Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. 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 receptor (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 β-agonists or long-acting β-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.
Introduction Prescription prior authorization (PA) and prohibitive out‐of‐pocket costs are encountered across all specialties of care. These barriers are burdensome for prescribers and patients due to the multiple steps required to gain approval for payer reimbursement for medications. Objectives The primary objective was to characterize clinical pharmacist impact on medication appeals and high cost resolution. Methods This was a retrospective review of medication access intervention data collected from January 1, 2021, through July 31, 2021, at an academic medical center where five clinical pharmacists are embedded across 11 specialty and family medicine clinics. Intervention data was documented for both specialty and nonspecialty prescriptions. The primary end point quantified and characterized interventions based on access issues, defined as insurance denial or high out‐of‐pocket cost. Additional end points included time to appeal determination, total time spent on appeal activities, the incidence of denials, duration of the interruption, and assistance dollars secured for cost‐related barriers. Results Over the 7‐mo period, there were 531 prescriptions identified for clinical pharmacist access intervention. Of the total interventions collected, 42% (n = 221) were appeals for insurance denials and 58% (n = 310) addressed high out‐of‐pocket cost. The approval rate of appeals was 94% (n = 208). The majority of appeals (89%) were submitted within 3 d. The median time to appeal determination was five calendar days. The estimated time spent on appeal activities by the clinical pharmacists was 6.8 work wk. There were 51 patients of therapy interruption. The total assistance dollars secured for high out‐of‐pocket costs reached an estimated $1 953 200 over the report period.ConclusionThis report characterizes an approach to effectively manage medication appeals and cost resolution through embedded clinical pharmacists. Leveraging embedded pharmacists' clinical knowledge and familiarity with payer processes in medication appeals achieved a 94% approval rate. The current payer process places a burden disproportionately on prescribers and patients, delaying or preventing medication access.
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