Access to Chagas disease treatment in the United States after the regulatory approval of benznidazole

Abstract

Approximately 300,000 persons in the United States (US) are infected with Trypanosoma cruzi, the protozoan that causes Chagas disease, but less than 1% are estimated to have received antiparasitic treatment. Benznidazole was approved by the US Food and Drug Administration (FDA) for treatment of T. cruzi infection in 2017 and commercialized in May 2018. This paper analyzes factors that affect access to benznidazole following commercialization and suggests directions for future actions to expand access. We applied an access framework to identify barriers, facilitators, and key actors that influence the ability of people with Chagas disease to receive appropriate treatment with benznidazole. Data were collected from the published literature, key informants, and commercial databases. We found that the mean number of persons who obtained benznidazole increased from just under 5 when distributed by the CDC to 13 per month after the commercial launch (from May 2018 to February 2019). Nine key barriers to access were identified: lack of multi-sector coordination, failure of health care providers to use a specific order form, lack of an emergency delivery system, high medical costs for uninsured patients, narrow indications for use of benznidazole, lack of treatment guidelines, limited number of qualified treaters, difficulties for patients to make medical appointments, and inadequate evaluation by providers to determine eligibility for treatment. Our analysis shows that access to benznidazole is still limited after FDA approval. We suggest six areas for strategic action for the pharmaceutical company that markets benznidazole and its allied private foundation to expand access to benznidazole in the US. In addition, we recommend expanding the existing researcher-clinician network by including government agencies, companies and others. This paper's approach could be applied to access programs for benznidazole in other countries or for other health products that target neglected populations throughout the world.

Clinical profile and mortality in patients with T. cruzi/HIV co-infection from the multicenter data base of the “Network for healthcare and study of Trypanosoma cruzi/HIV co-infection and other immunosuppression conditions”

“…T . cruzi infected people is estimated in Europe in 68,000–120,000 [ 3 ], and in the United States (US) >300,000 [ 4 ]. The control of vectorial transmission (through triatomine bugs) has improved in most Latin American territories, but the challenge now persists with oral and congenital transmissions and with blood transfusions and organ transplantation wherever its full prevention coverage has not been reached [ 1 , 2 ].…”

Use of benznidazole to treat chronic Chagas disease: An updated systematic review with a meta-analysis

“…The WHO Guidelines provides a conditional recommendation in adults with chronic Chagas disease without specific organ damage, based on low certainty regarding the effects of the intervention [ 15 ]. Nevertheless, after benznidazole approval by the US FDA, the monthly average of treated patients increase from five persons to 13 (comparing all the previous period to the 9 months following its commercialization), with 90% of these patients being adults, despite that the FDA’s indication was only for paediatric use [ 54 ]. In addition, it is expected that chronic Chagas disease would progressively increase its relevance in endemic and non-endemic areas as a consequence of the empowerment of affected populations [ 55 ], better knowledge of the disease by health workers [ 56 ], and better access to diagnosis and treatment [ 57 ].…”

Cytotoxicity of Essential Oil Cordia verbenaceae against Leishmania brasiliensis and Trypanosoma cruzi

“…There are currently only two anti-trypanosome drugs marketed: nifurtimox (Lampit ® , Bayer, Leverkusen, Germany), 3-methyl-4-(5′-nitrofurfurilideneamino) tetrahydro-4H-1,4-thiazine-1,1-dioxide; and benznidazole (Rochagan ® , Roche, Basel, Switzerland), N -benzyl-2-nitroimidazole acetamide [ 16 , 17 ]. However, both drugs can have numerous side effects in adults, in addition to inducing resistance in microorganisms [ 18 ].…”