Why Medicaid Programs in the United States Should Cover Guideline-Recommended Maintenance and Reliever Therapy for Asthma
Single Maintenance and Reliever Therapy (SMART) is a guideline-recommended, high-value treatment for asthma that reduces preventable exacerbations and downstream health care utilization.¹⁻⁴ SMART uses a single budesonide-formoterol inhaler for both daily maintenance and as-needed symptom relief,² simplifying therapy while ensuring anti-inflammatory treatment at times of highest risk.
Compared with traditional asthma therapy, SMART reduces severe asthma exacerbations by approximately 30–40%,³ with associated reductions in emergency department visits, hospitalizations, and systemic corticosteroid exposure.
Despite strong evidence and national guideline endorsement, SMART remains underutilized in Medicaid populations, in part due to formulary placement and quantity.⁵
Asthma facts⁶
1 in 12 U.S. children have asthma.
Approximately 28.2 million Americans have asthma.
Asthma accounts for more than $80 billion annually in U.S. healthcare costs.
About SMART
Strongly recommended by both GINA and NAEPP asthma guidelines.⁷⁻⁹
Preferred by many patients due to regimen simplicity.¹⁰
Reduces asthma attacks by ~30-40% compared with traditional therapy.¹¹
We recommend that Medicaid payors:
Include budesonide–formoterol inhalers on their preferred drug formulary (PDL).
Allow sufficient quantities (e.g., ≥2 budesonide–formoterol per month) to support to support both its maintenance and reliever use.
Minimize or eliminate prior authorization and step-therapy requirements for SMART-eligible patients.
Why Asthma Matters for Medicaid
Asthma is a common, costly chronic disease in the United States, affecting approximately 1 in 12 people.¹² It is characterized by chronic airway inflammation and recurrent episodes of wheezing, coughing, and shortness of breath.
Each year, about 40% of adults and children with asthma have one or more severe attacks.
Why Asthma Guidelines Changed
The Problem with Traditional Therapy
Historically patients with asthma were prescribed:
A daily maintenance inhaled corticosteroid (ICS) maintenance inhaler, and
A short-acting beta-agonist reliever inhaler (e.g., albuterol)¹⁷
In real-world use, many patients underuse their daily ICS and over-rely on SABAs, a pattern associated with increased exacerbations, emergency department visits, and hospitalizations.²⁰⁻²² This pattern is especially pronounced in Medicaid populations, where ICS adherence is lower and SABA use is higher.²⁰˒²²
Current Guideline Position
SMART is now recommended by:
The Global Initiative for Asthma (GINA)⁷
The Veterans Affairs / Department of Defense.²³
The National Asthma Education and Prevention Program (NAEPP)⁹
SMART Improves Outcomes
SMART consistently reduces severe asthma exacerbations and improves real-world medication use.SMART consistently reduces severe asthma exacerbations and improves real-world medication use.
Across randomized trials enrolling > 22,000 participants, SMART reduced the risk of severe asthma exacerbations by approximately 30–40% compared with traditional maintenance inhaler plus SABA regimens.²⁴⁻²⁶
These reductions translate directly into fewer emergency department visits, hospitalizations, and courses of systemic corticosteroids—key drivers of asthma-related costs in Medicaid populations.
SMART achieves these benefits without sacrificing day-to-day symptom control, while simplifying treatment by using a single inhaler for both maintenance and symptom relief.¹
Patient Preference for SMART
Patients consistently report that SMART is:
Easier to use
Simpler to remember
Better aligned with how they think inhalers should be used.
–47-year-old Missouri resident with asthma who tried MART
Guideline Recommendations for SMART
Both U.S. and international guidelines strongly recommend SMART for patients with moderate-to-severe asthma.⁷˒⁹
Inhalers Congruent with SMART and Supported by Guidelines
Budesonide-formoterol
Mometasone-formoterol²
Budesonide–formoterol is the only inhaler explicitly recommended by both GINA and NAEPP for SMART, as it was used in the majority of randomized clinical trials.
Mometasone–formoterol may be a reasonable alternative, but evidence supporting its use for SMART is more limited and largely extrapolated.
Implications for Medicaid Pharmacy Policy
Formulary policies should prioritize budesonide–formoterol for SMART use.
Restrictive policies that limit access to budesonide–formoterol may conflict with current guideline recommendations.
GINA 2025 recommends recommends ICS–formoterol–based therapy as preferred treatment for adolescents and adults with moderate-to-severe asthma. Source: Global Initiative for Asthma (GINA), 2025. Reproduced with permission. Available from www.ginasthma.org.
SMART Dosing: Implications for Medicaid Coverage
Key Coverage-Relevant Points
SMART uses the same inhaler for both daily maintenance and symptom relief.
Patients may require multiple inhalations per day of an inhaler that they are using for maintenance and symptom relief.
Therefore, a single 120-actuation inhaler may be insufficient to last a full month, even when used appropriately.
Guidelines support having an additional inhaler available (e.g., for school, work, or emergency use).
Policy Implication
Monthly quantity limits of one budesonide-formoterol inhaler are designed for traditional “maintenance-only” use inhalers and are not aligned with SMART use.
Restrictive limits may result in:
Premature inhaler exhaustion
Interrupted controller therapy
Increased reliance on emergency care
Recommendation for Medicaid Pharmacy Programs
Cover at least two budesonide–formoterol inhalers per month for patients prescribed SMART.
“SMART aligns anti-inflammatory therapy with how patients actually use inhalers. From a clinical perspective, it reduces preventable exacerbations.”
–Anne Dixon, MA, BM, BCh
Removing Policy Barriers to SMART
Despite strong evidence and guideline support, SMART remains substantially underused.
In real-world practice, fewer than 15% of patients with moderate-to-severe asthma receive SMART.³
Key Barriers Relevant to Medicaid Pharmacy Policy
Non-preferred formulary placement: Budesonide–formoterol is often not listed on preferred drug formularies, resulting in higher cost-sharing or access barriers that limit uptake.
Lack of distinction between ICS–formoterol and other ICS–LABA inhalers:
SMART specifically requires formoterol due to its rapid onset of action. Inhalers containing slower-onset LABAs are not appropriate for SMART, yet are often treated interchangeably in formulary design.
Quantity limits misaligned with guideline-based dosing
For patients requiring higher-intensity SMART, recommended use includes:
Scheduled daily dosing, plus
Additional inhalations as needed for symptom relief⁶
At these doses, a single 120-actuation inhaler may not last a full month, even when used appropriately.
Policy Implications
Ensuring formulary placement, product differentiation, and appropriate quantity limits are modifiable ways to improve SMART uptake.
Aligning these policies with guidelines can improve access while reducing preventable emergency department visits and hospitalizations.
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 patients.²⁷
SMART specifically requires formoterol as the long-acting beta-agonist (LABA) due to its rapid onset, which is essential for fast symptom relief. 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.²⁸
For patients on higher-dose SMART (GINA Step 4–5), the recommendation is:
2 inhalations twice daily, plus
1 inhalation as needed for symptoms⁷
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.
–Anna Volerman, MD, MPH, pediatrician at the University of Chicago School of Medicine
Is Covering SMART Worth It? Budget Impact for U.S. Payers
Yes! Evidence indicates that covering SMART is cost-saving or cost-neutral for U.S. healthcare payers, including Medicaid.
Although SMART may increase pharmacy spending modestly due to higher inhaler use, these costs are more than offset by reductions in asthma-related emergency department visits and hospitalizations.
What the Economic Evidence Shows
A recent U.S.-based economic analysis found that:
Annual net savings ranged from $17 to $138 per patient, depending on inhaler price and baseline exacerbation risk
Savings persisted even after accounting for higher medication costs with SMART
Reduced acute care utilization was the primary driver of savings, not changes in routine outpatient care
These estimates reflect one-year direct medical costs borne by payers including Medicaid.
What These Estimates Do Not Include
The analysis did not account for additional downstream benefits, such as:
Missed work or school days
Caregiver burden
Lost productivity
Long-term morbidity or premature mortality
Including these factors would likely increase the estimated value of SMART, particularly in high-risk Medicaid populations.
Bottom Line for Medicaid Programs
SMART shifts spending from high-cost, unplanned care to predictable pharmacy costs.
For Medicaid programs facing high rates of asthma-related emergency care, SMART represents a high-value coverage strategy rather than just a pharmacy cost increase.
Interactive tool: Estimate how SMART coverage affects budget impact across different inhaler prices and exacerbation rates.
At an inhaler cost of $187, SMART saved money in 57% of scernarios driven primarily by a reduction asthma-related emergency visits and hospitalizations..
Medicaid Coverage of SMART by State (2024)
State Medicaid programs vary widely in how they cover SMART therapy, particularly with respect to formulary status, prior authorization, quantity limits, and patient cost-sharing.
Key Coverage Dimensions Assessed
Coverage without quantity limits
Coverage without prior authorization
Coverage without patient copayments
Variation in these policies directly affects access to guideline-recommended asthma care and influences downstream emergency department and hospitalization rates.
(State-by-state maps below illustrate current variation in Medicaid SMART coverage. Data current as of 2024.)
What Happens When SMART Is Covered?
Missouri Medicaid (MO HealthNet) expanded access to SMART by aligning pharmacy policy with national asthma guidelines.
The goal was to increase use of effective controller therapy while reducing preventable acute care utilization.
Key Policy Actions
MO HealthNet:
Designated budesonide–formoterol (and mometasone–formoterol) as preferred therapies for SMART, without prior authorization⁹
Covered up to three inhalers per month to support guideline-based SMART dosing⁹
Implemented targeted limits on SABA overuse, restricting coverage to three SABA inhalers every six months for adults without prior authorization⁹
QUOTE FROM JOSH
What Happens when SMART is Covered
When Medicaid programs align coverage with SMART guidelines, multiple benefits could follow:
Reduced acute-care utilization
SMART lowers the risk of severe asthma exacerbations, leading to fewer emergency department visits, hospitalizations, and courses of systemic corticosteroids.
Alignment with standard of care
Coverage policies reflect current GINA and NAEPP recommendations for moderate-to-severe asthma.
Simplified treatment for patients
A single inhaler for both maintenance and relief improves patient satisfaction.
Lower total cost of care
Although pharmacy spending may increase modestly, reductions in emergency and inpatient care typically offset these costs, resulting in net savings or cost neutrality for payers.
Policy Recommendations for Medicaid Programs
To improve asthma outcomes and reduce preventable utilization, we recommend the following actions:
Core Recommendations
Place budesonide–formoterol on your Preferred Drug List
SMART requires formoterol due to its rapid onset for quick symptom relief.
Other ICS–LABA products are not appropriate substitutes for SMART.
Allow coverage of ≥2 budesonide–formoterol inhalers per month
SMART uses the same inhaler for daily maintenance and symptom relief.
Monthly quantity limits designed for maintenance-only inhalers do not align with SMART dosing.
Minimize patient cost-sharing for SMART
Higher inhaler costs are associated with reduced access, worse asthma control, and increased disparities.²⁹˒³⁰
Lower cost-sharing supports adherence and reduces reliance on emergency care.
Contact us at:
Dr. James Krings, kringsj@wustl.edu
Krutika Chauhan, c.krutika@wustl.edu
"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 supported by a Public Health Policy grant from the American Lung Association (ALA). The views expressed are those of the authors and do not necessarily reflect those of the ALA.
We thank Ted Floros, Adjunct Professor at Washington Univeristy in St. Louis, and his students Biruk Denma and Kaleb Urga for their contributions to data visualizations.