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Background: Enhancing primary health care (PHC) is considered a policy priority for health systems strengthening due to PHC's ability to provide accessible and continuous care and manage multimorbidity. Research in PHC often focuses on the effects of specific interventions (e.g. physicians' contracts) in health care outcomes. This informs narrowly designed policies that disregard the interactions between the health functions (e.g. financing and regulation) and actors involved (i.e. public, professional, private), and their impact in care delivery and outcomes. The purpose of this study is to analyse the interactions between PHC functions and their impact in PHC delivery, particularly in providers' behaviour and practice organisation., Methods: Following a systems thinking approach with data obtained through a three-round European Delphi process, we developed a framework that captures (1) the interactions between PHC functions by analysing correlations between PHC characteristics of participating countries, (2) how actors involved shaped these interactions by identifying the actor and level of devolution (or fragmentation) in the analysis, and (3) their potential effect on care delivery by exploring panellists' opinions., Results: A total of 59 panellists from 24 countries participated in the first round and 76% of the initial panellists (22 countries) completed the last round. Findings show correlations between governance, financing and regulation based on their degree of decentralisation. This is supported by panellists, who agreed that the actors involved in health system governance determine the type of PHC financing (e.g. ownership or payment mechanisms) and regulation (e.g. competences or gatekeeping), and this may impact care delivery and outcomes. Governance in our framework is an overarching function whose impact in PHC delivery is mediated through the degree of decentralisation (both delegation and devolution) of PHC financing and regulation., Conclusions: The application of this approach in policy implementation assessment intends to uncover limitations due to poor accountability and commitment to shared objectives. Its application in the design of health strategies helps foresee (and prevent) undesired or unexpected effects of narrow interventions. This approach will assist in the development of the realistic and long-term policies required for health systems strengthening.

This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access., (© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.)

Rising health care costs are an international concern, particularly in the United States, where spending on health care outpaces that of other industrialized countries. Consequently, there is growing desire in the United States and Europe to take a more value-based approach to health care, particularly with respect to the adoption and use of new health technology. This article examines medical device reimbursement and pricing policies in the United States and Europe, with a particular focus on value. Compared to the United States, Europe more formally and consistently considers value to determine which technologies to cover and at what price, especially for complex, costly devices. Both the United States and Europe have introduced policies to provide temporary coverage and reimbursement for promising technologies while additional evidence of value is generated. But additional actions are needed in both the United States and Europe to ensure wise value-based reimbursement and pricing policies for all devices, including the generation of better pre- and postmarket evidence and the development of new methods to evaluate value and link evidence of value to reimbursement.

Reimbursement is assessed by the Transparency Commission from the Health Authority (HAS) using a medical benefit (SMR) score that gives access to reimbursement, an "improvement of medical service rendered" (ASMR) that determines the added therapeutic value, and the target population. Assessing cancer drugs for reimbursement raises the same issues as other therapeutic classes, with some key differences. Overall survival (OS) is considered by the Transparency Commission as the endpoint for assessing clinical benefit, and yet it is not an applicable primary endpoint in all types of cancer. Later lines of treatment, particularly during the development process, may make it difficult to interpret OS as the primary endpoint. Therefore, progression-free survival (PFS) for metastatic situations and disease-free survival (DFS) in adjuvant situations are wholly relevant endpoints for decisions on the reimbursement of a new cancer drug. Effect size is assessed using actuarial survival curves of the product versus the comparator, and it is difficult to summarise them into one single parameter. Results are generally interpreted based on median survival, which is fragmented because it only measures one point of the curve. The hazard ratio measures the effect of treatment throughout the duration of survival and is therefore more comprehensive in quantifying clinical benefit. Determining an effect size threshold for granting reimbursement is difficult given the diversity of cancer settings and the level of medical need, which influences assessment of the clinical relevance of the observed difference. Rapid progress in comparators (700 molecules in development) and the identification of predictive factors of efficacy (biomarkers, histology, etc.) during development may lead to different ASMR scores per population, or to the restriction of the target population to a subgroup of the marketing authorisation (MA) population in which the expected effect size is greater. To address these issues, the roundtable recommends the possibility of early scientific opinions by the office of the Transparency Commission in order to discuss comparators and the relevance of responder subgroups. It also recommends the possibility of granting a temporary ASMR, on condition of subsequent confirmation by production of data, when reimbursement appears justified in a subpopulation of the MA for which only subgroup analysis is available., (© 2010 Société Française de Pharmacologie et de Thérapeutique.)