|MP 2.01.65||Aerosolized Antibiotics as a Treatment of Chronic Sinusitis|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/9:2009
|Return to Medical Policy Index|
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Chronic sinusitis is defined as a group of disorders characterized by inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks duration. Clinical signs include purulent drainage, and various imaging studies (i.e., plain film radiography, computed tomography, magnetic resonance imaging) may reveal polyps, edema, erythema, or granulation tissue of the sinuses. Chronic sinusitis may be associated with asthma, allergies, dental disease, polyposis, cystic fibrosis, and immunodeficiency syndromes. It is assumed that bacteria contribute to the pathophysiology of chronic sinusitis, but their exact contribution is still unclear. For example, chronic sinusitis probably represents a continuous spectrum of pathophysiologies ranging from a purely infectious etiology to noninfectious or allergic inflammation. In addition, it is possible that the presence of bacterial colonization may aggravate a noninfectious inflammation. Conventional treatment for chronic sinusitis includes various combinations of oral antibiotics, decongestants, mucolytics, and topical corticosteroids. Endoscopic sinus surgery to improve the ventilation within the osteomeatal complex may be offered to those patients who fail medical management. After endoscopic sinus surgery, the sinus ostia are patent and communicate with the nasal cavity, thus offering an opportunity to deliver aerosolized antibiotics topically to the sinus cavities. The use of aerosolized antibiotics has been studied in patients who have had endoscopic sinus surgery, both those with persistent symptoms of chronic sinusitis and those with acute exacerbations of underlying chronic sinusitis. In the latter group the presence of a mucopurulent discharge permits culturing and selection of antibiotic based on culture results. Aerosolized antibiotics as a treatment for chronic sinusitis without prior endoscopic surgery has not been studied.
In June 2006, the LC® Star Reusable Nebulizer with Nasal Adapter (PARI Innovative Manufacturers, Inc) was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for the inhalation treatment of aerosolized medications.
Aerosolized antibiotics are considered investigational as a technique of treating chronic sinusitis or acute exacerbations of chronic sinusitis.
Aerosolized antibiotics are delivered with a nebulizer, which may be identified with the HCPCS code EO575 (nebulizer,ultrasonic, large volume).
BlueCard/National Account Issues
Aerosolized antibiotics are not commercially available, but may be provided by a compounding pharmacy.
State or federal mandates (e.g., FEP) may dictate that all drugs approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational and thus these drugs may be assessed only on the basis of their medical necessity.
The policy was developed with an initial literature search in 2004, at which time there were three published clinical studies of aerosolized antibiotics- one small randomized controlled trial (1) and 2 case series (2,3). The policy was updated on a regular basis with a literature review using MEDLINE, most recently in July 2009. The following sections provide a summary of the published literature:
Chronic Sinusitis after Endoscopic Surgery
Two small randomized controlled trials have been published. Desrosiers and Salas-Prato reported in 2001 on a trial of 20 patients with chronic sinusitis persisting after endoscopic sinus surgery who were randomized to receive either a tobramycin solution or a saline only solution. (1) The solutions, aerosolized with a large-particle nebulizer, were administered twice daily for 4 weeks followed by a 4-week observational period. Outcomes measures included a quality of life questionnaire and assessment of the nasal mucosa using sinonasal endoscopy. The authors reported that both treatments were associated with equivalent improvements in symptoms, quality of life, and mucosal assessment. The addition of tobramycin appeared to add no benefit.
In 2008, Videler and colleagues (4) published a small pilot randomized controlled trial. The trial included 14 patients with chronic staphylococcal sinusitis. No differences in outcomes (symptom reduction, functional status, or endoscopic findings) were noted in patients receiving oral levofloxacin who underwent nasal irrigation with bacitracin/colimycin compared to those who received saline (placebo) irrigation. The study suggests no benefit from aerosolized antibiotics; the small sample size limits any conclusions from this study.
Acute Exacerbation of Underlying Chronic Sinusitis after Endoscopic Sinus Surgery
Two case series were identified. Vaughan and Carvalho reported in 2002 on 42 patients who were treated with a 3-month course of aerosolized antibiotics. (2) All patients had undergone prior endoscopic sinus surgery and had an acute exacerbation of the underlying chronic sinusitis, as evidenced by a mucopurulent discharge. The selection of antibiotic was based on the culture results. No other oral antibiotics were used during the 3-week treatment period. Outcomes were assessed by review of the results of endoscopy and assessment of patient symptoms using the Rhinosinusitis Outcome Measurement questionnaire. Based on the presence of purulent discharge, 28 patients were judged to be free of infection at the end of the treatment. An additional 10 patients responded to the initial course of therapy, but subsequently developed a new infection with a new organism. These 2 groups (38 of 44 patients) were considered treatment successes. Marked improvements were noted for nasal discharge and facial pain and pressure. However, without a control group, interpretation of the data is limited. It is not known if these outcomes are equivalent, better, or worse when compared to the standard treatment with oral antibiotics. The case series of Scheinberg and colleagues has the same limitations. This study included 41 patients with acute exacerbations of chronic sinusitis, although the report did not indicate how an acute exacerbation was identified. (3) The patients received 1 of 4 different antibiotics, although it is unclear how the choice of antibiotic was made. Outcomes were based on nasal obstruction, as assessed by endoscopic examination, and subjective assessments of facial pain, pressure, rhinorrhea, and malaise. All assessments were based on a 5-point scale, and were recorded before and after treatment. The lack of a control group limits the interpretation of these data.
In summary, the data on use of aerosolized antibiotics for chronic sinusitis are very limited. Two small randomized controlled trials with patients who had chronic sinusitis after endoscopic sinus surgery suggest no benefit. There are no comparative studies of oral antibiotics with aerosolized antibiotics for patients with acute exacerbations of chronic sinusitis after endoscopic sinus surgery. No published studies were identified that included patients with chronic sinusitis but who did not have endoscopic surgery. Thus, use of aerosolized antibiotics in the treatment of sinusitis is considered investigational because its impact on clinical outcomes is not known.
- Desrosiers MY, Salas-Prato M. Treatment of chronic rhinosinusitis refractory to other treatments with topical antibiotic therapy delivered by means of a large-particle nebulizer: results of a controlled trial. Otolaryngol Head Neck Surg 2001; 125(3):265-9.
- Vaughan WC, Carvalho G. Use of nebulized antibiotics for acute infections in chronic sinusitis. Otolarnygol Head Neck Surg 2002; 127(6):558-68.
- Scheinberg PA, Otsuji A. Nebulized antibiotics for the treatment of acute exacerbations of chronic rhinosinusitis. Ear Nose Throat J 2002; 81(9):648-52.
- Videler WJ, van Drunen CM, Reitsma JB et al. Nebulized bacitracin/colimycin: a treatment option in recalcitrant chronic rhinosinusitis with Staphylococcus aureus? A double-blind, randomized, placebo-controlled, cross-over pilot study. Rhinology 2008; 46:92-8
|ICD-9 Diagnosis||473.0–473.9||Chronic sinusitis code range|
|HCPCS||E0575||Nebulizer, ultrasonic, large volume|
Aerosolized Antibiotics, Chronic Sinusitis
Nebulizer, Chronic Sinusitis, Aerosolized Antibiotics
Sinusitis, Chronic, Aerosolized Antibiotics
|07/15/04||Add policy to Medicine section||New policy|
|05/23/05||Replace policy||Policy updated with literature review; policy statement unchanged|
|04/25/06||Replace policy||Policy updated with literature review; policy statement unchanged|
|09/18/07||Replace policy||Policy updated with literature review; policy statement unchanged|
|09/11/08||Replace policy||Policy updated with literature review; reference number 4 added. Policy statement unchanged.|
|09/10/09||Replace policy||Policy updated with literature review in July 2009; rationale rewritten. Policy statement unchanged.|