Equitable Access To High Cost Pharmaceuticals

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

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.

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.

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Concerns about affordable access to medicines reflect the emergence of new, high-priced medicines, as well as expectations regarding the cost of precision therapies coming to market. Compared with a decade ago, novel medicines are subject to longer delays between global launch and market access, even in wealthier countries. Various paths forward offer potential policy solutions to address problems with access to high-priced pharmaceuticals. This technical report considers four categories of policies - demand pooling, formal tiered pricing, risk-sharing agreements and policies to harness competition - with potential to ameliorate issues in ensuring timely, affordable and equitable access to effective medicines in the WHO European Region. Each approach offers the potential to address a different dimension of the affordability problem. The most promising strategies to tackle affordability of high-priced medicines are likely to entail a combination approach - for example, a test pilot of a single-buyer agreement using a combination of managed-entry agreements and tiered pricing for agreement signatories under an agreed formula. To facilitate policy development, stakeholder commitment to three underlying principles - solidarity, transparency and sustainability - is essential.

The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.

This encyclopedia covers the definitions, concepts, methods, theories, and application of evidence-based pharmaceutical public health and health services research. It highlights why and how this field has a significant impact on healthcare. The work aims to synthesize baseline knowledge as well as the latest and cutting-edge research-based information. The encyclopedia collates information on public health, health services research, evidence-based pharmacy practice and its impacts on patients, decision-makers and consumers. This reference work discusses all aspects of policy and practice decisions on medicines use, access and pharmacy services by covering broad aspects related to pharmacy practice, public health and health services research. The aim is to develop high-quality content, which will be a must-read and be used as a reference source at all pharmacy and medical schools in the world. The health services research investigates the impact of social factors, organizational policies, financing systems, medical technologies and personal influence on access, quality and cost of healthcare concerning the quality of life of the patients. This reference work fundamentally promotes the evidence-based evaluation of healthcare services and thus will improve the better access and delivery of healthcare services. Also, pharmacy, medical and health services students and researchers need a broad understanding of pharmaceutical public health, evidence-based approaches to delivering care, changing professional and patient behavior and undertaking research in these areas. In general, there is a need to build research capacity and capability in the pharmacy profession. EDITOR-IN-CHIEF: Professor Zaheer-Ud-Din Babar, University of Huddersfield SECTION EDITORS: Filipa Alves da Costa, University of LisbonZubin Austin, University of TorontoDalia Dawood, National Institute for Health and Care Excellence Andy Gray, University of Kwa Zulu-NatalRachele Hendricks-Sturrup, Duke Margolis Center for Health PolicyJason Hsu, Taiwan Medical UniversityRabia Hussain, Universiti Sains MalaysiaChristine Y. Lu, Harvard Medical School and Harvard Pilgrim Health Care InstituteMohamed Izham Mohamed Ibrahim, Qatar UniversityPrasad Nishtala, University of BathDerek Charles Stewart, College of Pharmacy, Qatar University Fatima Suleman, University of Kwa Zulu-NatalZaheer-Ud-Din Babar, University of Huddersfield

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 issue of how patents impact medicine has increased in significance within the last decade. The book provides an explanation of the current international infrastructure and explains how competing patent perspectives play a thus far unacknowledged role in promoting distortion and confusion.

This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.