Table 3.

Potential Real-world Barriers to the Implementation of Reliever Inhaled Corticosteroid–Formoterol Usage in the United States and Need for Future Research and Action

Potential Barrier to Implementation of Reliever ICS–Formoterol Inhalers in the United States	Explanation of Potential Barriers and Knowledge Gaps	Future Work Needed
Provider knowledge	• At least 60% of chronic asthma care occurs in primary care settings. • Specialist and primary care clinician knowledge of the logistics of a reliever-only ICS-formoterol approach and SMART is largely unknown.	• Better understanding of successful knowledge dissemination strategies in primary care and specialty settings.
Discordance between guidelines	• Important differences exist between the GINA and NAEPP recommendations. • The role this discordance plays in a provider’s decision to use ICS–formoterol inhalers on a reliever-only basis is unclear.	• Dissemination of GINA and NAEPP recommendations. • Expeditious update to NAEPP 2020 update that includes management recommendations at steps one and six. • Consider a more dynamic way to continuously update guidelines, given the increasing rate that evidence emerges.
Medico–legal and regulatory issues	• Clinical trials of new inhaler approach are primarily on the basis of dry-powder budesonide–formoterol (not available in the United States). • FDA-labeling of budesonide–formoterol does not include its use as a reliever inhaler.	• Explore the extent to which these factors influence clinician decision-making. • Encourage FDA approval of budesonide–formoterol for reliever use.
Pharmaceutical coverage concerns and cost	• Pharmacy benefits and formulary practices may preferentially cover ICS–LABA inhalers that do not include formoterol and cannot be used as a reliever device and with SMART. • Annual formulary changes may promote the substitution of formoterol-containing ICS–LABAs for non–formoterol-containing combinations.	• Comparative cost-effectiveness analyses of reliever ICS–formoterol therapy and SMART therapy as compared with traditional management. • Advocate for classifying rapid-onset and non–rapid-onset LABAs into separate pharmacological categories.
Patient preference for reliever nebulizers*	• Real-world usage of nebulizers for symptom relief is common in asthma. In patients who prefer nebulizers, instructions on how to or if we should use new inhaler approaches are not clear.	• Clarify what recommendations should be made to patients who prefer nebulizers when using the latest asthma recommendations/guidelines.
Integration into asthma action plans	• The use of asthma action plans is recommended. Historically, asthma action plans have not incorporated reliever ICS–formoterol usage or SMART.	• Develop, test, and disseminate model asthma action plans that use reliever-only ICS–formoterol and SMART.
Lack of incentives to move toward SMART	• Health systems and payers may not recognize the opportunity to reduce rates of severe asthma exacerbations with SMART.	• Study the effects of health plan or health system interventions to promote the uptake of SMART. • Examine the effects of SMART usage on preventable emergency care, hospitalization, and costs of asthma care on a system level.

Definition of abbreviations: FDA = U.S. Food and Drug Administration; GINA = Global Initiative for Asthma; ICS = inhaled corticosteroid; LABA = long-acting β₂ agonist; NAEPP = National Asthma Education and Prevention Program; SMART = Single Maintenance and Reliever Therapy.

^*We do not promote nebulizer usage of reliever asthma medications over inhaler usage as some studies have shown that nebulizers are associated with a higher risk of asthma morbidity (143). However, we do recognize that many real-world patients prefer nebulizers (68, 144). As such, in patients who clearly prefer nebulizer usage and in whom a provider is considering SMART or reliever-only ICS–formoterol therapy, optimal patient instructions should be explored and clarified.