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Introduction: Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations. Method: An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins. Results: A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs. Conclusion: Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs. [ABSTRACT FROM AUTHOR]

Background: Large-scale partnerships between universities and health services are widely seen as vehicles for bridging the evidence-practice gap and for accelerating the adoption of new evidence in healthcare. Recently, different versions of these partnerships - often called academic health science centres - have been established across the globe. Although they differ in structure and processes, all aim to improve the integration of research and education with health services. Collectively, these entities are often referred to as Research Translation Centres (RTCs) and both England and Australia have developed relatively new and funded examples of these collaborative centres.Methods: This paper presents findings from a rapid review of RTCs in Australia and England that aimed to identify their structures, leadership, workforce development and strategies for involving communities and service users. The review included published academic and grey literature with a customised search of the Google search engine and RTC websites.Results: RTCs are complex system-level interventions that will need to disrupt the current paradigms and silos inherent in healthcare, education and research in order to meet their aims. This will require vision, leadership, collaborations and shared learnings, alongside structures, processes and strategies to deliver impact in the face of complexity. The impact of RTCs in overcoming the deeply entrenched silos across organisations, disciplines and sectors needs to be captured at the systems, organisation and individual levels. This includes workforce capacity and public and patient involvement that are vital to understanding the evolution of RTCs. In addition, new models of leadership are needed to support the brokering and mobilisation of knowledge in complex organisations.Conclusions: The development and funding of RTCs represents one of the most significant shifts in the health research landscape and it is imperative that we continue to explore how we can progress the integration of research and healthcare and ensure research meets stakeholder needs and is translated via the collaborations supported by these organisations. Because RTCs are a recent addition to the healthcare landscape in Australia, it is instructive to review the processes and infrastructure needed to support their implementation and applied health research in England. [ABSTRACT FROM AUTHOR]

Background: In the regulation of healthcare, the subject of patient and family involvement figures increasingly prominently on the agenda. However, the literature on involving patients and families in regulation is still in its infancy. A systematic analysis of how patient and family involvement in regulation is accomplished across different health systems is lacking. We provide such an overview by mapping and classifying methods of patient and family involvement in regulatory practice in four countries; Norway, England, the Netherlands, and Australia. We thus provide a knowledge base that enables discussions about possible types of involvement, and advantages and difficulties of involvement encountered in practice.Methods: The research design was a multiple case study of patient and family involvement in regulation in four countries. The authors collected 1) academic literature if available and 2) documents of regulators that describe user involvement. Based on the data collected, the authors from each country completed a pre-agreed template to describe the involvement methods. The following information was extracted and included where available: 1) Method of involvement, 2) Type of regulatory activity, 3) Purpose of involvement, 4) Who is involved and 5) Lessons learnt.Results: Our mapping of involvement strategies showed a range of methods being used in regulation, which we classified into four categories: individual proactive, individual reactive, collective proactive, and collective reactive methods. Reported advantages included: increased quality of regulation, increased legitimacy, perceived justice for those affected, and empowerment. Difficulties were also reported concerning: how to incorporate the input of users in decisions, the fact that not all users want to be involved, time and costs required, organizational procedures standing in the way of involvement, and dealing with emotions.Conclusions: Our mapping of user involvement strategies establishes a broad variety of ways to involve patients and families. The four categories can serve as inspiration to regulators in healthcare. The paper shows that stimulating involvement in regulation is a challenging and complex task. The fact that regulators are experimenting with different methods can be viewed positively in this regard. [ABSTRACT FROM AUTHOR]