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Background: New targeted therapeutics for metastatic renal cell carcinoma (mRCC) enable an increment in progression-free survival (PFS) ranging from 2 to 6 months. Compared with best supportive care, everolimus demonstrated an additional PFS of 3 months in patients with mRCC whose disease had progressed on sunitinib and/or sorafenib. The only targeted therapy for mRCC currently reimbursed in Serbia is sunitinib. Objective: The aim of this study was to estimate the cost-effectiveness and the budget impact of the introduction of everolimus in Serbia in comparison to best supportive care, for mRCC patients refractory to sunitinib. Methods: A Markov model was designed corresponding with Serbian treatment protocols. A health care payer perspective was taken, including direct costs only. Treated and untreated cohorts were followed up over 18 cycles, each cycle lasting 8 weeks, which covered the lifetime horizon of mRCC patients refractory to the first-line treatment. Annual discounted rates of 1.5% for effectiveness and 3% for costs were applied. Transitions between health states were modeled by time-dependent probabilities extracted from published Kaplan-Meier curves of PFS and overall survival (OS). Utility values were obtained from the appraisals of other mRCC treatments. One-way and probabilistic sensitivity analyses were done to test the robustness and uncertainty of the base-case estimate. Lastly, the potential impacts of everolimus on the overall health care expenditures on annual and 4-year bases were estimated in the budget-impact analysis. Results: The incremental cost-effectiveness ratio for everolimus was estimated at €86,978 per quality-adjusted life-year. Sensitivity analysis identified the hazard multiplier, a statistical approximator of OS gain, as the main driver of everolimus cost-effectiveness. Furthermore, probabilistic sensitivity analyses revealed a wide 95% CI around the base-case incremental cost-effectiveness ratio estimate (€32,594–€425,258 per quality-adjusted life-year). Finally, an average annual budgetary impact of everolimus in first 4 years after its potential reimbursement would be around €270,000, contributing to <1% of the total budget in Serbian oncology. Conclusions: Everolimus as a second-line treatment of mRCC is not likely to be a cost-effective option under the present conditions in Serbia, with a relatively limited impact on its budget in oncology. A major constraint on the estimation of the cost- effectiveness of everolimus relates to the uncertainty around the everolimus effect on extending OS. How- ever, prior to a final decision on the acceptance/ rejection of everolimus, reassessment of the whole therapeutic group might be needed to construct an economically rational treatment strategy within the mRCC field. [ABSTRACT FROM AUTHOR]

Background: Albuminuria is a marker for renal and cardiovascular (CV) risk, allowing early diagnosis of subjects with elevated renal and CV risk. Objective: This study aimed to estimate the costeffectiveness and budget impact of various population-based screen-and-treat scenarios for elevated albuminuria levels (ie, microalbuminuria) in the Netherlands. Methods: A multistate transition Markov model was developed to simulate the natural course of albuminuria-based disease progression to dialysis and occurrence of CV events. Several population-based strategies directed at screening for elevated albuminuria were evaluated. These strategies depended on urinary albumin concentration (UAC), urinary albumin excretion (UAE), and age. Transition probabilities were derived from the observational community-based Prevention of Renal and Vascular End Stage Disease (PREVEND) cohort study. Health care costs (in year-2008 euros) and life-years gained were calculated over an 8-year period. In the base-case analysis, we analyzed screening for and treatment of microalbuminuria. Screening for microal-buminuria involved prescreening for UAC ≥20 mg/L, followed by a confirmation test for UAE ≥30 mg/d. Other options based on combinations of albuminuria for UAC prescreening (no prescreening, and ≥10, ≥20, ≥100, and ≥200 mg/L) and UAE confirmation test (≥15, ≥30, and ≥300 mg/d) for treatment were investigated in scenario analyses. Furthermore, these various strategies based on UAC and UAE values were analyzed in different subgroups based on age (all ages, aged ≥50 years, and aged ≥60 years). Results: The PREVEND study included 8592 Dutch residents aged 28 to 75 years at the time of initial screening. Among a hypothetical cohort of 1000 subjects identified and treated in the base-case analysis, it was estimated (based on PREVEND follow-up data) that, in the screening/treatment and no-screening scenarios, 76 versus 124 CV events occurred, 16 versus 27 CV deaths, and 3 versus 5 dialysis cases, respectively. The per-person difference in net costs for screening was calculated at €926 (€2003 vs €1077), and prevention of CV deaths was estimated to gain 0.0421 discounted life-year per person. Correspondingly, the cost-effectiveness was estimated at €22,000 per life-year gained. In the base-case analysis, probabilistic sensitivity analysis indicated that the likelihood of cost-effectiveness of a screen-and-treat strategy was 54%, 90%, and 95% for a maximum acceptable cost-effectiveness threshold of €20,000, €50,000, and €80,000 per life-year gained, respectively. Higher albuminuria thresholds for screening and start of treatment further improved the cost-effectiveness but reduced the overall health gains achieved. Limiting screening to those subjects aged ≥50 and ≥60 years resulted in more favorable cost-effectiveness compared with population-based screening without age restriction. Conclusions: Our analyses suggest the potentially favorable cost-effectiveness of population-based screening for albuminuria in the general Dutch population. The results offer health care decision-makers new tools for considering actual implementation of such screening. [Copyright &y& Elsevier]

Background: In the Netherlands, antihypertensive treatment for patients with mild hypertension is recommended if the 10-year cardiovascular disease (CVD) risk exceeds 20%. Recent evidence suggests that lifelong CVD risk estimates might be more informative than 10-year ones. In addition, the cost of antihypertensive treatment in the Netherlands has decreased during the last decade. Objective: The aim of this study is to estimate the cost-effectiveness of lowering systolic blood pressure (SBP) in patients ineligible for treatment in both a 10-year and a lifetime horizon. Methods: A Markov model was developed to assess the cost-effectiveness of SBP reduction compared with no reduction in patients with mild hypertension and low CVD risk. Modified SCORE (Systematic Coronary Risk Evaluation) risk estimates were used to predict fatal and nonfatal CVD events. We analyzed scenarios for different age groups, sexes, and SBP reductions. Specifically, SBP reductions due to hydrochlorothiazide (HCT) 25 mg and hypothetical reductions with HCT 12.5 mg-losartan 50 mg combination were assumed. Parameter uncertainty was assessed through a probabilistic sensitivity analysis. Results: In a 10-year horizon, in scenarios of SBP reduction with HCT 25 mg, the incremental cost-effectiveness ratio (ICER) estimates for men varied across different ages in the range of €6032 to €58,217 per life-year gained, whereas for women ICER estimates were in the range of €12,345 to €361,064 per life-year gained. In a lifetime horizon, the cost-effectiveness estimates were favorable for both sexes. In scenarios of hypothetical SBP reductions, more favorable ICER estimates compared with no reduction were found. A large uncertainty around the cost-effectiveness estimates was observed among all scenarios. Conclusion: Larger SBP reductions were found to be cost-effective in both a 10-year and lifetime horizon. These findings might call for more aggressive SBP reductions in patients with mild hypertension. However, a high level of uncertainty surrounds these cost-effectiveness estimates because they are based on CVD risk prediction modeling. [ABSTRACT FROM AUTHOR]