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Background The objective of this study was to carry out a cost-effectiveness analysis of dapagliflozin, as an add-on therapy to standard of care (SoC), for the treatment of type 2 diabetes mellitus (T2DM) in Spain, based on the results of the DECLARE-TIMI 58 trial. Methods A discrete event simulation model (Cardiff T2DM) based on the data observed in the DECLARE-TIMI 58 trial was adapted to the Spanish setting to estimate the costs and health outcomes of treatment with dapagliflozin in patients with T2DM who had or were at risk of atherosclerotic cardiovascular disease. Macrovascular events (hospitalization for heart failure, myocardial infarction, stroke, and unstable angina), end-stage renal disease and cardiovascular and non-cardiovascular mortality were modeled according to the survival equations of the DECLARE-TIMI 58 study. Microvascular events (blindness and ulcers) were estimated based on the risk equations of the UK Prospective Diabetes Study. The analysis was conducted from the Spanish National Health System perspective and the time horizon was 30 years. The results were evaluated in terms of cost per quality-adjusted life year (QALY) gained. Only direct health costs were included, and a 3% discount rate was applied to costs and health outcomes. Univariate and probabilistic sensitivity analyses (PSA) were made to assess the robustness of the results. Results In the main analysis, dapagliflozin was a dominant therapeutic option compared with placebo, with greater effectiveness (0.08 QALYs) and lower associated total costs per patient (€ -2,921). The univariate sensitivity analysis and the PSA confirmed the robustness of the results. The PSA showed the probability that dapagliflozin was a dominant alternative compared with placebo was 84.2% and that it was cost-effective of 92.1%, under a willingness-to-pay of € 20,000/QALY gained. Conclusions The analysis of data from the DECLARE-TIMI 58 trial shows that dapagliflozin would be a cost-effective option in Spain for the treatment of adult patients with T2DM, as an add-on therapy to SoC, compared with placebo.

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The objective of this study was to evaluate the cost-effectiveness of nivolumab in combination with ipilimumab (Nivo+Ipi) compared to current therapeutic alternatives in first-line treatment of patients with advanced melanoma regardless of biomarker status in Belgium from a healthcare payer perspective using 48-month survival data from the CheckMate 067 Phase III trial. Methods: A threestate partitioned survival model was developed from projections of overall survival and progression free survival based on a network meta-analysis which considers time-varying hazard ratios to estimate accrued quality-adjusted survival and costs over a 30-year time horizon. The analysis considered nivolumab monotherapy as the key comparator but also included ipilimumab, pembrolizumab, dabrafenib, dabrafenib + trametinib, vemurafenib + cobimetinib, and dacarbazine. Drug acquisition, administration, follow-up, subsequent therapy and adverse event costs were obtained via published sources and expert input. Adverse event frequencies were collected from the Checkmate 067 trial and published literature. Utility weights were estimated from the Checkmate 067 trial, based on Belgian tariffs. A 3% discount rate was applied to costs and 1.5% rate to utilities. Results were presented as incremental cost-utility ratios (ICURs). BRAF status specific patterns of subsequent treatment were assigned. Results: Nivo+Ipi was projected to have the greatest accrued survival among the competing treatments with 8.8 LYs and 6.2 QALYs. The comparisons vs. nivolumab resulted in an ICUR of approximately V22,000 per QALY. Pairwise ICURs for Nivo+Ipi vs. other treatments ranged from V25,000 per QALY (vs. ipilimumab) to V38,000 per QALY (vs. dacarbazine). Conclusions: The analysis highlighted that Nivo+Ipi is associated with the highest gain in quality-adjusted survival accompanied by higher costs compared to the current therapeutic alternatives. ICUR results indicated that Nivo+Ipi is a cost-effective option in the first-line treatment of advanced melanoma in Belgium.

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