Rare Diseases and Orphan Products


Book Description

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.




Competition and the Cost of Medicare's Prescription Drug Program


Book Description

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the Medicare Modernization Act, or MMA) substantially expanded the federal Medicare program by creating the prescription drug benefit known as Part D. In FY 2013, Medicare Part D covered 39 million people. The federal government spent $59 billion net of premiums on Part D in that year; after accounting for certain payments from states under the program, the net federal cost was $50 billion, which represented 10% of net federal spending for Medicare. A combination of broader trends in the prescription drug market and lower-than-expected enrollment in Part D has contributed to much lower spending for the program than projected when the MMA became law in 2003. This report examines the federal budgetary cost and competitive design of Medicare Part D and compares Medicare Part D and Medicaid Fee for Service. Figures and tables. This is a print on demand report.




Public Health in Pharmacy Practice


Book Description

"Public Health in Pharmacy Practice: A Casebook is a collaboration of over thirty-five experts in public health pharmacy. The twenty-one chapters cover a broad array of topics relevant to pharmacy applications of public health: cross-cultural care, health literacy and disparities, infectious disease, health promotion and disease prevention, medication safety, women's and rural health and more. Each chapter contains learning objectives and an introduction to the topic, followed by a case and questions. The chapter closes with commentary from the authors and patient-oriented considerations for the topic at hand"--Publisher's description




Making Medicines Affordable


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.




Medicare Primer


Book Description

This report provides a general overview of the Medicare program including descriptions of the program's history, eligibility criteria, covered services, provider payment systems, and program administration and financing.







Aging and Decision Making


Book Description

Decisions large and small play a fundamental role in shaping life course trajectories of health and well-being: decisions draw upon an individual's capacity for self-regulation and self-control, their ability to keep long-term goals in mind, and their willingness to place appropriate value on their future well-being. Aging and Decision Making addresses the specific cognitive and affective processes that account for age-related changes in decision making, targeting interventions to compensate for vulnerabilities and leverage strengths in the aging individual. This book focuses on four dominant approaches that characterize the current state of decision-making science and aging - neuroscience, behavioral mechanisms, competence models, and applied perspectives. Underscoring that choice is a ubiquitous component of everyday functioning, Aging and Decision Making examines the implications of how we invest our limited social, temporal, psychological, financial, and physical resources, and lays essential groundwork for the design of decision supportive interventions for adaptive aging that take into account individual capacities and context variables. - Divided into four dominant approaches that characterize the current state of decision-making science and aging neuroscience - Explores the impact of aging on the linkages between cortical structures/functions and the behavioral indices of decision-making - Examines the themes associated with behavioral approaches that attempt integrations of methods, models, and theories of general decision-making with those derived from the study of aging - Details the changes in underlying competencies in later life and the two prevailing themes that have emerged—one, the general individual differences perspective, and two, a more clinical focus




ANDA Litigation


Book Description

Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.




Delivering Health Care in America


Book Description

This resource provides a comprehensive overview of the basic structures and operations of the US health system, fom its historical origins and resources, to its individual services, cost, and quality. Using a unique "systems" approach, it brings together information into a highly accessible, easy-to-read text that clarifies the complexities of health care organization and finance, while presenting a solid overview of how the various components fit together.