Patient and Clinician Challenges with Anticholinergic Step Therapy in the Treatment of Overactive Bladder: A Narrative Review.

Anticholinergics have been used in the treatment of overactive bladder (OAB), but their use is limited by poor tolerability and anticholinergic-related side effects. Increasingly, providers are discontinuing anticholinergic prescribing because of growing evidence of the association of anticholinergic use with increased risk of cognitive decline and other adverse effects. Newer medications for OAB, the ß3-adrenergic receptor agonists mirabegron and vibegron, do not have anticholinergic properties and are typically well tolerated; however, many insurance plans have limited patient access to these newer OAB medications by requiring step therapy, meaning less expensive anticholinergic medications must be trialed and/or failed before a ß3-agonist will be covered and dispensed. Thus, many patients are unable to easily access these medications. Step therapy and other drug utilization strategies (e.g., prior authorization) are often used to manage the growing costs of pharmaceuticals, but these policies do not always follow treatment guidelines and may harm patients as a result of treatment delays, discontinuations, or related increases in adverse events. Medical professionals have called for reform of drug utilization strategies through partnerships that include clinicians and policymakers. This narrative review discusses prescribing patterns for OAB treatment and the effect of switching between drugs, as well as the costs of step therapy and prior authorization on patients and prescribers.

Payer Perspectives on Intravenous versus Subcutaneous Administration of Drugs.

The coronavirus disease 2019 (COVID-19) pandemic has brought increased attention to vulnerable populations such as older or immunocompromised patients and heightened the focus on alternatives to intravenous (IV) formulations, particularly those that may be administered in a non-clinical setting. Among these alternative formulations are subcutaneous (SC) injections, which comprise an increasing share of commercialized and pipeline therapies. While much has been published about the benefits and limitations of IV versus SC administration to patients and health systems, less attention has been given to payer considerations regarding these routes of administration. Accordingly, this article provides payer perspectives on some of the key differences between IV and SC administration as they relate to management and billing, cost, treatment adherence and safety, and patient preference and quality of life. The benefits and limitations of these drug administration routes to key healthcare stakeholders-namely patients, physicians, and payers-are also discussed. Considerations of relevance are highlighted, including the potential for misalignment of stakeholder interests and countervailing factors that may impact decision-making about IV and SC formulations.

Evaluating Outcomes in Patients with Overactive Bladder within an Integrated Healthcare Delivery System Using a Treatment Patterns Analyzer.

BACKGROUND: Overactive bladder (OAB) is a relatively common disease that has been linked to a variety of comorbidities, reductions in quality of life, and increased healthcare costs. Antimuscarinic agents are the standard of care among pharmacologic treatments for OAB, but these drugs are linked to high levels of anticholinergic burden, especially in the elderly. OBJECTIVE: To demonstrate how efficient data analysis can be used to identify gaps in care as a result of improvement strategies for OAB within an integrated healthcare delivery system setting. METHODS: We developed an OAB treatment patterns analyzer, a clinical outcomes software analysis program, to identify gaps in care, high anticholinergic burden, and potential quality improvement initiatives. Deidentified pharmacy and medical claims data from an integrated delivery network were imported into the OAB treatment patterns analyzer. Patients with a diagnosis of OAB who were continuously enrolled in the network between January 1, 2009, and December 31, 2013, were identified and were imported into the analyzer. The analyzer used National Drug Code; International Classification of Diseases, Ninth Edition, Clinical Modification; Current Procedural Terminology; and UB-92 codes to measure treatment patterns, comorbid conditions, anticholinergic burden, concomitant use with anticholinesterases, costs, and healthcare resource utilization. RESULTS: Of 157,710 members in the integrated delivery network population, 7309 patients met the study eligibility criteria. Of patients taking medications for OAB, 85% were nonadherent and 73% discontinued treatment within 1 year. Among 1147 patients in the integrated healthcare delivery system who were using medications for OAB, 39 (3.4%) patients were concomitantly taking anticholinesterase drugs and an antimuscarinic agent. The per-month plan-paid cost per member was $318.67. Of all the patients with OAB within the population, the rates of all-cause office visits, emergency department visits, and hospitalizations were 81%, 6%, and 4%, respectively. The rate of clinically relevant anticholinergic burden was 16%, with higher rates among patients with dementia who were also receiving a branded (20%) or generic (24%) antimuscarinic drug. CONCLUSION: In patients using medications for the treatment of OAB, the rates of medication persistence and adherence were poor. Antimuscarinic medications may place certain patient populations at risk for increased anticholinergic burden. Data included in the analyzer can be used to implement member-specific strategies to prevent poor outcomes and reduce associated healthcare costs and utilization.