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Author: Reza Mahjoub
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Many new and expensive drugs have been introduced in the past 10 years. However, at the time of introduction, the effectiveness of these drugs outside of clinical trials is often unknown. This creates a risk to third-party payers, as the outcome of these drugs in real-world practice is uncertain at the time of introduction. A pay-for-performance risk-sharing agreement is a type of contract that shares part of this risk with the manufacturer by linking the performance of a drug to the manufacturer's revenue. This dissertation consists of three essays to examine the performance of two types of pharmaceutical pay-for-performance risk-sharing agreements. In my first essay I examine the performance of a pay-for-performance risk-sharing agreement in which patients are assessed at some evaluation time to determine their response to the drug. The manufacturer rebates to the payer a proportion of the sales from all patients excluding the sales from those responding at the evaluation time. I model disease progression using a continuous time Markov chain with uncertain transition rates. I address the following questions regarding the performance of this agreement: What is the optimum evaluation time and under what conditions will the manufacturer make a profit? What is the distribution of the manufacturer's profit resulting from different sources of uncertainty? In the second essay I extend the model developed in the first essay to calculate the net monetary benefits of the payer and identify the conditions under which both parties have incentives to introduce the new drug. The third essay focuses on the analysis of a risk-sharing agreement in which patients are prescribed a drug only if their probability of response lies within a range of success probabilities. The payer determines this range such that the use of the drug is cost-effective. I generalize from the existing literature by allowing the rebate to be different from the price of the drug and incorporating two types of administrative costs. I seek to answer two important policy questions: First, under what conditions does the payer benefit from the agreement? Second, under what conditions does the agreement become welfare-improving?
Author: Reza Mahjoub
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Many new and expensive drugs have been introduced in the past 10 years. However, at the time of introduction, the effectiveness of these drugs outside of clinical trials is often unknown. This creates a risk to third-party payers, as the outcome of these drugs in real-world practice is uncertain at the time of introduction. A pay-for-performance risk-sharing agreement is a type of contract that shares part of this risk with the manufacturer by linking the performance of a drug to the manufacturer's revenue. This dissertation consists of three essays to examine the performance of two types of pharmaceutical pay-for-performance risk-sharing agreements. In my first essay I examine the performance of a pay-for-performance risk-sharing agreement in which patients are assessed at some evaluation time to determine their response to the drug. The manufacturer rebates to the payer a proportion of the sales from all patients excluding the sales from those responding at the evaluation time. I model disease progression using a continuous time Markov chain with uncertain transition rates. I address the following questions regarding the performance of this agreement: What is the optimum evaluation time and under what conditions will the manufacturer make a profit? What is the distribution of the manufacturer's profit resulting from different sources of uncertainty? In the second essay I extend the model developed in the first essay to calculate the net monetary benefits of the payer and identify the conditions under which both parties have incentives to introduce the new drug. The third essay focuses on the analysis of a risk-sharing agreement in which patients are prescribed a drug only if their probability of response lies within a range of success probabilities. The payer determines this range such that the use of the drug is cost-effective. I generalize from the existing literature by allowing the rebate to be different from the price of the drug and incorporating two types of administrative costs. I seek to answer two important policy questions: First, under what conditions does the payer benefit from the agreement? Second, under what conditions does the agreement become welfare-improving?
Author: Youyang Gao
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Outsourcing risks problem for the new ethical drugs manufacturing and commercialization is one of the most challenging problems for the pharmaceutical firms due to the big uncertainty of the FDA testing result, fluctuating market performance, changing government and finance environment. Motivated by the need of the ethical drugs risks sharing in the pharmaceutical industry, we are introducing a finite period analysis based on three different types of contracts which distinguished by the level of risk sharing including price discount, quantity flexibility and forecasting methods. These contracts are short term contract, long term time flexible contract and long term time inflexible contract. In order to analyze the performances of risk sharing of those contracts, we use mathematical functions to express the price discount, quantity flexibility and the demand risk and put them into the model of total extra outsourcing cost. By successfully use the concept of the Leibnitz's Rule and newsvendor model, we successfully simplified the problem and classified the level of risk sharing for each contract, and also realized the complexity for those contracts. At the end of this thesis, we use a numerical analysis to give an introduction of how our model could be used in the contract selection. A quantitative solution is followed after that introduction and will select the best contract strategy under certain circumstance. The purpose of this thesis is to generate cost functions for the contracts, and help the firm to select the best contract strategy under different circumstances.
Author:
Publisher: World Health Organization
ISBN: 9240011870
Category : Business & Economics
Languages : en
Pages : 70
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Book Description
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 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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Gerrit Reepmeyer
Publisher: Springer Science & Business Media
ISBN: 9783790816679
Category : Business & Economics
Languages : en
Pages : 316
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Book Description
The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107
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Book Description
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264223576
Category :
Languages : en
Pages : 144
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Book Description
This third edition of Health at a Glance: Europe presents a set of key indicators related to health status, determinants of health, health care resources and activities, quality of care, access to care, and health expenditure and financing in 35 European countries.
Author: Preetanshu Pandey
Publisher: Woodhead Publishing
ISBN: 0081001800
Category : Medical
Languages : en
Pages : 465
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Book Description
The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
