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A Call for Medicaid Programs to Cover SMART for Asthma
Single Maintenance and Reliever Therapy (SMART) is the guideline-recommended treatment for moderate-to-severe asthma. It uses a single budesonide-formoterol inhaler for both daily (maintenance) and as-needed (reliever) use. Using SMART lowers the risk of severe asthma attacks by about one-third.
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Asthma facts
1 in 10 U.S. children have asthma.
26 million Americans
have asthma.
Asthma costs the
U.S. more than $80 billion annually.
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About SMART
Guideline recommended by GINA and NAEPP.
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Preferred by patients and seen as simpler to use.
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Reduces asthma attacks by 30%.
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We recommend that all payors:
Include budesonide-formoterol inhalers on their preferred drug formulary.
Cover at least two budesonide-formoterol inhalers per month to support both its maintenance and reliever use.
Ensure budesonide-formoterol inhalers are available with minimal out-of-pocket costs.
Asthma in the United States
Asthma is the second-most common chronic respiratory disease in the United States (U.S.), affecting 1 in 12 people (see state-by-state data here). It is a chronic inflammatory disease that causes wheezing, coughing, and shortness of breath due to airway narrowing and sensitivity.
Each year, about 40% of adults and children with asthma have one or more severe attacks.
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40%
Each year asthma results in…
Asthma disparities in the U.S.
Changes in guideline recommendations for SMART prescription
Guidelines now recommend Single Maintenance and Reliever Therapy (SMART) – a single-inhaler approach – to improve asthma outcomes.
Asthma guidelines have undergone a major shift. In the past, patients with persistent asthma were prescribed two separate inhalers:
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A daily maintenance inhaler with an inhaled corticosteroid (ICS)
A reliever inhaler (like albuterol, a short-acting beta-agonist or SABA) for symptoms
However, in real-world use, many patients skip their maintenance ICS inhaler and rely mostly on their SABA reliever — a pattern linked to worse asthma outcomes. Medicaid patients, in particular, have been shown to have lower ICS adherence and higher SABA use.
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To address this, researchers developed a new strategy:
This is known as SMART (or MART), and it is now guideline recommended by both:
The Global Initiative for Asthma (GINA)³
The National Asthma Education and Prevention Program (NAEPP)²
SMART improves outcomes and is preferred by patients
Strong clinical evidence shows that SMART reduces the risk of severe asthma attacks and is preferred by patients.
Across multiple clinical trials with over 22,000 participants, SMART has proven more effective than traditional asthma treatments. In a recent meta-analysis, SMART reduced the risk of severe asthma exacerbations by about one-third compared to separate maintenance and SABA inhalers (relative risk: 0.68; 95% CI: 0.58–0.80).
Patients also report that SMART is easier to use, helps them feel more in control, and simplifies daily asthma management. It offers similar day-to-day symptom control as traditional regimens — with the added convenience of using only one inhaler for both maintenance and relief.
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“I like the combined approach [MART therapy] better because I forget to take my [everyday inhaler] so much. And I don’t forget to take my rescue inhaler because my body tells me when I need it.”
–47-year-old Missouri resident with
asthma who tried MART
Guideline recommendations for SMART
Both GINA and NAEPP strongly recommend prescribing SMART for patients with moderate-to-severe asthma.
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Based on strong evidence of effectiveness and safety, the Global Initiative for Asthma (GINA) in 2019, and the National Asthma Education and Prevention Program (NAEPP) in 2020, began recommending Single Maintenance and Reliever Therapy (SMART) as a preferred treatment.
In the U.S., there are two ICS-formoterol inhalers available that align with SMART:
Budesonide-formoterol
Mometasone-formoterol
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Most clinical trials on SMART used budesonide-formoterol, making it the only inhaler explicitly recommended by both GINA and NAEPP for SMART use. Mometasone-formoterol may be a reasonable alternative, though its use in SMART is based on limited or extrapolated data is .
GINA (Global Initiative for Asthma) 2025 recommendations for the management of individuals at least 12 years old with asthma. GINA 2025, reproduced with permission. Available from www.ginasthma.org.
GINA 2025 SMART dosing recommendations
In the 2025 Global Strategy for Asthma Management and Prevention, GINA recommends SMART dosing based on age and asthma severity.
Because patients on Step 4–5 SMART therapy may use multiple inhalations daily, they can finish a 120-actuation inhaler before the end of the month. Also, both adults and children may benefit from a second inhaler stored separately for emergency use.
Therfore, we recommend that healthcare payors cover at least two budesonide-formoterol inhalers per month to support safe and effective SMART use.
Inhaler: Budesonide-formoterol 80-4.5µg
Steps 1-2: no current evidence supporting use supporting SMART in this group.
Step 3: SMART: 1 inhalation once daily plus 1 inhalation as needed.
Step 4: SMART: 1 inhalation twice daily plus 1 inhalation as needed.
Step 5: SMART: no current evidence supporting use supporting SMART in this group.
SMART in children (Ages 6 to
11 years):
SMART in adolescents & adults (Ages 12 and up):
Inhaler: Budesonide-formoterol 160-4.5µg
Steps 1–2 (anti-inflammatory reliever therapy [AIR]): 1 inhalation as needed.
Step 3:S MART: 1 inhalation once or twice daily plus 1 inhalation as needed.
Step 4: SMART: 2 inhalations twice daily plus 1 inhalation as needed.
Step 5: SMART: 2 inhalations twice daily plus 1 inhalation as needed.
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“I like the combined approach [MART therapy] better because I forget to take my [everyday inhaler] so much. And I don’t forget to take my rescue inhaler because my body tells me when I need it.”
–Anne Dixon, MA, BM, BCh
Removing barriers to SMART
Despite the strong evidence and national guidelines support, SMART is still underprescribed.
Although SMART is proven to prevent asthma attacks, most patients still do not receive it. In one study at a large academic center, fewer than 15% of patients with moderate-to-severe asthma were prescribed MART²⁷.
A major barrier identified by clinicians is that pharmacy benefit managers (PBMs) often don’t list budesonide-formoterol on preferred drug formularies, making it financially out of reach for many patients²⁸.
SMART specifically requires formoterol as the long-acting beta-agonist (LABA) due to its rapid onset, which is essential for fast symptom relief⁴. However, many PBMs don’t distinguish ICS–formoterol from other ICS–LABA inhalers that contain slower-onset LABAs — which should not be used for SMART.
For patients on higher-dose SMART (GINA Step 4–5), the recommendation is:
· 2 inhalations twice daily, plus
· 1 inhalation as needed for symptoms³
At this dosage, patients will likely run out of a 120-actuation inhaler before the end of the month. Therefore, to support proper SMART use, PBMs should cover up to two ICS–formoterol inhalers per month.
“I like the combined approach [MART therapy] better because I forget to take
my [everyday inhaler] so much. And I don’t forget to take my rescue inhaler because my body tells me when I need it.”
–GINA representative
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Is covering SMART worth it? Cost savings for U.S. healthcare payors
SMART is more cost-effective than traditional inhaler therapy because it helps prevent expensive asthma-related complications.
SMART is more cost-effective than traditional inhaler therapy because it helps prevent expensive asthma-related complications.
A recent analysis found that if patients were prescribed SMART instead of traditional inhalers, U.S. healthcare payors would save money overall³⁰.
Annual savings to payors ranged from $17 to $138 per patient, even after accounting for slightly higher medication costs with SMART.
While SMART may require more frequent inhaler refills, these costs are offset by fewer emergency visits and hospitalizations due to better asthma control.
These analyses calculated one-year direct medical cost savings to payors, but did not include indirect costs like:
· Missed work or school
· Lost productivity
· Early mortality
When these broader factors are considered, SMART is likely even more cost-saving³¹, as it helps patients experience fewer severe asthma attacks and maintain daily functioning.
At an inhaler cost of $187, SMART saved money in 57% of simulations by reducing asthma-related complications.
Estimate how often SMART is cost-saving at different inhaler prices.
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Coverage of SMART within Medicaid by state in 2024
A case study in MART utilization
Missouri Medicaid Expands SMART Access: A Case Study in SMART Policy Implementation
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MO HealthNet, Missouri’s Medicaid program, now preferentially covers budesonide-formoterol for SMART in asthma patients. The goal is to increase the use of guideline-recommended asthma controllers³².
As part of this effort, MO HealthNet:
• Released a provider flyer promoting budesonide-formoterol and mometasone-formoterol as preferred therapies for maintenance and reliever use, without prior authorization.
• Covered up to three inhalers per month to ensure patients enough medication for SMART dosing.
• Issued a clinical update targeting SABA overuse, limiting SABA coverage without prior authorization to three inhalers every six months for adults.
What happens if SMART is covered in your state?
Reduced asthma-related illness and healthcare use:
· Multiple clinical trials show SMART reduces the risk of experiencing asthma exacerbations requiring systemic corticosteroids, ER visits, and hospitalizations.
Alignment with national asthma guidelines:
· Both GINA and the NAEPP strongly recommend SMART as the preferred therapy for patients with moderate-to-severe asthma.
Simplified inhaler use for patients:
· Patients prefer SMART because it is easier to manage a single inhaler for daily control and symptom relief.
· Budesonide-formoterol works with a spacer device.
Potential cost savings for Medicaid and health programs:
· Recent analyses show SMART generally lowers costs for healthcare payors by preventing expensive emergency or inpatient asthma care.
What we recommend in your state to improve asthma care
o Studies show that high inhaler costs limit access33, worsen asthma outcomes33, and drivehealthcare disparities34.
o We recommend minimizing patient cos-sharing for SMART whenever possible.
Reduce out-of-pocket costs for patients:
SMART uses the same inhaler for daily maintenance and as-needed relief, so patients often need more than one per monthly.
Therefore, we recommend all payors cover at least two budesonide-formoterol inhalers per month to support proper SMART use.
Cover at least 2 budesonide-formoterol inhalers each month:
SMART requires formoterol as the LABA due to its rapid onset for quick symptom relief.
We recommend that all states place budesonide-formoterol on their preferred drug list.
Prioritize coverage of budesonide-formoterol
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Support education for providers and patients
Additional Policy Options to Consider:
Despite guideline-recommendations, SMART remains unfamiliar to many providers and patients.
State-led education efforts can increase SMART awareness and improve outcomes.
Monitor and manage high albuterol use:
Administrative burdens like prior authorizations delay care.
When possible, reduce of eliminate barriers to SMART access.
Streamline prior authorization processes:
Frequent albuterol use is linked to bad asthma outcomes.
Consider refill limits or point-of-dispense alerts to encourage provider-patient conversations about albuterol overuse and switching to SMART.
(See p. 13 for MO HealthNet example).
About the team
We are a multidisciplinary team united in our goal of advocating for better access to evidence-based, guideline-recommended asthma care that can improve the health of asthma patients. By leveraging diverse expertise across pulmonary medicine, primary care, pediatrics, public health, pharmacy, policy research, and health communication, we aim to reduce disparities and improve asthma outcomes. Our members include:
Kaharu Sumino, MD, MPH Professor of medicine at Washington University School of Medicine
Krutika Chauhan, MBBS, MPH, CPH
Research supervisor
of "A Collaboration with Community Health Center to Implement SMART for Asthma" (CHEST) Study
Mario Castro, MD, MPH
Division chief of pulmonary, critical care and sleep medicine at the University of Kansas Medical Center
Lynn Gerald, PhD, MSPH
Assistant vice chancellor for population health sciences
at the University of Illinois Chicago School of Medicine
Anna Volerman, MD, MPH
Associate professor of medicine and pediatrics at the University of Chicago School of Medicine
Anne Dixon, MA, BM, BCh Professor of medicine at University of Vermont School of Medicine, chairwoman of medicine of the Vermont Lung Center
James Krings, MD, MSc
Assistant professor of medicine in pulmonary and critical care at Washington University School of Medicine
Asthma management
Chinmay Joshi
Health policy research assistant
Tri Pham, MD
Medicine resident at Washington University School of Medicine
Mark Huffman, MD MPH
William Bowen endowed professor of medicine,
co-director of the Global Health Center at Washington University in St. Louis
Sarah Eisenstein, PhD
Statistical analyst at Washington University in St. Louis
Joshua Moore, PharmD
Pharmacy director at MO HealthNet division (Missouri Medicaid).
Timothy McBride, PhD, MS
Becker professor, co-director of "Center for Advancing Health Services, Policy
& Economics Research" (CAHSPER) at Washington University in St. Louis
Abigail Barker, PhD
Research-associate professor associate director of policy partnerships at CAHSPER at Washington University in
St. Louis
Ross Brownson, PhD
Lipstein distinguished professor, director of the Prevention Research Center at Washington University School of Public Health
Health economics and policy
Khadijah Kareem, BA
Design researcher at HCDS at the Sam Fox School of Design & Visual Arts
Nicole Chen, BA
Design researcher at HCDS at the Sam Fox School of Design & Visual Arts
Hannah Kim, BFA
Graphic designer, illustrator at HCDS at the Sam Fox School of Design &
Visual Arts
Christine Watridge, BA
Program coordinator of HCDS at the Sam Fox School of Design &
Visual Arts
Penina Laker, MFA
Director of the Health Communication Design Studio (HCDS), associate professor of design at Washington University in St. Louis
Health communication design
References ↓
"I like the combined approach [MART therapy] better because I forget to take my [everyday inhaler] so much. And I don't forget to take my rescue inhaler because my body tells me when I need it."
-47-year-old St. Louis resident with asthma who tried MART
This policy brief was made possible through a grant from the American Lung Association (ALA).