Authors' objectives: To determine whether relevant evidence demonstrates that BT improves the net health outcome — including asthma control, exacerbations, quality of life, medication use, lung function, and adverse events — in patients with inadequately controlled severe persistent asthma compared with best medical care.

Authors' recommendations: There is a sizeable population with severe persistent asthma that could be considered for BT. Evidence from the 3 trials of BT applicable to individuals with severe persistent and inadequately controlled asthma—a single trial incorporated a sham control—is accompanied by uncertainty concerning the net health outcome. For FDA approval, superiority with respect to the primary outcomes (albeit changed in AIR2) must be considered together with safety. To judge impact on the net health outcome requires considering a set of informative health outcomes, including asthma control and exacerbations, QOL, ICS and LABA use, and lung function (primarily for safety). The substantial response observed following a sham procedure in AIR2 emphasizes the necessity of a sham control to estimate treatment effects. Although a number of outcomes in the AIR2 trial favored BT, others did not, and for those that did effect magnitudes could be interpreted as modest. BT is accompanied by a risk of adverse events during the treatment phase that may require hospitalization — a tradeoff for potential future benefit. Although under conditions of controlled trials and careful patient selection, the morbidity from adverse events was not described as concerning, adoption outside those settings where patient selection may be less strict and providers less experienced with the device could be accompanied by a different adverse event profile. There is very little published evidence obtained outside the investigational setting on potential harms and benefit.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.bcbs.com/blueresources/tec/vols/29/29_12.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)