Access

A practical guide to market access for pharmaceutical products. It is aimed both at students and specialists, providing the reader with guidance to plan for market access success by clinical development stage.

180 pages
Publisher: Routledge
ISBN13: 9798987940808

The book is divided into eight chapters that covers key aspects of pharmaceutical market access in emerging markets. From understanding the healthcare environment, to the personal and organizational mindset, to pricing, market access solutions and negotiations. The book is based on practical experience that gives the reader knowledge and know-how to apply practical market access solutions to improve access to innovative medicine in emerging markets.

118 pages
Publisher: Passionpreneur Publishing
ISBN13: 9781922456328

Die pharmazeutische Industrie steht im deutschen Gesundheitswesen häufig im Mittelpunkt kontroverser Kostendiskussionen. Als Resultat zielten die Maßnamen der Gesundheitspolitik in den letzten Jahren vorrangig auf (Kosten-)regulierungen der Arzneimittelindustrie ab, deren bisheriger Höhepunkt die Einführung des AMNOG im Jahr 2011 darstellte. Die bis dato freie Preisbildung wurde abgelöst durch ein zweistufiges Verfahren bestehend aus Nutzenbewertung und Preisverhandlung. Diese gravierenden Veränderungen der gesetzlichen Rahmenbedingungen für die Arzneimittelindustrie hatten einen erheblichen Bedeutungszuwachs des Themas Market Access zur Folge. Die Motivation zur Erstellung des Buches ist es, eine Publikation zu schaffen, die nicht nur den aktuellen Status widerspiegelt, sondern vielmehr auch die wesentlichen Instrumente und Verfahrensweisen aufzeigt und auch kritisch hinterfragt. Der Leser soll so einen Einblick in die Materie als auch nötiges Rüstzeug bei der konkreten Umsetzung erlangen. Das Buch dient dazu, Market Access Managern oder Interessierten fundiertes Hintergrundwissen zu vermitteln.

The pharmaceutical industry is often at the centre of controversial cost discussions in the German healthcare system. As a result, healthcare policy measures in recent years have primarily been aimed at (cost) regulation of the pharmaceutical industry, the high point of which to date was the introduction of the AMNOG in 2011. The previously free pricing process was replaced by a two-stage process consisting of benefit assessment and price negotiation. These serious changes to the legal framework for the pharmaceutical industry have resulted in a significant increase in the importance of the topic of market access. The motivation for creating the book is to create a publication that not only reflects the current status, but also shows the key instruments and procedures and also critically questions them. The reader should thus gain an insight into the subject matter and the necessary tools for concrete implementation. The book is intended to provide market access managers or interested parties with sound background knowledge.

535 pages
Publisher: Springer Gabler
ISBN13: 9783658261443

Idóneo para profesionales RIMA, de Marketing Farmacéutico, KAM, Delegados…
La comercialización de un medicamento, de un dispositivo o equipamiento médico o de cualquier producto financiado, debe tener en cuenta, incluso antes de su concepción, a los gestores sanitarios. Y los debe incorporar de forma obligatoria en todos los planes, también en el plan de marketing, a través del plan de acceso y Relaciones Institucionales. El marketing farmacéutico de estos productos no puede entenderse sin una gestión integrada de Market Access, que incluye a los ya no tan nuevos clientes, a la administración sanitaria y a los gestores.
Destinado a los profesionales que se dedican a ejercer su labor en este ámbito profesional, a los marketers farmacéuticos y a todos los profesionales vinculados de forma directa o indirecta con el sector de la salud, este es un libro pionero y de referencia para dicho sector cuyo objetivo es recopilar todo lo que debe saber sobre Market Access y Relaciones Institucionales.

Suitable for RIMA professionals, Pharmaceutical Marketing professionals, KAM, Delegates…
The marketing of a medicine, a medical device or equipment or any funded product must take into account, even before its conception, the health managers. And they must be incorporated in a mandatory manner in all plans, also in the marketing plan, through the access plan and Institutional Relations. The pharmaceutical marketing of these products cannot be understood without an integrated management of Market Access, which includes the no longer so new clients, the health administration and the managers.
Intended for professionals who are dedicated to carrying out their work in this professional field, pharmaceutical marketers and all professionals directly or indirectly linked to the health sector, this is a pioneering and reference book for said sector whose objective is to compile everything you need to know about Market Access and Institutional Relations.

896 pages
Publisher: Profit Editorial
ISBN13: 9788417942328

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University.

204 pages
Publisher: CRC Press
ISBN13: 9781138032187

Digital healthcare is heterogeneous along the entire treatment pathway, ranging from monitoring applications and artificial-intelligence-based diagnostics, to support for virtual reality surgery. Since the introduction of the Digital Health Act in Germany in early 2020, there has been a push toward digital innovative solutions, especially in the outpatient sector. 

This book analyzes current digital health law from an economic perspective, combining theory with real-world applications. It examines both the incentives and market access pathways for digital solutions and the price effects brought about by the new regulatory framework in Germany. Further, it discusses the difficulties in pricing due to the monopolistic BfArM register and negotiations with the association of all German health insurance companies. 

The book addresses a wide range of topics, including incentives for innovation, specifics of digital health applications, reimbursement and financing optionsfor digital health solutions. Lastly, it presents an outlook for the future and a comparison between Germany and other countries, namely the USA and Japan. Given its scope, this book will appeal to scholars of health economics, healthcare management and public health, as well as practitioners and professionals in the public health sector.

116 pages
Publisher: Springer
ISBN13: 9783030940270

Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice is a brand new publication that provides a uniquely comprehensive examination of the legal and business considerations relating to drug and device manufacturing and distribution, including market access, pricing, reimbursement, and promotion.

Each chapter provides a strong foundation for understanding medical product market access, as well as advanced topics for readers who have been practicing in the pharmaceutical and device industry for many years.

The treatise has been drafted with both new and experienced market access practitioners in mind. Although written through a lens of advising life sciences companies engaging in market access activities, Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice will also prove useful to stakeholders across the medical product supply chain—from manufacturers to distributors to payers to health care providers to government regulators—and the numerous additional entities that facilitate access to and distribution of medical products.

Note: addresses the US market exclusively.

366 pages
Publisher: AHLA
ISBN13: 9781663347893

A comprehensive review of the challenges that exist in patient accessibility to regenerative medicines (RMs), presenting clinical trials, marketing authorization, HTA, pricing, reimbursement, affordability, payment and partnership agreements of RMs and commercialization. Specfically, we investigated how COVID-19 has impacted the RM industry by elaborating on the disruptions it caused but also the new opportunities it brought. The ultimate goal of this work is to make strategic recommendations for manufacturers and decisions-makers on effective strategies to address the above obstacles and facilitate patient access to promising regenerative medicines.

250 pages
Publisher: CRC Press
ISBN13: 9781032431987

Are you fit for the new rules in Europe? The new EU regulations on medical devices and in vitro diagnostic medical devices (IVDs) are changing the rules of the game in this important area of health care. It is now necessary to adapt quickly to the new and more demanding rules on market access in Europe. This requires a thorough knowledge of the new rules for all those responsible and employed in the sector. A sound knowledge of the new EU regulations is also indispensable for the education, training and further education of students, and for staff in research and development, in regulatory affairs and quality management. For all those who are active and responsible in the field of medical technology, biomedical and clinical engineering, e-health and related fields. The new 3rd edition gives the latest stage of regulatory corrigenda, amendments and EU-target dates and reflects the latest Guidance documents of EU on this. Don't be late: those that fail to prepare - prepare to fail! 

336 pages
Publisher: Books on Demand
ISBN13: 9783753476858

The major advances in the field of biotechnology and molecular biology in the twenty-first century have led to a better understanding of the pathophysiology of diseases. A new generation of biopharmaceuticals has emerged, including a wide and heterogeneous range of innovative cell and gene therapies. These therapies aim to prevent or treat chronic and serious life-threatening diseases, previously considered incurable. This book describes the evolution and adaptation of the regulatory environment to assess these therapies in contrast with the resistance of health technology assessment (HTA) agencies and payers to acknowledge the specificity of cell and gene therapies and the need to adapt existing decision-making frameworks. This book provides insights on the learnings from the experience of current cell and gene therapies (regulatory approval, HTA, and market access), in addition to future trends to enhance patient access to these therapies.

146 pages
Publisher: CRC Press
ISBN13: 9780367408091

Der Marktzugang von Medizinprodukten wird zunehmend komplexer. Einerseits werden Produkte technisch immer anspruchsvoller, andererseits wandeln sich die nationalen und internationalen Regulierungen zur Zulassung kontinuierlich. Zu einem erfolgreichen Marktzugang gehört neben der Zulassung aber auch die Erstattungsfähigkeit durch die gesetzliche Krankenversicherung. Dieses Buch hat daher den Anspruch, praktische Hinweise zur Zulassung und Erstattung für Ihre Marktzugangsstrategien zu geben.

Market access for medical devices is becoming increasingly complex. On the one hand, products are becoming more and more technically sophisticated, and on the other, national and international regulations on approval are constantly changing. In addition to approval, successful market access also requires reimbursement by statutory health insurance. This book therefore aims to provide practical advice on approval and reimbursement for your market access strategies.

303 pages
Publisher: Springer Gabler
ISBN13: 9783658234751

Market access is the process by which a pharmaceutical company gets its product available on the market after having obtained a marketing authorization from a regulatory agency and by which the product becomes available for all patients for whom it is indicated as per its marketing authorization.

It covers a group of activities intended to provide access to the appropriate medicine for the appropriate group of patients at the appropriate price (in most countries). Market Access may also be seen as activities that support the management of potential barriers, such as non-optimal price and reimbursement levels, the restriction of the scope of prescribing for the drug or complicated prescription writing or funding procedures.

Since there are cultural differences among countries, any Market Access strategy needs to be culturally sensitive.

Pharmaceutical Market Access in emerging markets has been extensively discussed in our previous book, published in 2016. The present book focuses on developed markets with the goal of helping students, academics, industry personnel, government workers, and decision makers understand the environment in developed markets.

Note: this is an open book and can be downloaded free of charge - click here.

326 pages
Publisher: SEEd
ISBN13: 9788897419747

The definition of Market Access was first reported by the World Trade Organization as “to open markets for trade and improve transparency, reciprocity, and non-discrimination in international trade”. Pharmaceutical Market Access is different and it could be defined as achieving the optimal price for a product or service and/or the maximum reimbursement for the approved target population with no restrictions on funding for the medical technology. By the way, Market Access is not only the market authorization, but it also includes overlapping activities like pricing, health technology assessment, formulary, and reimbursement. Market Access is one of the most important activities for pharmaceutical companies and emerging countries represent an important opportunity for launching new products. It was reported that the Compounded Average Growth Rate (CAGR) was 6.0% in the period 2011-2017, and expected sales exceeding 1.1 trillion USD by 2017 for emerging countries. Furthermore, CAGR 2008-2012 for recently launched pharmaceuticals were 9.8% for emerging countries and 1.5% for the top 8 developed countries. The Market Access processes in the most important emerging countries in the selected regions are defined in this book with the aim to help local experts, local government officers, headquarter managements, and everyone who want to learn more about healthcare system and health policies pathways of Market Access, mapping and structure of decision makers, challenges and catalyzers for Market Access in the emerging countries.

238 pages
Publishers: SEEd
ISBN13: 9781973307570