BackgroundSurgical 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.MethodsAn 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.ResultsA 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.ConclusionsThe majority of the selected studies confirmed that Floseal® showed improvements over other haemostatic agents in achieving haemostasis and reducing blood loss.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2482-14-111) contains supplementary material, which is available to authorized users.

In 2007, spending on orphan drugs in five European countries was acceptable in terms of the percentage of these countries' overall drug expenditure. Mean annual costs per patient of orphan drugs varied widely, with costs being related to the prevalence of the disease for which the product is indicated.

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IntroductionCompare cost of the interstitial liquid glucose flash monitoring (FM) system (FreeStyle Libre 2) versus self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes mellitus (T1DM) in Spain.Research design and methodsA model was developed to estimate, with the perspective of the Spanish health system, the annual costs associated with glucose monitoring and hypoglycemic events management in T1DM population, with multiple insulin daily doses (MDI). According to published evidence, rate of severe hypoglycemia (SHE) of 4.90 episodes per patient-year was applied. Reduction of SHE (58.6%) was modeled associated with FM use. Published rates of hospital care (20.2%) and subsequent admission (16%) were assumed for SHE. The daily consumption of strips and lancets was 9 in patients with SMBG (before and after 4 daily intakes and at bedtime) and 0.5 for FM users (according to IMPACT trial findings). Annual consumption of 26 FM sensors was considered (1 every 14 days). Unit costs (in € of 2019, excluding VAT) were obtained from literature and national databases. Sensitivity analyses (SA) were carried out to evaluate the model robustness.ResultsThe total annual cost/patient was €4437 for SMBG and €2526 for FM. The use of FM would be associated with an annual savings in the costs of monitoring and managing hypoglycemic events of €1911 per patient-year. In a hypothetical cohort of 1000 patients with T1DM MDI, FM could avoid in 1 year 4900 SHE, 93 hospitalizations for SHE. In addition, the use of FM would generate total savings of up to €1 910 000 per year. In the SA with alternative hypoglycemia events rates and use of strips and lancets, and including non-SHE episodes, savings from €370 000 to €1 760 000 were observed with FM.ConclusionsThe use of the FM system to monitor glucose in adults with T1DM treated with MDI, would reduce hypoglycemic events and would result in cost savings for the health system.

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IVT-AFL 2q8 versus ranibizumab 0.5q4, and an indirect comparison of IVT-AFL 2q8 with ranibizumab 0.5PRN data. A de novo health economic model combined these clinical inputs with Dutch-specific costs associated with treatment, monitoring, and indirect caregiving, and utility inputs relevant to a Dutch population. Total quality-adjusted life-years (QALYs) and costs were calculated over a 15-year horizon. Uncertainty around the outcomes was tested through sensitivity analyses. Results: Compared with ranibizumab 0.5q4, a 2-year treatment IVT-AFL is associated with a significantly lower cost of € 7337 (95% CI: € 7248-€ 7435) over a 15-year horizon. There is no significant difference in QALYs (-0.0027 [95% CI: -0.0057 to 0.0001]). IVT-AFL 2q8 also has significantly lower total costs than ranibizumab 0.5PRN (€ 2450 [95% CI: € 2349-€ 2549]), with a nonsignificant gain of 0.0007 QALYS (95% CI: -0.0023 to 0.0036). Probabilistic analyses show that, due to its lower costs, IVT-AFL 2q8 treatment had an estimated > 99% probability of being cost-effective compared with both of the ranibizumab treatment strategies at a willingness-to-pay threshold of € 20,000 per QALY, the proposed informal Dutch threshold. The univariate analyses did not alter the conclusions. ConClusions: The analysis showed that IVT-AFL 2q8 treatment is associated with cost savings versus ranibizumab 0.5q4 or 0.5PRN. There is no significant difference in total QALYs between the treatments. Due to lower overall costs, IVT-AFL is a costeffective treatment option for wAMD patients in the Netherlands.

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Primary immunodeficiency diseases (PID), which are comprised of over 400 genetic disorders, occur when a component of the immune system is diminished or dysfunctional. Patients with PID who require immunoglobulin (IG) replacement therapy receive intravenous IG (IVIG) or subcutaneous IG (SCIG), each of which provides equivalent efficacy. We developed a cost-minimization model to evaluate costs of IVIG versus SCIG from the Spanish National Healthcare System perspective. The base case modeled the annual cost per patient of IVIG and SCIG for the mean doses (per current expert clinical practice) over 1 year in terms of direct (drug and administration) and indirect (lost productivity for adults and parents/guardians of pediatric patients) costs. It was assumed that all IVIG infusions were administered in a day hospital, and 95% of SCIG infusions were administered at home. Drug costs were calculated from ex-factory prices obtained from local databases minus the mandatory deduction. Costs were valued on 2018 euros. The annual modeled costs were €4,266 lower for patients with PID who received SCIG (total €14,466) compared with those who received IVIG (total €18,732). The two largest contributors were differences in annual IG costs as a function of dosage (– €1,927) and hospital administration costs (– €2,688). However, SCIG incurred training costs for home administration (€695). Sensitivity analyses for two dose-rounding scenarios were consistent with the base case. Our model suggests that SCIG may be a cost-saving alternative to IVIG for patients with PID in Spain.