Race and ethnicity, not just insurance, is associated with biologics initiation in asthma and related conditions.

BACKGROUND: There are pre-existing inequities in asthma care. OBJECTIVES: We sought to evaluate effect modification by race of the effect of insurance on biologic therapy use in patients with asthma and related diseases. METHODS: We conducted inverse probability weighted analyses using electronic health records data from 2011 to 2020 from a large health care system in Boston, Mass. We evaluated the odds of not initiating omalizumab or mepolizumab therapy within 1 year of prescription for an approved indication. RESULTS: We identified 1132 individuals who met study criteria. Twenty-seven percent of these patients had public insurance and 12% belonged to a historically marginalized group (HMG). One-quarter of patients did not initiate the prescribed biologic. Among patients with asthma, individuals belonging to HMG had higher exacerbation rates in the period before initiation compared to non-HMG individuals, regardless of insurance type. Among HMG patients with asthma, those with private insurance were less likely to not initiate therapy compared to those with public insurance (odds ratio [OR]: 0.67, and 95% CI: 0.56-0.79). Among non-HMG with asthma, privately insured and publicly insured individuals had similar rates of not initiating the prescribed biologic (OR: 1.02; 95% CI: 0.95-1.09). Among those publicly insured with asthma, HMGs had higher odds of not initiating therapy compared to non-HMGs (OR: 1.16; 95% CI: 1.03-1.31), but privately insured HMG and non-HMG did not differ significantly (OR: 0.99; 95% CI: 0.91-1.07). CONCLUSIONS: Publicly insured individuals belonging to HMG are less likely to initiate biologics when prescribed despite having more severe asthma, while there are no inequities by insurance in individuals belonging to other groups.

Factors Associated With Asthma Biologic Prescribing and Primary Adherence Among Adults in a Large Health System.

BACKGROUND: The availability of asthma biologics may not benefit all patients equally. OBJECTIVE: We sought to identify patient characteristics associated with asthma biologic prescribing, primary adherence, and effectiveness. METHODS: A retrospective, observational cohort study of 9,147 adults with asthma who established care with a Penn Medicine asthma subspecialist was conducted using Electronic Health Record data from January 1, 2016, to October 18, 2021. Multivariable regression models were used to identify factors associated with (1) receipt of a new biologic prescription; (2) primary adherence, defined as receiving a dose in the year after receiving the prescription, and (3) oral corticosteroid (OCS) bursts in the year after the prescription. RESULTS: Factors associated with a new prescription, which was received by 335 patients, included being a woman (odds ratio [OR] 0.66; P = .002), smoking currently (OR 0.50; P = .04), having an asthma hospitalization in the prior year (OR 2.91; P < .001), and having 4+ OCS bursts in the prior year (OR 3.01; P < .001). Reduced primary adherence was associated with Black race (incidence rate ratio 0.85; P < .001) and Medicaid insurance (incidence rate ratio 0.86; P < .001), although most in these groups, 77.6% and 74.3%, respectively, still received a dose. Nonadherence was associated with patient-level barriers in 72.2% of cases and health insurance denial in 22.2%. Having more OCS bursts after receiving a biologic prescription was associated with Medicaid insurance (OR 2.69; P = .047) and biologic days covered (OR 0.32 for 300-364 d vs 14-56 d; P = .03). CONCLUSIONS: In a large health system, primary adherence to asthma biologics varied by race and insurance type, whereas nonadherence was primarily explained by patient-level barriers.

Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making.

The Food and Drug Administration is tasked with evaluating the efficacy and safety of a drug. Despite having a regimented appraisal process in place, safety evidence can emerge during clinical trials as well as from observations and studies conducted after the drug has been on the market, which might require a boxed warning. The boxed warning is the most severe warning that the Food and Drug Administration can give to an approved drug. It is commonly referred to as a Black Box Warning because it is outlined in the package insert by a thick black box to garner the attention of prescribers and patients. There are currently more than 400 medications that have boxed warnings, and the information addressing major risks associated with a particular drug may, appropriately or inappropriately, influence patient and clinician decision making. Health care professionals must use the best evidence and clinical judgment in determining whether to prescribe medications with these warnings. Use of an approved drug at dosages or for indications other than what it was originally licensed for is referred to as "off-label" and is legal, commonplace, and may be evidence-based. All drugs may expose patients to possible harm, so prescribers have an obligation to discuss the best available evidence regarding benefits and harms so that patients can participate in shared decision making.

Revefenacin, a once-daily, long-acting muscarinic antagonist, for nebulized maintenance therapy in patients with chronic obstructive pulmonary disease.

PURPOSE: This article reviews the efficacy and safety of revefenacin, the first once-daily, long-acting muscarinic antagonist, when delivered via a standard jet nebulizer in patients with chronic obstructive pulmonary disease (COPD). SUMMARY: Revefenacin 175 µg is indicated for the maintenance treatment of patients with moderate to very severe COPD. Preclinical studies showed that revefenacin is a potent and selective antagonist with similar affinity for the different subtypes of muscarinic receptors (M1-M5). Furthermore, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose dependent and lasted longer than 24 hours, demonstrating a long duration of action. In phase 2 and 3 trials, treatment with revefenacin was demonstrated to result in statistical improvements in pulmonary function (≥100 mL, P < 0.05) vs placebo, including among patients with markers of more severe disease and those who received concomitant long-acting ß-agonists or long-acting ß-agonists together with inhaled corticosteroids. Revefenacin was also demonstrated to have efficacy similar to that of tiotropium. The clinical trial findings indicated no significant difference between revefenacin and tiotropium with regard to rates of adverse events. Overall, revefenacin was well tolerated, with COPD worsening/exacerbation, dyspnea, headache, and cough among the most common adverse events noted in the clinical trials. CONCLUSIONS: Revefenacin treatment delivered via nebulization led to improvements in lung function in patients with COPD. It was also generally well tolerated, with no major safety concerns. Revefenacin provides a viable treatment option for patients with COPD and may be a suitable alternative for those with conditions that may impair proper use of traditional handheld inhalers.

US Propofol Drug Shortages: A Review of the Problem and Stakeholder Analysis.

BACKGROUND: Drug shortages have increased in recent years in the United States, with a majority involving sterile injectable drugs. Propofol, a sterile injectable drug, is frequently used as a sedative, thanks to its rapid onset of action and a short recovery period. However, propofol is complicated and expensive to manufacture, and recent events involving major manufacturers have led to shortages of the drug in the United States. OBJECTIVES: To review the events leading to the shortage of propofol and to discuss how the shortage is affecting various healthcare stakeholders, as an example of the systemwide problem of drug shortages in the United States. DISCUSSION: Manufacturers currently have little economic incentive to produce propofol, a generic drug whose production is costly and carries a high liability. The enforcement of good manufacturing practices by the US Food and Drug Administration is beneficial for the safety of US citizens, but it can inherently lead to a sudden halt in the manufacturers' production of drugs. Hospitals are affected because they must develop a plan to address current and potential shortages, including restricting the use of medications that have a shortage and shifting to alternative agents. CONCLUSION: The shortage of propofol significantly impacted the delivery of care in the United States in 2009, and various stakeholders are working to increase the existing supply of propofol and to investigate the use of alternative medications when the supply runs short. The case of propofol presented in this article is used to illustrate a systemwide view of the impact of drug shortages on the US healthcare system.