Cost-utility analysis of idelalisib in combination with rituximab in relapsed or refractory chronic lymphocytic leukaemia.

OBJECTIVE: To evaluate the incremental cost-utility ratio (ICUR) of idelalisib in combination with rituximab (IR) versus rituximab monotherapy (R) in the treatment of patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL), from the Spanish National Health System (NHS) perspective. METHODS: A partitioned survival Markov model for a lifetime horizon (30 years) was developed to estimate costs (€, 2016) and quality-adjusted life years (QALY) with IR and R. Initial cohort included patients with CLL receiving a second or subsequent line (2L) of treatment with IR or R. Survival data were based on CLL clinical trial. Drug, administration, monitoring, adverse events and clinical management of CLL costs were included in the model. Costs and outcomes were discounted using a 3% annually. Deterministic and probabilistic sensitivity analyses (PSA) were performed. RESULTS: Compared to R, 2L IR treatment resulted in QALY gain of 3.147 (4.965 versus 1.818). Total costs were €118 254 for IR versus €23 874 for R. ICUR was €29 990/QALY gained with IR versus R. In the PSA, IR was cost-effective in 78% of iterations using a threshold of €45 000/QALY. CONCLUSION: IR can be considered a cost-effective treatment compared to R, in the treatment of R/R CLL patients for the Spanish NHS.

Cost Effectiveness of the 13-Valent Pneumococcal Conjugate Vaccination Program in Chronic Obstructive Pulmonary Disease Patients Aged 50+ Years in Spain.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are at elevated risk of pneumococcal infection. A 13-valent pneumococcal conjugate vaccine (PCV13) was approved for protection against invasive disease and pneumonia caused by Streptococcus pneumoniae in adults. This study estimated the incremental cost-effectiveness ratio (ICER) of vaccinating COPD patients ≥50 years old with PCV13 compared with current vaccination policy (CVP) with 23-valent pneumococcal polysaccharide vaccine. METHODS: A Markov model accounting for the risks and costs for all-cause non-bacteremic pneumonia (NBP) and invasive pneumococcal disease (IPD) was developed. All parameters, such as disease incidence and costs (€; 2015 values), were based on published data. The perspective of the analysis was that of the Spanish National Healthcare System, and the horizon of evaluation was lifetime in the base case. Vaccine effectiveness considered waning effect over time. Outcomes and costs were both discounted by 3% annually. RESULTS: Over a lifetime horizon and for a 629,747 COPD total population, PCV13 would prevent 2224 cases of inpatient NBP, 3134 cases of outpatient NBP, and 210 IPD extra cases in comparison with CVP. Additionally, 398 related deaths would be averted. The ICER was €1518 per quality-adjusted life-year (QALY) gained for PCV13 versus CVP. PCV13 was found to be cost effective versus CVP from a 5-year modelling horizon (1302 inpatient NBP and 1835 outpatient NBP cases together with 182 deaths would be prevented [ICER €25,573/QALY]). Univariate and probabilistic sensitivity analyses confirmed the robustness of the model. CONCLUSIONS: At the commonly accepted willingness-to-pay threshold of €30,000/QALY gained, PCV13 vaccination in COPD patients aged ≥50 years was a cost-effective strategy compared with CVP from 5 years to lifetime horizon in Spain.

Cost effectiveness of lanthanum carbonate in chronic kidney disease patients in Spain before and during dialysis.

AIMS: In Spain, the first line treatment of hyperphosphatemia in Chronic Kidney Disease (CKD) consists of calcium-based phosphate binders (CB). However, their use is associated with vascular calcification and an increased mortality risk. The aim of this study was to assess the incremental cost-effectiveness of second-line Lanthanum Carbonate (LC) treatment in patients not responding to CB (calcium carbonate and calcium acetate). MATERIAL AND METHODS: A lifetime Markov model was developed considering three health states (predialysis, dialysis and death). Transitions between states and efficacy data were obtained from randomized clinical trials and the European Dialysis and Transplant Association Annual report. Mortality rate was adjusted with the relative risk related to serum phosphorus levels. According to the Spanish healthcare system perspective, only medical direct costs were considered. Dialysis costs (2013 prices in Euros) were obtained from diagnosis-related groups. Drug costs were derived from ex-factory prices, adjusted with 7.5% mandatory rebate. Quality of life estimates were based on a published systematic review. Costs and benefits were discounted at 3%. Deterministic and probabilistic sensitivity analyses (PSA) were conducted. RESULTS: At the end of simulation, costs per patient with LC therapy were 1,169 and 5,044 with CB alone. 4.653 Quality Adjusted Life Years (QALYs) were gained per patient treated with LC, and 4.579 QALYs with CB. CB therapy is dominated by the LC strategy (i.e. lower costs, higher QALYs). Assuming a 30,000/QALY threshold, LC was dominant in 100% of PSA simulations. CONCLUSIONS: LC is a cost-effective second line treatment of hyperphosphatemia in CKD patients irrespective of dialysis status in Spain.

Use of Floseal®, a human gelatine-thrombin matrix sealant, in surgery: a systematic review.

BACKGROUND: Surgical bleeding can be associated with an increased risk of morbidity and mortality across all surgical areas. Thus, numerous products have been developed to achieve haemostasis. A flowable haemostatic matrix such as Floseal® can quickly and reliably stop bleeding across the full spectrum of bleeding scenarios. The aim of this study was to systematically review clinical and economic evidence regarding the use of Floseal® in surgical procedures. METHODS: An extensive literature search was conducted in PubMed, EMBASE, and the Cochrane Library over the period spanning 2003-2013 to identify publications related to Floseal® use in all types of surgical procedures. Case reports and case series studies were excluded. RESULTS: A total of 27 papers met the selection criteria and were analysed. In the studies, blood loss and the time to achieve haemostasis were the most reported outcomes used to assess the efficacy of Floseal®. The majority of published studies (64%) examined the use of Floseal® compared with conventional methods (such as electrocautery or suturing). The remaining 36% of the studies evaluated the use of Floseal® compared with other haemostatic agents, such as Surgicel®, Gelfoam®, and Hemostase®. FloSeal® has been demonstrated to be an efficacious method in surgical procedures to reduce the time to achieve haemostasis, the frequency of intra- and postoperative bleeding, and the length of hospital stay, among other primary outcomes, resulting in less consumption of health resources. CONCLUSIONS: The majority of the selected studies confirmed that Floseal® showed improvements over other haemostatic agents in achieving haemostasis and reducing blood loss.