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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.
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.
With ever increasing demands on the constrained resources available for health care services, no one involved in decision making in health care can continue to ignore the economic costs of the services provided or the relative value for money offered by the available treatments. Economic evaluation has therefore become an important and indispensable tool for medical deci sion making, alongside the well-known methods for clinical eval uation. This is also true for cancer, despite the aura of sanctity often of surrounding this dreaded disease and the apparent willingness the general population to spend large sums in this area and do "everything possible" for the patients. In recent years, articles dealing with assessing the costs and benefits of various cancer treatments have begun to appear in scientific medical and eco nomic journals. This book provides a comprehensive survey and assessment of the current state of the art of economic evaluations and cost ana lyses in cancer. It gives an introduction to the methods available for economic evaluations, before surveying and assessing the available publications. Separate chapters are devoted to the most prevalent cancers, and in each chapter the current clinical prac tice and research problems are summarized in order to provide a background for the economic analyses. At the end, a summary assessment of the literature is provided along with some sugges tions for a future research agenda.
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.
Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs Incorporates existing guidelines and recommendations by international organizations Compares and contrasts how different countries fund and police high-cost drug access Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing Reviews novel pharmaceuticals of current research interest
Clinical economics is a new and evolving discipline that addresses the economic implications of changes in medical practice. As applied to cancer care, clinical economics assesses the costs and effectiveness of new cancer interventions and can be a valuable endpoint in selected clinical trials. Through the integration of economics into clinical evaluations, information can be developed that contributes to the decisions of patients, clinicians, health care managers, and policymakers as to the most effective allocation of cancer care resources.
In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
This groundbreaking book presents a unique and practical approach to the evolving field of exercise oncology - the study of physical activity in the context of cancer prevention and control. Presenting the current state of the art, the book is sensibly divided into four thematic sections. Following an opening chapter presenting an overview and timeline of exercise oncology, the chapters comprising part I discuss primary cancer prevention, physical activity and survivorship, and the mechanisms by which these operate. Diagnosis and treatment considerations are discussed in part II, including prehabilitation, exercise during surgical recovery, infusion and radiation therapies, and treatment efficacy. Post-treatment and end-of-life care are covered in part III, including cardio-oncology, energetics and palliative care. Part IV presents behavioral, logistical and policy-making considerations, highlighting a multidisciplinary approach to exercise oncology as well as practical matters such as reimbursement and economics. Written and edited by experts in the field, Exercise Oncology will be a go-to practical resource for sports medicine clinicians, family and primary care physicians, oncologists, physical therapy and rehabilitation specialists, and all medical professionals who treat cancer patients.