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Bronchial Thermoplasty Summary

Bronchial Thermoplasty Summary - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Respiratory, Related


References:
1. Cox G, Miller JD, McWilliams A, Fitzgerald JM, Lam S. Bronchial thermoplasty for asthma. Am J Respir Crit Care Med. 2006;173(9):965-969.
2. ECRI. Bronchial Thermoplasty for Treating Adult Patients with Severe Persistent Asthma. 2013.
3.Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2015. Available from: www.ginasthma.org
4. 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):116-124.
5. 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.e1293.
Bronchial Thermoplasty Summary for Primary Care Providers
Overview: Bronchial Thermoplasty (BT) is an innovative procedure for the treatment of severe
persistent asthma. This procedure is performed in an outpatient setting under moderate sedation, and
is accomplished in three separate bronchoscopic sessions scheduled approximately 3 weeks apart. In
the first procedure, airways under direct vision and reachable by the bronchoscope in the right lower
lobe are treated. During the second procedure, targeted airways in the left lower lobe are treated, and
in the third and final procedure, targeted airways in both upper lobes are treated.1-2
Target Population: A potential treatment option for highly-selected patients aged 18 years and older
with uncontrolled asthma, despite use of recommended therapeutic regimens and referral to an asthma
specialist (Step 5).3 (GINA Evidence B)
Technology Assessment Review: Alair™ BT has been reviewed multiple times by the UW Health
Technology Assessment Committee since 2010. In that time, the reimbursement picture has become
clearer and the long term clinical and safety benefits have been maintained. In January 2015, the
committee recommended adoption of Alair Thermoplasty for use at UW Health.* Insurance prior
authorization was suggested and once in use, the program’s performance will be reviewed after one
year (or 12 patients).
Outcomes: Bronchial thermoplasty has been studied in four clinical studies in patients with asthma;
three of which were randomized controlled clinical trials and the results for which have been published
in peer-reviewed journals. Most notably, published data from the Asthma Intervention Research 2
(AIR2) clinical trial demonstrates that bronchial thermoplasty continues to show benefits in adult
patients with severe uncontrolled asthma out to at least five years.4 Bronchial thermoplasty was shown
to provide long term asthma control, demonstrated by a sustained reduction in the rate of severe
exacerbations (asthma attacks) and emergency room (ER) visits over a five year period after
treatment.5
Risk assessment: The most common side effect found in the clinical studies was an expected
transient increase in the frequency and worsening of respiratory-related symptoms, including asthma
(multiple symptoms), respiratory tract infections, wheezing, dyspnea, and chest pain.
Long-term follow-up out to 5 years has been completed in 4 studies: the safety profile for the BT treated
patients has demonstrated consistency over time based on the percent of subjects reporting respiratory
adverse events, the number of respiratory adverse events per subject, and the number of
hospitalizations and emergency room visits due to respiratory symptoms per subject.
Pre-Approval Needs: While non-coverage policies exist, there is a need to request pre-approval to the
insurer by submitting documentation that supports a severe asthma diagnosis. This documentation is
inclusive of differentiating other respiratory-related disorders (i.e., COPD, bronchiectasis, vocal cord
dysfunction, obstructive sleep apnea), management of comorbidities (i.e., allergic rhinitis, sinusitis,
GERD), and observations of compliance and/or attempts to manage their asthma with current standard
medications (i.e., minimum of ICS+LABA) over at least a 3 month period yet still demonstrating
evidence of exacerbations, activity limitation and/or risk of future exacerbations. As coverage policies
get implemented, a shorter, more specific pre-authorization form may be required.
Last reviewed/revised: 07/2015 | Contact CCKM for revisions.
Asthma – Pediatric/Adult – Inpatient/Ambulatory Clinical Practice Guideline
* Note: Acquisition of the technology is considered separately in the capital budgeting process.
Copyright © 2015 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 07/2015CCKM@uwhealth.org