Aerobika® OPEP device proves to be a cost-effective treatment option in the management of post-exacerbation COPD patients.

Plattsburgh, NY, USA — The Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device (Monaghan Medical Corporation) is a cost-effective treatment option in the management of COPD exacerbations, according to a study published October 20th in the International Journal of COPD.[1] This study, which used data from the published literature and national fee schedules to model the cost-effectiveness of the Aerobika® OPEP device, shows that it provides both clinical benefit and direct medical cost savings in a post-exacerbation care COPD population.

COPD is a major (and growing) source of morbidity, mortality and healthcare utilization, with hospitalization for acute exacerbations being the biggest cost driver.[2] Once a patient experiences an exacerbation, the risk of further exacerbation is increased two- to four-fold[3], and many patients experience two or three exacerbations every year.[4] As many as one in five patients discharged from hospital following an exacerbation are re-admitted within 30 days.[5]

The economic burden on the healthcare system associated with COPD is significant; in the US alone, the cost of COPD in 2010 was estimated to be US $50 billion; $30 billion in direct healthcare expenditure, with the remainder accounted for by indirect costs such as productivity losses and costs to families.[6] Approximately half of the direct costs could be accounted for by hospital care for COPD exacerbations,[6] which supports the GOLD guideline treatment goals of minimizing the negative impact of exacerbations and preventing recurrences.[2] Healthcare systems in many countries acknowledge the problem, and policies are now being put in place to try to address it; the US Medicare Hospital Readmission Reduction Program penalizes hospitals for excess 30-day, all-cause readmissions after a hospitalization for an acute exacerbation of COPD.[7]

The Aerobika® OPEP device is a drug-free, handheld mechanical oscillating positive expiratory pressure (OPEP) device that has been designed to address the structural and functional challenges in the airways of patients with COPD. When the patient exhales through the device, it helps to expand the airways, loosen and expel mucus from the lungs and may also enhance drug deposition. It has been shown to improve lung function, exercise capacity and quality of life in COPD patients,[8] and a recent real-word study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period.[9] Using data from the latter study to provide real-world input, the authors of this current analysis showed cost savings ($553 per patient) and improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) with the Aerobika® OPEP device compared with no OPEP/PEP use, and concluded that the device provides cost-effective treatment for post-exacerbation COPD patients.

The authors also used various scenarios to investigate the likelihood of the benefit continuing over a full year, and predicted further clinical and cost benefits (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). Author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development noted, “Our model provides evidence of clinical and cost benefits of the Aerobika® OPEP device in that critical 30-day period following an exacerbation. Given the high burden of COPD – in particular, costs relating to exacerbations – in the US population, we would expect that even a small benefit would have a significant impact on the healthcare system”. He went on to say that, although further studies would be needed to validate the long-term effectiveness, these data also give a good indication that the benefits will be sustained with long-term use.

“With the increasing pressure to improve care and reduce hospital admissions, the previously-published real-world study showing exacerbation reductions in the critical 30-day post exacerbation period gave us useful insights into the benefits of integrating the Aerobika® OPEP device into standard clinical practice”, noted Dr Jason Suggett (Group Director of Global Science and Technology, TMI). “This new analysis now gives us clear evidence that such clinical benefits would be translated into cost-effectiveness in this post-exacerbation population. In addition, new data presented at CHEST 2017 demonstrating that the generation of the proprietary pressure/oscillation pattern of the Aerobika* device efficiently generates oscillations throughout a high percentage of each exhaled breath, and with consistently high pressure amplitudes. The Aerobika* device demonstrated efficient and effective performance related to therapeutic effectiveness nearly twice that of other devices tested.”[10]

About Monaghan Medical Corporation (MMC, USA)
MMC offers leading aerosol drug delivery devices and respiratory management products including AeroEclipse® II BAN, AeroChamber Plus® aVHC and the Aerobika® device (http://www.monaghanmed.com/aerobika) exclusively in the United States. MMC’s strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. MMC focuses on developing cost-efficient, outcome-based solutions for its customers.

About the Aerobika® device
The Aerobika® OPEP device (http://www.monaghanmed.com/Aerobika-OPEP) is a hand-held, robust, easy-to-use, drug-free oscillating positive expiratory pressure (OPEP) device designed to help expel mucus from the lungs, expand airways and enhance drug deposition. When the patient exhales through the device, intermittent resistance creates a unique pressure-oscillation dynamic, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out. The Aerobika® OPEP device is designed to function independent of angle of use or flow rate, and allows for a direct aerosol pathway for patients using a nebulizer for medication delivery. The Aerobika® OPEP device has been shown to significantly improve forced vital capacity (FVC), 6-min walk distance (6MWD), and St. George’s Respiratory Questionnaire (SGRQ) score in COPD patients.[8] The Aerobika® OPEP device is available in the US via Monaghan Medical Corporation (http://www.monaghanmed.com), and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International (http://www.trudellmed.com).

About the study
A one-year Markov model was used to estimate the cost-effectiveness of the Aerobika® OPEP device in patients who had experienced an exacerbation in the previous month, or a post-exacerbation care population, with input data from the published literature and national fee schedules. Using a base-case assumption that the benefit of the Aerobika® OPEP device would last 30 days, cost-savings ($553 per patient) and improved outcomes (ie, 6 fewer exacerbations per 100 patients per year) were demonstrated when compared with no OPEP/positive expiratory pressure use. Assuming a scenario with effect beyond the conservative 30 day time frame, the Aerobika® OPEP device continued to show benefit (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). One-way sensitivity analyses were conducted for all input variables, increasing or decreasing the effect by 20%, to determine the impact of change on costs and health effects; the results supported the robustness of the base-case conclusions.

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

Words or phrases accompanied by ® are trademarks and registered trademarks of Monaghan Medical Corporation or an affiliate of Monaghan Medical Corporation. © 2017 Monaghan Medical Corporation.

1. Khoudigian S, Kowal S, Suggett J, D. C. Cost-effectiveness of the Aerobika* oscillating positive expiratory pressure device in the management of COPD exacerbations. International journal of chronic obstructive pulmonary disease. 2017;In Press.
2. Global strategy for the diagnosis, management and prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
3. Khakban A, Sin DD, FitzGerald JM, et al. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291.
4. Puhan MA, Chandra D, Mosenifar Z, et al. The minimal important difference of exercise tests in severe COPD. Eur Respir J. 2011;37(4):784-790.
5. Guerrero M, Crisafulli E, Liapikou A, et al. Readmission for Acute Exacerbation within 30 Days of Discharge Is Associated with a Subsequent Progressive Increase in Mortality Risk in COPD Patients: A Long-Term Observational Study. PLoS One. 2016;11(3):e0150737.
6. Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of chronic obstructive pulmonary disease in the USA. Clinicoecon Outcomes Res. 2013;5:235-245.
7. Shah T, Press VG, Huisingh-Scheetz M, White SR. COPD Readmissions: Addressing COPD in the Era of Value-based Health Care. Chest. 2016;150(4):916-926.
8. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
9. Burudpakdee C, Seetasith A, Dunne P, et al. A real-world study of 30-day exacerbation outcomes in chronic obstructive pulmonary disease (COPD) patient managed with Aerobika OPEP. Pulmonary Therapeutics. 2017.
10. Meyer A and Suggett J. A Laboratory Assessment into the Efficiency and Effectiveness of Different Oscillating Positive Expiratory Pressure Devices by Means of Patient Simulated Expiratory Waveforms. Presented at CHEST 2017.