The main analysis conservatively assumes 50 percent switching at discontinuation. The cost per quality-adjusted life-year (QALY) gained with early ETA/MTX treatment is €13,500 (societal perspective, incremental cost of €15,500 and incremental QALYs of 1.15). With 75 percent switching, the cost per QALY gained was €10,400. Over 20 years, the cost per QALY gained was €8,200. Results were further sensitive to the time patients remained on half dose and the perspective. CONCLUSIONS AND POLICY IMPLICATIONS: This study combines clinical trial and clinical practice data to explore cost-effective treatment scenarios in early RA, including the use of biologics. Our results indicate that a situation where a considerable proportion of patients achieve remission, dose-adjustments will increase the cost-effectiveness of treatment.

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Objectives: Heart failure (HF) has a prevalence of 915.000 people in Italy and it is one of the main public health problems, with poor survival rates, high disability, significant economic burden and reduction in quality of life. A new treatment, sacubitril/valsartan, reduced CV death and HF hospitalizations compared to standard of care. Aim of the study was to assess the cost-effectiveness of sacubitril/valsartan compare to enalapril. MethOds: A 2-state Markov model, with 'alive' and 'dead' states, was developed to predict the effect of treatment options in terms of CV Mortality, Hospitalisation and Health-related quality of life (HRQL). The economic model is structured as a regression-based cohort model. Based on the data of the PARADIGM-HF clinical trial, CV Mortality was estimated using parametric survival curves, Hospitalization rates were estimated using a negative binomial regression model and HRQL was estimated as a longitudinal analysis of EQ-5D values using a mixed-effects regression model. The model estimated costs, Life Years (LYs) and Quality-Adjusted Life Years (QALY) using 30 year time horizon and the Italian NHS perspective. Results were presented as incremental cost-effectiveness ratios (ICERs) per QALY gained. Cost and outcomes were discounted at 3.5%. Results: The model reported a better survival in the patients treated with sacubitril/valsartan compare to enalapril, with an improvement of 0.30 LY and 0.26 QALY gained. The treatment cost with sacubitril/valsartan (assumed because not yet available in Italy) increased the overall cost that is partially offset by the reduction of the hospitalization costs. Comparing the difference in costs and QALYs, sacubitril/valsartan results as the cost-effectiveness option with an ICER of € 22,431 below the willingness to pay threshold of € 50,000 usually applied in Italy. cOnclusiOns: Sacubitril/valsartan is a cost-effective treatment option in Heart Failure patients with Reduced Ejection Fraction. Future investigations that incorporate real-world evidence with sacubitril/ valsartan are required to confirm these results.

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