aetna considers obiltoxaximab (Anthim) injection in combination with appropriate anti-bacterial drugs medically necessary for the treatment of inhalational anthrax. Because anthrax is considered to be a potential agent for use in biological warfare, the Department of Defense (DOD) has begun mandatory vaccination of all active duty military personnel who might be involved in conflict. Before sharing sensitive information, make sure you're on a federal government site. pii: 07-0969. By the later stages of the disease… Without treatment, more than half of patients with gastrointestinal anthrax die. FDA approves treatment for inhalational anthrax. } Use of anthrax vaccine in the United States. Anthrax is treated by antibiotics. On the basis of studies that demonstrated the effectiveness of ciprofloxacin in reducing the incidence and progression of inhalation anthrax in animal models, the FDA approved the use of ciprofloxacin following aerosol exposure to Bacillus anthracis spores to prevent development or progression of inhalation anthrax in humans. Which single antibiotic or combination of antibiotics will be most effective for you depends on how you were infected with anthrax, your age, your overall health and other factors. The ACIP guidelines note that anthrax vaccine is contraindicated in persons who have recovered from anthrax because of previous observations of more severe adverse events among recipients with a vaccine history of anthrax than among non-recipients. When the vaccine is used to treat unvaccinated people who have been exposed to anthrax, the schedule is compressed to three subcutaneous doses. 2017;23(1):56-65. Cutaneous anthrax can usually be successfully treated with antibiotics and some antibiotics have also been approved for post-exposure prophylaxis. list-style-type: decimal; } J Pediatric Infect Dis Soc. @media print { With delayed treatment, anti-toxin-antimicrobial treatment increased rabbit survival. Use of anthrax vaccine in response to terrorism: Supplemental recommendations of the Advisory Committee on Immunization Practices. Silver Spring, MD: FDA; March 25, 2015. Injection anthrax causes infection deep under the skin or in muscle. All animals were administered aerosolized B. anthracis spores, and efficacy was determined by survival at the end of the studies. Time from B. anthracis exposure to symptoms or hospitalization and skin and limb findings at presentation did not differ between nonsurvivors and survivors. Recently, surgical removal of infected tissue has been used successfully to treat injection anthrax. All surviving animals developed toxin-neutralizing antibodies. However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to out-weigh this risk. The most frequently reported side effects were bruising, cough, headache, hives, nasal congestion, pruritus, swelling and pain at the infusion site, and upper respiratory tract infections. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Surgical infection society guidelines for vaccination after traumatic injury. These researchers conducted a systematic review of anti-toxin treatment of inhalation anthrax in humans and experimental animals to inform anti-toxin recommendations during a large-scale or mass anthrax incident. Use doxycycline or any quinolone (eg, ciprofloxacin, levofloxacin) for postexposure prophylaxis (PEP) to prevent inhalational anthrax. Military personnel deployed to areas with high-risk for exposure to the organism (as when it is used as a biological warfare weapon). Migone TS, Subramanian GM, Zhong J, et al. display: block; Pediatric anthrax: Implications for bioterrorism preparedness. The safety of raxibacumab was evaluated in 326 healthy human volunteers. An estimated 83 % of human vaccines develop a vaccine-induced immune response after 2 doses of the vaccine and greater than 95 % develop a fourfold rise in antibody titer after 3 doses. ol.numberedList LI { BioThrax vaccine will not treat an active in Anthrax is diagnosed by isolating B. anthracis from the blood, skin lesions, or respiratory secretions or by measuring specific antibodies in the blood of persons with suspected cases. In some cases, treatment with monoclonal antibodies — raxibacumab and obiltoxaximab Because of these factors, the ACIP does not recommend pre-exposure vaccination for the above groups. Although the precise correlation between antibody titer and protection against disease is not clear, these studies of post-exposure vaccine regimens used in combination with antibiotics in non-human primates have consistently documented that 2 to 3 doses of vaccine were sufficient to prevent development of disease once antibiotics were discontinued. Use of anthrax vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. 2018;9(5). The case fatality rate for cutaneous anthrax is estimated to be 20% without antibiotic treatment. National Health Service, Department of Health. Anthim is also approved for the prevention of inhalational anthrax when alternative therapies are not available or not appropriate. MMWR Recomm Rep. 2000;49(RR-15):1-20. Certain regions of the world (South and Central America, Southern and Eastern Europe, Asia, Africa, the Caribbean, and the Middle East) report more anthrax in animals than others. Following naturally occurring anthrax among livestock, cutaneous and rare gastrointestinal exposures among humans are possible, but inhalation anthrax has not been reported. Links to various non-Aetna sites are provided for your convenience only. This Clinical Policy Bulletin may be updated and therefore is subject to change. Cutaneous and rare gastrointestinal exposures of humans are possible following outbreaks of anthrax in livestock. Efficacy of ETI-204 monoclonal antibody as an adjunct therapy in a New Zealand white rabbit partial survival model for inhalational anthrax. Last Review Inhalation, ingestion, and injection anthrax, as well as anthrax meningitis are less common. On December 14, 2012, FDA approved raxibacumab injection to treat inhalational anthrax. Anthrax most commonly occurs in wild and domestic lower vertebrates (antelopes, camels, cattle, goats, sheep, and other herbivores), but it can also occur in humans when they are exposed to infected animals or tissue from infected animals. If infection occurs, treatment is with antibiotics and possibly antitoxin. The ACIP guidelines recommend anthrax vaccine as a component of post-exposure prophylaxis in pregnant women exposed to aerosolized B. anthracis spores. Grabenstein JD. Overall, the results from this study indicated that a sub-therapeutic regimen consisting of an antibiotic in combination with an anti-PA MAb results in increased survival compared to the antibiotic alone and would provide an effective therapeutic strategy against symptomatic anthrax in non-vaccinated individuals. Although anaphylaxis following anthrax vaccination is extremely rare and no anaphylaxis deaths associated with Anthrax Vaccine Adsorbed (AVA) have been reported, this adverse event can be life-threatening. The ACIP guidelines recommend post-exposure anthrax vaccination for the following indications: Note: Medically necessary post-exposure anthrax vaccinations are covered for medically necessary indications regardless of whether the member has preventive services benefits.