Ebook New health technologies - Managing access, value and sustainability: Part 2
➤ Gửi thông báo lỗi ⚠️ Báo cáo tài liệu vi phạmNội dung chi tiết: Ebook New health technologies - Managing access, value and sustainability: Part 2
Ebook New health technologies - Managing access, value and sustainability: Part 2
New Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2e Paris, Luke Slawomirski and Allison ColbertMedical devices cover a wide range of products of varying complexity and clinical risk Practitioners' aptitude in using medical devices in clinical settings also varies. Regulation, coverage andfunding of devices thus present a considerable challenge for Ebook New health technologies - Managing access, value and sustainability: Part 2policy makers who need to balance the often competing objectives of safety, effectiveness, equity and timely access. Regulatory requirements for medicEbook New health technologies - Managing access, value and sustainability: Part 2
al devices were historically less stringent than those for pharmaceutical products. This chapter examines the current state of play for medical deviceNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2 (determining their inclusion in payment schedules and the reimbursement level for their use). It provides a series of recommendations to improve these aspects of regulatory regimes in OECD countries and other health care systems. The chapter also describes the institutional requirements and policy Ebook New health technologies - Managing access, value and sustainability: Part 2framework needed to enable sound regulatory, coverage and funding decisions. These include governance, information infrastructure and stakeholder invoEbook New health technologies - Managing access, value and sustainability: Part 2
lvement.We thank country delegates and experts, as well as B1AC members, for their comments on earlier versions of this chapter and during the expert New Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2uth Lopert (George Washington University) Stefano Bonacina (Karolinska Institutet) and Inaki Gutierrez Ibarluzea (Osteba).1174. ENSURING TIMELY AND AFFORDABLE ACCESS TO MEDICAL DEVICESInưoductionMedical devices comprise a very broad range 0Í health technologies, from tongue depressors, splints, cann Ebook New health technologies - Managing access, value and sustainability: Part 2ulas and endoscopes, Io artificial organs and other implantable devices, to complex radiological equipment (Box 4.1). More recent examples include mobEbook New health technologies - Managing access, value and sustainability: Part 2
ile applications (apps) and wearables, web-enabled products and biosensors, and in Ultra diagnostics (IVD) permitting clinical intervention based on mNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2 clinical activity in a range of ways, and this interaction is constantly evolving as providers find new uses and applications for existing products. The total number of registered products in the United States and Europe alone exceeds 200 000 (Kirisits and Redekop, 2013).Box 4.1. Definition of medi Ebook New health technologies - Managing access, value and sustainability: Part 2cal deviceA medical device can be defined as "any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended byEbook New health technologies - Managing access, value and sustainability: Part 2
the manufacturer to be used, alone or in combination, for human beings for one or more of tire specific medical purposes of:•Diagnosis, prevention, mNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2r disability;•Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state:•Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations;•And which does not achieve its Ebook New health technologies - Managing access, value and sustainability: Part 2 principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function byEbook New health technologies - Managing access, value and sustainability: Part 2
such means.Products specifically intended for the cleaning, disinfection or sterilisation of medical devices and devices for the purpose of control oNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2|x-:in Ihiiliiimcril and <>l Illi" Council tin Mrdk'iil Drvkxis, and Ainrndin)'Dim-live 20O1/IỈVEC, Rejiulalion (EC) No. 171V2002 and R<-|>ulaliEbook New health technologies - Managing access, value and sustainability: Part 2
and influence health outcomes. As discussed in Chapter 2, diffusion and use of medical technology is an important driver of health care expenditure grNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2nability.118NEW HEALTH TECHNOLOGIES MANAGING ACCESS, VALUE ANO SUSTAINABILITY o OECD 20174. ENSURING TIMELY AND AFFORDABLE ACCESS TO MEDICAL DEVICESIn general terms, a framework for regulating and funding medical devices should aim to balance three core primary objectives:•ensuring that devices are Ebook New health technologies - Managing access, value and sustainability: Part 2clinically safe, performant, and effective where relevant;•facilitating timely and equitable patient access to beneficial health technology; and•ensurEbook New health technologies - Managing access, value and sustainability: Part 2
ing that expenditure on devices produces value to patients and health care systems.Tension can arise between these objectives. Expediency must be balaNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2nnovation, employment, growth, export and trade) may result in tension with goals of managing costs. In addition, each objective will be prioritised differently by stakeholder groups, adding a political dimension to the process. Finally, concepts such as equity are not easily defined empirically.The Ebook New health technologies - Managing access, value and sustainability: Part 2se difficulties, as well as the breadth and inherent complexities of medical devices as a class of health technology, present a unique challenge for pEbook New health technologies - Managing access, value and sustainability: Part 2
olicy makers. Yet the requirements for approval and clinical use of devices are often less strict than those for pharmaceutical products. The current New Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2creasing complexity of medical product supply chains bring this incongruity into focus and are likely to intensify the challenges associated with device regulation and reimbursement in the near future. At the 67th World Health Assembly, delegates agreed that regulatory systems for medical products, Ebook New health technologies - Managing access, value and sustainability: Part 2including devices, need to be strengthened and periodically evaluated (WHO, 2014), and recent literature called for medical device regulation to be boEbook New health technologies - Managing access, value and sustainability: Part 2
lstered (Sorenson and Drummond, 2014; Kirisits and Redekop, 2013; Campillo-Artero, 2013). The WHO subsequently developed a global model for regulatoryNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2on at the time of writing (WHO, 2016).This chapter examines current systems of regulation and funding of medical devices in OECD countries, as well as their advantages and weaknesses, and proposes ways to improve value in the management of medical devices. Section 1 discusses regulation, which inclu Ebook New health technologies - Managing access, value and sustainability: Part 2des marketing authorisation, monitoring, review and post-market evaluation of devices in terms of their safety, effectiveness and performance.SectionEbook New health technologies - Managing access, value and sustainability: Part 2
2 focuses on coverage and funding. Coverage entails decisions by payers on whether the use of a product should be funded. Funding determines how. and New Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2isconnected processes. Rather, scope exists for recognising alignment between the two. Both face similar conceptual and evidentiary challenges. Considerable overlap often arises in the evidence, expertise and deliberations required to make regulatory, coverage and funding decisions, particularly if Ebook New health technologies - Managing access, value and sustainability: Part 2established as a cycle of periodic review. Although a critical approach is needed, resource or information sharing could reduce costs and potential deEbook New health technologies - Managing access, value and sustainability: Part 2
lays associated with medical device regulation and market entry.Section 3 discusses the institutional and contextual requirements necessary for regulaNew Health Technoloóe»: Managing Acceta. Value and Sustainabibty c OECD 2017Chapter 4Ensuring timely and affordable access to medical devicesbyValérie Ebook New health technologies - Managing access, value and sustainability: Part 2 an integrated information infrastructure and of sound public policy fundamentals such as transparency, stakeholder engagement and consultation.NEW HEALTH TECHNOLOGIES MANAGING ACCESS. VALUE AND SUSTAINABILITY o OECD 2017119 Ebook New health technologies - Managing access, value and sustainability: Part 2Gọi ngay
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