Medical Policy: 02.01.45
Original Effective Date: July 2011
Reviewed: February 2017
Revised: February 2016
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.
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 radiofrequency 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 at 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.
For individials who have asthma refractory to standard treatment who receive bronchial thermoplasty, the evidence includes 3 randomized controlled trials (RCTs) and meta-analyses of these RCTs. The AIR2 trial is the largest RCT, and the only 1 double-blinded and sham-controlled, with sites in the United States. Over 1 year, bronchial thermoplasty was not found to be superior to sham treatment on the investigator-designed primary efficacy outcome of mean change in quality of life score, but was found to be superior on related outcome, improvement in quality of life of at least 0.5 points on the Asthma Quality of Life Questionnaire. There was a high response rate 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, outcomes. In the AIR and RISA trials, there were improvements in quality of life for the bronchial thermoplasty group compared to the medical management group. However, given the lack of benefit in the AIR2 trial, it is possible that the difference in quality of life for these 2 trials were due at least in part to a placebo effect. There are no long-term sham-controlled efficacy data. 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, but not in the post treatment period. Safety data up to 5 years have been reported in the RCTs for the patients treated with bronchial thermoplasty but not for control patients. Rates of adverse events in years 2 to 5 were similar to those in year 1 post treatment. Conclusions cannot be drawn about the effect of bronchial thermoplasty on the net health outcome due to the limited amount of sham-controlled data (1 RCT) on the short term efficacy of bronchial thermoplasty, the uncertain degree of treatment benefit in that single sham-controlled trial, the lack of long term sham-controlled data in the face of high initial placebo response, and the presence of substantial adverse events. 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 whether there are patient subgroups that might benefit. The evidence is insufficient to determine the effects on net health outcomes. Additional well designed studies are needed to identify long term safety and efficacy of bronchial thermoplasty for the treatment of severe, persistent asthma and therefore, is considered investigational.
In a 2015 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.”
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.
GINA is an international network of organizations and professionals 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 2016. 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 in selected patients. The long term effects compared with control patients including lung function are not known.
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 an 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 trials 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…”
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.”
In 2014, the British Thoracic Society and the Scottish Intercollegiate Guidelines Network published a revised national guideline on management of asthma. The guideline stated:
The guideline includes a summary of recommended stepwise management of asthma in adults. Bronchial thermoplasty is not specifically mentioned in the stepwise management summary, but step 5 includes recommendations to consider other treatments to minimize the use of steroid tablets and to refer patients for specialty care.
In April 2010, the Alair® Bronchial Thermoplasty System (Asthmatx, Inc. Sunnyvale, CA, now part of Boston Scientific Corp.) was approved by the U.S. Food and Drug Administration (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 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 bronchial thermoplasty. Support by professional societies/organizations in the form of published consensus statements is variable. Although results are promising for a targeted population, the evidence is insufficient to determine the effects on net health outcomes. Additional well designed studies are needed to identify long term safety and efficacy of bronchial thermoplasty for the treatment of severe, persistent asthma and therefore, is considered investigational.
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