This book explores topics of importance to all who have an interest in economic methods for assessment of the efficacy and effectiveness of new cancer treatments and in regulatory measures relating to their marketing authorization and pricing. Targeted therapies and modern immunotherapy are placing a substantial strain on health care budgets. Regulation and economic methods to assess the parameters for establishing efficacy and effectiveness are therefore of prime importance. Payer authorities have to determine whether the use of these novel therapies yields clinical benefits that justify their increasing cost. In the simplest terms, cost-effectiveness analyses quantify the ratio between the extent to which an intervention raises healthcare costs and the extent to which it improves health outcomes. Rigorous cost-effectiveness analyses translate all health outcomes into quality-adjusted life years. On the other hand, in order to sustain innovation, price regulations must be coupled with efforts to ensure that drug companies are still able to recoup their investments in high-risk and high-costs research programs. Ultimately, decisions regarding health care expenditures are also a question of society’s willingness to pay.

Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few treatments options were previously available. As a result, the survival of patients with cancer has steadily improved and, in most cases, patients who are not cured may receive multiple lines of treatment, often with financial consequences for the patients, insurers and healthcare systems. Although many books exist that address economic evaluation, Economic Evaluation of Cancer Drugs using Clinical Trial and Real World Data is the first unified text that specifically addresses the economic evaluation of cancer drugs. The authors discuss how to perform cost-effectiveness analyses while emphasising the strategic importance of designing cost-effectiveness into cancer trials and building robust economic evaluation models that have a higher chance of reimbursement if truly cost-effective. They cover the use of real-world data using cancer registries and discuss how such data can support or complement clinical trials with limited follow up. Lessons learned from failed reimbursement attempts, factors predictive of successful reimbursement and the different payer requirements across major countries including US, Australia, Canada, UK, Germany, France and Italy are also discussed. The book includes many detailed practical examples, case studies and thought-provoking exercises for use in classroom and seminar discussions. Iftekhar Khan is a medical statistician and health economist and a lead statistician at Oxford Unviersity’s Center for Statistics in Medicine. Professor Khan is also a Senior Research Fellow in Health Economics at University of Warwick and is a Senior Statistical Assessor within the Licensing Division of the UK Medicine and Health Regulation Agency. Ralph Crott is a former professor in Pharmacoeconomics at the University of Montreal in Quebec, Canada and former head of the EORTC Health Economics Unit and former senior health economist at the Belgian HTA organization. Zahid Bashir has over twelve years experience working in the pharmaceutical industry in medical affairs and oncology drug development where he is involved in the design and execution of oncology clinical trials and development of reimbursement dossiers for HTA submission.

While a number of books have looked at the intersection between human health in general and other topics, such as climate change or diet, this book focuses specifically on cancer as it impacts and is impacted by social justice issues. The massive explosion of research knowledge of cancer immunology and genomics is holding out great promise of therapeutic advances, yet other human actions—climate change, pollution, business decisions, advertising – are fostering health inequalities as well as increasing risks. Those involved in cancer care and research are in a unique position to let their experiences and knowledge inform the public, yet very often have not taken strong public roles when it comes to discussing issues surrounding tobacco, climate change and health risks, financial toxicity of treatments, and diet choices. Written by a multidisciplinary team of authors and for medical oncologists, cancer researchers, occupational health workers, and related medical students, residents, and fellows, this book encourages oncologists to address public health care and the societal issues associated with cancer risk. This volume discusses the overarching theme of environmental justice and oncology, focuses on business and cancer (such as clinical trials, drug development and profits, and global disparities), as well as animals and cancer.

The multidisciplinary book assesses the legal and economic uncertainties surrounding the collection, storage, provision and economic development of biological samples (tumors, tissues, cells) and associated personal data related to oncology. Public, partly public and private sector actors in the field of cancer care and research hold collections supported by significant public and social funding. Under certain conditions, particularly in the context of networking (sometimes promoted by public authorities), these collections can also represent major economic assets and scientific resources. However, this involves a number of issues and institutional constraints: legal: the will of the source person; non-pecuniary damage; freedom to establish collections; competence in deciding on their use; legal frameworks for their distribution; desire for return on investment for public institutions, notably in terms of industrial and intellectual property. Economic: cost of establishing and running biological resource centres; destroying resources; emerging markets; profit sharing. public health policy choices: prioritisation of therapeutic measures over research (fundamental or clinical trials); conservation of resources; promotion of scientific (and not commercial) value of collections. The establishment, heritage recognition ("patrimonialisation"), development and sharing of these resources thus merit our calling into question present practices and their evolution, as well as the leverage available to public authorities (incentives, legislation, regulation) in a context where norms emerge from professional practice to become widely used in collaborative networks. Filling a gap in the current literature on law and economics, which pays little heed to these specific considerations, this book explores these considerations to bring to light the economic implications of ethical choices and governance issues in the health sector (structural organisation of local, national and European actors in oncology). It is intended for researchers in fields such as law, economics and biomedical sciences, as well as for public policymakers.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Unlike many other areas in health care, the practice of oncology presents unique challenges that make assessing and improving value especially complex. First, patients and professionals feel a well-justified sense of urgency to treat for cure, and if cure is not possible, to extend life and reduce the burden of disease. Second, treatments are often both life sparing and highly toxic. Third, distinctive payment structures for cancer medicines are intertwined with practice. Fourth, providers often face tremendous pressure to apply the newest technologies to patients who fail to respond to established treatments, even when the evidence supporting those technologies is incomplete or uncertain, and providers may be reluctant to stop toxic treatments and move to palliation, even at the end of life. Finally, the newest and most novel treatments in oncology are among the most costly in medicine. This volume summarizes the results of a workshop that addressed these issues from multiple perspectives, including those of patients and patient advocates, providers, insurers, health care researchers, federal agencies, and industry. Its broad goal was to describe value in oncology in a complete and nuanced way, to better inform decisions regarding developing, evaluating, prescribing, and paying for cancer therapeutics.