Consequences and Alternatives to Step Therapy in Overactive Bladder Care - Step-therapy is a utilization management strategy where insurers implement a tiered treatment pathway, and patients and physicians must obtain approval for restricted therapies by documenting failure of prior steps. Step therapy has been under increasing scrutiny because it may hinder access to necessary care. One prevalent syndrome where step therapy requirements are widely utilized, and impede access to patient-centered care, is overactive bladder (OAB). Alternatives to step therapy, including patient-centered treat-to-target approach, where therapy is determined based on severity of symptoms, have replaced step therapy for many chronic conditions. However, these patient-centered strategies have not been explored in OAB. OAB is characterized by urinary urgency, frequency, nocturia and/or urgency incontinence and affects up to 1/3 of Americans, primarily older women. While many therapies are available, currently patients and clinicians must navigate clinical tradeoffs and policy barriers associated with non-evidence-based step therapy that make treatment complex. Recent updates to national guidelines have admitted that there is no evidence to support the need for people with OAB to proceed with treatment using a stepwise approach. However, many payers require step-therapy for both medication coverage and procedural coverage of effective, minimally invasive therapies. The overarching aims of this proposal are to clarify the impact of step therapy as well as to evaluate alternative strategies in OAB care. First, we will use a nationally funded, multi-institutional electronic health record (EHR) dataset and a validated computational phenotype for overactive bladder to identify factors associated with update of minimally invasive therapies for OAB care (Aim 1). Next, we will quantify the impact of insurance provider on the utilization of these therapies using a regression discontinuity design (Aim 2). Findings from this study directly address the NIDDK mission to support clinical research to improve urological health. Specifically, it will allow patients, clinicians and policymakers to data to understand the impact of current step therapy policies, provide data for crafting exemption policies and support future trials evaluating practice policies and guidelines for minimally invasive OAB therapies.
