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ADAPTIVE APPROACHES TO LICENSING, HEALTH TECHNOLOGY ASSESSMENT, AND INTRODUCTION OF DRUGS AND DEVICES

Part of: Special Collection - Policy Forums

Published online by Cambridge University Press:  12 June 2014

Don Husereau ,
Chris Henshall  and
Jamil Jivraj
Don Husereau
Affiliation:
Institute of Health Economics; Department of Epidemiology and Community Medicine, University of Ottawa; University for Health Sciences, Medical Informatics, and Technology
Chris Henshall
Affiliation:
Economics Research Group, Brunel University; Health Technology Assessment International Policy Forum
Jamil Jivraj
Affiliation:
Health Technology Assessment International
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Abstract

Background: Adaptive approaches to the introduction of drugs and medical devices involve the use of an evolving evidence base rather than conventional single-point-in-time evaluations as a proposed means to promote patient access to innovation, reduce clinical uncertainty, ensure effectiveness, and improve the health technology development process.

Methods: This report summarizes a Health Technology Assessment International (HTAi) Policy Forum discussion, drawing on presentations from invited experts, discussions among attendees about real-world case examples, and background paper.

Results: For adaptive approaches to be understood, accepted, and implemented, the Forum identified several key issues that must be addressed. These include the need to define the goals of and to set priorities for adaptive approaches; to examine evidence collection approaches; to clarify the roles and responsibilities of stakeholders; to understand the implications of adaptive approaches on current legal and ethical standards; to determine costs of such approaches and how they will be met; and to identify differences in applying adaptive approaches to drugs versus medical devices. The Forum also explored the different implications of adaptive approaches for various stakeholders, including patients, regulators, HTA/coverage bodies, health systems, clinicians, and industry.

Conclusions: A key outcome of the meeting was a clearer understanding of the opportunities and challenges adaptive approaches present. Furthermore, the Forum brought to light the critical importance of recognizing and including a full range of stakeholders as contributors to a shared decision-making model implicit in adaptive pathways in future discussions on, and implementation of, adaptive approaches.

Keywords

Insurancecoverage*Drug Approval/legislation and jurisprudence*Drug approval/methods*Licensure/legislation & jurisprudence*Adaptive approaches
Type
Policies
Information
International Journal of Technology Assessment in Health Care , Volume 30 , Issue 3: Theme: Adaptive Approaches to Licensing , July 2014 , pp. 241 - 249
Copyright
Copyright © Cambridge University Press 2014 

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References

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Husereau Supplementary Material

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