Abstract

The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The aim of this study was to estimate the direct costs of therapies recommended by the Ministry of Health (MH) for VL treatment in Brazil. The analytical perspective used was that adopted by the Brazilian Public Health System. Three drugs and four regimens were included: 1) N-methyl glucamine antimoniate intramuscularly at 20mg per kg per day for 30 days; 2) N-methyl glucamine antimoniate intravenously at 20mg per kg per day for 30 days; 3) amphotericin B deoxycholate at 1mg per kg per day for 21 days; and 4) liposomal amphotericin B at 3mg per kg per day for a 7 days treatment. The estimated direct costs of treatment for an adult patient using N-methylglucamine antimoniate administered via the intramuscular and intravenous routes were USD 418.52 and USD 669.40, respectively. The estimated cost of treatment with amphotericin B deoxycholate was USD 1,522.70. Finally, the estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. This analysis indicates the economic feasibility of replacing N-methyl glucamine antimoniate with liposomal amphotericin B, which allows a shorter treatment period with less toxicity compared with other treatments, provided that the purchase value used by the WHO and transferred to the MH is maintained.

Highlights

  • The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost

  • This study included three drugs and four treatment regimens listed in the Ministry of Health (MH) recommendations for Visceral leishmaniasis (VL) treatment: 1) N-methylglucamine antimoniate administered intramuscularly in outpatient settings – 20mg per kg per day for a 30 days treatment; 2) N-methylglucamine antimoniate administered intravenously in outpatient services – 20mg per kg per day for a 30 -days treatment; 3) amphotericin B deoxycholate administered at the hospital – 1mg per kg per day for a 21- day treatment; and 4) liposomal amphotericin B administered in-hospital– 3mg per kg per day for a 7-day treatment

  • The estimated direct costs of therapy with liposomal amphotericin B were United States Dollars (USD) 11,559.15 and USD 659.79 based on the prices adopted by the Câmara de Regulação de Medicamentos (CMED) and World Health Organization (WHO), respectively (Table 1)

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Summary

Introduction

The drugs available for visceral leishmaniasis (VL) treatment in Brazil have specific characteristics in terms of operability, effectiveness, toxicity, and cost. The estimated costs of treatment with liposomal amphotericin B were USD 659.79, and USD 11,559.15 using the price adopted by the WHO and the Drug Regulation Board, respectively. In Brazil, the Ministry of Health (MH) recommends the following drugs for VL treatment: N-methylglucamine antimoniate, amphotericin B deoxycholate, and liposomal amphotericin B. In contrast with the other drugs, liposomal amphotericin B (AmBisome®) is produced in the United States, and its patent is pending, making it very expensive: United States Dollars (USD) 11,239.36 to treat an adult patient, when considering the price value adopted by the Drug Regulation Board [Câmara de Regulação de Medicamentos (CMED)] of Machado de Assis TS et al - Costs of treating visceral leishmaniasis the National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária (ANVISA)]12. This cost reduction allowed the drug to be incorporated into the Public Health System in Brazil

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