Budget impact analysis of venetoclax for the management of acute myeloid leukemia from the perspective of the social security and the private sector in Argentina.

OBJECTIVE: This study aimed to estimate the budget impact of the incorporation of venetoclax for the treatment of patients with Acute Myeloid Leukemia (AML) over 75 years of age or those with comorbidities and contraindications for the use of intensive chemotherapy, from the perspective of the social security and the private third-party payers in Argentina. METHODS: A budget impact model was adapted to estimate the cost difference between the current scenario (azacitidine, decitabine and low doses of cytarabine) and the new scenario (incorporation of venetoclax) for a third-party payer over a time horizon of three years. Input parameters were obtained from a literature review, validated or complemented by expert opinion using a modified Panel Delphi approach. All direct medical costs were estimated by the micro-costing approach and were expressed in US dollars (USD) as of September 2020 (1 USD = 76.18 Argentine pesos). RESULTS: For a third-party payer with a cohort of 1,000,000 individuals covered, incorporating venetoclax was associated with an average budget impact per-member per-month (PMPM) of $0.11 USD for the social security sector and $0.07 USD for the private sector. The duration of treatment with venetoclax was the most influential parameter in the budget impact results. CONCLUSION: The introduction of venetoclax was associated with a positive and slight budget impact. These findings are informative to support policy decisions aimed to expand the current treatment landscape of AML.

Cost-effectiveness of a centrifugal-flow pump for patients with advanced heart failure in Argentina.

BACKGROUND: Centrifugal-flow pumps are novel treatment options for patients with advanced heart failure (HF). This study estimated the incremental cost-effectiveness ratio (ICER) of centrifugal-flow pumps for patients with advanced HF in Argentina. METHODS: Two Markov models were developed to estimate the cost-effectiveness of a centrifugal-flow pump as destination therapy (DT) in patients with contraindication for heart transplantation, and as bridge-to-transplant (BTT), with a lifetime horizon using the third-party payer Social Security (SS) and Private Sector (PS) perspectives. Clinical, epidemiological, and quality-adjusted life years (QALY) parameters were retrieved from the literature. Direct medical costs were estimated through a micro-costing approach (exchange rate USD 1 = ARS 59.95). RESULTS: The centrifugal-flow pump as a DT increased the per patient QALYs by 3.5 and costs by ARS 8.1 million in both the SS and PS, with an ICER of ARS 2.3 million per QALY. Corresponding values for a centrifugal-flow pump as BTT were 0.74 QALYs and more than ARS 8 million, yielding ICERs of ARS 11 million per QALY (highly dependent on waiting times). For the 1, 3, and 5 GDP per QALY thresholds, the probability of a centrifugal-flow pump to be cost-effective for DT/BTT was around 2%/0%, 40%/0%, and 80%/1%, respectively. CONCLUSION: The centrifugal-flow pump prolongs life and improves the quality of life at significantly higher costs. As in Argentina there is no current explicit cost-effectiveness threshold, the final decision on reimbursement will depend on the willingness to pay in each subsector. Nevertheless, the centrifugal-flow pump as a DT was more cost-effective than as a BTT.

Improving the monitoring of chronic heart failure in Argentina: is the implantable pulmonary artery pressure with CardioMEMS Heart Failure System cost-effective?

BACKGROUND: The CardioMEMS® sensor is a wireless pulmonary artery pressure device used for monitoring symptomatic heart failure (HF). The use of CardioMEMS was associated with a reduction of hospitalizations of HF patients, but the acquisition cost could be high in low-and-middle income countries. Evidence of cost-effectiveness is needed to help decision-makers to allocate resources according to "value for money". This study is aimed at estimating the cost-effectiveness of CardioMEMS used in HF patients from the third-party payer perspective -Social Security (SS) and Private Sector (PS)- in Argentina. METHODS: A Markov model was developed to estimate the cost-effectiveness of CardioMEMS versus usual medical care over a lifetime horizon. The model was applied to a hypothetical population of patients with HF functional class III with at least one hospitalization in the previous 12 months. The main outcome was the incremental cost-effectiveness ratio (ICER). To populate the model we retrieved clinical, epidemiological and utility parameters from the literature, whilst direct medical costs were estimated through a micro-costing approach (exchange rate USD 1 = ARS 76.95). Uncertainties in all parameters were assessed by deterministic, probabilistic and scenario sensitivity analysis. RESULTS: Compared with the usual medical care, CardioMEMS increased quality-adjusted life years (QALY) by 0.37 and increased costs per patient by ARS 1,081,703 for SS and ARS 919,051 for PS. The resultant ICER was ARS 2,937,756 per QALY and ARS 2,496,015 per QALY for SS and PS, respectively. ICER was most sensitive to the hazard ratio of HF hospital admission and the acquisition price of CardioMEMS. The probability that CardioMEMS is cost-effective at one (ARS 700,473), three (ARS 2,101,419,) and five (ARS 3,502,363) Gross Domestic Product per capita is 0.6, 17.9 and 64.1% for SS and 5.4, 33.3 and 73.2% for PS. CONCLUSIONS: CardioMEMS was more effective and more costly than usual care in class III HF patients. Since in Argentina there is no current explicit threshold, the final decision to determine its cost-effectiveness will depend on the willingness-to-pay for QALYs in each health subsector.

Anticoagulantes orales directos en fibrilación auricular no valvular / Direct oral anticoagulants in nonvalvular atrial fibrillation

El presente informe es producto del trabajo colaborativo de la Comisión Nacional de Evaluación de Tecnologías de Salud (CONETEC), dependiente del Ministerio de Salud de la Nación y creada por RM N° 623/2018. La CONETEC realiza evaluaciones y emite recomendaciones a la autoridad sanitaria sobre la incorporación, forma de uso, financiamiento y políticas de cobertura de las tecnologías sanitarias desde una perspectiva global del sistema de salud argentino. En sus evaluaciones y recomendaciones, la CONETEC tiene en cuenta criterios de calidad, seguridad, efectividad, eficiencia y equidad, evaluados bajo dimensiones éticas, médicas, económicas y sociales. Sus resultados son consensuados mediante discusiones públicas y ponderados a través de un marco de valor explícito, con la participación de todos los actores involucrados en el proceso de toma de decisiones en salud. Los informes y recomendaciones de esta comisión surgen de este proceso público, transparente y colaborativo, siendo de libre consulta y acceso para toda la sociedad.

In vitro transduction of antimicrobial resistance genes into Escherichia coli isolates from backyard poultry in Mexico.

The transmission of multidrug-resistant pathogens and antimicrobial resistance genes is an emerging problem involving multiple factors (humans, domestic animals, wildlife). The aim of this study was to investigate the presence of Escherichia coli isolates with different antimicrobial resistance genes from backyard poultry and to demonstrate the in vitro transduction phenomenon of these genes between phages from migratory wild birds and poultry E. coli isolates. We collected 197 E. coli isolates from chickens, turkeys, and ducks in backyard production units (northern region of the State of Mexico). Isolates were resistant to ampicillin (80.7%), tetracycline (64.4%), carbenicillin (56.3%), and nalidixic acid and trimethoprim-sulfamethoxazole (both, 26.9%). Moreover, the genes blaTEM (56.3%), tetB (20.8%), tetA (19.2%), sulI (7.6%), sulII (10.1%), qnrA (9.6%), and qnrB (5.5%) were found. In vitro transduction using phages from migratory wild birds sampled in the wetland Chimaliapan (State of Mexico) was successfully achieved. It was possible to transduce qnrA, tetB, blaTEM, and sulII genes to E. coli isolates from poultry. This is the first report that describes the transduction of antimicrobial resistance genes from phages of migratory wild birds to poultry and suggests the possible transmission in backyard production units.