Bronchial Thermoplasty (BT) Position Statements And Guidelines

Society Position Statements

American College of Asthma, Allergy and Immunology (ACAAI), May 2015

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 bronchial thermoplasty for those adult patients who meet the stringent requirements.1

INTERASMA (Global Asthma Association), October 2014

BT is an innovative concept for the treatment of severe asthma that is opening a new avenue in the management of patients with uncontrolled refractory symptoms. BT can offer an excellent alternative as an add-on therapy in severe asthma patients carefully selected. In this context, BT should not be considered "experimental". On the contrary, it should be considered an important option for patients suffering this condition and should be covered and paid by the social security system and/or private insurances to facilitate the accessibility to this treatment for this special group of patients.2

American College of Chest Physicians (CHEST), May 2014

Bronchial thermoplasty offers treatment for patients with severe asthma who continue to be symptomatic despite maximal medical treatment. We believe the literature supports bronchial thermoplasty as a therapeutic option for patients with severe asthma. Therefore, we recommend that all public and private insurers provide coverage and payment for bronchial thermoplasty for those adult patients with severe persistent, poorly-controlled asthma who continue to experience asthma exacerbations, emergency department visits and hospitalizations despite maximal medical treatment.3

Inclusion of BT in Guidelines & Asthma Management Strategy Statements

Post publication of 5 Year data from AIR2 Trial

Global Initiative for Asthma (GINA), May 2014 & 2015

BT now included as an option in Step 5 as add-on therapy for patients with severe asthma still symptomatic despite ICS and LABA4

Spanish Guideline on the Management of Asthma (GEMA), May 2015

BT may be considered for treatment of adult patients with severe asthma at Step 6 of their management guidelines5

Associazione Italiana Pneumologi Ospedalieri (AIPO), January 2015

Bronchial thermoplasty is a non-pharmacological procedure carried out by bronchoscopy which – by delivering radio frequencies on the bronchial walls – aims at reducing the smooth muscles of the breathing tract and is proposed as a therapeutical instrument for acute bronchial asthma in adults which is not controlled by the best medical therapy. Randomised controlled clinical studies have proven the safety and efficacy of bronchial thermoplasty in the short and long term, with persistent benefits for at least five years. In a majority of patients, bronchial themoplasty has caused better control of asthma and an improvement in the quality of life, since they are able to obtain a significant reduction of acute exacerbations, of visits to the emergency room for worsening, use of medications when required. This study specifies the recommendations for such treatment, lays down criteria for choosing patients and describes how the procedure is carried out.

Supplements available online provide a form for informed consent (which may be used for bronchial thermoplasty candidate patients) and an economic evaluation of the treatment.6

British Thoracic Society (BTS), October 2014

Bronchial thermoplasty treatment has been shown to reduce the frequency of severe asthma attacks, emergency department visits and days lost from school or work in the year after treatment. Emergency department visits, but not severe asthma attacks, are reduced in the period from first treatment to one year post-treatment. The reduction in the frequency of asthma attacks and emergency department visits may persist for up to five years after treatment.7, 13

Prior to publication of 5 year data from AIR2 Trial

American Thoracic Society (ATS)/European Respiratory Society (ERS) Guidelines on Severe Asthma, May 2013

"We recommend that bronchial thermoplasty is performed in adults with severe asthma only in the context of an Institutional Review Board-approved independent systematic registry or a clinical study"8

Wechsler and Cox rebuttal & Chung et al. response, July 2014

"We do not believe that this recommendation should limit access to bronchial thermoplasty."9,10

Patient Advocacy Position Statements

Allergy & Asthma Network (AAN), June 2015

Patients with severe asthma often struggle to achieve a normal quality of life, with few treatment options. Scientific literature supports the Bronchial Thermoplasty Alair System as an effective therapy for some of these patients. Allergy & Asthma Network believes patients have the right to receive this therapy when their physician determines it is appropriate, and we urge health insurance payers to offer coverage.

The Network recommends that all public and private insurers provide coverage and payment for Bronchial Thermoplasty for patients with severe persistent, poorly controlled asthma who continue to experience asthma exacerbations, emergency department visits and hospitalizations despite the best medical treatment.11

Asthma & Allergy Foundation of America (AAFA), 2009

At the 2009 FDA Panel meeting to consider approval of BT, AAFA urged approval of BT by the FDA. Now, AAFA urges that health plans and insurance carriers fully cover the costs of this procedure for those whose severe asthma is not well managed by less invasive therapies and whose physicians deem it appropriate. We would hate to see patients denied this treatment option, who cannot get their asthma wellcontrolled with conventional therapy alone and who are fully insured.12


The Alair™ Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long-acting beta-agonists.

As with any procedure, there are risks, and individual results may vary. The most common adverse event of BT is a temporary worsening of respiratory-related symptoms. These events typically occur within one day of the BT procedure and usually resolve within a week with standard care. There is a small risk (3.4% per procedure) that symptoms may require hospitalization.1

References

  1. American College of Asthma, Allergy and Immunology (ACAAI). Statement On Bronchial Thermoplasty. May 2015.
  2. INTERASMA (Global Asthma Association). Bronchial Thermoplasty: An Additional Option for Managing Patients with Severe Asthma. October 2014
  3. CHEST American College of Chest Physicians. Position Statement for Coverage and Payment for Bronchial Thermoplasty. May 12, 2014
  4. From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015. May 19, 2015
  5. GEMA4.0. Guía española para el manejo del asma © 2015, Comité Ejecutivo de la GEMA. Todos los derechos reservados ISBN: 978-84-7989-840-3. Depósito legal: M-13523-2015.
  6. Associazione Italiana Pneumologi Ospedalieri (AIPO). Rassegna di Patologia dell'Apparato Respiratorio - fascicolo 1/2015.
  7. British Thoracic Society (BTS). British guideline on the management of asthma. October 2014.
  8. Kian Fan Chung et al: International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–373 | DOI: 10.1183/09031936.00202013
  9. Wechsler ME and Cox GP. Letter to Editor. Eur Respir J 2014; 44: 267 | DOI: 10.1183/09031936.00043514
  10. Kian Fan Chung, Sally E. Wenzel and Jan L. Brozek for the ERS/ATS Task Force on Definition, Evaluation and Treatment of Severe Asthma. Response to Letter to Editor. Eur Respir J 2014; 44: 267–268 | DOI: 10.1183/09031936.00064614
  11. Allergy & Asthma Network (AAN). Bronchial Thermoplasty. June 2015
  12. Asthma Allergy Foundation of America (AAFA). Patient Advocacy Support for Full Medical Coverage for Bronchial Thermoplasty (BT) to Treat Severe Asthma. 2012
  13. In the U.S., the Alair™ Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).
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