Access Plan for Benznidazole in the United States: Expanding Access to Treatment for Chagas Disease

Abstract

Approximately 300,000 persons are infected with the causal agent of Chagas disease (CD) in the United States (US) but less than 1% of them are estimated to have been treated. In 2017, the US Food and Drug Administration approved benznidazole, a medicine for CD treatment, and Exeltis USA began supplying it commercially in May 2018. Despite this FDA approval, access to CD treatment remains limited to date. This Access Plan was developed as a Doctor of Public Health DELTA project to provide a strategic guide to expand access to benznidazole in the US. The project applies the access framework found in the public health literature to understand barriers, facilitators, and key actors that shape CD patients’ ability to obtain and use benznidazole. In addition, key barriers to CD diagnosis are also examined. The Access Plan identifies seven key barriers to benznidazole: 1) no formal structure to facilitate collaboration between key actors, 2) physician’s failure to use specific paper forms to order benznidazole, 3) lack of emergency benznidazole delivery, 4) uncertain financial sustainability of Exeltis’ drug subsidy program, 5) limited number of treaters offering CD treatment, 6) obstacles for patients seeking medical appointments, and 7) inadequate evaluation of patient eligibility for treatment. The project also found five key barriers to diagnosis: 1) limited screening opportunities at the primary care level, 2) limited access to physicians for seropositive blood donors, 3) limited physician knowledge about diagnostic procedures, 4) uncertain affordability of testing, and 5) unknown reliability of the currently used diagnostics. To overcome these barriers, the Access Plan proposes eight areas of strategic actions in which Exeltis and Fundación Mundo Sano could take actions in collaboration with other actors. These areas are intended to: 1) establish emergency benznidazole delivery, 2) ensure financial sustainability of the drug subsidy program, 3) organize and educate treaters, 4) promote patient networking, 5) implement pilot screening projects, 6) educate providers about diagnostic testing, 7) promote development of guidelines for screening, diagnosis and treatment, and 8) facilitate multi-sectorial coordination. Taking the actions proposed in this Access Plan will contribute to expanding access to CD treatment in the US.