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Medical Policy: 02.01.45
Original Effective Date: July 2011
Reviewed: May 2012
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Bronchial thermoplasty is an emerging procedure intended to treat severe asthma that has been unresponsive to standard medical therapy. During this minimally invasive procedure a standard flexible bronchoscope is placed through the patient’s mouth or nose into the most distal targeted airway and a catheter is inserted into the working channel of the bronchoscope. After placement, the electrode array in the top of the catheter is expanded, and radiofrequency energy is delivered from a proprietary controller and used to heat tissue to 65 degrees Centigrade over a 5 mm area. The positioning of the catheter and application of thermal energy is repeated several times in contiguous areas along the accessible length of the airway. At the end of the treatment session, the catheter and bronchoscope are removed. A course of treatment consists of 3 separate procedures in different regions of the lung scheduled about 3 weeks apart. The procedure is performed on an outpatient basis with conscious sedation and requires approximately 1 hour to complete.
In April 2010, the Alair Bronchial Thermoplasty System (Asthmatx, Inc. Sunnyvale, CA) was approved by the FDA through the premarket approval (PMA) process for use in adults with severe and persistent asthma whose symptoms are not adequately controlled with inhaled corticosteroids and long-acting beta-agonists (LABA). Use of the treatment is contraindicated in patients with implantable devices and those with sensitivities to lidocaine, atropine, or benzodiazepines. It should also not be used while patients are experiencing an asthma exacerbation, active respiratory infection, bleeding disorder, or within 2 weeks of making changes in their corticosteroid regimen. The same area of the lung should not be treated more than once with bronchial thermoplasty.
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Prior Approval:
Not applicable
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Policy:
Bronchial thermoplasty for the treatment of asthma is considered investigational because the impact on net health outcomes has not been established.
Rationale:
Several small case series and 3 randomized, controlled trials (RCT) evaluating the safety and efficacy of bronchial thermoplasty have been published. All of the RCTs were supported by Asthmatx, the manufacturer of the Alair system. Only one of the RCTs, the AIR2 trial had sites in the United States. AIR2 was also the only published trial that was double-blind and sham-controlled. The high rate of response in the sham group of this study suggests a large placebo effect with novel asthma treatments, particularly for the subjective outcomes such as quality of life; this calls into question conclusions about efficacy in the earlier trials that did not have a sham control. In the AIR2 rial, bronchial thermoplasty provided benefit in terms of quality of life and some, but not all, secondary outcomes. It is unclear, however, which patients are most likely to respond to treatment. Data from the AIR2 suggests that those with more severe asthma may experience the greatest improvement.
Long-term safety data up to five years are available from participants in the AIR trial and do not suggest a high rate of delayed complications following bronchial thermoplasty. However, long-term safety data are not yet available from the two other RCTs and long-term data on clinical outcomes such as exacerbation rates and quality of life are not available. Clinical trials are underway to study the long-term safety of the Alair device in participants in the RISA and AIR2 trials, and the AIR2 trial is evaluating long-term efficacy for up to 5 years. Other ongoing trials are evaluating safety of the Alair device in a United States setting and predictors of response to treatment.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- 0276T Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe
- 0277T Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes
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Selected References:
- Castro M, Rubin AS, Laviolette M et al. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med 2010; 181(2):116-24.
- Cox G, Thomson NC, Rubin AS et al. Asthma control during the year after bronchial thermoplasty. N Engl J Med 2007; 356(13):1327-37.
- Pavord ID, Cox G, Thomson NC et al. Safety and efficacy of bronchial thermoplasty in symptomatic severe asthma. Am J Resir Crit Care Med 2007; 176(12):1185-91.
- Thomson NC, Rubin AS, Niven RM et al. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. BMC Pulm Med 2011; 11:8.
- Canadian Agency for Drugs and Technologies in health (CADTH). Bronchial thermoplasty: A hot approach to asthma treatment? Health Technol Update. 2007;6:5.
- Cox G. Bronchial thermoplasty. Clin Chest med. 2010;31(1):135-40.
- Wechsler ME. Bronchial thermoplasty for asthma: A critical review of a new therapy. Allergy Asthma Proc. 2008;29(4):365-70.
- Castro M, Rubin A, Laviolette M et al. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul; 107(1):65-70. Epub 2011 Apr 14.
- Gildea TR, Khatri SB, Castro M. Bronchial thermoplasty: a new treatment for severe refractory asthma. Cleve Clin J Med. 2011 Jul; 78(7):477-85.
- ECRI Institute. Plymouth Meeting (PA): Emerging Technology Evidence Report. Bronchial Thermoplasty for treatment of adult patients with severe persistent asthma. January 2012.
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Policy History:
Date Reason Action
July 2011 Evidence review New policy
May 2012 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.
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