Efficacy, Safety, and Cost-Minimization Analysis of Continuous Infusion of Low-Dose Gemcitabine Plus Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma.

BACKGROUND: Malignant pleural mesothelioma (MPM) is rare and aggressive neoplasia, with a poor prognosis; furthermore, the monetary cost of its treatment represents a major challenge for many patients. The economic burden this malignancy imposes is underscored by the fact that asbestos exposure, which is the most frequent risk factor, is much more prevalent in the lower socioeconomic population of developing countries. The aims of the present study were to evaluate the efficacy, safety, and cost of continuous infusion of low-dose Gemcitabine plus Cisplatin (CIGC) as a treatment strategy for patients with unresectable MPM. METHODS: We performed a prospective cohort study to determine efficacy and safety of continuous infusion gemcitabine at a dose of 250 mg/m2 in a 6-h continuous infusion plus cisplatin 35 mg/m2 on days 1 and 8 of a 21-day cycle in patients with unresectable MPM. We also performed a cost-minimization analysis to determine if this chemotherapy regimen is less expensive than other currently used regimens. RESULTS: The median number of chemotherapy cycles was six (range 1-11 cycles); objective response rate was documented in 46.2%, and disease control rate was seen in 81.2%. Median PFS was 8.05 months (CI 95% 6.97-9.13); median OS was 16.16 months (CI 95% 12.5-19.9). The cost minimization analysis revealed savings of 66.4, 61.9, and 97.7% comparing CIGC with short-infusion gemcitabine plus cisplatin (SIGC), cisplatin plus pemetrexed (CP), and cisplatin plus pemetrexed and bevacizumab (CPB), respectively. Furthermore, this chemotherapy regimen proved to be safe at the administered dosage. CONCLUSION: CIGC is an effective and safe treatment option for patients with unresectable MPM; besides, this combination is a cost-saving option when compared with other frequently used chemotherapy schemes. Therefore, this treatment scheme should be strongly considered for patients with unresectable MPM and limited economic resources.

Cost-effectiveness analysis of first and second-generation EGFR tyrosine kinase inhibitors as first line of treatment for patients with NSCLC harboring EGFR mutations.

BACKGROUND: Tyrosine-kinase inhibitors (TKIs) have become the cornerstone treatment of patients with non-small cell lung cancer that harbor oncogenic EGFR mutations. The counterpart of these drugs is the financial burden that they impose, which often creates a barrier for accessing treatment in developing countries. The aim if the present study was to compare the cost-effectiveness of three different first and second generation TKIs. METHODS: We designed a retrospective cost-effectiveness analysis of three different TKIs (afatinib, erlotinib, and gefitinib) administered as first-line therapy for patients with NSCLC that harbor EGFR mutations. RESULTS: We included 99 patients with the following TKI treatment; 40 treated with afatinib, 33 with gefitinib, and 26 with erlotinib. Median PFS was not significantly different between treatment groups; 15.4 months (95% CI 9.3-19.5) for afatinib; 9.0 months (95% CI 6.3- NA) for erlotinib; and 10.0 months (95% CI 7.46-14.6) for gefitinib. Overall survival was also similar between groups: 29.1 months (95% CI 25.4-NA) for afatinib; 27.1 months (95% CI 17.1- NA) for erlotinib; and 23.7 months (95% CI 18.6-NA) for gefitinib. There was a statistically significant difference between the mean TKIs costs; being afatinib the most expensive treatment. This difference was observed in the daily cost of treatment (p < 0.01), as well as the total cost of treatment (p = 0.00095). Cost-effectiveness analysis determined that afatinib was a better cost-effective option when compared with first-generation TKIs (erlotinib and gefitinib). CONCLUSION: In our population, erlotinib, afatinib, and gefitinib were statistically equally effective in terms of OS and PFS for the treatment of patients with advanced EGFR-mutated NSCLC population. Owing to its marginally increased PFS and OS, the cost-effectiveness analysis determined that afatinib was a slightly better cost-effective option when compared with first-generation TKIs (erlotinib and gefitinib).

Nimotuzumab (CIMAher®) en pacientes cubanos con cáncer de cabeza y cuello estadios III/IV: Análisis de impacto presupuestario / Nimotuzumab (CIMAher®) in Cuban patients with head and neck cancer stage III/IV: Budget impact analysis

En Cuba, el cáncer es la segunda causa de muerte con 24.902 defunciones en el 2018; de ellas, 795 fueron por tumores de laringe y 826 por tumores de labio, cavidad bucal y faringe. El anticuerpo monoclonal nimotuzumab (CIMAher®) está registrado como tratamiento combinado con radioterapia o quimioterapia para el cáncer de células escamosas de cabeza y cuello estadios avanzados. Del mismo se conoce su efectividad y perfil de seguridad, no así el impacto económico que acarrearía la incorporación del mismo al Sistema Nacional de Salud (SNS) cubano; de forma tal de asignar y reajustar presupuestos en la esfera de medicamentos. Por tanto, se hizo necesario realizar un análisis de impacto presupuestario, con el objetivo de estimar el impacto financiero de la incorporación del nimotuzumab (CIMAher®) al paquete de beneficios del SNS cubano. Se tomaron los datos de prevalencia e incidencia de la enfermedad en los estadios III/IV. Se estableció un escenario actual con la terapia radio/quimioterapia secuencial y una tasa de penetración de 100%. El escenario futuro fue radio/quimioterapia secuencial + nimotuzumab (CIMAher®) con tasa anual de penetración 20, 40, 60, 80 y 100 por ciento. La perspectiva fue desde el SNS y un horizonte temporal de 5 años (2019-2023). El análisis de impacto presupuestal mostró que, desde perspectiva, horizonte y tasa de penetración establecidos, el SNS debe invertir aproximadamente de 10 a 65 millones de pesos cubanos (CUP); cifras menores al presupuesto destinado a salud pública(AU)

In Cuba, cancer is the second cause of death with 24,902 deaths in 2018; 795 were due to laryngeal tumors and 826 due to tumors of the lip, oral cavity and pharynx. The monoclonal antibody nimotuzumab (CIMAher®) is registered as a combined treatment with radiotherapy or chemotherapy for advanced squamous cell carcinoma of the head and neck. Its effectiveness and safety profile are known, but not their economic impact into the Cuban National Health System (NHS); in order to allocate and readjust budgets in the field of medicines. Therefore, it was necessary to perform a budget impact analysis in order to estimate the financial impact of the incorporation of nimotuzumab (CIMAher®) into the benefits package of the Cuban NHS. Data on prevalence and incidence of the disease in stages III / IV were taken into account. The current scenario was with the therapy radio/sequential chemotherapy and penetration rate of 100 percent. The future scenario was radio/sequential chemotherapy + nimotuzumab (CIMAher®) and annual penetration rate of 20, 40, 60, 80 and 100 percent. The perspective was from the NHS and a time horizon of five years (2019-2023). The budget impact analysis showed that from an established perspective, horizon and penetration rate, the NHS must invest 10-65 million Cuban pesos (CUP) approximately; lower values than the budget allocated to Public Health(AU)

Economic impact of the chronic kidney disease: Perspective of the Instituto Mexicano del Seguro Social / Impacto económico de la enfermedad renal crónica: Perspectiva del Instituto Mexicano del Seguro Social

In Mexico, as in other parts of the world, end-stage renal disease (ESRD) constitutes a public health problem associated with high morbidity, mortality, costs and a diminished quality of life. The Instituto Mexicano del Seguro Social (IMSS) attends to, approximately, 73% of the Mexican population requiring dialysis or transplant. In 2014, the treatment of ESRD represented 15% of the total annual expenditure of IMSS major program (Disease and Maternity Security), i.e. approximately $13 250 million Mexican pesos (MP); this expense was invested in only 0.8% of patients (those with ERSD). There are few economic evaluation studies showing the real cost of kidney replacement therapies from institution's perspective. In order to reduce the global cost of ESRD, it is necessary to implement appropriate strategies of prevention, diagnosis and treatment to reduce incidence and progression of chronic kidney disease; to intensify research studies for a better understanding of etiological factors, mechanism of kidney damage progression and identification of new therapeutic agents; to create a national kidney disease registry, and to incorporate the economic evaluation methodology in the decision-making, in order to identify improved cost-benefit or cost-effective strategies.

En México, al igual que en otras partes del mundo, la enfermedad renal crónica terminal (ERCT) constituye un problema de salud pública asociado a elevada morbilidad, mortalidad, grandes costos y una calidad de vida disminuida. El Instituto Mexicano del Seguro Social (IMSS) atiende aproximadamente al 73% de la población mexicana que requiere diálisis o trasplante. En el año 2014, el tratamiento de la ERCT representó para el Instituto el 15% del gasto total anual de su mayor programa (Seguro de Enfermedades y Maternidad), aproximadamente $13 250 millones de pesos; este gasto se invirtió en tan solo el 0.8% de los derechohabientes (población con ERCT). Con el objetivo de disminuir la carga global de la ERCT, es necesario: 1) Implementar estrategias de prevención, diagnóstico y tratamiento de la ERC desde estadios más tempranos; 2) Fortalecer estudios de investigación dirigidos a una mejor comprensión de factores etiológicos, mecanismos de progresión de daño renal e identificar nuevos agentes terapéuticos; 3) Contar con un registro nacional de enfermedades renales; 4) Incorporar en la toma de decisiones, estudios de evaluación económica para identificar estrategias con un mayor costo-beneficio o costo-efectividad en el tratamiento de la ERC.

A systematic review and mixed treatment comparison of monotherapy in early Parkinson's disease: implications for Latin America.

Parkinson's disease (PD) is the second most common neurodegenerative disease. There are no clinical trials comparing all available pharmacological therapies for the treatment of early PD. The objective of this review is to indirectly analyze the efficacy of antiparkinson drugs currently available in Latin America. A systematic review was performed exploring only placebo-controlled randomized trials comparing antiparkinson monotherapy (levodopa, pramipexole, rasagiline, or selegiline) in patients with PD on Hoehn and Yahr stages I through III published from January 1994 to May 2014. The primary outcome was the mean change in the Unified PD Rating Scale (UPDRS) I, II and III. A mixed treatment comparison analysis (indirect comparisons) through a random-effects model was performed. Levodopa demonstrated the highest effects in terms of UPDRS score improvement both from baseline and when compared to other treatments. Levodopa showed a 60.1% probability of granting the greatest reduction in UPDRS I, II and III.

Six-month efficacy and safety of amfepramone in obese Mexican patients: a double-blinded, randomized, controlled trial.

Amfepramone, also known as diethylpropion, is an anorectic drug used for the short-term treatment of obesity; however, its efficacy and safety during periods greater than 3 months has been scarcely studied. To evaluate the 6-month efficacy and safety of amfepramone treatment in obese adult Mexican patients resistant to diet and exercise, a double-blinded, randomized, and placebo-controlled clinical trial study was designed on 156 volunteers with a body mass index (BMI) greater than 30 kg/m2 and less than 45 kg/m2. Patients were randomized to receive a 75 mg tablet of amfepramone or placebo daily for 6 months. Primary outcome was the absolute body weight loss, whereas secondary outcomes were the percentage of patients who achieved at least 5% or 10% weight loss, as well as the improvement of anthropometric and metabolic parameters. Amfepramone treatment produced a superior efficacy to decrease body weight than placebo at 3 months (-4.9±0.25 kg vs. -0.7±0.32 kg) and 6 months (-7.7±0.52 kg vs. -1.1±0.7 kg). In addition, 64 and 34 patients achieved at least 5% or 10% weight loss, respectively, with amfepramone at 6 months, compared with 8 and 0 patients on placebo. Amfepramone also significantly improved BMI and waist circumference, but it only showed a favorable tendency in the waist-hip index (WHI), glucose, total cholesterol, low-density lipoproteins (LDL), high-density lipoproteins (HDL), triglycerides, heart rate, systolic blood pressure, and diastolic blood pressure at 3 and 6 months. Amfepramone produced only mild adverse events, and they were presented in a greater number than placebo only at 3 months, dry mouth being the the main adverse event. Data suggest that amfepramone is effective and well tolerated in obese Mexican patients during a 6-month regimen.

Comparison of cost-utility between automated peritoneal dialysis and continuous ambulatory peritoneal dialysis.

BACKGROUND AND AIMS: The use of automated peritoneal dialysis (APD) is increasing compared to continuous ambulatory peritoneal dialysis (CAPD). Surprisingly, little data about health benefits and cost of APD exist, and virtually no information comparing the cost-utility between CAPD and APD is available. We undertook this study to evaluate and compare the health-related quality of life (HRQOL) and cost-utility indexes in patients on CAPD vs. APD METHODS: This was a prospective cohort of patients initiating dialysis (2008-2009). Two questionnaires were self-administered: European Research Questionnaire Quality of Life (EQ-5D) and Kidney Disease Quality of Life (short form, KDQOL-SF, Rand, Santa Monica, CA). Direct medical costs (DMC) were determined from the health provider perspective including the following medical resource utilization: outpatient clinic/emergency care, dialysis procedures, medications, laboratory tests, hospitalization, and surgery. Cost-utility indexes were calculated dividing total mean cost by indicators of the HRQOL. RESULTS: One hundred twenty-three patients were evaluated: 77 on CAPD and 46 on APD. Results of the EQ-5D and KDQOL-SF questionnaires were significantly better in APD compared to the CAPD group. Main costs in both APD and CAPD were attributed to hospitalization and dialysis procedures followed by medication and surgery. Outpatient clinic visits and laboratory tests were significantly more costly in CAPD than in APD, whereas dialysis procedures were more expensive in the latter. Cost-utility indexes were significantly better in APD compared to CAPD. CONCLUSIONS: A significant cost-utility advantage of APD vs. CAPD was observed. The annual DMC per-patient were not different between groups but the HRQOL was better in the APD compared to the CAPD group.

Comparison of direct medical costs between automated and continuous ambulatory peritoneal dialysis.

OBJECTIVE: We set out to estimate the direct medical costs (DMCs) of peritoneal dialysis (PD) and to compare the DMCs for continuous ambulatory PD (CAPD) and automated PD (APD). In addition, DMCs according to age, sex, and the presence of peritonitis were evaluated. METHODS: Our retrospective cohort analysis considered patients initiating PD, calculating 2008 costs and, for comparison, updating the results for 2010. The analysis took the perspective of the Mexican Institute of Social Security, including outpatient clinic and emergency room visits, dialysis procedures, medications, laboratory tests, hospitalizations, and surgeries. RESULTS: No baseline differences were observed for the 41 patients evaluated (22 on CAPD, 19 on APD). Median annual DMCs per patient on PD were US$15 072 in 2008 and US$16 452 in 2010. When analyzing percentage distribution, no differences were found in the DMCs for the modality groups. In both APD and CAPD, the main costs pertained to the dialysis procedure (CAPD 41%, APD 47%) and hospitalizations (CAPD 37%, APD 32%). Dialysis procedures cost significantly more (p = 0.001) in APD (US$7 084) than in CAPD (US$6 071), but total costs (APD US$15 389 vs CAPD US$14 798) and other resources were not different. The presence of peritonitis increased the total costs (US$16 075 vs US$14 705 for patients without peritonitis, p = 0.05), but in the generalized linear model analysis, DMCs were not predicted by age, sex, dialysis modality, or peritonitis. A similar picture was observed for costs extrapolated to 2010, with a 10% - 20% increase for each component--except for laboratory tests, which increased 52%, and dialysis procedures, which decreased 3%, from 2008. CONCLUSIONS: The annual DMCs per patient on PD in this study were US$15 072 in 2008 and US$16 452 in 2010. Total DMCs for dialysis procedures were higher in APD than in CAPD, but the difference was not statistically significant. In both APD and CAPD, 90% of costs were attributable to the dialysis procedure, hospitalizations, and medications. In a multivariate analysis, no independent variable significantly predicted a higher DMC.