Regulatory and Economic Aspects in Oncology

Regulatory and Economic Aspects in Oncology PDF Author: Evelyn Walter
Publisher: Springer
ISBN: 3030012077
Category : Medical
Languages : en
Pages : 205

Get Book Here

Book Description
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.

Regulatory and Economic Aspects in Oncology

Regulatory and Economic Aspects in Oncology PDF Author: Evelyn Walter
Publisher: Springer
ISBN: 3030012077
Category : Medical
Languages : en
Pages : 205

Get Book Here

Book Description
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.

Assessing and Improving Value in Cancer Care

Assessing and Improving Value in Cancer Care PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309138140
Category : Medical
Languages : en
Pages : 164

Get Book Here

Book Description
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.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225

Get Book Here

Book Description
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.

Cancer and Society

Cancer and Society PDF Author: Eric H. Bernicker
Publisher: Springer
ISBN: 3030058557
Category : Medical
Languages : en
Pages : 186

Get Book Here

Book Description
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.

Making Medicines Affordable

Making Medicines Affordable PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309468086
Category : Medical
Languages : en
Pages : 235

Get Book Here

Book Description
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Delivering Affordable Cancer Care in the 21st Century

Delivering Affordable Cancer Care in the 21st Century PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030926944X
Category : Medical
Languages : en
Pages : 95

Get Book Here

Book Description
Rising health care costs are a central fiscal challenge confronting the United States. National spending on health care currently accounts for 18 percent of gross domestic product (GDP), but is anticipated to increase to 25 percent of GDP by 2037. The Bipartisan Policy Center argues that "this rapid growth in health expenditures creates an unsustainable burden on America's economy, with far-reaching consequences". These consequences include crowding out many national priorities, including investments in education, infrastructure, and research; stagnation of employee wages; and decreased international competitiveness.In spite of health care costs that far exceed those of other countries, health outcomes in the United States are not considerably better. With the goal of ensuring that patients have access to high-quality, affordable cancer care, the Institute of Medicine's (IOM's) National Cancer Policy Forum convened a public workshop, Delivering Affordable Cancer Care in the 21st Century, October 8-9, 2012, in Washington, DC. Delivering Affordable Cancer Care in the 21st Century summarizes the workshop.

Principles of Cancer Treatment and Anticancer Drug Development

Principles of Cancer Treatment and Anticancer Drug Development PDF Author: Wolfgang Link
Publisher: Springer Nature
ISBN: 3030187225
Category : Medical
Languages : en
Pages : 156

Get Book Here

Book Description
This book explains how current medicines against cancer work and how we find new ones. It provides an easy-to-understand overview of current options to treat patients with cancer, which includes Surgery, Radiation therapy, Chemotherapy, Targeted therapy and Immunotherapy. The efficiency of all these treatments is limited by the capacity of cancer cells to escape therapy. This book explains the mechanisms of anti-cancer drug resistance and strategies to overcome it. The discovery and development process of a new drug is detailed beginning with the identification and validation of a therapeutic target, the identification of an inhibitor of the target and its subsequent preclinical and clinical development until its approval by regulatory authorities. Particular emphasis has been given to specific aspects of the development process including lead generation and optimization, pharmacokinetics, ADME analysis, pharmacodynamics, toxicity and efficacy assessment, investigational new drug (IND) and new drug application (NDA) and the design of clinical trial and their phases. The book covers many aspects of modern personalized oncology and discusses economic aspects of our current system of developing new medicines and its impact on our societies and on future drug research. The author of this book, Dr. Link counts with more than 20 years of experience in biomedical research reflected in numerous publications, patents and key note and plenary presentations at international conferences. Interested readers, students and teachers should read this book as it provides a unique way to learn/teach about basic concepts in oncology and anti-cancer drug research.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309163358
Category : Medical
Languages : en
Pages : 151

Get Book Here

Book Description
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care PDF Author: Abdul Kader Mohiuddin
Publisher: Universal-Publishers
ISBN: 1627343083
Category : Medical
Languages : en
Pages : 690

Get Book Here

Book Description
The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.

Distributional Cost-Effectiveness Analysis

Distributional Cost-Effectiveness Analysis PDF Author: Richard Cookson
Publisher:
ISBN: 0198838190
Category : Business & Economics
Languages : en
Pages : 385

Get Book Here

Book Description
Distributional cost-effectiveness analysis aims to help healthcare and public health organizations make fairer decisions with better outcomes. It can provide information about equity in the distribution of costs and effects - who gains, who loses, and by how much - and the trade-offs that sometimes occur between equity and efficiency. This is a practical guide to methods for quantifying the equity impacts of health programmes in high, middle, and low-income countries. The methods can be tailored to analyse different equity concerns in different decision making contexts. The handbook provides both hands-on training for postgraduate students and analysts and an accessible guide for academics, practitioners, managers, policymakers, and stakeholders. Part I is an introduction and overview for research commissioners, users, and producers. Parts II and III provide step-by-step guidance on how to simulate and evaluate distributions, with accompanying spreadsheet training exercises. Part IV concludes with discussions about how to handle uncertainty about facts and disagreement about values, and the future challenges facing this growing field. Book jacket.