Latest Review Date: July 2024

Category: Surgery                                                                  

POLICY:

Bronchial thermoplasty is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Bronchial thermoplasty is a potential treatment option for individuals with severe persistent asthma.  It consists of radiofrequency energy delivered to the distal airways with the aim of decreasing smooth muscle mass believed to be associated with airway inflammation.

Asthma

Asthma, a chronic lung disease, affects approximately 8.7% of adults and 6.2% of children in the United States (U.S.). As of 2018, 14.3% of Black children under 18 in the U.S. had asthma, followed by 8% of Hispanic children, 5.6% of White children, and 3.6% of Asian children. In the U.S., the burden of asthma falls disproportionately on Black, Hispanic, and American Indian/Alaska Native individuals; these groups have the highest rates, deaths, and hospitalizations. Compared to White Americans, Black Americans are 1.5 times more likely to have asthma, and Puerto Rican Americans are almost 2 times more likely to have asthma. In 2020 and 2021, asthma exacerbations accounted for nearly 1 million emergency department visits and 3517 deaths overall, respectively. Black Americans are 5 times more likely than White Americans to visit the emergency department for asthma and 3 times more likely to die from asthma. Asthma symptoms include episodic shortness of breath that is generally associated with other symptoms such as wheezing, coughing, and chest tightness. Objective clinical features include bronchial hyperresponsiveness, airway inflammation, and reversible airflow obstruction (at least 12% improvement in forced expiratory volume in 1-second post-bronchodilator, with a minimum of 200 mL improvement). However, there is substantial heterogeneity in the inflammatory features of patients diagnosed with asthma, and this biologic diversity is responsible, at least in part, for the variable response to treatment in the asthma population.

Management

Management of asthma consists of environmental control, patient education, management of comorbidities and regular follow-up for all affected individuals, as well as a stepped approach to medication treatment. Guidelines from the National Heart, Lung and Blood Institute (NHLBI) define six pharmacologic steps: Step 1 for intermittent asthma and Steps 2 through 6 for persistent asthma.  The preferred daily medications: Step 1: short-acting beta-agonists as needed; Step 2: low-dose inhaled corticosteroids (ICS); Step 3: ICS and long-acting beta-agonists (LABA) or medium-dose ICS; Step 4: medium dose ICS and LABA; Step 5: high-dose ICS and LABA; and, Step 6: high-dose ICS and LABA, and oral corticosteroids. A focused update in 2020 addressed the use of add-on long-acting antimuscarinic agents (LAMA), immunotherapy, and bronchial thermoplasty (see Practice Guidelines and Position Statements).

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, the controlled delivery of radiofrequency energy to heat tissues in the distal airways. 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 (i.e., Steps 5 and 6 in the stepwise approach to care).

Bronchial thermoplasty procedures are performed on an outpatient basis, and each session lasts approximately one hour. During the 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°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. A course of treatment consists of three separate procedures in different regions of the lung scheduled about three weeks apart.

KEY POINTS:

The policy was created with a literature review through April 29, 2024.

Summary of Evidence

For individuals who have asthma refractory to standard treatment who receive bronchial thermoplasty added to medical management, the evidence includes 3 randomized controlld trials (RCTs) and observational studies. Relevant outcomes are symptoms, quality of life (QOL), hospitalizations, and treatment-related morbidity. Early studies (Research in Severe Asthma [RISA], Asthma Intervention Research [AIR]) investigated safety outcomes, finding similar rates of adverse events and exacerbations between the bronchial thermoplasty and control groups. These trials were limited by their lack of sham control. The AIR2 trial is the largest of the 3 published RCTs, and the only trial that is double-blind 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-designated primary efficacy outcome of mean change in the QOL score but was found to be superior on a related outcome, improvement in the QOL of at least 0.5 points on the Asthma Quality of Life Questionnaire (AQLQ) score. There was a high response rate in the sham group of the AIR2 trial, suggesting a large placebo effect, particularly for subjective outcomes such as QOL. There are limited long-term sham-controlled efficacy data. Findings on adverse events from the 3 trials have suggested that bronchial thermoplasty is associated with a relatively high rate of adverse events, including hospitalizations during the treatment period, but not in the posttreatment period. Safety data up to 10 years have been reported for patients in the AIR2 trial, with a higher rate of new cases of bronchiectasis observed in bronchial thermoplasty-treated patients. Data from a United Kingdom registry showed that 20% of bronchial thermoplasty procedures were associated with a safety event (ie, procedural complications, emergency respiratory readmissions, emergency department visits, and/or postprocedure overnight stays), with uncertain benefit. 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 short-term efficacy, the uncertain degree of treatment benefit in that single sham-controlled trial, the lack of sufficient long-term sham-controlled data in the face of a high initial placebo response, and the presence of substantial adverse events. Also, 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 that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Chest Physicians

In May 2014, the American College of Chest Physicians posted a position statement on coverage and payment for bronchial thermoplasty. The document stated in part:

"…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 clinical 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 the reduction in asthma symptoms achieved by bronchial thermoplasty for at least 5 years..."

Global Initiative for Asthma (GINA)

Global Initiative for Asthma (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 2023. The organization has recommended stepped care for treatment of asthma. Step 5 options for patients with uncontrolled symptoms and/or exacerbations include referral for phenotypic investigation and potential add-on treatment. Bronchial thermoplasty may be considered as an add-on treatment in adults with severe asthma that remains uncontrolled despite optimization of asthma therapy and referral to a severe asthma specialty center. GINA notes that bronchial thermoplasty should only be administered in the context of a systematic registry or a clinical study, as the evidence for efficacy and long-term safety is limited.

A guide for the diagnosis and management of difficult-to-treat and severe asthma was first published in 2019, the most recent updated was issued in 2023. For patients whose asthma remains uncontrolled despite GINA step 4 or 5 treatment with no evidence of type 2 inflammation (ie, medium- or high-dose inhaled corticosteroids and long-acting ß-agonists), treatment options include a trial of long-acting muscarinic agent (LAMA), low-dose azithromycin, interleukin-4 receptor antagonist (dupilumab), or anti-thymic stromal lymphoprotein (tezepelumab). Oral corticosteroids are considered as a last resort. Bronchial thermoplasty with registry enrollment may also be considered for patients who do not respond to type 2-targeted biologic therapy. The guidance notes that the evidence for the efficacy and long-term safety of bronchial thermoplasty is limited.

National Asthma Education and Prevention Program

In 2020, the National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) Expert Panel Working Group published focused updates to the National Heart, Lung, and Blood Institute's guidelines for the diagnosis and management of asthma. This update was based on prior systematic reviews of the evidence published by the Agency for Healthcare Research and Quality.

The following conditional recommendation based on low certainty evidence on the use of bronchial thermoplasty was issued:

• "In individuals ages 18 years and older with persistent asthma, the Expert Panel conditionally recommends against bronchial thermoplasty.
• Individuals ages 18 years and older with persistent asthma who place a low value on harms (short-term worsening symptoms and unknown long term side effects) and a high value on potential benefits (improvement in quality of life, a small reduction in exacerbations) might consider bronchial thermoplasty."

For patients who opt to choose this intervention via shared decision-making, the panel recommends that clinicians offer the procedure in the setting of a clinical trial or registry study to facilitate the collection of long-term outcomes.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (2018) published guidance on bronchial thermoplasty for severe asthma. The guidance stated: "Current evidence on the safety and efficacy on bronchial thermoplasty for severe asthma is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit." It was also noted that "further research should report details of patient selection and long-term safety and efficacy outcomes."

U.S Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

bronchial thermoplasty, Alair, asthma, Alair Bronchial Thermoplasty System, radiofrequency energy

APPROVED BY GOVERNING BODIES:

On April 27, 2010, Alair Bronchial Thermoplasty System (Asthmatx, Inc., Sunnyvale, Ca. now part of Boston Scientific Corporation) 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.  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 two weeks of making changes in their corticosteroid regimen.  The same area of the lung should not be treated more than once with bronchial thermoplasty.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT 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

REFERENCES:

1. A prospective observational study of biopredictors of bronchial thermoplasty response in patients with severe refractory asthma (BTR study) (NCT01185275).www.clinicaltrials.gov.
2. AIR2 extension study to demonstrate longer-term (>1 year) durability of effectiveness (PAS1) (NCT01350414).www.clinicaltrials.gov.
3. American College of Chest Physicians (ACCP). Position Statement for Coverage and Payment for Bronchial Thermoplasty. 2014. www.chestnet.org/News/CHEST-News/2014/05/Position-Statement-for-Coverage-and-Payment-for-Bronchial-Thermoplasty.
4. American College of Chest Physicians (ACCP). Position Statement for Coverage and Payment for Bronchial Thermoplasty. 2014; www.chestnet.org/News/CHEST-News/2014/05/Position-Statement-for-Coverage- and-Payment-for-Bronchial-Thermoplasty.
5. Asthma and Allergy Foundation of America. Asthma Disparities in America: A Roadmap to Reducing Burden on Racial and Ethnic Minorities. 2020. aafa.org/asthmadisparities.
6. Blue Cross Blue Shield AsssociationTechnology Evaluation Center (TEC). Bronchial thermoplasty for treatment of inadequately controlled severe asthma. TEC Assessments 2014; Volume 29, Tab 12.
7. British Thoracic Society, Scottish Intercollegiate Guidelines Network (SIGN). SIGN 141: British guideline on the management of asthma. 2014;www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2014/.
8. Bronchial thermoplasty in severe persistent asthma (PAS2) (NCT01350336).www.clinicalttrials.gov.
9. Burn J, Sims AJ, Keltie K, et al. Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics. J Asthma. Oct 2017; 54(8):872-879.
10. Castro M, Rubin A, Laviolette M et al.  Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma.  Ann Allergy Asthma Immunol 2011; 107(1):65-70.
11. Centers for Disease Control & Prevention, National Center for Health Statistics. Asthma. Updated November 2023; www.cdc.gov/nchs/fastats/asthma.htm.
12. Centers for Disease Control and Prevention. Asthma FastStats. 2017. www.cdc.gov/asthma/faststats.html.
13. Chaudhuri R, Rubin A, Sumino K, et al. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials. Lancet Respir Med. May 2021; 9(5): 457-466.
14. Chung KF, Wenzel SE, Brozek JL et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43(2):343-73.
15. Chupp G, Kline JN, Khatri SB, et al. Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study. Chest. Mar 2022; 161(3): 614-628.
16. Chupp G, Laviolette M, Cohn L, et al. Long-term outcomes of bronchial thermoplasty in subjects with severe asthma: a comparison of 3-year follow-up results from two prospective multicentre studies. Eur Respir J. Aug 2017; 50(2).
17. Cloutier MM, Baptist AP, Blake KV, et al. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. Dec 2020; 146(6): 1217-1270.
18. d'Hooghe JNS, van den Berk IAH, Annema JT, et al. Acute radiological abnormalities after bronchial thermoplasty: a prospective cohort trial. Respiration. Jul 2017; 94(3):258-262
19. Global Initiative for Asthma (GINA). A GINA Pocket Guide for Health Professionals. Difficult-to-Treat & Severe Asthma in Adolescents and Patients: Diagnosis and Management [V2.0]. April 2019; ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf.
20. Global Initiative for Asthma (GINA). Diagnosis and management of difficult-to-treat & severe asthma [V4.0]. August 2023; ginasthma.org/severeasthma/.
21. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. May 2014. www.ginasthma.org/local/uploads/files/GINA_Pocket_2014_Jun11.pdf.
22. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2017; ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/. National Heart Lung and Blood Institute National Heart Lung and Blood Institute. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma (EPR-3). 2007. www.nhlbi.nih.gov/guidelines/asthma.
23. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022; ginasthma.org/wp-content/uploads/2022/05/GINA-Main-Report-2022-FINAL-22-05-03-WMS.pdf.
24. Global Initiative for Asthma (GINA). Pocket Guide for Asthma Management and Prevention (for Adults and Children Older than 5 Years). April 2021; ginasthma.org/wp-content/uploads/2021/04/Main-Pocket-Guide-2021-FINAL-WM.pdf.
25. Global Initiative for Asthma. Asthma Management and Prevention for Adults and Children Older than 5 Years. ginasthma.org/wp-content/uploads/2019/04/GINA-2019-main-Pocket-Guide-wms.pdf.
26. Global Initiative for Asthma. Global Initiative for Asthma Management and Prevention. GINA; 2018.
27. Grant MD. Bronchial thermoplasty for treatment of inadequately controlled severe asthma. Technol Eval Cent Assess Program Exec Summ. Mar 2015; 29(12): 1-5.
28. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
29. James DR, Lyttle MD. British guideline on the management of asthma: SIGN Clinical Guideline 141, 2014. Dec 2016; 101(6):319-322.
30. Langton D, Sha J, Ing A, et al. Bronchial thermoplasty: activations predict response. Respir Res. Jul 4 2017; 18(1):134.
31. National Center for Health Statistics. Health, United States, 2019: Figure 010. 2021. www.cdc.gov/nchs/hus/contents2019.htm.
32. National Heart Lung and Blood Institute. Guidelines for the Diagnosis and Management of Asthma (EPR-3). 2012; www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma.
33. National Institute for Health and Care Excellence. Bronchial thermoplasty for severe asthma. Interventional procedures guidance [IPG635]. 2018 www.nice.org.uk/guidance/ipg635.
34. National Institute for Health and Care Excellence. Bronchial thermoplasty for severe asthma. Interventional procedures guidance [IPG635]. 2018.www.nice.org.uk/guidance/ipg635.
35. Pavord ID, Thomson NC, Niven RM et al. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol 2013; 111(5):402-407.
36. Pavord ID, Thomson NC, Niven RM, et al. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013;111(5):402-407.
37. 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.
38. Torrego A, Herth FJ, Munoz-Fernandez AM, et al. Bronchial Thermoplasty Global Registry (BTGR): 2-year results. BMJ Open. Dec 16 2021; 11(12): e053854.
39. Torrego A, Sola I, Munoz AM et al. Bronchial thermoplasty for moderate or severe persistent asthma in adults. Cochrane Database Syst Rev 2014; 3:CD009910.
40. Wechsler ME, Laviolette M, Rubin AS et al. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol 2013; 132(6):1295-1302.
41. Zhou JP, Feng Y, Wang Q, et al. Long-term efficacy and safety of bronchial thermoplasty in patients with moderate-to-severe persistent asthma: a systemic review and meta-analysis. J Asthma. Feb 2016; 53(1):94-100.

POLICY HISTORY:

Medical Policy Group, June 2010 (2)

Medical Policy Administration Committee, June 2010

Available for comment June 18-August 2, 2010

Medical Policy Panel, July 2011

Medical Policy Group, September 2011 (2):  Key Points and References updated

Medical Policy Group, November 2011 (3): Added new CPT Codes effective 1/1/2012

Medical Policy Panel, July 2012

Medical Policy Group, July 2012 (2):  Key Points and References updated.

Medical Review Committee, July 2012

Medical Policy Group, November 2012: 2013 Coding Updates – Added Codes 31660 & 31661 effective 1/1/13 and discontinued Codes 0276T & 0277T effective 1/1/13

Medical Policy Panel, July 2013

Medical Policy Group, July 2013 (2): 2013 updates to Description, Key Points and Governing Bodies information; no change in policy statement

Medical Policy Group, October 2013 (2): Removed ICD-9 Procedure codes; no change to policy statement.

Medical Policy Panel, July 2014

Medical Policy Group, July 2014 (5): Policy updated Key points Practice Guidelines and Position Statements; Added references. Policy statement unchanged.

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (2): 2015 Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, June 2016

Medical Policy Group, June 2016 (7): Updates to Key Points and References; no change to policy statement.

Medical Policy Panel, July 2017

Medical Policy Group, July 2017 (7): 2017 Updated Key Points and References. Deleted Previous Coding section from 2012. No change in Policy Statement.

Medical Policy Panel, June 2018

Medical Policy Group, July 2018 (7): 2018 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (5): Updates to Description, Key Points, and References. No change in Policy Statement.

Medical Policy Panel, June 2020

Medical Policy Goup, June 2020 (5): Updates to Description, Key Points, and References. No change in Policy Statement.

Medical Policy Panel, June 2021

Medical Policy Group, June 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, June 2022

Medical Policy Group, June 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (5): Updates to Description, Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, June 2024

Medical Policy Group, July 2024 (5): Updates to Description, Key Points; Practice Guidelines and Position Statements, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.