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.

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.

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.

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.

“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.

The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.