Medical Policy: 02.01.45
Original Effective Date: July 2011
Reviewed: February 2016
Revised: February 2016
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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.
The goal of the treatment of asthma is to achieve and maintain clinical control by eliminating symptoms during both the day and night, to normalize measures of lung function, and to reduce the risk of exacerbations.
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 and is a potential treatment option for patients with severe persistent asthma.
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 a standard flexible bronchoscope is placed through the patient’s mouth or nose into the 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 used to heat tissue to 65 degrees Celsius 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.
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.
The results of the AIR-2 trial have generated enormous interest, controversy, and confusion regarding the true efficacy of bronchial thermoplasty for severe asthma. The FDA approved bronchial thermoplasty for the treatment of severe asthma and this approval was based on the results of the AIR-2 trial. Current marketing of thermoplasty highlights its use for patients with severe asthma, which is interpreted by most clinicians as meaning oral corticosteroid dependence, frequent exacerbations, or a significantly reduced FEV1 with poor quality of life (QOL). However, these types of patients were specifically excluded from the AIR-2 trial which raises questions about the efficacy of bronchial thermoplasty.
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
American College of Allergy, Asthma and Immunology (ACCA)
In a 2012 statement on bronchial thermoplasty the ACAAI notes: “Bronchial thermoplasty is a well-studied treatment for patients with very severe asthma who continue to be symptomatic despite maximal medical treatment including steroids, long-acting beta agonists (LABAs), long-acting muscarinic agents (LAMAs), leukotriene antagonists and biologics. The device to deliver this therapy is FDA approved. The scientific literature supports bronchial thermoplasty as a therapeutic consideration for some carefully chosen patients with severe asthma. Carefully selected patients with severe persistent asthma who have persistent burden of disease, asthma exacerbations, emergency department visits or hospitalizations despite maximal medical treatment may benefit from this procedure. Therefore, ACAAI recommends that insurers provide coverage for bronchial thermoplasty for those adult patients who meet the stringent requirements.”
National Institute of Health and Clinical Excellence (NICE)
In 2012 NICE published a guideline IPG419 bronchial thermoplasty for severe asthma. The guideline notes that evidence on the efficacy of bronchial thermoplasty for severe asthma shows improvement in symptoms and quality of life, and reduced exacerbations and admission to hospital. Evidence on safety is adequate in the short and medium term. More evidence is required on the safety of the procedure in the long term. Therefore, ths procedure should only be used with special arrangements for clinical governance, consent and audit for research. NICE encourages further research into bronchial thermoplasty for severe asthma. Research outcomes should include objective measurements of lung function, symptom control, medication requirements and quality of life. Long-term safety and efficacy outcomes are particularly important.
In 2015 NICE published Individual Research Recommendation Details regarding IPG419 that notes: NICE encourages further research into bronchial thermoplasty for severe asthma. Research outcomes should include objective measurements of lung function, symptom control, medication requirements and quality of life. Long-term safety and efficacy outcomes are particularly important.
Evidence on the efficacy of bronchial thermoplasty for severe asthma shows improvement in symptoms and quality of life, and reduced exacerbations and admission to hospital. Evidence on safety is adequate in the short and medium term. More evidence is required on the safety of the procedure in the long term. Therefore, ths procedure should only be used with special arrangements for clinical governance, consent and audit for research.
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 2015. 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):
In 2014, a joint task force of the European Respiratory Society and American Thoracic Society published guidelines on the definition, evaluation and treatment of severe asthma. The guideline was based on a systematic review of the literature. It includes the statement: “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.” The authors remarked: “This is a strong recommendation, because of the very low confidence in the available estimates of effects of BT in patients with severe asthma.”
British Thoracic Society and Scottish Intercollegiate Guidelines Network
In 2014, the British Thoracic Society and the Scottish Intercollegiate Guidelines Network published a revised national guideline on management of asthma. The guideline stated:
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:
Patients should not be treated while the following conditions are present:
Bronchial thermoplasty is considered investigational for the treatment of asthma and all other indications.
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 thermoplasty (BT) for the treatment of severe, persistent asthma or any indications and therefore, is considered investigational.
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