(454) Variations in Practice Patterns of Xiaflex Providers Throughout the United States

Abstract

Abstract Introduction Intralesional Collagenase Clostridium Histolyticum (CCH; Xiaflex; Endo Pharmaceuticals, Dublin, Ireland) is the only FDA-approved intralesional therapy to treat bothersome penile curvature in men with Peyronie’s Disease (PD). Clinicians who administer CCH must be certified through a risk evaluation and management strategy (REMS) program. However, provider availability is highly dependent on geography and many patients must travel great distances to undergo evaluation and treatment with CCH by an experienced injector. Objective The goal of the current study is to describe the landscape of certified CCH injectors with respect to location and clinical background/training. Methods Patients are currently able to use an online “locate a specialist” tool through Endo Pharmaceuticals to identify clinicians in their local geographic area who are certified to administer CCH. Using this tool, a list of all providers who offer CCH injections was compiled throughout the continental United States. Pertinent information that was gathered included geographic location, type of provider or level of training [Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), Physician Assistant (PA), Nurse Practitioner (NP), and Registered Nurse (RN)], and gender of providers. This information was compared to state population data (United State Census Bureau) to determine per capita coverage. Results A total of 1947 Xiaflex providers were identified: 1749 Doctors of Medicine (MD; 90%), 115 Doctor of Osteopathic Medicine (DO; 6%), 60 Physician Assistants (PA; 3%), 21 Nurse Practitioners (NP; 1%), and 1 Registered Nurse (RN; 0.05%). Out of the 1947 providers, only 95 (4.9%) were women. Most women administering Xiaflex were MDs (73%), followed by PAs (12%), NP and DOs (7%), and RN (1%). Xiaflex providers were available in all states except for Hawaii and Alaska. Providers were distributed throughout the United States with the average provider per capita ratio of 230,240. Wyoming, Washington D.C., Rhode Island, and Georgia had the best provider per capita at <10,000 while New Mexico had the worst provider per capita ratio at 2,117,522. Conclusions Our results show significant variation in certified CCH injector availability for patients across the United States. < 5% of all certified clinicians are female and 4% were advanced practice providers. Further work is needed to characterize and remedy gender disparities amongst providers, and ensure greater access for patients who desire an FDA-approved non-surgical treatment for their PD-associated curvature. Disclosure No