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

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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.

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.

Drug Safety and Pricing

Drug Safety and Pricing PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 130

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Book Description


The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498511
Category : Medical
Languages : en
Pages : 103

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Book Description
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.

The Right Price

The Right Price PDF Author: Peter J. Neumann
Publisher: Oxford University Press
ISBN: 0197512909
Category : Medical
Languages : en
Pages : 312

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Book Description
The US prescription drug business is a $500 billion industry whose rising prices carry profound consequences for patients, caregivers, employers and taxpayers across the nation. In the United States, average prices of leading brand-name drugs are two to four times higher than prices charged in other wealthy countries, raising questions as to what Americans are getting for the extra expense. On the other hand, healthy industry returns have arguably fueled life-saving innovation. With the advent of ever more targeted and powerful treatments, including cell- and gene-based therapies with multi-million-dollar price tags, the need for sensible drug pricing policies will only intensify. The Right Price sheds light on the controversial topic of drug pricing by providing an accessible guide to pharmaceutical markets and analytic techniques used to measure the value of drug therapies. It illustrates the need for value-based pricing through real-life stories of patients and their experiences with the drug industry and explains why simple solutions like price controls and the importation of cheaper drugs from other countries are problematic. This volume describes how researchers and policy makers have pursued drug valuation efforts in the past, and lays out a series of recommendations, based on years of shared author experience serving on national drug policy platforms, for how to further improve pharmaceutical value assessment in the United States. With unique industry insights and clear narrative, The Right Price unveils why the pricing of drugs continues to be so challenging and how public and private officials can create more informed policies to achieve the right balance between drug pricing and value.

Drug Safety Data

Drug Safety Data PDF Author: Michael J. Klepper
Publisher: Jones & Bartlett Learning
ISBN: 0763769126
Category : Medical
Languages : en
Pages : 332

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Book Description
Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides pharmaceutical scientists, researchers and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for premarketing risk assessment. This unique resource enhances the ability of pharmaceutical professionalsùthose with and without clinical trainingùto determine the risk of a drug or biologic­ ahead of its release, thereby reducing unnecessary jeopardy to the patient. Authors Dr. Michael Klepper and Dr. Barton Cobert, who together bring decades of pharmaceutical research and drug safety expertise, discuss how quality planning, safety training and data standardization result in significant cost, time and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides the definitive guide to drug safety data analysis and reporting. Key features include: Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports Pragmatic tipsàand mistakes to avoid Simple explanations of what safety data are collected, and what the data mean Practical approaches to determining a drug effect and understanding its clinical significance Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical Examples of user-friendly data displays that enhance safety signal identification Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting Relevant material for the required training of drug safety/pharmacovigilance professionals SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)

Prescription Drug Pricing: Background, Discount Programs and Cost Lowering Strategies

Prescription Drug Pricing: Background, Discount Programs and Cost Lowering Strategies PDF Author: Elias B. Toft
Publisher: Nova Snova
ISBN: 9781536176681
Category :
Languages : en
Pages : 248

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Book Description
Chapter 1 examines the actions of drug companies in raising prescription drug prices in the United States, as well as the effects of these actions on the Federal and state budgets, and on American families. Chapter 2 addresses frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The 340B Drug Pricing Program requires drug manufacturers to sell outpatient drugs at discounted prices to covered entitiesâeligible clinics, hospitals, and othersâin order to have their drugs covered by Medicaid. Covered entities are only allowed to provide 340B drugs to certain eligible patients. Chapter 3 reviews the Health Resources and Services Administration's (HRSA) oversight of the 340B Program to ensure compliance with program rules. In 2017, nearly 60% of U.S. adults aged 18â64 reported being prescribed medication in the past 12 months. Approximately 70% of prescription medications carry out-of-pocket costs. Strategies to reduce prescription drug costs at the individual level are discussed in chapters 4 and 5. Each year, Americans pay more for prescription drugs, and rising drug prices have a disproportionate impact on older Americans. Chapter 6 examines the history of rising drug prices for the brand-name drugs most commonly prescribed for seniors. Generic drugsâcopies of brand-name drugsâlead to significant cost savings. Before a generic drug can be marketed, FDA must approve the generic drug application. According to FDA, applications go through an average of three cycles of review before being approved, which may take years. Chapter 7 examines 1) the first review cycle approval rate of generic drug applications in recent years and factors that may have contributed to whether applications were approved; and 2) changes FDA has made to increase the first review cycle approval rate.

Drug Safety and Pricing

Drug Safety and Pricing PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 128

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Book Description


The Future of Drug Safety

The Future of Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309103045
Category : Medical
Languages : en
Pages : 347

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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

Drug Safety and Pricing

Drug Safety and Pricing PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 117

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Book Description


The Price of Global Health

The Price of Global Health PDF Author: Mr Ed Schoonveld
Publisher: Gower Publishing, Ltd.
ISBN: 1472438825
Category : Business & Economics
Languages : en
Pages : 495

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Book Description
The Price of Global Health is a unique, much-needed and invaluable resource for anybody interested or involved in, or affected by, the development, funding and use of prescription drugs. The second edition includes new chapters on payer value story development, oncology, orphan drugs and payer negotiations. Country chapters have also been updated to reflect changes in healthcare systems, including the Affordable Care Act in the US, AMNOG in Germany, and medico-economic requirements in France. Almost every chapter has been updated with new examples and illustrations.