Medication Cost-Savings and Utilization of Generic Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) Drug Products in the USA.

BACKGROUND: In the USA, drug costs associated with the inhaled corticosteroid (ICS) and long acting ß agonist (LABA) combination products have been increasing since 2001. In January 2019, the first generic ICS/LABA drug product was approved by the U.S. Food and Drug Administration. METHODS: We investigated retrospectively the effects of the first approved generic ICS/LABA drug from 2019 to 2020 on the wholesale cost-savings and prescription dispensing using the IQVIA data system in the USA. RESULTS: The marketing of the first generic for fluticasone propionate and salmeterol xinafoate dry powder inhaler was associated with $941 million in drug cost-savings during the first year for this class of medications. Although the brand-name drug manufacturer concurrently introduced its authorized generic, these cost-savings were driven by the averaged unit cost of the approved generic at $115, compared to $169 for the authorized generic and $334 for the branded product. Generic initiation and substitution with the first generic were, respectively, higher compared to those with authorized generics; however, overall dispensing of the first generic was lower than that of its branded product. As in the case of budesonide and formoterol fumarate dry powder inhaler, marketing of authorized generics alone was not associated with any noticeable change in sales or prescription cost-saving. CONCLUSION: We estimated that more than 20% of prescription cost-saving was achieved for the ICS/LABA dry powder inhalers in the first year following the introduction of the first approved generic, even though generic utilization remained lower than that of the branded counterpart.

Indoor Environmental Interventions for Furry Pet Allergens, Pest Allergens, and Mold: Looking to the Future.

Over the last 2 to 3 decades, significant advances have been made in understanding the role that indoor allergen exposures play with regard to respiratory health. Multiple studies have confirmed that sensitization and exposure to indoor allergens can be a risk factor for asthma morbidity. Environmental interventions targeting key indoor allergens have been evaluated with the aims of examining their causal effects on asthma-related outcomes and identifying clinically efficacious interventions to incorporate into treatment recommendations. Historically, it appeared that the most successful intervention, as performed in the Inner-City Asthma Study, was individually tailored, targeting multiple allergens in a predominantly low-income, minority, and urban pediatric population. Recent studies suggest that single-allergen interventions may be efficacious when targeting the most clinically relevant allergen for a population. In this article, we review recent literature on home environmental interventions and their effects on specific indoor allergen levels and asthma-related outcomes.

Atopy as a Modifier of the Relationships Between Endotoxin Exposure and Symptoms Among Laboratory Animal Workers.

BACKGROUND: Exposure to endotoxin is known to trigger airway inflammation and symptoms, and atopy may modify the relationship between endotoxin exposure and symptom development. OBJECTIVE: To test the a priori hypothesis that atopic status modifies the relationship between endotoxin exposure and respiratory symptom development. METHODS: A prospective study of laboratory workers at The Jackson Laboratories was conducted. Allergy skin testing was performed and population demographic and clinical information was obtained at baseline. Personal exposure assessments for airborne endotoxin and surveys of self-reported symptoms were performed every 6 months. Cox proportional hazards models were used to examine the relationship between endotoxin exposure and development of mouse-associated symptoms and multivariate regression was used to test for interaction. RESULTS: Overall, 16 (9%) of 174 worker-participants developed mouse-associated rhinoconjunctivitis symptoms by 24 months and 8 (5%) developed mouse-associated lower respiratory symptoms by 24 months. Among workers with endotoxin exposure above the median (≥2.4 EU m-3), 5 (6% of 80) atopics reported mouse-associated rhinoconjunctivitis symptoms at 24 months as compared to 3 (3% of 94) non-atopics. Among workers below the median endotoxin exposure (<2.4 EU m-3), 1 (1% of 80) atopic reported mouse-associated rhinoconjunctivitis symptoms at 24 months as compared to 7 (7% of 94) non-atopics. For the combination of symptoms, the adjusted hazard ratio was 6.8 (95% confidence interval: 0.7-67.2) for atopics and 0.07 (95% confidence interval: 0.01-0.5) for non-atopics. CONCLUSION: In this occupational cohort, atopic workers may be more susceptible to, and non-atopic workers protected from, endotoxin-associated upper and lower respiratory symptoms.

Mouse allergen is the major allergen of public health relevance in Baltimore City.

BACKGROUND: Cockroach and mouse allergens have both been implicated as causes in inner-city asthma morbidity in multicenter studies, but whether both allergens are clinically relevant within specific inner-city communities is unclear. OBJECTIVE: Our study aimed to identify relevant allergens in Baltimore City. METHODS: One hundred forty-four children (5-17 years old) with asthma underwent skin prick tests at baseline and had clinical data collected at baseline and 3, 6, 9, and 12 months. Home settled dust samples were collected at the same time points for quantification of indoor allergens. Participants were grouped based on their sensitization and exposure status to each allergen. All analyses were adjusted for age, sex, and serum total IgE level. RESULTS: Forty-one percent were mouse sensitized/exposed, and 41% were cockroach sensitized/exposed based on bedroom floor exposure data. Mouse sensitization/exposure was associated with acute care visits, decreased FEV1/forced vital capacity percentage values, fraction of exhaled nitric oxide levels, and bronchodilator reversibility. Cockroach sensitization/exposure was only associated with acute care visits and bronchodilator reversibility when exposure was defined by using bedroom floor allergen levels. Mouse-specific IgE levels were associated with poor asthma health across a range of outcomes, whereas cockroach-specific IgE levels were not. The relationships between asthma outcomes and mouse allergen were independent of cockroach allergen. Although sensitization/exposure to both mouse and cockroach was generally associated with worse asthma, mouse sensitization/exposure was the primary contributor to these relationships. CONCLUSIONS: In a community with high levels of both mouse and cockroach allergens, mouse allergen appears to be more strongly and consistently associated with poor asthma outcomes than cockroach allergen. Community-level asthma interventions in Baltimore should prioritize reducing mouse allergen exposure.

The indoor environment and its effects on childhood asthma.

PURPOSE OF REVIEW: Indoor pollutants and allergens cause asthma symptoms and exacerbations and influence the risk of developing asthma. We review recent studies regarding the effects of the indoor environment on childhood asthma. RECENT FINDINGS: Exposure to some indoor allergens and second hand smoke are causally related to the development of asthma in children. Many recent studies have demonstrated an association between exposure to indoor pollutants and allergens and airways inflammation, asthma symptoms, and increased healthcare utilization among individuals with established asthma. Genetic polymorphisms conferring susceptibility to some indoor exposures have also been identified, and recent findings support the notion that environmental exposures may influence gene expression through epigenetic modification. Recent studies also support the efficacy of multifaceted environmental interventions in childhood asthma. SUMMARY: Studies have provided significant evidence of the association between many indoor pollutants and allergens and asthma morbidity, and have also demonstrated the efficacy of multifaceted indoor environmental interventions in childhood asthma. There is also a growing body of evidence suggesting that some indoor pollutants and allergens may increase the risk of developing asthma. Future studies should examine mechanisms whereby environmental exposures may influence asthma pathogenesis and expand the current knowledge of susceptibility factors for indoor exposures.