Comprehensive economic evaluation of thermotherapy for the treatment of cutaneous leishmaniasis in Colombia.

BACKGROUND: Cutaneous leishmaniasis causes a high disease burden in Colombia, and available treatments present systemic toxicity, low patient compliance, contraindications, and high costs. The purpose of this study was to estimate the cost-effectiveness of thermotherapy versus Glucantime in patients with cutaneous leishmaniasis in Colombia. METHODS: Cost-effectiveness study from an institutional perspective in 8133 incident cases. Data on therapeutic efficacy and safety were included, calculating standard costs; the outcomes were disability adjusted life years (DALYs) and the number of patients cured. The information sources were the Colombian Public Health Surveillance System, disease burden studies, and one meta-analysis of controlled clinical trials. Incremental cost-effectiveness was determined, and uncertainty was evaluated with tornado diagrams and Monte Carlo simulations. RESULTS: Thermotherapy would generate costs of US$ 501,621; the handling of adverse effects, US$ 29,224; and therapeutic failures, US$ 300,053. For Glucantime, these costs would be US$ 2,731,276, US$ 58,254, and US$ 406,298, respectively. With thermotherapy, the cost would be US$ 2062 per DALY averted and US$ 69 per patient cured; with Glucantime, the cost would be US$ 4241 per DALY averted and US$ 85 per patient cured. In Monte Carlo simulations, thermotherapy was the dominant strategy for DALYs averted in 67.9% of cases and highly cost-effective for patients cured in 72%. CONCLUSION: In Colombia, thermotherapy can be included as a cost-effective strategy for the management of cutaneous leishmaniasis. Its incorporation into clinical practice guidelines could represent savings of approximately US$ 10,488 per DALY averted and costs of US$ 116 per additional patient cured, compared to the use of Glucantime. These findings show the relevance of the incorporation of this treatment in our country and others with similar parasitological, clinical, and epidemiological patterns.

The direct costs of treating human visceral leishmaniasis in Brazil.

INTRODUCTION:: 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. METHODS:: 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. RESULTS:: 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. CONCLUSIONS:: 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.

The direct costs of treating human visceral leishmaniasis in Brazil

Abstract INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The efficacy of thermotherapy to treat cutaneous leishmaniasis in Colombia: a comparative observational study in an operational setting.

An open label, comparative study to compare the efficacy of thermotherapy to meglumine antimoniate in treating cutaneous leishmaniasis patients in an operational context was carried out in Chaparral, Colombia. After enrollment patients were followed-up for up to 100 days. Per protocol and intention-to-treat cure rates for 47 patients treated using thermotherapy (one-time 50 degrees C applications for 30s) were 100 and 19%, respectively. Per protocol and intention-to-treat cure rates for meglumine antimoniate (20 mg/kg body weight administered intramuscularly for 21 d) were 78 and 23%, respectively.

Short communication: The cost-effectiveness of cutaneous leishmaniasis patient management during an epidemic in Chaparral, Colombia in 2004.

We calculated ranges for the cost per disability adjusted life year (DALY) averted for cutaneous leishmaniasis (CL) treatment during an ongoing epidemic of CL in Chaparral, Colombia. Using operational clinical and cost data, we calculated that the cost of treating leishmaniasis patients with standard pentavalent antimony was US$345 (95% CI 277-488) per patient treated and cured. The cost per DALY averted per patient cured with antimony was estimated to be approximately US$15 000 (95% CI 12 226-21 532).

[Cost-effectiveness analysis of samario-153 (Quadramet) for the treatment of patients with prostate cancer and bone metastases]. / Análisis coste-efectividad de samario-153 (Quadramet) en el tratamiento del dolor en pacientes con cáncer de próstata y metástasis óseas.

OBJECTIVE: To evaluate the cost-effectiveness of samarium [153Sm-EDTMP] (Quadramet) compared to conventional therapy in the treatment of pain in patients with prostate cancer and bone metastases. METHOD: A decision tree model for the treatment of bone pain due to metastases was adapted to the Spanish context. The model represents the standard treatment patterns in Spain for the study population. The time-course of the model is 4 months and it computes an estimate for the cost of pain control per patient. The effectiveness data for the model derive from a randomised trial. The current treatment patterns have been established according to the consensus opinions of a group of medical experts. RESULTS: The cost of pain control per patient is euro 12,515.39 for conventional therapy and euro 5,595.52 for samarium-153 (Quadramet) therapy. The incremental cost-effectiveness analysis shows that samarium-153 (Quadramet) is a dominant therapy. It presents lower costs and higher efficacy than the conventional strategy. The sensitivity analyses showed these results to be robust. CONCLUSION: Samarium-153 (Quadramet) is cost-effective in treating pain in patients with prostate cancer and bone metastases.

[A comparative study between the efficacy of pentamidine isothionate given in three doses for one week and N-methil-glucamine in a dose of 20mgSbV/day for 20 days to treat cutaneous leishmaniasis]. / Estudo comparativo da efic cia de isotionato de pentamidina administrada em tr s doses durante uma semana e de N-metil-glucamina 20mgSbV/kg/dia durante 20 dias para o tratamento da forma cut nea da leishmaniose tegumentar americana.

Seventy-nine patients with cutaneous leishmaniasis were included in this study. The experimental group (n = 38) was treated with pentamidine isothionate in a dose of 4mg/kg/day on alternate days, for one week. The control group (n = 41) was treated with N-methylglucamine in a dose of 20mgSbV/kg/day for 20 days. Twenty-one isolates were identified using monoclonal antibody technique. We characterized Leishmania (Viannia) braziliensis, most frequently. There was a cure rate of 71.05% of the patients in the experimental group and 73.17% in the control group (p = 0.47). We found a statistical significance regarding frequency of ECG alterations between the experimental and control group (p<0.05). In our study pentamidine was as effective as antimonial for the treatment of american cutaneous leishmaniasis. It proved to be a safer drug considering heart toxicity. Moreover, it requires less time to complete the treatment.

Recombinant human granulocyte-macrophage colony-stimulating factor reverses neutropenia and reduces secondary infections in visceral leishmaniasis.

Twenty-four patients with acute visceral leishmaniasis and leukopenia (< 1500 neutrophils/mm3) due to Leishmania chagasi were studied, 4 in an open-label pilot study and 20 in a double-blind, placebo-controlled trial. Patients received granulocyte-macrophage colony-stimulating factor (GM-CSF), 5 micrograms/kg daily, or placebo for 10 days, plus 10-20 mg/kg pentavalent antimony daily for 20 days. In GM-CSF recipients, neutrophil counts increased threefold and fourfold over baseline at 5 and 10 days, respectively, and were significantly higher than those in placebo recipients (P < .02). Eosinophil and monocyte counts were significantly increase in GM-CSF recipients at 10 days (P < or = .03). Secondary infections occurred in 3 GM-CSF and in 8 placebo recipients (P = .04). All patients had complete resolution of their leishmaniasis at 3 months. Few adverse events were recorded. GM-CSF, 5 micrograms/kg daily for 10 days, was safe, rapidly reversed neutropenia, and reduced the number of secondary infections in patients with leishmaniasis.