A comprehensive meta-analysis reveals that implementing single maintenance and reliever therapy (SMART) for patients with moderate-to-severe asthma leads to notable reductions in healthcare expenditures through enhanced clinical outcomes.
Cost Savings and Guideline Recommendations
Although major asthma management guidelines strongly endorse SMART, the combination inhalers essential for this approach lack FDA approval for dual use as both rescue and maintenance treatments. This regulatory gap has created significant hurdles for insurance reimbursement across the United States. Researchers argue that demonstrating clear economic benefits from SMART should prompt payers to revise their policies, advocating for wider inclusion on preferred drug formularies to improve access for patients.
In their detailed study published in JAMA Network Open, James G. Krings, MD, MSc, from Washington University School of Medicine in St. Louis, and his team reported that SMART therapy lowered overall annual costs associated with asthma management by $54 per patient. When factoring in the modest gain of 0.0006 quality-adjusted life-years (QALYs) per patient relative to standard therapy, the savings increased to $118 annually. The authors emphasized that, considering SMART’s proven clinical advantages alongside this positive economic profile, broadening insurance coverage emerges as a logical, data-driven method to elevate asthma control on a broader population scale.
Mechanism and Proven Benefits of SMART
SMART involves a single inhaler device that merges an inhaled corticosteroid (ICS) with the long-acting beta agonist (LABA) formoterol, enabling it to function effectively for both routine daily maintenance and immediate relief during asthma attacks. Extensive clinical evidence has shown this unified strategy significantly decreases the incidence of severe asthma exacerbations when pitted against monotherapy with either the ICS or LABA alone. For several years now, leading asthma guidelines have issued robust endorsements for SMART as a preferred treatment regimen for eligible patients.
Nevertheless, no SMART formulations have received FDA authorization for combined daily and as-needed application in cases of moderate-to-severe persistent asthma. For instance, budesonide/formoterol carries approval solely for maintenance purposes, excluding its use for acute symptom relief in asthma patients.
Insurance Barriers Hindering SMART Adoption
These approval limitations have translated into persistent challenges with insurance coverage, severely impeding the integration of SMART into everyday U.S. clinical practice. Krings and colleagues highlighted that numerous pharmacy benefit managers (PBMs) fail to list ICS-formoterol pressurized metered-dose inhalers (pMDIs)—the sole inhalers compatible with SMART—on their favored drug tiers, thereby limiting patient availability. Certain formularies restrict coverage to just one ICS-formoterol inhaler monthly, which proves inadequate for SMART protocols demanding both regular maintenance dosing and additional reliever doses as needed.
The researchers posited that uncovering these financial upsides ought to sway payer choices toward greater formulary acceptance of SMART therapies. They underscored that, despite elevated upfront medication expenses, SMART proved equivalent or even somewhat cheaper for U.S. healthcare payers in comparison to conventional asthma regimens across most evaluated scenarios.
Even relatively small boosts in SMART utilization nationwide could translate into substantial savings at the population level. As an illustration, elevating the national adoption rate of SMART from 10% to 20% could produce roughly $250 million in direct healthcare cost reductions over a five-year period, according to their projections.
Methodology of the Economic Analysis
To reach these conclusions, the investigators drew comparative effectiveness data for SMART versus traditional asthma care from a systematic review encompassing six randomized controlled trials involving a total of 11,988 participants. They integrated these findings with prevailing asthma guideline recommendations. This dataset fueled a sophisticated probabilistic decision-tree model employing Monte Carlo simulations to evaluate comprehensive asthma management expenses between the two approaches.
In 2024 U.S. dollars, the projected yearly cost for asthma care per patient on SMART amounted to $2,181, versus $2,235 for those on standard therapy. Savings varied between $17 and $138 per patient annually, contingent upon specific inhaler pricing structures, as detailed by Krings and co-authors.
In both treatment arms, inhalers accounted for approximately 80% of direct costs, averaging $1,877 per patient yearly for SMART compared to $1,738 for conventional therapy. Importantly, SMART also yielded lower annual morbidity expenses linked to asthma, at $304 per patient versus $497 for traditional care.
Simulation Results and Cost-Effectiveness
Overall, SMART emerged as less costly per patient in 57% of the model simulations excluding QALY considerations, and it demonstrated superior cost-effectiveness in 67% of runs when QALYs were incorporated. The modeled expenditures encompassed inhaler prescriptions, severe exacerbations, clinic consultations resulting in oral corticosteroid prescriptions, emergency department encounters, and hospital admissions. The team acknowledged that information on outpatient visits not leading to oral corticosteroid prescriptions was lacking and thus presumed equal across strategies.
Limitations and Future Considerations
Among the study’s constraints, the included SMART trials were predominantly conducted prior to the widespread introduction of biologic therapies for severe asthma. However, biologics are utilized in only about 2% of asthma patients, and guidelines continue to support SMART even for those on biologics. Additionally, the analysis lacked longitudinal data suitable for a Markov model, which could more accurately capture recurring exacerbations and intricate health-state shifts over time.
