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.
No comments:
Post a Comment