ABSTRACT
BACKGROUND: Sacubitril/valsartan (an Angiotensin receptor-neprilysin inhibitor-ARNI) is one of the cornerstones in the management of patients with heart failure with reduced ejection fraction (HFrEF) having demonstrated significant reductions in both mortality and hospitalisations as compared with enalapril. It proved to be a cost-effective treatment in many countries with stable economies. In Argentina, a country with chronic financial instability and a fragmented health care system, the estimation of its cost-effectiveness requires to consider local financial data. OBJECTIVES: To estimate the cost-effectiveness of sacubitril/valsartan in HFrEF in Argentina. METHODS: We populated an Excel-based cost-effectiveness model, previously validated, using inputs from the pivotal phase-3 PARADIGM-HF trial and from local sources. As the main problem to consider was the financial instability, we adopted a differential approach to cost discounting based on the opportunity cost of capital. Thus, a discount rate for costs were set at 31.6%, using the BADLAR rate published by the Central Bank of Argentina. Discount for effects were set at 5% as is the current practice. Costs were expressed in Argentinian pesos (ARS). We used the perspective for both the social security and private payers at a 30-year horizon. The primary analysis was the incremental cost-effectiveness ratio (ICER) versus enalapril, the previous standard of care. Alternative scenarios performed included a 5% cost discount rate and 3 a 5-year horizon (as is usually used). RESULTS: In Argentina the cost-per quality adjusted life-year (QALY) gained for sacubitril/valsartan versus enalapril was 391,158 ARS and 376,665 ARS for a social security and a private payer, respectively, at a 30- year horizon. These ICERs were under the cost- effectiveness threshold of 520,405.79 ARS (1 Gross domestic product (GDP) per capita) suggested by Argentinian health technology assessment bodies. Probabilistic sensitivity analysis showed an acceptability of sacubitril/valsartan as a cost-effective alternative of 86.40% and 88.25% for social security and private payers, respectively. CONCLUSION: Sacubitril/valsartan is a cost-effective treatment in HFrEF using local inputs that considered the financial instability. For both payers considered the cost per QALY gained are under the cost-effectiveness threshold considered.
ABSTRACT
BACKGROUND: Hypertension (HTN) is one of the major risk factors for cardiovascular disease in Western countries, and disease control is of major relevance in order to reduce cardiovascular morbidity and mortality. Different approaches have shown efficacy, and one of the proven therapies for HTN control is the blockade of the renin-angiotensin-aldosterone system, which may be accomplished by means of various drugs with different modes of action. Aliskiren is a novel direct renin inhibitor that reduces both angiotensin I and II blood levels. Different randomized clinical trials (phase II and III) have shown its safety and efficacy either alone or in combination with hydrochlorothiazide. However, although aliskiren has been on the market for some years, reports on the post-marketing experience with aliskiren in the real-world setting are lacking. METHODS: The Aliskiren in Latin America Study (ALAS) was designed with the aim of describing the effectiveness of aliskiren at reducing blood pressure (BP) values by prospectively assessing BP control in outpatient clinics in different countries in Latin America. A total of 435 sites in 5 Latin American countries (Mexico, Ecuador, Colombia, Argentina, and Venezuela) enrolled 4588 patients who had just been initiated on aliskiren (either alone or in combination with hydrochlorothiazide) based on their treating physicians' discretion, and they were followed for a 6-month period. Prior antihypertensive drugs could be continued if their doses were not modified along the study. RESULTS: At the end of the follow-up period, a statistically significant reduction in BP values was observed, with a mean systolic BP reduction of 29.2 mmHg and a mean diastolic BP reduction of 13.78 mmHg from baseline at the 6-month visit. CONCLUSION: The BP reduction levels and the low adverse event rate demonstrate the adequate efficacy and safety profile of aliskiren (alone or with hydrochlorothiazide).
