The Act On The Reform Of The Market For Medicinal Products Amnog A Question Of Power

Author : Sara Schlenkrich
Publisher : diplom.de
ISBN 13 : 3954898594
Total Pages : 66 pages
Book Rating : 4.96/5 ( download)

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Download or read book The Act on the Reform of the Market for Medicinal Products (AMNOG): A question of power?! written by Sara Schlenkrich and published by diplom.de. This book was released on 2015-02-01 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past, high costs have been incurred in particular by the market launch of new medicinal products. To date, it was not necessary to demonstrate an additional therapeutic benefit. This changed with the Act on the Reform of the Market for Medicinal Products (AMNOG), which entered into force on the 1st of January 2011. It brought about a fundamental change in the balance of power on the pharmaceutical market. This study therefore sets out to answer the following question: What impact does the early benefit assessment in the context of the AMNOG have on the stakeholders of the healthcare system? To answer this question, this survey first presents the theoretical foundations of the law, of the early benefit assessment and the bodies involved. It then takes stock of the decisions taken to date before describing the impact on the selected stakeholders.

Author : Sara Schlenkrich
Publisher : GRIN Verlag
ISBN 13 : 3656766010
Total Pages : 74 pages
Book Rating : 4.18/5 ( download)

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Download or read book The early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products (AMNOG) written by Sara Schlenkrich and published by GRIN Verlag. This book was released on 2014-10-10 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bachelor Thesis from the year 2013 in the subject Health - Miscellaneous, grade: 1,4, Neisse University Görlitz, course: V282129, language: English, abstract: The Act on the Reform of the Market for Medicinal Products, which entered into force on the 1st of January 2011, brought about a fundamental change in the balance of power on the pharmaceutical market. This thesis therefore sets out to answer the following question: What impact does the early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products have on the stakeholders of the healthcare system? To answer this question, this work first presents the theoretical foundations of the law, of the early benefit assessment and the bodies involved. It then takes stock of the decisions taken to date before describing the impact on the selected stakeholders. The following findings were reached: As the representative of the statutory health insurance funds, the Central Federal Association of Statutory Health Insurance Funds has gained in power and now decides, as a member of the Federal Joint Committee, on the added benefit of a drug and, depending on this decision, also on the future reimbursement rate. Pharmaceutical companies, however, are losing clout and must comply with the guidelines and assessments of the early benefit assessment. Patients stand to gain and lose out from the early benefit assessment. They are the ones who are ultimately dependent on the medicinal product and its improvement and benefit from a proven benefit. However, they have no say in the early benefit assessment procedure.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.84/5 ( download)

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Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author :
Publisher : World Health Organization
ISBN 13 : 9240011870
Total Pages : 70 pages
Book Rating : 4.78/5 ( download)

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Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.13/5 ( download)

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Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Author : Lawton R. Burns
Publisher : Cambridge University Press
ISBN 13 : 9780521838986
Total Pages : 400 pages
Book Rating : 4.83/5 ( download)

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Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.

Author : Jeff Elton
Publisher : John Wiley & Sons
ISBN 13 : 111917189X
Total Pages : 288 pages
Book Rating : 4.98/5 ( download)

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Download or read book Healthcare Disrupted written by Jeff Elton and published by John Wiley & Sons. This book was released on 2016-02-08 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: “During a time of tremendous change and uncertainty, Healthcare Disrupted gives executives a framework and language to determine how they will evolve their products, services, and strategies to flourish in a increasingly value-based healthcare system. Using a powerful mix of real world examples and unanswered questions, Elton and O’Riordan lead you to see that ‘no action’ is not an option—and push you to answer the most important question: ‘What is your role in this digitally driven change and how can your firm can gain competitive advantage and lead?’”—David Epstein, Division Head, Novartis Pharmaceuticals “Healthcare Disrupted is an inspirational call-to-action for everyone associated with healthcare, especially the innovators who will develop the next generation of therapeutics, diagnostics, and devices.”—Bob Horvitz, Ph.D., David H. Koch Professor of Biology, MIT; Nobel Prize in Physiology or Medicine “In a time of dizzying change across all fronts: from biology, to delivery, to the use of big data, Health Disrupted captures the impact of these forces and thoughtfully develops new approaches to value creation in the healthcare industry. A must-read for those who strive to capitalize on change and reinvent the industry.”—Deborah Dunsire, M.D., president and CEO, FORUM Pharmaceuticals Healthcare at a Crossroad: Seismic Shifts, New Business Models for Success Healthcare Disrupted is an in-depth look at the disruptive forces driving change in the the healthcare industry and provides guide for defining new operating and business models in response to these profound changes. Based on original research conducted by Accenture and years of experience working with the most successful companies in the industry, healthcare experts Jeff Elton and Anne O’Riordan provide an informed, insightful view of the state of the industry, what's to come, and new emerging business models for life sciences companies play a different role from the past in to driving superior outcomes for patients and playing a bigger role in creating greater value for healthcare overall. Their book explains how critical global healthcare trends are challenging legacy strategies and business models, and examines why historical leaders in the industy must evolve, to stay relevant and compete with new entrants. Healthcare Disrupted captures this pivotal point in time to give executives and senior managers across pharmaceutical, biopharmaceutical, medical device, medical diagnostics, digital technology, and health services companies an opportunity to step back and consider the changing landscape. This book gives companies options for how to adapt and stay relevant and outlines four new business models that can drive sustainable growth and performance. It demonstrates how real-world data (from Electronic Medical Records, health wearables, Internet of Things, digital media, social media, and other sources) is combining with scalable technologies and advanced analytics to fundamentally change how and where healthcare is delivered, bridging to the health of populations, and broadening the resposibility for both. It reveals how this shift in healthcare delivery will significantly improve patient outcomes and the value health systems realize.

Author : Tomasz Burzykowski
Publisher : Springer Science & Business Media
ISBN 13 : 0387270809
Total Pages : 417 pages
Book Rating : 4.07/5 ( download)

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Download or read book The Evaluation of Surrogate Endpoints written by Tomasz Burzykowski and published by Springer Science & Business Media. This book was released on 2005-11-24 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.

Author : P.-J. Proudhon
Publisher : Courier Corporation
ISBN 13 : 048616358X
Total Pages : 304 pages
Book Rating : 4.81/5 ( download)

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Download or read book General Idea of the Revolution in the Nineteenth Century written by P.-J. Proudhon and published by Courier Corporation. This book was released on 2013-01-23 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Influential 1851 work, the basis for later radical and anarchist theory, posits an ideal society in which frontiers are abolished, national states eliminated, and authority decentralized among communes or locality associations.

Author : Lars Schweizer
Publisher : Saint Philip Street Press
ISBN 13 : 9781013277788
Total Pages : 0 pages
Book Rating : 4.83/5 ( download)

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Download or read book Advances in Pharma Business Management and Research written by Lars Schweizer and published by Saint Philip Street Press. This book was released on 2020-10-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master's theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.