Medical Policy: 02.01.45
Original Effective Date: July 2011
Reviewed: March 2015
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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.
Asthma is a common chronic inflammatory disorder of the airways characterized by bronchial hyper-responsive (BHR), reversible airflow limitation, and recurrent episodes of wheezing, shortness of breath, chest tightness and cough. Asthma is a complex syndrome with many clinical and inflammatory phenotypes. Most patients with asthma have mild to moderate disease and can be easily controlled by regular use of inhaled corticosteroids (ICS) combined with short acting inhaled B2 agonists for relief of symptoms. However, some patients asthma continues to be poorly controlled in terms of ongoing symptoms, frequent exacerbations, persistent and variable airway obstruction, and frequent requirements for B2 agonists despite aggressive treatment.
Management of asthma consists of environmental control, patient education, management of comorbidities, and regular follow up for all affected patients, as well as a stepped approach to medication treatment. Despite this multidimensional approach, many patients continue to experience considerable morbidity. In addition to ongoing efforts to optimally implement standard approaches to asthma treatment, new therapies are being developed. One recently developed therapy is bronchial thermoplasty.
Bronchial thermoplasty is based on the premise that patients with asthma have an increased amount of smooth muscle in the airway and that contraction of this smooth muscle is a major cause of airway constriction. The thermal energy delivered via bronchial thermoplasty aims to reduce the amount of smooth muscle and thereby decrease muscle mediated bronchoconstriction with the ultimate goal of reducing asthma-related morbidity. Bronchial thermoplasty is intended as a supplemental treatment for patients with severe persistent asthma.
During the procedure the clinician will introduce a catheter into the patient’s lungs through the channel of a flexible bronchoscope. The catheter has an expandable wire basket tip. The four arms of the expanded basket contact the airway wall. Controlled thermal energy is delivered to heat tissue to 65 ËšC for about 10 seconds to heat the airway smooth muscle. All accessible airways distal to the mainstem bronchus that are 3 to 10 mm in diameter are treated once, except those in the right middle lobe, which are left untreated due to difficulty with access. The heat generated by the thermal energy is intended to reduce airway smooth muscle mass and responsiveness while leaving surrounding tissue undamaged.
After the first treatment session, previously treated airways are evaluated by bronchoscopy before proceeding with further treatment. 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.
Three industry sponsored randomized controlled trials (RTCs) on bronchial thermoplasty have been published (AIR, RISA, AIR2). The largest RCT with the most rigorous methodology was the AIR2 trial. This was the only published trial that was double blinded and sham controlled, and also the only published RTC with sites in the United States. Over 1 year, bronchial thermoplasty was not found to be superior to sham treatment on the investigator-designated primary efficacy outcome, mean change in quality-of-life of ate least 0.5 points on the Asthma Quality of Life Questionnaire scale. There was a high rate of response in the sham group of the AIR2 trial, which suggests a large placebo effect, particularly for subjective outcomes such as quality of life. On the secondary outcomes, bronchial thermoplasty provided greater benefit than sham treatment on some, but not all of the outcomes. In the AIR trial and RISA trial, there were improvements in quality of life for the bronchial thermoplasty group. However, given the lack of benefit in the AIR2 trial, it s possible that the difference in quality of life for these other trials were due to placebo effect.
There are longer-term (3 year) comparative published data from the AIR trial. Rates of hospitalizations and respiratory adverse advents did not differ significantly in the groups that received bronchial thermpolasty versus medication in years 2 and 3. Data up to 5 years in the bronchial thermoplasty group did not suggest delayed complications. For the sham controlled AIR2 trial, 2 year follow up data are available only for bronchial thermoplasty group. In year 2, patients did not experience an increase in severe exacerbations or asthma adverse events compared with year 1.
Findings on adverse events from the 3 trials suggest that bronchial thermoplasty is associated with a relatively high rate of adverse events including hospitalizations during the treatment period. Safety data up to 5 years has been reported on the RTCs for the patients treated with bronchial thermoplasty but not for control groups. Rates of adverse events in years 2 to 5 were similar to those in the first year following treatment.
Bronchial thermoplasty (BT) is a minimally invasive technique that has been proposed to treat patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta2 agonists. Although there is some published peer reviewed evidence suggesting improved outcomes with follow up to five years in selected subsets of individuals with asthma, the ability to determine improved health outcomes is limited by small study populations, which precludes the ability to draw affirmative conclusions and generalize findings to routine clinical practice. Further, an increase in respiratory related adverse events, including hospitalizations has been noted post treatment with BT. Support by professional societies/organizations in the form of published consensus statements is variable. Although results are promising for a targeted population, data is insufficient to support the safety and longer term effectiveness of bronchial theramoplasty (BT) for the treatment of severe, persistent asthma or any indications and therefore, is considered investigational.
Practice Guidelines and Position Statements
Global Initiative for Asthma (GINA)
GINA is an international network of organizations and professional with expertise in asthma. The group has been updating a report entitled Global Strategy for Asthma Management and Prevention annually since 2002, the most recent update was issued in 2014. GINA recommends stepped care for the treatment of asthma. Step 1 consists of reliever inhaler use on an as needed basis. Step 2 involves low dose controller medication plus as needed reliever medication. Step 3 includes one or two controllers plus as needed reliever medication. Step 4 is two or more controllers plus as needed reliever medication. Step 5 involves higher level of care and/or add-on treatment. According to the GINA document, options for add-on treatment include bronchial thermoplasty for some adults with severe asthma (Evidence B). The document notes that evidence on bronchial thermoplasty is limited and the long term effects are not known.
American College of Chest Physicians (ACCP)
As of March 2014, ACCP does not address bronchial thermoplasty in any of their national guidelines. In May 2014, ACCP posted a position statement on Coverage and Payment for Bronchial Thermoplasty for Severe Persistent Asthma. The document states in part,
“CHEST believes that based on the strength of the clinical evidence, bronchial thermoplasty offers and important treatment option for adult patients with severe asthma who continue to be symptomatic despite maximal medical treatment and, therefore should not be considered experimental. Randomized controlled trails of bronchial thermoplasty for severe asthma have shown a reduction in the rate of severe exacerbations, emergency department visits, and days lost from school or work. Additionally, data published in December 2013 demonstrates the persistence of reduction in asthma symptoms achieved by bronchial thermoplasty for at least 5 years…”
European Respiratory Society (ERS) and American Thoracic Society (ATS): International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma 2014. These guidelines state: We recommend that bronchial thermoplasty (BT) is performed in adults with severe asthma only in the context of an Institutional Review Board-approved independent systematic registry or a clinical study….This is a strong recommendation, because of the very low confidence in the currently available estimates of effects of BT in patients with severe asthma. Both potential benefits and harms may be large and the long term consequences of this new approach to asthma therapy utilizing an invasive physical intervention are unknown. Specifically designed studies are needed to define its effects on relevant objective primary outcomes such as exacerbation rates, and on long term effects on lung function. Studies are also needed to better understand the phenotypes of responding patients, its effects in patients with severe obstructive asthma (FEV1, 60% of predicted value) or in whom systemic corticosteroids are used, and its long term benefits and safety.
British Thoracic Society
2011 Guideline for Advanced Diagnostic and Therapeutic Flexible Bronchoscopy in Adults. This guideline states: Bronchial thermoplasty (BT) is a possible treatment in selected patients with severe asthma already on maximal therapy, although its place in the treatment of asthma remains to be established. Long term safety and efficacy remains unclear. Hence, treatment should be limited to a few specialist centers in carefully selected patients. Longer term follow up of treated patients is recommended.
In April 2010, the Alair® Bronchial Thermoplasty System (Asthmatx, Inc. Sunnyvale, CA, now part of Boston Scientific Corp.) was approved by the FDA through the premarket approval (PMA) process for the use in adults with severe and persistent asthma whose symptoms are not adequately controlled with inhaled corticosteroids and long acting beta agonists. The labeling also lists the following contraindications:
Patients with the following conditions should not be treated:
- Presence of a pacemaker, internal defibrillator, or other implantable electronic devices
- Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
- Patients previously treated with the Alair System should not be retreated in the same area(s). No clinical data are available studying the safety and/or effectiveness of repeat treatments.
Patients should not be treated while the following conditions are present:
- Active respiratory infection
- Asthma exacerbation or changing dose of systemic corticosteroids for asthma (up or down) in the past 14 days
- Known coagulopathy
- As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatlet agents, aspirin and NSAIDS before the procedure with physician guidance.
Bronchial thermoplasty for the treatment of asthma is considered investigational.
Based on peer reviewed literature there is uncertain degree of benefit and the presence of substantial adverse advents leave a large degree of uncertainty about the impact of bronchial thermoplasty on the net health outcome. There is also a lack of conclusive evidence confirming long term efficacy and safety. In addition, there is a lack of data on patient selection factors for this procedure, and as a result, it is not possible to determine which patient’s receive the most benefit. As a result, bronchial thermoplasty is considered investigational for the treatment of asthma.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 31660 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe
- 31661 Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes
- 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.
- Jilcy M, Theraputic option for severe asthma. Arch Med Sci. 2012 September 8; 8(4): 589-597.
- ECRI. Product Brief. Alair Bronchial Thermoplasty System (Boston Scientific, Inc) for Treating Asthma. January 2014.
- National Institute for Health and Clinical Excellence. Bronchial Thermoplasty for Severe Asthma, Issued January 2012.
- National Guideline Clearinghouse. British Thoracic Society Guideline for Advanced Diagnostic and Therapeutic Flexible Bronchoscopy in Adults, Du Rand IA, et al. November 2011.
- MedPage Today. Meeting Coverage at the American Academy of Allergy, Asthma and Immunology meeting. Bronchial Thermoplasty in Asthma: Ready or Not? Published March 2, 2014.
- American Academy of Allergy Asthma & Immunology, Bronchial Thermoplasty Provides Long Term Asthma Control, published online September 3, 2013.
- MedScape Reference. Bronchial Thermoplasty, Mahmoud Mahafzah, MBBS, Zab Mosenifar, M.D. et al. Updated December 26, 2013.
- UpToDate. Treatment of Severe Asthma in Adolescents and Adults. Sally Wenzel, M.D. Topic last updated January 3, 2014.
ECRI. Emerging Technology Report. Bronchial Thermoplasty (Alair System) for Treating Adult Patients with Severe Symptomatic Asthma. October 2014. Also available at www.ecri.org
American College of Chest Physicians 2014 position statement for Coverage and Payment for Bronchial Thermoplasty for Severe Persistent Asthma. Also available at chestnet.org
Canadian Agency for Drugs and Technologies in Health (CADTH), Bronchial Thermoplasty for Severe Asthma: Clinical and Cost Effectiveness and Guidelines, March 27, 2014. Also available at www.cadth.ca
Medscape. Bronchial Thermoplasty for Asthma: 5 Year Efficacy Results. August 2013. Also available at www.medscape.com
Medscape. Bronchial Thermoplasty: Interventional Therapy in Asthma, 2014. Also available at www.medscape.com
Stephen Bickness, Rekha Chaudhuri and Neil C. Thomson, How to: Bronchial Thermoplasty in Asthma, Breath March 1, 2014 vol. 10 no. 1 48-59
UpToDate. Treatment of Severe Asthma in Adolescents and Adults, Sally Wenzel, M.D.. Topic last updated January 30, 2015. Also available at www.uptodate.com
American Academy of Allergy Asthma and Immunology Asthma Treatment and Management. Also available at www.aaaai.org
Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention updated May 2014. Also available at www.ginasthma.org
BCBSA TEC Assessment, Bronchial Thermoplasty for Treatment of Inadequately Controlled Severe Asthma, December 10, 2014. Also available at www.bcbs.com/bluersources/tec/volume 29
Date Reason Action
July 2011 Evidence review New policy
May 2012 Annual review Policy renewed
May 2013 Annual review Policy renewed
April 2014 Annual review Policy renewed
March 2015 Annual review Policy renewed
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*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.