CAM 20165

Aerosolized Antibiotics as a Treatment of Chronic Sinusitis

Category:Medicine   Last Reviewed:January 2019
Department(s):Medical Affairs   Next Review:January 2999
Original Date:July 2004    

Description:
Aerosolized antibiotics are antibiotics delivered with a nebulizer directly to the sinuses. They are proposed as a treatment for patients who have chronic sinusitis or acute exacerbations of chronic sinusitis.

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 U.S. Food and Drug Administration (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.

Related Policies:
701105 Balloon Sinuplasty for Treatment of Chronic Sinusitis

Policy:
Aerosolized antibiotics are considered INVESTIGATIONAL as a technique of treating chronic sinusitis or acute exacerbations of chronic sinusitis.

Policy Guidelines
Aerosolized antibiotics are delivered with a nebulizer, which may be identified with the HCPCS code E0575 (nebulizer, ultrasonic, large volume).

Benefit Application
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.

Rationale
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 four weeks followed by a four-week observational period. Outcomes measured 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 three-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 three-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 treatment. An additional 10 patients responded to the initial course of therapy, but subsequently developed a new infection with a new organism. These two 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 one of four 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 five-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 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.

References:

  1. 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.
  2. Vaughan WC, Carvalho G. Use of nebulized antibiotics for acute infections in chronic sinusitis. Otolaryngol Head Neck Surg 2002; 127(6):558-68.
  3. Scheinberg PA, Otsuji A. Nebulized antibiotics for the treatment of acute exacerbations of chronic rhinosinusitis. Ear Nose Throat J 2002; 81(9):648-52.
  4. 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(2):92-8.

Coding Section

Codes Number Description
ICD-9 Diagnosis   473.0-473.9 Chronic sinusitis code range 
HCPCS E0575 Nebulizer, ultrasonic, large volume  
ICD-10-CM (effective 10/01/15)  J320  Chronic maxillary sinusitis 
  J321  Chronic frontal sinusitis 
  J322  Chronic ethmoidal sinusitis 
  J323  Chronic sphenoidal sinusitis 
  J324  Chronic pansinusitis 
  J328  Other chronic sinusitis 
  J329  Chronic sinusitis, unspecified 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/30/2019 

Annual review, no change to policy intent. 

01/29/2018 

Annual review, no change to policy intent. 

01/19/2017 

Annual review, no change to policy intent. 

01/11/2016 

Annual review, no change to policy intent. Deleting index. 

09/22/2015 

Added ICD-10 coding to policy. 

01/20/2015 

Annual review, no change to policy intent. Added guidelines and coding. 

01/13/2014

Added Related Policies.

 


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