In the KEYNOTE-024 trial, pembrolizumab demonstrated significant improvements in progressionfree survival (PFS) and overall survival (OS) versus Standard-of-Care (SoC) platinum-based doublets for first-line treatment of PD-L1-positive (≥50%) metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with no EGFR mutations or ALK translocations. This study aims to assess the cost-effectiveness of pembrolizumab versus SoC platinum-based chemotherapy from the French healthcare system perspective. Methods: A three-state partitioned-survival model was adapted to project outcomes and costs of squamous and non-squamous NSCLC patients respectively, over a 10-year time horizon. Clinical and utility data were collected from the trial. A network meta-analysis was performed to consider platinum-based triplets also used for nonsquamous NSCLC. Direct medical costs were considered based on ressources identified from the trial and literature. Costs and outcomes were discounted at 4% per year. Incremental cost-effectiveness ratios (ICERs) were calculated as cost per Life Year (LY) and cost per Quality-Adjusted Life Year (QALY). Sensitivity and scenario analyses were performed to assess the robustness of results. Results: For squamous NSCLC, pembrolizumab was projected to increase life expectancy of patients by 0.93 LY (11 months), and 0.74 QALY (9 months) for an incremental cost of €62,032 compared with platinum-based doublets. The ICER of pembrolizumab versus platinum-based doublets was €66,825/LY and €84,097/QALY. For non-squamous NSCLC, pembrolizumab was projected to increase life expectancy of patients by 0.85-1.32 LYs (10.2-15.8 months) and 0.64-1.02 QALYs (7.7-12.2 months) for an incremental cost varying from €-14,947-+47,064 depending on the specific comparator. The ICER of pembrolizumab versus platinum-based chemotherapy with paclitaxel plus bevacizumab was €62,846/LY and €78,729/QALY; regimens including pemetrexed were dominated. Results were most sensitive to extrapolations of survival outcomes and assumptions for continued effectiveness and treatment duration of pembrolizumab. Conclusions: Pembrolizumab appears cost-effective versus SoC chemotherapy for first-line treatment of PD-L1positive (50%) metastatic NSCLC patients in France, assuming willingness-to-pay under 100,000€/QALY (OECD threshold in the discussion section). prognosis of lung cancer is generally poor with a 5-year overall survival rate estimated at 10-15% worldwide [2]. In France, 5-year and 10-year survivals rates were 17% and 10% in 2015, respectively [3]. The poor prognosis of lung cancer can be explained by a diagnosis at an advanced stage of the disease. In 2012, about 1.6 million deaths due to lung

To analyse with a cost minimisation analysis (CMA) the per-patient costs and potential savings of MVASI ® (bevacizumab biosimilar) compared with originator Avastin ® in all reimbursed indications in Italy and to estimate with a budget impact analysis (BIA) the consequences of bevacizumab biosimilar introduction over the next 5 years. Methods: In both analyses, only drug costs were included as no differences in administration costs are expected between treatment. Official, public drug prices were used for Avastin ® , and a mandatory flat 20% discount was applied for MVASI ® . The budget impact analysis was based on bevacizumab expenditure in Italy in 2017 derived from the Italian pharmaceutical expenditure report. Uptake of bevacizumab biosimilars and market shares of biosimilars were based on the case history of rituximab biosimilars. A deterministic sensitivity analysis (DSA) was conducted to complement the budget impact estimates. Results: MVASI ® was shown to generate savings ranging from V5.797 (in metastatic colorectal cancer) to V11.595 (in advanced or metastatic renal cell cancer) per patient per year vs. Avastin. The BIA of introducing bevacizumab biosimilars in Italy could generate savings of 145.4 million euros over the next 5 years. The DSA demonstrated that the drivers of savings are the total bevacizumab market use in Year 5 and the biosimilar uptake rate in Year 5. With an increasing discount over time, savings through the adoption of bevacizumab biosimilars will be much higher. Conclusions: The CMA demonstrated that substantial savings can be achieved with the adoption of MVASI ® . The BIA showed that the introduction of bevacizumab biosimilars may produce major cost savings using a conservative fixed 20% discount for biosimilars over a five-year time horizon. This confirms the importance of a successful biosimilar adoption which could potentially provide additional resources to fund innovative treatments that can improve patient care.

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Results: The median patient follow-up duration for this cohort was 15.3 months (range: 1 day to 40 months). Baseline cohort characteristics were similar: median age was 66-69 years (overall range, 34-84); 55-57% were men. Median rwToT was 10.0 months for patients with PD-L1 TPS ≥50%, 6.2 months with TPS 1-49%, and 4.9 months with TPS <1%. In the PD-L1 TPS ≥50% cohort, 26% of patients remained on pembrolizumab at 2 years. Conclusions: The rwToT with pembrolizumab increased with PD-L1 TPS level, although the rwToT with pemetrexed in each cohort was substantially shorter. A considerable proportion of patients remained on pembrolizumab at 2 years, suggesting long-term benefit.

OBJECTIVES: The Patient-Oriented Prostate Utility Scale (PORPUS-U) is the only econometric instrument specifically designed for prostate cancer patients. The Expanded Prostate cancer Index Composite (EPIC) and the SF-36 are the most used instruments in these patients. This study aims to estimate the PORPUS-U index by EPIC and SF-36 scores to allow cost-utility analysis. METHODS: The Spanish Multicentric Localized Prostate Cancer Study in new therapeutic modalities included patients diagnosed between 2014 and 2017 (n¼469). PORPUS-U, EPIC and SF-36 were administered by telephone. The predictive model was constructed with the evaluation 3 months after treatment, and validated with evaluations at 6, 12, 24 and 36 months. A linear regression model was constructed with the logarithmic transformation of the PORPUS-U index as the dependent variable, and EPIC scores and the SF-36 physical and mental summary components as explanatory variables. All possible first level interactions were tested. R2 and Root Mean Square Error (RMSE) of the model were considered. Agreement between the estimated index and the observed one was calculated with the Intraclass Correlation Coefficient (ICC). RESULTS: The model chosen included six EPIC scores (urinary incontinence and irritative-obstructive, sexual function and bother, bowel and hormonal) and the two summary components of the SF-36: R2¼0.793, RMSE¼0.036 and ICC¼0.914. The validation models showed RMSE ranging 0.031-0.045 and ICC ranging 0.838-0.922. The means (SD) of the PORPUS-U index observed and predicted by the model were: 0.97 (0.04) vs. 0.96 (0.05) at 6 months, 0.97 (0.05) vs. 0.96 (0.06) at 12 months, 0.96 (0.05) vs. 0.96 (0.07) at 24 months and 0.97 (0.06) vs. 0.95 (0.06) at 36 months. CONCLUSIONS: The model constructed with EPIC scores and the two SF-36 summary components presented a good predictive capacity to estimate the PORPUS-U utility index, which could be useful to allow cost-utility analysis in studies without an econometric instrument.

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