Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective.

INTRODUCTION: The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. AREAS COVERED: The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. EXPERT OPINION: Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.

Evidence-based approach to the introduction of positron emission tomography in ontario, Canada.

PURPOSE: The uptake of new health care technologies is usually driven by industry promotion, physician interest, patient demand, and institutional ability to acquire the technology. The introduction of positron emission tomography (PET) scanning in the province of Ontario, Canada, followed a different path. METHODS: The Ontario provincial government, through its Ministry of Health and Long-Term Care, commissioned a systematic review of the literature. When this found only weak evidence that PET has a positive impact on clinical outcomes, the Ministry introduced a provincial PET evaluation program to close the evidence gap. RESULTS: This article describes the challenges encountered establishing the PET evaluation program. These included the design and conduct of the initial clinical trials, the establishment of a PET cancer registry, standardizing how PET scans were performed and reported, and gaining acceptance by health professionals for the evaluative program. CONCLUSION: The proliferation of health technologies is a key driver of increasing health care costs. The Ontario approach to the introduction of PET is a model worth consideration by health systems seeking to ensure that they receive value for money based on a strong evidentiary base when introducing new health technologies.

Health technology assessment and primary data collection for reducing uncertainty in decision making.

BACKGROUND: Health care expenditures continue to escalate, and pressures for increased spending will continue. Health care decision makers from publicly financed systems, private insurance companies, or even from individual health care institutions, will continue to be faced with making difficult purchasing, access, and reimbursement decisions. As a result, decision makers are increasingly turning to evidence-based platforms to help control costs and make the most efficient use of existing resources. Most tools used to assist with evidence-based decision making focus on clinical outcomes. HEALTH TECHNOLOGY ASSESSMENT: Health technology assessment (HTA) is increasing in popularity because it also considers other factors important for decision making, such as cost, social and ethical values, legal issues, and factors such as the feasibility of implementation. In some jurisdictions, HTAs have also been supplemented with primary data collection to help address uncertainty that may still exist after conducting a traditional HTA. ROLE OF PRIMARY DATA COLLECTION: The HTA process adopted in Ontario, Canada, is unique in that assessments are also made to determine what primary data research should be conducted and what should be collected in these studies. In this article, concerns with the traditional HTA process are discussed, followed by a description of the HTA process that has been established in Ontario, with a particular focus on the data collection program followed by the Programs for Assessment of Technology in Health Research Institute. An illustrative example is used to show how the Ontario HTA process works and the role value of information analyses plays in addressing decision uncertainty, determining research feasibility, and determining study data collection needs.

Health technology assessment: a comprehensive framework for evidence-based recommendations in Ontario.

OBJECTIVES: This study describes the development of a framework for health technology decisions, for Ontario Health Technology Advisory Committee (OHTAC) in Ontario, Canada. METHODS: OHTAC convened a "Decision Determinants Sub-Committee" in January 2007, which undertook a systematic literature review and conducted key informant interviews to develop an explicit decision-making framework. RESULTS: The "Decision Determinants Sub-Committee" offered recommendations about decision criteria, and the process by which decisions are made. Decision criteria include (i) overall clinical benefit, (ii) consistency with societal and ethical values, (iii) value for money, and (iv) feasibility of adoption into the health system. The decision process should be transparent and fair and should use a deliberative process in delivering recommendations. CONCLUSIONS: This methodology is currently being pilot tested in a live environment: OHTAC. It will be evaluated and revised according to its feasibility, acceptability, and perceived usefulness.