Pharmacoequity and Biologics in the Allergy Clinic: Providing the Right Care, at the Right Time, Every Time, to Everyone.

Pharmacoequity refers to equity in access to pharmacotherapy for all patients and is an especially large barrier to biologic agents in patients with allergic diseases. Value-based care models can prompt clinicians to address social determinants of health, promoting pharmacoequity. Pharmacoequity is influenced by numerous factors including socioeconomic status, which may be mediated through insurance status, educational attainment, and access to specialist care. In addition to lower socioeconomic status, race and ethnicity, age, locations isolated from care systems, and off-label indications for biologic agents all constitute barriers to pharmacoequity. Whereas pharmaco-inequity is more apparent for expensive biologics, it also affects many other allergy treatments including epinephrine autoinjectors and SMART for asthma. Current programs aimed at alleviating cost barriers are imperfect. Patient assistance programs, manufacturer-sponsored free drug programs, and rebates often increase the complexity of care, with resultant inequity, particularly for patients with lower health literacy. Ultimately, single silver-bullet solutions are elusive. Long-term improvement instead requires a combination of research, advocacy, and creative problem-solving to design more intelligent and efficient systems that provide timely access to necessary care for every patient, every time.

Patient-Centered Practice Guidelines: GRADEing Evidence to Incorporate Certainty, Balance Between Benefits and Harms, Equity, Feasibility, and Cost-Effectiveness.

The practice of medicine in recent years has emphasized the use of evidence-based clinical guidelines to help inform treatment decisions. Since its development in 2004, the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach has offered a systematic process for reviewing and summarizing the certainty of evidence found in the medical literature regarding various treatment options. To develop truly patient-centered care guidelines, this appraisal of the certainty of evidence must be combined with an understanding of the balance between benefits and harms, patient preferences, equity, feasibility, cost-effectiveness, and policy implications. This review examines each of these domains in detail, exploring the process and benefits of developing relevant, patient-focused guidelines directly applicable to the practice of modern medicine.

The Role of Access and Cost-Effectiveness in Managing Asthma: A Systematic Review.

BACKGROUND: Inconsistent and unequal access to medical care is an issue that predates the COVID19 pandemic, which only worsened the problem. Limited access to care from asthma specialists and other specialists treating comorbid diseases may adversely affect asthma. OBJECTIVE: The purpose of this review is to identify health disparities associated with access to care for asthma, and cost-effectiveness of therapies and interventions addressing this health disparity. METHODS: A narrative systematic review was undertaken using MeSH searches of English language articles published in CINAHL, Scopus, or PubMed. RESULTS: A total of 725 articles were identified. Barriers recognized from the literature included access to diagnostic spirometry, access to specialists, medication formulary restrictions, and issues leading to medical nonadherence. Telemedicine, school-based health care interventions, digital applications, and non-office-based digital spirometry could be used to address these gaps in access to asthma care while potentially being cost-effective. CONCLUSION: With the widespread adoption of telemedicine because of the pandemic, and adoption of other mobile services, we now have potential tools that can increase access to asthma care, which can help address this health care inequity. Evidence is limited, but favorable, that some of these tools may be cost-effective.

A Practical Guide to Understanding Cost-Effectiveness Analyses.

Cost-effectiveness analysis is a way to understand the value of a health care intervention in terms of assessing the money spent to produce beneficial outcomes. Cost-effectiveness analyses are used by various stakeholders for such purposes because health care resources and financing may be scarce, depending on the economy, and certain interventions may be costly to produce such outcomes compared with other options. These analyses are built on well-researched and robust inputs for costs and outcomes and may be modeled using a technique called Markov chain models, which allow transitions among various health states (eg, alive, dead, outgrow allergy, allergy relapses) relative to the condition of interest to reflect a base-case scenario. Then, the margins of the inputs are explored for a sensitivity analysis of potential findings. These analyses should be investigated from multiple perspectives (eg, society, health care payer). Limitations of the analysis should be clearly stated. Although such models are an informative way to explore a situation and can be performed without additional direct patient intervention, a weakness of the approach is that this may overlook individual patient nuances. Cost-effectiveness analyses are important policy tools to show, on average, an optimal way to improve value in population health.

Influenza epidemics: The role of allergists-immunologists.

OBJECTIVE: To review influenza epidemics and pandemics for practicing allergists-immunologists. DATA SOURCES: English-language articles published in PubMed from 1990 to present with relevance to allergic disorders and articles cited by or similar to these articles. STUDY SELECTIONS: A total of 472 articles were identified from PubMed. Two independent reviewers appraised the titles for relevance. RESULTS: A total of 212 relevant articles were selected. Additional articles and government websites increased the number to 295 relevant citations. CONCLUSION: Influenza epidemics and pandemics have recurred throughout history. Patients with asthma and immunodeficiency are at an increased risk. Nonpharmaceutical interventions, vaccination, and neuraminidase inhibitors are key strategies for the prevention and treatment of influenza epidemics/pandemics. Allergists play a vital role in protecting high-risk groups and increasing influenza vaccination coverage.

A call for cost-effectiveness analysis for biologic therapies in chronic rhinosinusitis with nasal polyps.

OBJECTIVE: To identify the need for cost-effectiveness analysis of biologic therapies in the treatment of chronic rhinosinusitis (CRS). DATA SOURCES: Clinical trials of monoclonal antibodies (omalizumab, benralizumab, mepolizumab and dupilumab) for nasal polyposis or chronic rhinosinusitis published on PubMed. STUDY SELECTIONS: Clinical trials of biologic therapies in CRS and nasal polyposis. RESULTS: No cost-effectiveness analyses of biologic therapies in CRS have been performed. CONCLUSION: As more clinical trials of biologic therapies for CRS are conducted, there is a need for cost-effectiveness analysis. Future analyses should consider these therapies as part of medical therapeutic options compared with surgery. To increase generalizability, analyses should include samples from allergy and primary care clinics rather than only otolaryngology clinics.

Loss of bronchoprotection with ICS plus LABA treatment, ß-receptor dynamics, and the effect of alendronate.

BACKGROUND: Loss of bronchoprotection (LOBP) with a regularly used long-acting ß2-adrenergic receptor agonist (LABA) is well documented. LOBP has been attributed to ß2-adrenergic receptor (B2AR) downregulation, a process requiring farnesylation, which is inhibited by alendronate. OBJECTIVE: We sought to determine whether alendronate can reduce LABA-associated LOBP in inhaled corticosteroid (ICS)-treated patients. METHODS: We conducted a randomized, double-blind, placebo-controlled, parallel-design, proof-of-concept trial. Seventy-eight participants with persistent asthma receiving 250 µg of fluticasone twice daily for 2 weeks were randomized to receive alendronate or placebo while initiating salmeterol for 8 weeks. Salmeterol-protected methacholine challenges (SPMChs) and PBMC B2AR numbers (radioligand binding assay) and signaling (cyclic AMP ELISA) were assessed before randomization and after 8 weeks of ICS plus LABA treatment. LOBP was defined as a more than 1 doubling dose reduction in SPMCh PC20 value. RESULTS: The mean doubling dose reduction in SPMCh PC20 value was 0.50 and 0.27 with alendronate and placebo, respectively (P = .62). Thirty-eight percent of participants receiving alendronate and 33% receiving placebo had LOBP (P = .81). The after/before ICS plus LABA treatment ratio of B2AR number was 1.0 for alendronate (P = .86) and 0.8 for placebo (P = .15; P = .31 for difference between treatments). The B2AR signaling ratio was 0.89 for alendronate (P = .43) and 1.02 for placebo (P = .84; P = .44 for difference). Changes in lung function and B2AR number and signaling were similar between those who did and did not experience LOBP. CONCLUSION: This study did not find evidence that alendronate reduces LABA-associated LOBP, which relates to the occurrence of LOBP in only one third of participants. LOBP appears to be less common than presumed in concomitant ICS plus LABA-treated asthmatic patients. B2AR downregulation measured in PBMCs does not appear to reflect LOBP.

Patients with chronic rhinosinusitis and obstructive sleep apnea have increased paroxysmal limb movement.

BACKGROUND: Patients with chronic rhinosinusitis (CRS) frequently experience sleep disruption and are at a higher than normal risk for obstructive sleep apnea (OSA). The purpose of this study was to determine how CRS affects polysomnography findings and sleep-related breathing in OSA. METHODS: A cohort study was performed that included 107 adult patients with CRS and comorbid OSA (CRS+OSA group) and 137 patients with OSA and without CRS as the control group. An electronic medical records database was used to identify eligible subjects. Comorbid conditions and polysomnography data were compared between the two groups by using logistic and linear regression analyses. RESULTS: A total of 246 patients were included: 107 patients in the CRS+OSA group and 137 patients with OSA and without CRS in the control group. After adjusting for demographic factors, the patients in the CRS+OSA group had a lower body mass index (BMI) and higher age at the time of diagnosis of OSA (p < 0.001). The patients in the CRS+OSA group had higher odds of having asthma and eczema. There was an increase in the periodic limb movement (PLM) index in the CRS+OSA group. Apnea and hypopnea indices were similar in the two groups. CONCLUSION: Patients with CRS developed OSA at a lower BMI; patients CRS and OSA had similar sleep-related breathing patterns but higher risks for PLMs compared with patients with OSA and without CRS.

A computable phenotype for asthma case identification in adult and pediatric patients: External validation in the Chicago Area Patient-Outcomes Research Network (CAPriCORN).

Objective: Comprehensive, rapid, and accurate identification of patients with asthma for clinical care and engagement in research efforts is needed. The original development and validation of a computable phenotype for asthma case identification occurred at a single institution in Chicago and demonstrated excellent test characteristics. However, its application in a diverse payer mix, across different health systems and multiple electronic health record vendors, and in both children and adults was not examined. The objective of this study is to externally validate the computable phenotype across diverse Chicago institutions to accurately identify pediatric and adult patients with asthma. Methods: A cohort of 900 asthma and control patients was identified from the electronic health record between January 1, 2012 and November 30, 2014. Two physicians at each site independently reviewed the patient chart to annotate cases. Results: The inter-observer reliability between the physician reviewers had a κ-coefficient of 0.95 (95% CI 0.93-0.97). The accuracy, sensitivity, specificity, negative predictive value, and positive predictive value of the computable phenotype were all above 94% in the full cohort. Conclusions: The excellent positive and negative predictive values in this multi-center external validation study establish a useful tool to identify asthma cases in in the electronic health record for research and care. This computable phenotype could be used in large-scale comparative-effectiveness trials.