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Aims: Heart failure is a chronic progressive condition, with considerable burden on patients' quality of life and economic burden for the healthcare systems. Before the approval of empagliflozin, there were no proven effective treatments for patients with heart failure with left ventricular ejection fraction (HF LVEF) > 40%. The aim of this study was to evaluate the cost‐effectiveness of empagliflozin + standard of care (SoC) compared with SoC alone for patients with HF LVEF > 40%, from the perspective of the healthcare systems of the United Kingdom (UK), Spain, and France, and to quantify the healthcare costs for these patients. Methods and results: A lifetime Markov cohort state‐transition model was developed based on discrete health states defined by Kansas City Cardiomyopathy Questionnaire‐Clinical Summary Score quartiles to track disease severity. Model inputs relied primarily on the EMPEROR‐Preserved trial data or obtained from published literature or country‐specific databases, as well as local guidelines for the requirements for the conduct of the economic evaluation of healthcare technologies. The total lifetime cost of receiving SoC per patient was £10 092, €15 765, and €14 958 in the UK, Spain, and France, respectively, which increased by £1407, €1148, and €1485, respectively, with the addition of empagliflozin to the SoC. Empagliflozin + SoC was associated with significantly reduced number of hospitalization for HF or cardiovascular death compared with SoC alone, which was a key driver offsetting its drug acquisition costs. The incremental cost‐effectiveness ratio per quality‐adjusted life year (QALY) gained was consistently favourable at £14 851, €11 706, and €15 447 in the UK, Spain, and France, respectively. Scenario analysis using the New York Heart Association functional class showed similar results. Probabilistic sensitivity analyses showed more than 50% probability for cost‐effectiveness for a willingness‐to‐pay (WTP) threshold of £/€20 000/QALY for the three countries. Conclusions: Empagliflozin was found to be the first targeted treatment option that is clinically effective and cost‐effective for patients with HF LVEF > 40%. Prescribing empagliflozin with SoC to patients with HF LVEF > 40% is expected to improve clinical outcomes and patients' quality of life and substantially below accepted WTP threshold for the healthcare systems in the UK, Spain, and France. [ABSTRACT FROM AUTHOR]

This article considers whether organized labour's engagement with shareholder activism represents a shift in unions' traditional stakeholder preferences on corporate governance under pension fund capitalism. It does so in light of recent critiques of the class power thesis of corporate governance which suggest greater fluidity and fragmentation in labour's approach. Adopting a diverse case study strategy to compare organized labour's actions in the United States, United Kingdom and France, the article explains these activities as innovative strategies, similar to other revitalization initiatives, designed to advance traditional agendas by alternative means. The article thus concludes that, while organized labour's shareholder activism is unexpected under the class power thesis, its core preferences remain largely unchanged. [ABSTRACT FROM AUTHOR]

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Treatment with new and/or innovative drugs with uncertain safety and efficacy profile is associated with substantial ethical concerns. The main objective of this paper is to present guidance on the use of such drugs contained in: (i) major international codes and guidelines pertaining to medical ethics and biomedical research; (ii) national codes of medical ethics and professional conduct of the USA, Canada, Australia, New Zealand, the UK, Ireland, France and Germany. Out of the four international codes and guidelines analysed, only the Declaration of Helsinki addresses the question of the use of unproven drugs. Among national codes, only two (USA and New Zealand) explicitly allow for use of new or innovative drugs. Moreover, treatment with unproven drugs seems to be permissible under the French code, though this is not stated explicitly. The remaining codes do not contain any articles on the use of new and innovative drugs. An update of existing articles, as well as the addition of new guidelines to the codes, should be considered in view of the rapid pace of development and introduction to clinical practice of new drugs. This work is relevant to innovative off-label applications of approved drugs and expanded access to investigational drugs., (© 2018 The British Pharmacological Society.)