Background: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. Objective: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. Methods: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. Results: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of economic evaluation by various agents, but they remain uncoordinated. Conclusions: Poor governance at the highest level of decision making is the main reason for the lack of interest in economic evaluation. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.

IntroductionEconomic evaluations are becoming increasingly important due to limitations in economic resources, the expense of many new treatments, the need to allocate health spending as effectively as possible, and the need to inform decision makers. Based on the data from the apixaban studies (ARISTOTLE and AVERROES), several economic evaluations have been performed in various countries to demonstrate the efficacy of apixaban versus warfarin and aspirin or other new oral anticoagulants (NOACs) for preventing stroke in patients with non-valvular atrial fibrillation (NVAF).The aim of this study was to perform a systematic literature review of published economic evaluations with apixaban in the indication of stroke prevention in patients with NVAF.MethodsA search in PubMed, Cochrane Library, Google Scholar, and Index Medicus Español was conducted in June 2015. Inclusion and exclusion criteria were established. The main characteristics were recorded for all relevant articles after being reviewed. In addition, a weighted version of the Drummond’s checklist was used to further assess the quality of the selected studies.ResultsAfter review, 26 cost-effectiveness analyses through Markov models were included; the identified economic evaluations represent different willingness-to-pay (WTP) thresholds, discount rates, medical costs, and healthcare systems. Apixaban was compared with warfarin/acenocoumarol in 7 of them (27%), with warfarin/NOACs in 14 (54%), with aspirin in 2 (8%), and with warfarin/aspirin in 3 (11%). Models were conducted from Europe (69%), USA (23%), Australia (4%), and Latin America (4%). All models reported cost/quality-adjusted life years (QALYs) gained, 92% reported using a payer perspective, and 8% using a societal perspective; the median quality score of the selected studies was 89 (out of 119), with a range of 55–103. In models performed in Europe, incremental cost-effectiveness ratios (ICERs) of apixaban versus warfarin ranged from €5607/QALY to €57,245/QALY, while ICERs versus aspirin ranged from being dominant to €7334/QALY. In models carried out in the USA, ICERs of apixaban versus warfarin ranged from being dominant to $93,063/QALY.ConclusionDifferent cost-effectiveness analyses suggest that apixaban is a cost-effective therapeutic option according to the WTP thresholds used in countries where cost-effectiveness analyses, were performed.FundingBMS and Pfizer.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-016-0066-2) contains supplementary material, which is available to authorized users.

The median time from approval by the EMA of innovative drugs since the reimbursement in Spain in 2013 is double that of 2008. The main driver of delays in the process of P&R seems to be the budget impact of the drug instead of its unit price.

Objectives: The surgical site infection (SSI) is the most often acquired hospital infection in Spain, about 19.4% of all nosocomial infections. The prevalence of this adverse event is 8.01%, generating high economic impact on hospital costs and undermining the quality of care. The risk of SSI has increased in recent years and infections have become more resistant to treatments. About 50% of SSIs are preventable, their costs are avoidable, and health technology can help avoiding them. The aim of this study is to analyze the economic impact that could represent the use of anti-bacterial sutures compared with conventional ones in Spanish hospitals. MethOds: An interactive Excel model was developed using data obtained through a published literature review. The rate of reduction of SSI with antibacterial suture is 30%. The incremental cost per patient with SSI is between € 9,657 and € 10,112.63. Two scenarios were designed: 100% of surgeries with normal sutures and 100% of surgeries with anti-bacterial sutures. A sensitivity analysis for the variables of greatest uncertainty was performed (cost per SSI). Results: The budget impact of the use of antibacterial sutures resulted in a 24% of cost savings related to the normal sutures. It represents savings of € 5.4M per year for an average Spanish hospital, and € 1,264M per year for the whole Spanish Health System. The results of the sensitivity analysis shows that even by changing the effectiveness of the suture and using the most unfavourable data found in the literature for the cost of an SSI, the use of the antibacterial suture still produces savings of 24% compared with the use of normal suture. cOnclusiOns: This budget impact analysis provides new evidence that reinforces the use of antibacterial sutures, because it may reduce the risk of SSI, the negative effects of its consequences and associated costs and significantly improving the quality of care for surgical patients in Spain.Objectives: The 2013 WHO-guidelines recommend viral load (VL) monitoring plus CD4-count monitoring for patients on antiretroviral treatment (ART) in resourcelimited settings. We calculated the budget impact (BI) of VL monitoring strategies at the Infectious Diseases Institute (IDI), a large urban HIV program in Kampala, Uganda. MethOds: We calculated cost for the first 2 years of ART (drugs/tests/ staff) for three strategies: (1) Immunologic monitoring, standard of care (SOC): 6-monthly CD4-count (2) New WHO-guidelines: SOC plus 6-monthly VL (3) A novel strategy: exclusive-VL (no CD4-counts after ART start), with VL at 3-months (to support adherence monitoring) and at 24 months. Patients with VL > 400copies/ml VL at 3-months will receive adherence counseling and repeat VL at 6-months. All costs are current actual costs at IDI and presented as 2012 USD ($): CD4-count= $9; VL= $65; first-line patients $206/year in year-1 and $272/year in year-2; second-line patients= $1381/year. For each strategy, rates of switch to second-line were estimated using IDI clinic data (1) SOC: 27%, 29%, 32% at 6...

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